WO2011043996A1 - Verifying, via radio-frequency identification, completeness of a sample analysis in a chemical analytical procedure - Google Patents

Verifying, via radio-frequency identification, completeness of a sample analysis in a chemical analytical procedure Download PDF

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Publication number
WO2011043996A1
WO2011043996A1 PCT/US2010/051126 US2010051126W WO2011043996A1 WO 2011043996 A1 WO2011043996 A1 WO 2011043996A1 US 2010051126 W US2010051126 W US 2010051126W WO 2011043996 A1 WO2011043996 A1 WO 2011043996A1
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Prior art keywords
steps
radio
analytical procedure
frequency identification
computing device
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PCT/US2010/051126
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French (fr)
Inventor
James T. Posillico
Pieter Roos
Michael Kagan
John Fralick
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Molecular Biometrics, Inc.
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Application filed by Molecular Biometrics, Inc. filed Critical Molecular Biometrics, Inc.
Publication of WO2011043996A1 publication Critical patent/WO2011043996A1/en

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    • HELECTRICITY
    • H04ELECTRIC COMMUNICATION TECHNIQUE
    • H04QSELECTING
    • H04Q9/00Arrangements in telecontrol or telemetry systems for selectively calling a substation from a main station, in which substation desired apparatus is selected for applying a control signal thereto or for obtaining measured values therefrom
    • HELECTRICITY
    • H04ELECTRIC COMMUNICATION TECHNIQUE
    • H04QSELECTING
    • H04Q2209/00Arrangements in telecontrol or telemetry systems
    • H04Q2209/40Arrangements in telecontrol or telemetry systems using a wireless architecture
    • H04Q2209/47Arrangements in telecontrol or telemetry systems using a wireless architecture using RFID associated with sensors

Definitions

  • Systems for performing chemical analytical procedures typically include an analysis of both the item to be subjected to the analysis as well as an analysis of a control sample with which to account for variability in equipment.
  • conventional environments for performing chemical analytical procedures of samples - such as, for example, spectral analyses of samples - do not typically provide functionality for automatically verifying how much of a procedure has been completed or that portions or steps of the procedure have been completed in a particular order.
  • conventional systems typically provide functionality for preventing completion of a portion of the procedure before pre -requisite steps have been completed.
  • the present disclosure relates to methods and systems for verifying completeness of chemical analytical procedures.
  • the present disclosure relates to methods and systems for verifying, via a radio-frequency identification tag, completeness of an analysis of a sample in a chemical analytical procedure.
  • a method for verifying, via a radio-frequency identification tag, completeness of an analysis of a sample in a chemical analytical procedure includes storing, by a radio-frequency identification tag, an indication of completion of at least one of a plurality of steps in a chemical analytical procedure.
  • a computing device receives a request for initiation of a subsequent step in the plurality of steps in the chemical analytical procedure.
  • the computing device requests from the radio-frequency identification tag, an identification of a number of completed steps in the plurality of steps in the chemical analytical procedure.
  • the computing device authorizes initiation of the subsequent step in the plurality of steps in the chemical analytical procedure, responsive to receiving the identification of the number of completed steps in the plurality of steps.
  • these may include chromatography (e.g., HPLC or TLC), mass spectroscopy, electrochemical analysis, nuclear magnetic resonance spectroscopy (NMR), fluorescence spectroscopy, refractive index spectroscopy (RI), ultraviolet spectroscopy (UV), infrared spectroscopy (IR) (e.g., near-infrared spectroscopy or Fourier transform infrared spectroscopy), Raman spectroscopy, radiochemical analysis, an immunoassay, Light Scattering analysis (LS), etc. and any combination thereof.
  • chromatography e.g., HPLC or TLC
  • mass spectroscopy electrochemical analysis
  • fluorescence spectroscopy e.g., refractive index spectroscopy (RI), ultraviolet spectroscopy (UV), infrared spectroscopy (IR) (e.g., near-infrared spectroscopy or Fourier transform infrared spectroscopy), Raman spect
  • the chemical analytical procedure is executed as part of a medical diagnostic or prognostic procedure.
  • U.S. Patent Publication No. 20070054347 describes methods and systems which employ spectral analysis of certain fluids in order to make diagnostic and prognostic predictions about various oxidative stress dependent diseases, including neurodegenerative diseases.
  • a correlation is initially established between a particular diagnosis or prognosis and spectra of a fluid obtained using a chosen analytical modality for a population of patients with known diagnosis or prognosis.
  • a spectrum of the relevant fluid is obtained using the chosen modality.
  • the diagnosis or prognosis for the patient is then predicted using the acquired spectrum and the established correlation.
  • the spectral analysis is performed using magnetic resonance (e.g., NMR). In some embodiments, the spectral analysis is performed using mass spectroscopy. In some embodiments, the procedure may involve prognostic predictions (e.g., predicting the likelihood that a patient will respond to a particular type of therapy). It is to be understood that these methods may also be applied outside the realm of neurodegenerative diseases.
  • prognostic predictions e.g., predicting the likelihood that a patient will respond to a particular type of therapy. It is to be understood that these methods may also be applied outside the realm of neurodegenerative diseases.
  • U.S. Patent Publication No. 20060247536 describes methods and systems which employ spectral analysis of amniotic fluid in order to make predictions about the health of a mother and her fetus during pregnancy. Thus, in some embodiments, spectral analysis of amniotic fluid may be used to make predictions about fetal growth and the likely birth weight of the infant.
  • the radio-frequency identification tag 102 stores an indication of completion of at least one of a plurality of steps in a chemical analytical procedure.
  • the RFID tag 102 includes a circuit for storing information.
  • the RFID tag 102 includes an antenna for transmitting information.
  • the RFID tag 102 is an active tag, including a power source.
  • the RFID tag 102 is a passive tag and does not require a power source.
  • the receiver 106 may receive, from a computing device 100 or RFID reader 116, a request for data stored in a storage element 104 and the transmitter 108 may send a response to the requesting device including a copy of data retrieved from the storage element 104.
  • a single transceiver on the RFID tag 102 provides both receiving and transmitting functionality.
  • the RFID tag 102 is referred to as a promiscuous tag.
  • an active RFID tag 102 is attached to a sample 122.
  • an RFID tag 102 collecting and storing measurements of environmental conditions is attached to a case or vehicle storing the sample 122 and an identification of the RFID tag 102 is attached to the sample 122; for example, the sample 122 may include an identification number of the RFID tag 102 attached to a case or vehicle, the identification number printed on the sample 122 or encoded by a bar code that is on the sample 122.
  • a plurality of active RFID tags 102 is used.
  • the RFID tag 102 includes a storage element 104.
  • the storage element 104 stores an identification of a sample to which the RFID tag 102 is attached.
  • the storage element 104 stores an indication of completion of at least one of a plurality of steps in a chemical analytical procedure.
  • the storage element 104 includes memory to which a user may write data; the memory may be protected by password, or other security mechanism, to prevent unauthorized modification.
  • a computer chip embedded in a housing such as that provided by Maxim Integrated Products, Inc., of Sunnyvale, CA, stores the information instead of or in addition to an RFID tag 102.
  • a sample cell 122 has a cylindrical shape and has at least one window and at least one feed conduits at each end; light is propagating along the axial direction of the cylindrical shape through at least one end window, and the cylindrical shape has an axial length sufficient to allow analysis of the sample through an end window, and the sample cell is capable of holding a volume of fluid sample in a bubble free manner.
  • the term "cylindrical" is intended to mean that the shape is elongated having two ends being parallel to one another and delimiting its length alone an elongated axis and each of the end being joined together by a curved surface generated by a straight line moving along a curve while being substantially perpendicular to the end surfaces.
  • a flow cell device 122 has a feed conduit adapted to facilitate the trapping of air bubbles as a result of the action of fluid flow in the feed conduit.
  • a manufacturer generates the RFID tag 102 and stores, in the storage element 104, an identifier of the RFID tag 102. In one of these embodiments, the manufacturer generates the RFID tag 102 and stores, in the storage element 104, an identifier associating the RFID tag 102 with the manufacturer.
  • the computing device 100 includes functionality for associating the RFID tag 102 with a sample cell identifier. In one of these embodiments, for example, the computing device 100 executes an application allowing a user to generate an identifier associating the RFID tag 102 with a sample cell identifier.
  • the application 110 includes the receiver.
  • the authorization component 114 includes functionality for determining whether to authorize a use of the chemical analysis component 120 requested by a user via the application 110. In another embodiment, the authorization component 114 includes functionality for determining, responsive to information received from the radio- frequency identification tag 102, that at least one of the plurality of steps in the chemical analytical procedure is complete. In still another embodiment, the authorization component 114 includes functionality for determining, responsive to information received from the radio-frequency identification tag 102, that at least one of the plurality of steps in the chemical analytical procedure is incomplete. In still even another embodiment, the authorization component 114 includes functionality for determining, responsive to information received from the radio-frequency identification tag 102, that a sample cell 122 previously underwent spectral analysis. In yet another embodiment, the authorization component 114 includes a policy engine comparing data retrieved from the RFID tag 102 with rules for determining whether to authorize use of the chemical analysis component 120.
  • the authorization component 114 includes functionality for authorizing initiation of the subsequent step in the plurality of steps in the chemical analytical procedure, responsive to confirming an association between the radio-frequency identification tag and a control sample. In still even another embodiment, the authorization component 114 includes functionality for authorizing initiation of the subsequent step in the plurality of steps in the chemical analytical procedure, responsive to confirming an association between the radio- frequency identification tag and a test sample. In yet another embodiment, the authorization component 114 includes functionality for preventing initiation of the subsequent step in the plurality of steps in the chemical analytical procedure, responsive to receiving an indication of completion of the at least one of the plurality of steps.
  • a radio-frequency identification tag stores an indication of completion of at least one of a plurality of steps in a chemical analytical procedure (202).
  • the radio-frequency identification tag 102 stores an indication of completion of an analysis of a sample.
  • the radio-frequency identification tag 102 stores an indication of completion of an analysis of a test sample.
  • the radio-frequency identification tag 102 stores an indication of completion of an analysis of a control sample.
  • the radio-frequency identification tag 102 stores an indication of completion of a pre-analysis step; for example, a step such as a temperature control step described in greater detail below may be completed prior to a step in a chemical analytical procedure.
  • the radio-frequency identification tag 102 stores an indication of completion of a temperature control process; for example, the RFID tag 102 may store an indication received from an RFID reader/writer 116 in communication with a temperature control component.
  • the radio-freauencv identification tag 102 stores an indication that a temperature of the sample cell 122 has stabilized; for example, an RFID writer in communication with a temperature control component modifying a temperature of the sample cell 122 may store in the RFID tag 102 an indication that the sample cell 122 has reached a certain temperature.
  • the plurality of steps in the chemical analytical procedure includes an analysis of sperm. In yet another embodiment, the plurality of steps in the chemical analytical procedure includes an analysis of a test sample in which an embryo (or oocyte) developed.
  • the plurality of steps in the chemical analytical procedure includes an analysis of a test sample. In another embodiment, the plurality of steps in the chemical analytical procedure includes an analysis of a control sample. In still another embodiment, completion of a step in the plurality of steps includes transmission of an indication of completion of the step for storage by the RFID tag 102.
  • the RFID tag 102 stores an indication of a type of sample cell 122 with which the RFID tag 102 is associated. In another embodiment, the RFID tag
  • the RFID tag 102 stores an identification of a type of anti-counterfeiting mechanism with which the RFID tag 102 has been programmed.
  • the RFID tag 102 may store a value of "0" in an anti-counterfeiting field to indicate that no anti- counterfeiting mechanism is in place; alternatively, the RFID tag 102 may store a non-zero value in the anti-counterfeiting field to identify a type of anti-counterfeiting mechanism employed by the RFID tag 102.
  • anti-counterfeiting mechanism may include mechanisms employing checksums derived from a unique identifier of the RFID tag 102, or other mechanisms known in the art.
  • the RFID tag 102 may store data used to authenticate the RFID tag 102 and prevent counterfeiting; for example, the RFID tag 102 may store a checksum derived from a unique identifier of the RFID tag 102.
  • a user of the computing device 100 interacting with the user interface 112 may request initiation of the subsequent step and the application 110, receiving the request from a user interface element in the user interface 112, may transmit a request for authorization to the authorization component 114.
  • the computing device requests from the radio-frequency identification tag, an identification of a number of completed steps in the plurality of steps in the chemical analytical procedure (206).
  • the authorization component 114 transmits a request to the RFID tag 102 for an identification of a number of completed steps in the plurality of steps in the chemical analytical procedure.
  • the authorization component 114 transmits the request to the RFID reader 116 for transmission to the RFID tag 102.
  • the RFID reader 116 retrieves the
  • the authorization component 114 may access a data structure associating a first patient identifier with an identifier of a first sample 122, while the RFID tag 102 stores an association between a second patient identifier and the first identifier of the sample 122, or of the first patient identifier with an identifier of a second sample 122b, or of a second patient identifier and an identifier of a second sample 122b.
  • the authorization component 114 may prevent performance of additional steps in the chemical analytical procedure and alert a user of the system as to a possible error.
  • the authorization component 114 accesses a data structure (such as a table, database or other data structure stored on or accessible by the computing device 100) stores information such as, by way of example, and without limitation, the following:
  • identification tag 102 allows for a level of process control not readily available in most diagnostic systems.
  • FIG. 3B depicts an embodiment in which the main processor 321
  • I/O device 330a-330n may be present in the computing device 100.
  • Input devices include keyboards, mice, trackpads, trackballs, microphones, and drawing tablets.
  • Output devices include video displays, speakers, inkjet printers, laser printers, and dye-sublimation printers.
  • the I/O devices may be controlled by an I/O controller 323 as shown in FIG. 3A.
  • the computing device 100 can be any workstation, desktop computer, laptop or notebook computer, server, handheld computer, mobile telephone or other portable telecommunication device, media playing device, a gaming system, mobile computing device, or any other type and/or form of computing, telecommunications or media device that is capable of communication and that has sufficient processor power and memory capacity to perform the operations described herein.
  • the network environment comprises one or more clients 302a- 302n (also generally referred to as local machine(s) 302, client(s) 302, client node(s) 302, client machine(s) 302, client computer(s) 302, client device(s) 302, endpoint(s) 302, or endpoint node(s) 302) in communication with one or more remote machines 306a-306n (also generally referred to as server(s) 306 or remote machine(s) 306) via one or more networks 304.
  • clients 302a- 302n also generally referred to as local machine(s) 302, client(s) 302, client node(s) 302, client machine(s) 302, client computer(s) 302, client device(s) 302, endpoint(s) 302, or endpoint node(s) 302
  • remote machines 306a-306n also generally referred to as server(s) 306 or remote machine(s) 306
  • the system may include multiple, logically-grouped remote machines 306.
  • the logical group of remote machines may be referred to as a server farm 38.
  • the remote machines 306 may be geographically dispersed.
  • a server farm 38 may be administered as a single entity.
  • the server farm 38 comprises a plurality of server farms 38.
  • the remote machines 306 within each server farm 38 can be heterogeneous - one or more of the remote machines 306 can operate according to one type of operating system platform (e.g., WINDOWS NT, WINDOWS 2003, WINDOWS 2008, manufactured by Microsoft Corp. of Redmond, Washington), while one or more of the other remote machines 306 can operate on according to another type of operating system platform (e.g., Unix or Linux).
  • operating system platform e.g., WINDOWS NT, WINDOWS 2003, WINDOWS 2008
  • the article of manufacture may be a flash memory card or a magnetic tape.
  • the article of manufacture includes hardware logic as well as software or programmable code embedded in a computer readable medium that is executed by a processor.
  • the computer-readable programs may be implemented in any programming language, such as LISP, PERL, C, C++, C#, PROLOG, or in any byte code language such as JAVA.
  • the software programs may be stored on or in one or more articles of manufacture as object code.

Abstract

A method for verifying, via a radio-frequency identification tag, completeness of an analysis of a sample in a chemical analytical procedure, includes storing, by a radio-frequency identification tag, an indication of completion of at least one of a plurality of steps in a chemical analytical procedure. A computing device receives a request for initiation of a subsequent step in the plurality of steps in the chemical analytical procedure. The computing device requests from the radio-frequency identification tag, an identification of a number of completed steps in the plurality of steps in the chemical analytical procedure. The computing device authorizes initiation of the subsequent step in the plurality of steps in the chemical analytical procedure, responsive to receiving the identification of the number of completed steps in the plurality of steps in the chemical analytical procedure.

Description

VERIFYING, VIA RADIO-FREQUENCY IDENTIFICATION, COMPLETENESS OF A SAMPLE ANALYSIS IN A CHEMICAL ANALYTICAL PROCEDURE
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to United States Provisional Patent
Application serial number 61/249,077 filed on October 6, 2009, the entire contents of which are hereby incorporated by reference.
BACKGROUND
[0002] Conventional medical diagnostic devices are regulated and subject to agency review. Medical devices typically also undergo formal risk analysis to show that the device is safe and effective for use in the hands of customers. One of the foremost risks is an operator not following protocol. Typically, however, this cannot be monitored entirely. Operator compliance may generate large risks, especially if the quality of the result depends upon operator compliance.
[0003] Systems for performing chemical analytical procedures typically include an analysis of both the item to be subjected to the analysis as well as an analysis of a control sample with which to account for variability in equipment. However, conventional environments for performing chemical analytical procedures of samples - such as, for example, spectral analyses of samples - do not typically provide functionality for automatically verifying how much of a procedure has been completed or that portions or steps of the procedure have been completed in a particular order. Nor do conventional systems typically provide functionality for preventing completion of a portion of the procedure before pre -requisite steps have been completed. FIELD
[0004] The present disclosure relates to methods and systems for verifying completeness of chemical analytical procedures. In particular, the present disclosure relates to methods and systems for verifying, via a radio-frequency identification tag, completeness of an analysis of a sample in a chemical analytical procedure.
SUMMARY
[0005] In one aspect, a method for verifying, via a radio-frequency identification tag, completeness of an analysis of a sample in a chemical analytical procedure, includes storing, by a radio-frequency identification tag, an indication of completion of at least one of a plurality of steps in a chemical analytical procedure. A computing device receives a request for initiation of a subsequent step in the plurality of steps in the chemical analytical procedure. The computing device requests from the radio-frequency identification tag, an identification of a number of completed steps in the plurality of steps in the chemical analytical procedure. The computing device authorizes initiation of the subsequent step in the plurality of steps in the chemical analytical procedure, responsive to receiving the identification of the number of completed steps in the plurality of steps.
[0006] In another aspect, a system for verifying, via a radio-frequency identification tag, completeness of an analysis of a sample in a chemical analytical procedure includes a radio-frequency identification tag and a computing device. The radio-frequency
identification tag stores an indication of completion of at least one of a plurality of steps in a chemical analytical procedure. The computing device receives a request for initiation of a subsequent step in the plurality of steps in the chemical analytical procedure. The computing device requests, from the radio-frequency identification tag, an identification of a number of completed steps in the plurality of steps in the chemical analytical procedure. The computing device authorizes initiation of the subsequent step in the plurality of steps in the chemical analytical procedure, responsive to receiving the identification of the number of completed steps in the plurality of steps.
BRIEF DESCRIPTION OF THE DRAWINGS
[0007] The foregoing and other objects, aspects, features, and advantages of the disclosure will become more apparent and better understood by referring to the following description taken in conjunction with the accompanying drawings, in which:
[0008] FIG. 1 is a block diagram depicting one embodiment of a system for verifying, via a radio-frequency identification tag, completeness of an analysis of a sample in a chemical analytical procedure;
[0009] FIG. 2 is a flow diagram depicting one embodiment of a method for verifying, via a radio-frequency identification tag, completeness of an analysis of a sample in a chemical analytical procedure;
[0010] FIGs. 3A-3B are block diagrams depicting embodiments of computers useful in connection with the methods and systems described herein; and
[0011] FIG. 3C is a block diagram depicting an embodiment of a network
environment comprising local machines in communication with remote machines.
DETAILED DESCRIPTION OF VARIOUS EMBODIMENTS
[0012] The present disclosure refers to published documents including certain published patent applications. The entire contents of each of these documents are
incorporated herein by reference.
[0013] Referring now to FIG. 1, a block diagram depicts one embodiment of a system for verifying, via a radio-frequency identification tag, completeness of an analysis of a sample in a chemical analytical procedure. In brief overview, the system includes a computing device 100 and a radio frequency identification tag 102. The radio frequency identification tag 102 includes a storage element 104, a receiver 106, and a transmitter 108. The computing device 100 includes an application 110, a user interface 112, and an authorization component 114. The computing device 100 may be in communication with a radio frequency identification reader 116. The radio frequency identification reader 116 may be in communication with a chemical analysis component 120. The radio frequency identification reader 116 may be in communication with the radio frequency identification tag 102. The radio frequency identification tag 102 may be associated with a sample 122.
[0014] In some embodiments, a system for verifying completeness of an analysis of a sample in a chemical analytical procedure - such as, by way of example, a spectral analysis - provides functionality for determining whether one or more steps in a chemical analytical procedure have been completed before authorizing execution of subsequent steps. In one of these embodiments, for example, by determining a number or type of analyses completed, by a chemical analysis component 120, on a substance for analysis (such as the contents of the sample 122), as identified by a radio frequency identification tag 102, a computing device can determine whether to authorize or to prevent subsequent analyses. In another of these embodiments, prevention of subsequent analyses in environments in which a pre-requisite step has not been completed may result in an improvement to the quality of the chemical analytical procedure.
[0015] In some embodiments, the chemical analytical procedure may involve the compositional analysis of one or more samples (e.g., a control sample, a test sample, a fraction of a test sample obtained by chromatographic separation). In general, compositional analysis involves identifying specific molecular markers within a sample. It is to be understood that these methods do not necessarily require the identity of the marker to be known (e.g., in some embodiments, a marker may be identified based on the presence of characteristic peaks in a chromatograph or mass spectrum without determining the identity of the marker). It will be appreciated that, a compositional analysis may be performed using any known technique that is capable of identifying the marker(s) in question. For example, these may include chromatography (e.g., HPLC or TLC), mass spectroscopy, electrochemical analysis, nuclear magnetic resonance spectroscopy (NMR), fluorescence spectroscopy, refractive index spectroscopy (RI), ultraviolet spectroscopy (UV), infrared spectroscopy (IR) (e.g., near-infrared spectroscopy or Fourier transform infrared spectroscopy), Raman spectroscopy, radiochemical analysis, an immunoassay, Light Scattering analysis (LS), etc. and any combination thereof. In particular, in some embodiments, a chromatographic technique such as HPLC may be combined with one or more of mass spectroscopy, electrochemical analysis, NMR spectroscopy, fluorescence spectroscopy, RI spectroscopy, UV spectroscopy, IR spectroscopy, Raman spectroscopy, radiochemical analysis, an immunoassay, and LS analysis. In some embodiments, the chemical analytical procedure may involve two or more different compositional analyses (e.g., using two or more different techniques for identifying the marker(s) of interest.
[0016] In some embodiments, the chemical analytical procedure may involve the spectral analysis of one or more samples (e.g., a control sample, a test sample, a fraction of a test sample obtained by chromatographic separation). In general, spectral analysis involves making correlations based on spectra of samples without necessarily identifying the specific molecules that are responsible for spectral features in a given sample. In some embodiments, correlations may be made using information from an entire spectrum. In some embodiments, correlations may be made using information from one or more regions of a spectrum (e.g., one or more wavelength regions in a spectrum, one or more wavelengths in a spectrum, etc.). It will be appreciated that, a spectral analysis may be performed using any known technique that is capable of producing a spectrum of the sample in question. For example, these may include chromatography (e.g., HPLC or TLC), mass spectroscopy, nuclear magnetic resonance spectroscopy (NMR), fluorescence spectroscopy, refractive index spectroscopy (RI), ultraviolet spectroscopy (UV), infrared spectroscopy (IR) (e.g., near-infrared spectroscopy or Fourier transform infrared spectroscopy), Raman spectroscopy, etc. and any combination thereof. In particular, in some embodiments, a chromatographic technique such as HPLC may be combined with one or more of mass spectroscopy, NMR spectroscopy, fluorescence spectroscopy, RI spectroscopy, UV spectroscopy, IR spectroscopy, and Raman spectroscopy. In some embodiments, the chemical analytical procedure may involve two or more different spectral analyses (e.g., using two or more different spectroscopic techniques).
[0017] In some embodiments, the chemical analytical procedure may involve both a spectral analysis and a composition analysis of one or more samples. For example, spectral analysis may be used as an initial sample filter followed by a secondary compositional analysis of samples that satisfy the requirements of the spectral filter. Alternatively, spectral analysis may be used as a secondary filter following a primary compositional analysis. In some embodiments, the chemical analytical procedure may involve subjecting each sample to both a spectral analysis and a composition analysis.
[0018] In some embodiments the chemical analytical procedure is executed as part of an assisted reproductive procedure, including in vitro fertilization. For example, U.S. Patent Publication No. 20070160973 describes methods and systems which employ spectral analysis of certain fluids in order to make predictions about the state of different types of cells involved in in vitro fertilization, including embryos, spermatazoa, oocytes, cells from the uterine wall, etc. The selected fluid is one which is exchanging metabolites with the cell in question. A correlation is initially established between the state of a particular type of cell and spectra of a fluid obtained using a chosen analytical modality for a population of cells with known outcome. For the cell being analyzed, a spectrum of the relevant fluid is obtained using the chosen modality. The state of the cell is then predicted using the acquired spectrum and the established correlation. Thus, in some embodiments the spectral analysis procedure involves obtaining and then analyzing spectra of body fluids and/or gamete or embryo culture media used in in vitro fertilization procedures. In some embodiments, the procedure involves predicting the viability of an oocyte based on spectral analysis of follicular fluid or culture media. In some embodiments, the procedure involves predicting the viability of a spermatozoid based on spectral analysis of seminal plasma or culture media. In some embodiments, the procedure involves predicting the viability of an embryo based on the spectral analysis of culture media. In some embodiments, the spectral analysis is performed using single or multiwavelength optical absorption, Raman scattering or optical fluorescence. In some embodiments, optical absorption may be within the infrared range (e.g., near infrared range). In some embodiments, the spectral analysis is performed using magnetic resonance (e.g., NMR). In some embodiments, the spectral analysis is performed using mass spectroscopy. In some embodiments, instead of predicting embryo or gamete viability, the procedure may involve determining one or more of: a time to transfer an embryo into a uterus; a time to subject an embryo to short term storage for future transfer into a uterus; a time to subject an embryo to cryopreservation for future transfer into a uterus; an adjustment to the culture medium to continue growing of an embryo; and a time to transfer an embryo into a different culture medium to continue growing of the embryo. In some embodiments, the chemical analytical procedure is a procedure executed as part of a metabolomics process, metabolomics including the science that examines and integrates the dynamic interplay between multiple molecules in a sample (both in fluids and in solid tissue) to understand and/or make predictions about complex biological processes and functions.
[0019] In some embodiments the chemical analytical procedure is executed as part of a medical diagnostic or prognostic procedure. For example, U.S. Patent Publication No. 20070054347 describes methods and systems which employ spectral analysis of certain fluids in order to make diagnostic and prognostic predictions about various oxidative stress dependent diseases, including neurodegenerative diseases. A correlation is initially established between a particular diagnosis or prognosis and spectra of a fluid obtained using a chosen analytical modality for a population of patients with known diagnosis or prognosis. For the patient being analyzed, a spectrum of the relevant fluid is obtained using the chosen modality. The diagnosis or prognosis for the patient is then predicted using the acquired spectrum and the established correlation. Thus, in some embodiments the spectral analysis procedure involves obtaining and then analyzing spectra of body fluids (e.g., whole blood, blood plasma, blood serum, and cerebrospinal fluid). In some embodiments, the procedure involves predicting the likelihood that a patient has a neurodegenerative disease based on spectral analysis of one of these body fluids. In some embodiments, the procedure involves predicting the likelihood that a patient has Mild Cognitive Impairment (MCI). In some embodiments, the procedure involves predicting the likelihood that a patient has Alzheimer's Disease. In some embodiments, the procedure involves predicting the likelihood that a patient has Vascular Cognitive Impairment (VCI). In some embodiments, the procedure involves predicting the likelihood that a patient has Parkinson's Disease. In one of these embodiments, by way of example, the procedure is executed as part of a process for detecting a neurodegenerative disease (e.g., Parkinson's Disease and Alzheimer's Disease). In some embodiments, the spectral analysis is performed using single or multiwavelength optical absorption, Raman scattering or optical fluorescence. In some embodiments, optical absorption may be within the infrared range (e.g., near infrared range). In some
embodiments, the spectral analysis is performed using magnetic resonance (e.g., NMR). In some embodiments, the spectral analysis is performed using mass spectroscopy. In some embodiments, the procedure may involve prognostic predictions (e.g., predicting the likelihood that a patient will respond to a particular type of therapy). It is to be understood that these methods may also be applied outside the realm of neurodegenerative diseases. For example, U.S. Patent Publication No. 20060247536 describes methods and systems which employ spectral analysis of amniotic fluid in order to make predictions about the health of a mother and her fetus during pregnancy. Thus, in some embodiments, spectral analysis of amniotic fluid may be used to make predictions about fetal growth and the likely birth weight of the infant. U.S. Patent Publication No. 20060247536 also describes compositional analytical methods and systems that use specific molecular markers in amniotic fluid in order to make predictions about the health of a mother and her fetus during pregnancy. Thus, in some embodiments, these markers may be used to make predictions about the likelihood that the mother will develop Gestational Diabetes Mellitus (GDM).
[0020] Referring now to FIG. 1, and in greater detail, the computing device 100 may be a computing device 100 as described below in connection with FIGs. 3A-3C. The computing device 100 receives a request for initiation of a subsequent step in the plurality of steps in the chemical analytical procedure. The computing device 100 requests, from the radio-frequency identification tag 102, an identification of whether at least one step in the plurality of steps in the chemical analytical procedure has been completed. The computing device 100 authorizes initiation of the subsequent step in the plurality of steps in the chemical analytical procedure, responsive to receiving an indication of completion of the at least one of the plurality of steps.
[0021] Radio-Frequency Identification (RFID) is a method of automatic identification using radio waves. In one embodiment, the computing device 100 includes a radio-frequency identification (RFID) reader 116. In another embodiment, the computing device 100 is in communication with the RFID reader 116; for example, the RFID reader 116 may be a separate device that functions as an intermediary between the computing device 100 and the RFID tag 102. In some embodiments, the RFID reader 116 includes functionality for transmitting, to a radio-frequency identification tag, information for storage. In one of these embodiments, and by way of example, the RFID reader 116 includes a transmitter for sending, to the RFID tag 102, an indication of completion of at least one of a plurality of steps in a chemical analytical procedure. In another of these embodiments, such an RFID reader 1 16 may be referred to as an RFID reader/writer 116.
[0022] In one embodiment, the RFID reader 116 retrieves data from the RFID tag 102 and transmits the retrieved data to the computing device 100. In another embodiment, the RFID reader 116 is used to energize a power source on the RFID tag 303. In still another embodiment, the RFID reader 116 is used to activate an RFID tag 102 configured to measure environmental conditions. In yet another embodiment, the RFID reader 116 reads information stored by the RFID tag 102. In some embodiments, the RFID reader 116 is a reader such as those produced by Feig Electronic GmbH of Weilburg, Germany, by Motorola Corporation of Schaumburg, IL, USA, EmbedTech Industries, Inc., of Raymond, ME, USA, or by KSW Microtec AG of Dresden, Germany. In some embodiments, the RFID reader 116 is a combination RFID-tag reader and bar-code scanner.
[0023] The radio-frequency identification tag 102 stores an indication of completion of at least one of a plurality of steps in a chemical analytical procedure. In one embodiment, the RFID tag 102 includes a circuit for storing information. In another embodiment, the RFID tag 102 includes an antenna for transmitting information. In still another embodiment, the RFID tag 102 is an active tag, including a power source. In yet another embodiment, the RFID tag 102 is a passive tag and does not require a power source.
[0024] In some embodiments, the RFID tag 102 has memory capacity. In one of these embodiments, the RFID tag 102 having memory capacity functions may store significant amounts of data. In another of these embodiments, the RFID tag 102 may provide functionality analogous to an electronic bar code. In other embodiments, information can be added to the RFID tag 102. In still other embodiments, the RFID tag 102 can be queried and read without direct line-of-sight. In one of these embodiments, because the RFID tag 102 can be read without direct line-of-sight, an RFID reader 116 can read information on the RFID tag 102 without opening a case, container or storage component within which the RFID tag 102 resides.
[0025] In other embodiments, the RFID tag 102 can be configured to attach to and fit on various sized objects, including, for example, on a sample cell or a label attached to a sample cell. In one of these embodiments, the RFID tag 102 may be incorporated into an object during its production including into or on a body or label of a sample cell. RFID technology can be combined with various other devices, such as Global Positioning Systems and temperature sensors to enable the sensing and storage of additional data.
[0026] In one embodiment, depicted in FIG. 1, the RFID tag 102 is attached to a sample 122. In another embodiment, the RFID tag 102 is embedded in a label on the sample 122. In still another embodiment, the RFID tag 102 is an RFID label; for example, the RFID tag 102 may be a chip embedded in a label such as those produced by NXP Semiconductors Netherlands B.V., of The Netherlands. In still even another embodiment, the RFID tag 102 includes a transmitter 108 for sending information to a device, such as an RFID reader 116 or a computing device 100. In yet another embodiment, the RFID tag 102 includes a receiver 106 for receiving information from a device, such as an RFID reader 116 or a computing device 100. For example, the receiver 106 may receive, from a computing device 100 or RFID reader 116, a request for data stored in a storage element 104 and the transmitter 108 may send a response to the requesting device including a copy of data retrieved from the storage element 104. In some embodiments a single transceiver on the RFID tag 102 provides both receiving and transmitting functionality.
[0027] In one embodiment, the RFID tag 102 includes a sensor for measuring a plurality of values of the environmental condition. In another embodiment, the RFID tag 102 includes a sensor for measuring temperature. In still another embodiment, the RFID tag 102 includes a sensor for measuring humidity. In still even another embodiment, the RFID tag 102 includes a sensor for measuring vibration. In yet another embodiment, the RFID tag 102 includes a sensor for identifying location. In some embodiments, the RFID tag 102 includes a sensor for measuring a level of ambient light. In one of these embodiments, the RFID tag 102 includes a sensor for measuring a level of ultraviolet light. In other embodiments, the RFID tag 102 is in communication with a sensor that measures environmental conditions. In one of these embodiments, the RFID tag 102 may receive data for storage from the sensor; for example, a sensor may measure an environmental condition (such as ambient temperature for a sample 122) and transmit the measured environmental condition to the RFID tag 102 for storage.
[0028] In some embodiments, the RFID tag 102 is referred to as a promiscuous tag.
In one of these embodiments, the RFID tag 102 responds to all requests for data stored on the RFID tag 102. In other embodiments, the RFID tag 102 is referred to as a secure tag. In one of these embodiments, the RFID tag 102 requires authentication prior to responding to a request, for example via passwords or secure keys. In still other embodiments, the RFID tag 102 is a tag such as those used in the RFID-embedded tags produced by EmbedTech
Industries, Inc., of Raymond, ME, or by KSW Microtec AG of Dresden, Germany. In still even other embodiments, the RFID tag 102 is a tag such as the VARIOSENSE line of tags or the passive RFID transponders produced by KSW Microtec AG of Dresden, Germany. In further embodiments, the RFID tag 102 includes a sensor for measuring the plurality of values of the environmental condition, including, but not limited to, sensors for measuring temperature, humidity, motion levels, or ambient light.
[0029] In some embodiments, an active RFID tag 102 is attached to a sample 122. In one of these embodiments, an RFID tag 102 collecting and storing measurements of environmental conditions is attached to a case or vehicle storing the sample 122 and an identification of the RFID tag 102 is attached to the sample 122; for example, the sample 122 may include an identification number of the RFID tag 102 attached to a case or vehicle, the identification number printed on the sample 122 or encoded by a bar code that is on the sample 122. In another of these embodiments, a plurality of active RFID tags 102 is used.
[0030] In other embodiments, a plurality of passive RFID tags 102 is used. In still other embodiments, a plurality of RFID tags 102 is used, some of which are active and some of which are passive. In one of these embodiments, and for example, a passive RFID tag 102 is attached to a sample 122 and an active RFID tag 102' is attached to a case, tray, or other container storing the sample 122; the two tags may be associated so that, for example, a passive tag includes an identification number for the sample 122 and the same identification number is associated with a plurality of measurements of environmental conditions made by a tag attached to the container storing the sample 122.
[0031] In some embodiments, the RFID tag 102 includes a storage element 104. In one of these embodiments, the storage element 104 stores an identification of a sample to which the RFID tag 102 is attached. In another of these embodiments, the storage element 104 stores an indication of completion of at least one of a plurality of steps in a chemical analytical procedure. In still another of these embodiments, the storage element 104 includes memory to which a user may write data; the memory may be protected by password, or other security mechanism, to prevent unauthorized modification. In other embodiments, a computer chip embedded in a housing such as that provided by Maxim Integrated Products, Inc., of Sunnyvale, CA, stores the information instead of or in addition to an RFID tag 102.
[0032] In other embodiments, the storage element 104 stores data in an ODBC- compliant database. For example, the database may be provided as an ORACLE database, manufactured by Oracle Corporation of Redwood Shores, Calif. In still other embodiments, the database can be a Microsoft ACCESS database or a Microsoft SQL server database, manufactured by Microsoft Corporation of Redmond, Wash. In further embodiments, the database may be a custom-designed database based on an open source database such as the MYSQL family of freely-available database products distributed by MySQL AB Corporation of Uppsala, Sweden, and Cupertino, CA.
[0033] In one embodiment, the sample 122 is a container storing a fluid for analysis by a device such as the chemical analysis component 120. In another embodiment, the sample 122 is referred to as a sample cell 122. In still another embodiment, the sample 122 is a plastic container with an optical window that minimizes absorption of infrared light. In yet another embodiment, the sample 122 is a plastic container with a calcium fluoride window that minimizes absorption of infrared light.
[0034] In some embodiments, the term "fluid" is intended to mean a subset of the phases of matter; fluids include liquids, gels, and flexible solids. In some embodiments, a fluid sample includes, without limitation, a homogeneous solution or heterogeneous mixture, which may be a liquid, suspension or gel. In some embodiments, the fluid sample is susceptible to being analyzed using various methods, and may be, for example, effluent liquids from various sources, laboratory samples for different purposes including forensic, and biological samples such as aqueous proteinaceous liquid, bacteria and cell suspensions, cell culture media, cell culture components, blood, blood products, blood components, whole blood, blood plasma, blood serum, serum, plasma, lymph, mucus secretions, breast milk, follicular fluid, vaginal fluid, uterine fluid, saliva, semen, seminal fluid, tear fluid, reconstituted lyophilized feces, urine, saliva, amniotic fluid, and cerebrospinal fluid.
[0035] In some embodiments, fluid samples may be contained in a vessel referred to as a sample cell or cuvette. In one of these embodiments, by way of example, the sample cell is a sample cell for spectrometric analysis as described in International Patent Publication Number WO/2009/000069. In another of these embodiments, the sample cell 122 contains two sides of optical quality material that allow light to pass through the sample. In still another of these embodiments, a sample cell 122 has a cylindrical shape and has at least one window and at least one feed conduits at each end; light is propagating along the axial direction of the cylindrical shape through at least one end window, and the cylindrical shape has an axial length sufficient to allow analysis of the sample through an end window, and the sample cell is capable of holding a volume of fluid sample in a bubble free manner. In such an embodiment, the term "cylindrical" is intended to mean that the shape is elongated having two ends being parallel to one another and delimiting its length alone an elongated axis and each of the end being joined together by a curved surface generated by a straight line moving along a curve while being substantially perpendicular to the end surfaces. In yet another of these embodiments, a flow cell device 122 has a feed conduit adapted to facilitate the trapping of air bubbles as a result of the action of fluid flow in the feed conduit.
[0036] In some embodiments, a microscope slide or similar device is used to capture a thin layer of fluid for analysis. In one of these embodiments, this device may include one or more wells for analysis. In another of these embodiments, the device may be a device such as the multiwell microscope slides produced by Thermo Fisher Scientific Inc., of Waltham, MA.
[0037] In one embodiment, the sample cell 122 contains a fluid sample that is undergoing an analysis (such as a chemical analytical procedure). In another embodiment, the fluid sample is referred to as a test sample. In still another embodiment, the test sample may be removed from the sample cell 122 and replaced with a second fluid sample that acts as a control; the second fluid sample may be referred to as a control sample. In some embodiments, there are multiple sample cells 122. In one of these embodiments, by way of example, a first sample cell 122a contains a test sample and a second sample cell 122b contains a control sample.
[0038] In some embodiments, a manufacturer generates the RFID tag 102 and stores, in the storage element 104, an identifier of the RFID tag 102. In one of these embodiments, the manufacturer generates the RFID tag 102 and stores, in the storage element 104, an identifier associating the RFID tag 102 with the manufacturer. In other embodiments, the computing device 100 includes functionality for associating the RFID tag 102 with a sample cell identifier. In one of these embodiments, for example, the computing device 100 executes an application allowing a user to generate an identifier associating the RFID tag 102 with a sample cell identifier. In another of these embodiments, and as a further embodiment, the computing device 100 executes an application provided by or in communication with the RFID reader 116, which generates an identifier associating the RFID tag 102 with a sample cell identifier. Similarly, in other embodiments, the computing device 100 includes functionality - such as, for example, an application executed by the computing device 100— for generating an identifier associating the RFID tag 102 with at least one of: a patient identifier, a control sample identifier, and a test sample identifier. [0039] In one embodiment, the computing device 100 is in communication with a chemical analysis component 120. In some embodiments, the computing device 100 is physically connected to the chemical analysis component 120. In other embodiments, the computing device 100 is connected to the chemical analysis component 120 via a network 304 as described above in connection with FIG. 3C. In still other embodiments, the computing device 100 is in communication with a temperature control device, directly or via a network 304.
[0040] In some embodiments, the chemical analysis component 120 is a spectrometer, e.g., a mass spectrometer, an NMR spectrometer, a fluorescence spectrometer, a refractive index spectrometer, an ultraviolet spectrometer, an infrared spectrometer (e.g., a near-infrared spectrometer or Fourier transform spectrometer), a Raman spectrometer, etc. In some embodiments, the chemical analysis component 120 is a chromatographic device (e.g., an HPLC or TLC device). In some embodiments, the chemical analysis component 120 is an electrochemical device. Typically, these include one or more detectors that measure molecules that undergo oxidation or reduction reactions. Detection is generally accomplished by measuring gains or loss of electrons from samples as they pass between electrodes at a given difference in electrical potential. In some embodiments, the chemical analysis component 120 is a radiochemical device. In general, these devices involve using
radiolabeled material, e.g., tritium (3H) or carbon 14 (14C). They normally operate by detecting fluorescence associated with beta-particle ionization. In some embodiments, the chemical analysis component 120 is a light scattering detector. These detectors include a light source which emits a parallel beam of light. The beam of light strikes particles in solution, and some light is then reflected, absorbed, transmitted, or scattered. Different wavelengths of scattered light can be used to identify different molecules (e.g., infrared, etc.). In other embodiments, the chemical analysis component 120 is an instrument used in analyzing an immunoassay. In still other embodiments, the chemical analysis component 120 is an instrument used in light microscopy. In still even other embodiments, the chemical analysis component 120 is an instrument used in fluorescence microscopy. In some embodiments, the chemical analysis component 120 is an instrument used in flow cytometry. In yet other embodiments, the chemical analysis component 120 is an instrument used in chromatography. [0041] In some embodiments, the chemical analysis component 120 may include more than one device. In particular, in some embodiments, a chromatographic device such as an HPLC device may be combined with one or more of a mass spectrometer, an NMR spectrometer, a fluorescence spectrometer, a refractive index spectrometer, an ultraviolet spectrometer, an infrared spectrometer (e.g., a near-infrared spectrometer or Fourier transform spectrometer), a Raman spectrometer, etc.
[0042] In some embodiments, the system may include more than one chemical analysis component 120. In particular, in some embodiments, a system may be designed for the sequential analysis of a sample by two or more chemical analysis components 120. It will be appreciated that each chemical analysis component 120 may have any one or more of the general functions that are described herein for a chemical analysis component 120. Thus, in some embodiments, the system 100 may include two or more different chemical analysis components 120 for performing a compositional analysis. In some embodiments, the system 100 may include two or more different chemical analysis components 120 for performing a spectral analysis (e.g., an infrared and a Raman spectral analysis or a mass spectroscopic and an NMR spectral analysis). In some embodiments, the system 100 may include two or more different chemical analysis components 120 for performing a compositional analysis and a spectral analysis (e.g., a compositional analysis using a chromatographic device combined with a mass spectrometer and a spectral analysis using an infrared spectrometer).
Advantageously the system of the present invention may be used to track the progress of a sample as it circulates through each analytical step (i.e., in order to confirm that the proper sequence of steps is being followed).
[0043] In one embodiment, the computing device 100 includes an application 110. In another embodiment, the application 110 is a software application program executed by the computing device 100. In still another embodiment, the application 110 generates a user interface 112. In still even another embodiment, the computing device 100 displays the user interface 112 to a user of the computing device 100 on a display device connected to the computing device 100. In yet another embodiment, the application 110 includes functionality allowing a user to control the chemical analysis component 120; for example, the application 110 may generate a user interface 112 including a user interface element allowing a user to initiate a chemical analysis of a sample 122. [0044] In one embodiment, the application 110 includes functionality for receiving an indication of completion of at least one of a plurality of steps in a chemical analytical procedure and for transmitting, to the radio-frequency identification tag, the indication of completion of the at least one of a plurality of steps in the chemical analytical procedure. In another embodiment, and by way of example, the application 110 may generate a user interface element displayed in the user interface 112 and receive the indication of completion from a user via the user interface element. In still another embodiment, and as a further example, the application 110 may receive the indication of completion via a communications channel with the chemical analysis component 120. In yet another embodiment, the application 110 indirectly transmits the indication to the RFID tag 102; for example, the application 110 may include a communications channel with the RFID reader 116 over which the application 110 may transmit the indication to the RFID reader 116 for forwarding to the RFID tag 102.
[0045] In one embodiment, the application 110 includes functionality for receiving a request for initiation of a subsequent step in the plurality of steps in the chemical analytical procedure and for transmitting, to the radio-frequency identification tag 102, a request for the identification of whether at least one of the in the plurality of steps in the chemical analytical procedure has been completed. In another embodiment, for example, the application 110 generates a user interface element displayed in the user interface 112 and receives the request via the user interface element. In yet another embodiment, the application 110 indirectly transmits the request to the RFID tag 102; for example, the application 110 may include a communications channel with the RFID reader 116 over which the application 110 may transmit the request to the RFID reader 116 for forwarding to the RFID tag 102.
[0046] In one embodiment, the computing device 100 includes an authorization component 114. In another embodiment, the authorization component 114 is a software application program executed by the computing device 100. In still another embodiment, the authorization component 114 is in communication with the application 110. In still even another embodiment, the authorization component 114 is in communication with the RFID reader 116. In yet another embodiment, the authorization component 114 is provided as part of the application 110.
[0047] In one embodiment, the computing device 100 includes a receiver receiving, from the radio-frequency identification tag, an indication that the at least one of the nluralitv of steps in the chemical analytical procedure is complete. In another embodiment, the receiver is the RFID reader 116. In still another embodiment, the receiver is in
communication with the RFID reader 116. In some embodiments, the application 110 includes the receiver.
[0048] In one embodiment, the authorization component 114 includes functionality for determining whether to authorize a use of the chemical analysis component 120 requested by a user via the application 110. In another embodiment, the authorization component 114 includes functionality for determining, responsive to information received from the radio- frequency identification tag 102, that at least one of the plurality of steps in the chemical analytical procedure is complete. In still another embodiment, the authorization component 114 includes functionality for determining, responsive to information received from the radio-frequency identification tag 102, that at least one of the plurality of steps in the chemical analytical procedure is incomplete. In still even another embodiment, the authorization component 114 includes functionality for determining, responsive to information received from the radio-frequency identification tag 102, that a sample cell 122 previously underwent spectral analysis. In yet another embodiment, the authorization component 114 includes a policy engine comparing data retrieved from the RFID tag 102 with rules for determining whether to authorize use of the chemical analysis component 120.
[0049] In one embodiment, the authorization component 114 includes functionality for determining that an analysis of the sample cell during a chemical analytical procedure has occurred, responsive to information received from the radio-frequency identification tag. In another embodiment, the authorization component 114 includes functionality for authorizing initiation of the subsequent step in the plurality of steps in the chemical analytical procedure, responsive to confirming an association between the radio-frequency identification tag and a sample cell identifier. In another embodiment, the authorization component 114 includes functionality for authorizing initiation of the subsequent step in the plurality of steps in the chemical analytical procedure, responsive to confirming an association between the radio- frequency identification tag and a patient identifier. In still another embodiment, the authorization component 114 includes functionality for authorizing initiation of the subsequent step in the plurality of steps in the chemical analytical procedure, responsive to confirming an association between the radio-frequency identification tag and a control sample. In still even another embodiment, the authorization component 114 includes functionality for authorizing initiation of the subsequent step in the plurality of steps in the chemical analytical procedure, responsive to confirming an association between the radio- frequency identification tag and a test sample. In yet another embodiment, the authorization component 114 includes functionality for preventing initiation of the subsequent step in the plurality of steps in the chemical analytical procedure, responsive to receiving an indication of completion of the at least one of the plurality of steps.
[0050] Referring now to FIG. 2, a flow diagram depicts one embodiment of a method for verifying, via a radio-frequency identification tag, completeness of an analysis of a sample in a chemical analytical procedure. In brief overview, the method 200 includes storing, by a radio-frequency identification tag, an indication of completion of at least one of a plurality of steps in a chemical analytical procedure (202). The method includes receiving, by a computing device, a request for initiation of a subsequent step in the plurality of steps in the chemical analytical procedure (204). The method includes requesting, by the computing device, from the radio-frequency identification tag, an identification of a number of completed steps in the plurality of steps in the chemical analytical procedure (206). The method includes authorizing, by the computing device, initiation of the subsequent step in the plurality of steps in the chemical analytical procedure, responsive to receiving the
identification of the number of completed steps in the plurality of steps (208).
[0051] A radio-frequency identification tag stores an indication of completion of at least one of a plurality of steps in a chemical analytical procedure (202). In one embodiment, the radio-frequency identification tag 102 stores an indication of completion of an analysis of a sample. In another embodiment, the radio-frequency identification tag 102 stores an indication of completion of an analysis of a test sample. In still another embodiment, the radio-frequency identification tag 102 stores an indication of completion of an analysis of a control sample. In yet another embodiment, the radio-frequency identification tag 102 stores an indication of completion of a pre-analysis step; for example, a step such as a temperature control step described in greater detail below may be completed prior to a step in a chemical analytical procedure.
[0052] In one embodiment, the radio-frequency identification tag 102 stores an indication of completion of a temperature control process; for example, the RFID tag 102 may store an indication received from an RFID reader/writer 116 in communication with a temperature control component. In another embodiment, the radio-freauencv identification tag 102 stores an indication that a temperature of the sample cell 122 has stabilized; for example, an RFID writer in communication with a temperature control component modifying a temperature of the sample cell 122 may store in the RFID tag 102 an indication that the sample cell 122 has reached a certain temperature. As another example, and in some embodiments, the radio-frequency identification tag 102 stores an indication that the sample cell 122 has maintained a temperature for a period of time; for example, an RFID writer in communication with a temperature control component modifying a temperature of the sample cell 122 may store in the RFID tag 102 an indication that the sample cell 122 has maintained a certain temperature for a number of minutes or seconds.
[0053] In one embodiment, the computing device 100 receives, from the chemical analysis component 120, an indication of completion of the at least one of the plurality of steps. In another embodiment, the application 110, executing on the computing device 100, receives, from the chemical analysis component 120, the indication of completion. In still another embodiment, the computing device 100 transmits the received indication of completion to the RFID tag 102 for storage. In still even another embodiment, the computing device 100 transmits the received indication of completion to the RFID reader 116, which transmits the received indication to the RFID tag 102. In still another embodiment, the chemical analysis component 120 transmits the indication of completion of the at least one of the plurality of steps to the RFID reader 116, which transmits the received indication to the RFID tag 102. In yet another embodiment, the RFID tag 102 stores the received indication of completion. In some embodiments, other components involved in the completion of at least one of the plurality of steps transmit, directly or indirectly, to the RFID tag 102, information identifying completion of at least one of the plurality of steps. In one of these embodiments, and by way of example, a temperature control component transmits, to the RFID tag 102, an indication of completion of the at least one of the plurality of steps. In another of these embodiments, and as another example, a temperature control component transmits to an RFID writer, for transmission to the RFID tag 102, an indication of completion of the at least one of the plurality of steps.
[0054] In some embodiments, storing the indication of completion of at least one of a plurality of steps in a chemical analytical procedure occurs as a result of a user input to a machine, such as the chemical analysis component 120. In one of these embodiments, by way of example, a user interface displayed by at least one of the chemical analysis component 120 and the computing device 100 receives an identification of an insertion of a test sample into the chemical analysis component 120. In another of these embodiments, the user input to the machine triggers completion of at least one of a plurality of steps and of the storage of the indication of completion of the at least one of the plurality of steps.
[0055] In one embodiment, the plurality of steps in the chemical analytical procedure includes an analysis of an oocyte. In another embodiment, the plurality of steps in the chemical analytical procedure includes an analysis of an embryo. In still another
embodiment, the plurality of steps in the chemical analytical procedure includes an analysis of sperm. In yet another embodiment, the plurality of steps in the chemical analytical procedure includes an analysis of a test sample in which an embryo (or oocyte) developed.
[0056] In some embodiments, the plurality of steps in the chemical analytical procedure includes an analysis of any fluid, including, for example, the fluids described above in connection with FIG. 1. In other embodiments, the plurality of steps in the chemical analytical procedure includes a step of preparing a fluid for analysis; for example, the plurality of steps may include a temperature control step in which a fluid is warmed or cooled to a particular temperature prior to performance of a chemical analysis. In still other embodiments, the plurality of steps includes a first step of performing an analysis of a substance in the sample 122 and a second step of repeating the analysis of the substance in the sample 122. In further embodiments, the plurality of steps includes a first step of performing an analysis of a first substance in the sample 122 and a second step of replacing the first substance in the sample 122 with a second substance prior to an analysis of the second substance.
[0057] In one embodiment, the plurality of steps in the chemical analytical procedure includes an analysis of a test sample. In another embodiment, the plurality of steps in the chemical analytical procedure includes an analysis of a control sample. In still another embodiment, completion of a step in the plurality of steps includes transmission of an indication of completion of the step for storage by the RFID tag 102. In yet another embodiment, and by way of example, the chemical analysis component 120 completes an analysis of a test sample in a sample cell 122; the chemical analysis component 120 transmits, to the computing device 100, an indication of completion of at least one of a plurality of steps in a chemical analytical procedure; a user of the system 100 removes the test sample from the sample cell 122 and replaces the test samnle with a control samnle: and the user, via the application 1 10, requests initiation of a subsequent step in the plurality of steps (e.g., chemical analysis of the control sample contained in the sample cell 122).
[0058] In some embodiments, the RFID tag 102 includes functionality allowing a user to store data on the RFID tag 102. In one of these embodiments, for example, the RFID tag 102 includes functionality for receiving, from at least one of the computing device 100 and the RFID reader 1 16, data for storage. In some embodiments, write protection is
implemented by locking individual blocks of four bytes each within the storage element 104. In one of these embodiments, a first block contains values that are pre-initialized (for example, by a manufacturer of the RFID tag 102), written to user memory, and locked to prevent further modification. In other embodiments, blocks of data within the storage element 104 are writeable by users, instead of write protected after manufacture of the RFID tag 102. In one of these embodiments, a second block contains values written to user- accessible memory. In another of these embodiments, the values in these data blocks may subsequently be modified; for example, a value may be modified to indicate completion of a step in the plurality of steps.
[0059] In some embodiments, the RFID tag 102 stores the indication of completion in the storage element 104. In one of these embodiments, the RFID tag 102 stores the indication of completion in a database stored by the storage element 104. In one of these embodiments, the RFID tag 102 stores the indication of completion in a table stored by the storage element 104. In other embodiments, the RFID tag 102 stores an identifier of the sample cell 122 to which the RFID tag 102 is attached. In still other embodiments, the RFID tag 102 stores a type of chemical analytical procedure. In further embodiments, and by way of example and without limitation, the RFID tag 102 stores the indication of completion and analysis-related information in a data structure such as the following:
Page Block Byte Field Name Description
0 1 0 "Used" flag Initially set to zero ("unused") indicating that the
RFID tag 102 has not been read (i.e., "used") by the application 110. Several non-zero values may be written to this field to indicate that the RFID tag 102 (and, hence, the sample 122) is passing through different steps in a process during which the RFID label may be read more than once.
[0060] In one embodiment, the RFID tag 102 stores an indication of a type of sample cell 122 with which the RFID tag 102 is associated. In another embodiment, the RFID tag
102 stores an identification of a type of anti-counterfeiting mechanism with which the RFID tag 102 has been programmed. For example, and in still another embodiment, the RFID tag 102 may store a value of "0" in an anti-counterfeiting field to indicate that no anti- counterfeiting mechanism is in place; alternatively, the RFID tag 102 may store a non-zero value in the anti-counterfeiting field to identify a type of anti-counterfeiting mechanism employed by the RFID tag 102. Examples of anti-counterfeiting mechanism may include mechanisms employing checksums derived from a unique identifier of the RFID tag 102, or other mechanisms known in the art. In yet another embodiment, the RFID tag 102 may store data used to authenticate the RFID tag 102 and prevent counterfeiting; for example, the RFID tag 102 may store a checksum derived from a unique identifier of the RFID tag 102.
[0061] A computing device receives a request for initiation of a subsequent step in the plurality of steps in the chemical analytical procedure (204). In one embodiment, the application 110 executing on the computing device 100 receives, from a user of the computing device 100, via the user interface 112, the request for initiation of the subsequent step. In another embodiment, the application 110 executing on the computing device 100 receives, from the chemical analysis 120, a request for authorization to initiate execution of the subsequent step. In still another embodiment, the authorization component 114 executing on the computing device 100 receives a request for authorization to initiate execution of the subsequent step. For example, and in some embodiments, a user of the computing device 100 interacting with the user interface 112 may request initiation of the subsequent step and the application 110, receiving the request from a user interface element in the user interface 112, may transmit a request for authorization to the authorization component 114.
[0062] The computing device requests from the radio-frequency identification tag, an identification of a number of completed steps in the plurality of steps in the chemical analytical procedure (206). In one embodiment, the authorization component 114 transmits a request to the RFID tag 102 for an identification of a number of completed steps in the plurality of steps in the chemical analytical procedure. In another embodiment, the authorization component 114 transmits the request to the RFID reader 116 for transmission to the RFID tag 102. In still another embodiment, the RFID reader 116 retrieves the
identification from the RFID tag 102 and transmits the retrieved identification to the authorization component 114.
[0063] In one embodiment, the computing device 100 requests an indication of whether the chemical analysis component 120 has completed a specific step in the chemical analytical procedure; for example, the computing device 100 may request an indication of whether the chemical analysis component 120 has performed a spectral analysis of a test sample in which an embryo developed. In another embodiment, the computing device 100 requests an indication of how many steps in a chemical analytical procedure the chemical analysis component 120 has performed; for example, the RFID tag 102 may have stored a non-zero value (such as, by way of example, "4") indicating a number of steps in the chemical analytical procedure that the chemical analysis component 120 has performed. In still another embodiment, the computing device 100 requests an indication of whether a type of step was completed; for example, the computing device 100 may request an indication of whether a temperature control step was performed. In yet another embodiment, the computing device 100 requests both an indication of a number of steps having a common type were completed; for example, the computing device 100 may request an indication of how many spectral analyses were completed for a control sample, or for a test sample, or other fluid.
[0064] In one embodiment, the computing device 100 receives the indication from the
RFID tag 102. In another embodiment, the computing device 100 receives the indication from the RFID reader 116. In still another embodiment, the computing device 100 transmits the received indication to the authorization component 114. [0065] The computing device authorizes initiation of the subsequent step in the plurality of steps in the chemical analytical procedure, responsive to receiving an indication of completion of the at least one of the plurality of steps (208). In one embodiment, the authorization component 114 authorizes initiation of the subsequent step in the plurality of steps in the chemical analytical procedure, responsive to receiving an indication of completion of the at least one of the plurality of steps. In another embodiment, the authorization component 114 accesses a mapping, table, database, or other data structure, that identifies a number of steps to have been completed before initiation of the requested subsequent step. In still another embodiment, the authorization component 114 compares the received indication of completion with the accessed mapping to determine whether to authorize initiation of the subsequent step. In still even another embodiment, and by way of example, the authorization component 114 may receive an indication that a third step in the plurality of steps has been completed and receive a request for initiation of a fifth step in the plurality of steps, while the accessed mapping indicates that a fourth step should have been completed before initiation of the fifth step; in such an embodiment, the authorization component 114 would deny the request to initiate the subsequent step. In yet another embodiment, and as another example, the authorization component 114 receives an indication that a first type of step in the plurality of steps has completed and receive a request for initiation of a third step in the plurality of steps, while the accessed mapping indicates that a second type should have been completed prior to initiation of the third step; in such an embodiment, the authorization component 114 would deny the request to initiate the subsequent step. In a further embodiment, and as an additional example, the authorization component 114 receives an indication that a third step of a first type has been completed and received a request for authorization of initiation of a fourth step of a second type, while the mapping indicates that the third step of the first type is the only prerequisite to initiation of the fourth step of the second type; in such an embodiment, the authorization component 114 would authorize the request to initiate the subsequent step.
[0066] In one embodiment, the computing device 100 authorizes initiation of the subsequent step in the plurality of steps in the chemical analytical procedure, responsive to confirming an association between the radio-frequency identification tag and a patient identifier. For example, in addition to verifying a number or type of step completed, the authorization component 114 may also verify that the RFID tag 102 associated with the sample 122 is also associated with a specified patient identifier and, should the authorization component 1 14 determine that there is no association between the RFID tag 102 and the specified patient identifier, the authorization component 114 may prevent execution of additional steps in the chemical analytical procedure. In another embodiment, and as a further example, the authorization component 114 may access a data structure associating a first patient identifier with an identifier of a first sample 122, while the RFID tag 102 stores an association between a second patient identifier and the first identifier of the sample 122, or of the first patient identifier with an identifier of a second sample 122b, or of a second patient identifier and an identifier of a second sample 122b. In such embodiments, by identifying an error between a specified patient identifier and the sample 122 presented for analysis, the authorization component 114 may prevent performance of additional steps in the chemical analytical procedure and alert a user of the system as to a possible error.
[0067] In some embodiments, the authorization component 114 accesses a data structure (such as a table, database or other data structure stored on or accessible by the computing device 100) stores information such as, by way of example, and without limitation, the following:
Figure imgf000026_0001
[0068] In another embodiment, the computing device 100 authorizes initiation of the subsequent step in the plurality of steps in the chemical analytical procedure, responsive to confirming an association between the radio-frequency identification tag and a sample cell identifier. In still another embodiment, the computing device 100 authorizes initiation of the subsequent step in the plurality of steps in the chemical analytical procedure, responsive to confirming an association between the radio-frequency identification tag and a test sample identifier.
[0069] In one embodiment, the computing device 100 authorizes initiation of the subsequent step in the plurality of steps in the chemical analytical procedure, responsive to confirming an association between the radio-frequency identification tag and a control sample identifier. For example, in this embodiment, the authorization component 114 may access a data structure (such as a table, database or other data structure stored on or accessible by the computing device 100) that associates an identification of a control sample with the RFID tag 102; verification of this association may allow the authorization component 114 to prevent additional steps in a chemical analytical procedure should, for example, an incorrect control sample have been placed in the sample 122 (for example, if the RFID tag 102 stores an identification of the sample 122 and an identification of a first control sample while the authorization component 114 determines that the RFID tag 102 should have stored an identification of the sample 122 and an identification of a second control sample, raising a question as to whether the sample 122 contains the appropriate control sample). In another embodiment, the computing device 100 authorizes initiation of the subsequent step in the plurality of steps in the chemical analytical procedure, responsive to confirming an association between a test sample identifier and a control sample identifier. For example, in this embodiment, the authorization component 114 may access a data structure (such as a table, database or other data structure stored on or accessible by the computing device 100) that associates an identification of a control sample with an identification of a test sample; verification of this association may allow the authorization component 114 to prevent additional steps in a chemical analytical procedure should, for example, an incorrect control sample have been placed in the sample 122 (for example, if the RFID tag 102 stores an identification of a first control sample and an identification of a first test sample while the authorization component 114 determines that the RFID tag 102 should have stored an identification of a second control sample and an identification of the first test sample, raising a question as to whether the sample 122 contains the appropriate control sample). In some embodiments, the RFID tag 102 stores an identification of a sample 122, the identification also identifying a manufacturer of the sample 122. In other embodiments, the identification of the sample 122 identifies a manufacturer of the RFID tag 102. In still other embodiments, using an identifier of a manufacturer as the identifier of the sample 122 stored in the RFID tag 102 ensures that the sample 122 is associated with an approved RFID tag 102. In further embodiments, using an identifier of a manufacturer as the identifier of the sample 122 stored in the RFID tag 102 ensures that the sample 122 is approved for use in a particular procedure.
[0070] In one embodiment, the computing device 100 determines that an analysis of a fluid contained in the sample 122 during a chemical analytical procedure has occurred, responsive to information retrieved from the radio-frequency identification tag. In such an embodiment, the computing device 100 may prevent a second analysis of the fluid contained in the sample 122. For example, the computing device 100 may determine that the fluid has already been subjected to the chemical analytical procedure and prevent duplicate analysis of the fluid. In another example, the RFID tag 102 may contain an identification of completion of a procedure, indicating that contents of the sample 122 have previously been subjected to an analysis; the computing device 100 may use the identification of completion of the procedure to prevent re-use of the sample cell 122 in the same or a different chemical analytical procedure.
[0071] In one embodiment, the authorization component 114 authorizes initiation of the subsequent step in the plurality of steps in the chemical analytical procedure, responsive to receiving an indication of completion of the at least one of the plurality of steps. In another embodiment, the authorization component 114 transmits, to the application 110, authorization to initiate the subsequent step. In still another embodiment, the application 110, in communication with the chemical analysis component 120, initiates execution of the subsequent step. In other embodiments, the computing device 100 prevents initiation of the subsequent step in the plurality of steps in the chemical analytical procedure, responsive to receiving an indication of a lack of completion of the at least one of the plurality of steps.
[0072] In some embodiments, the systems and methods described herein for verifying completeness of an analysis of a sample in a chemical analytical procedure provide functionality for confirming that pre-requisite steps in a chemical analytical procedure have been completed before authorizing execution of subsequent steps. In one of these
embodiments, for example, by determining a number or type of analyses completed, by a chemical analysis component 120, on a substance for analysis (such as the contents of the sample 122), as identified by a radio frequency identification tag 102, a computing device can determine whether to authorize or to prevent subsequent analyses. In another of these embodiments, prevention of subsequent analyses in environments in which a nre-reauisite step has not been completed may result in an improvement to the quality of the chemical analytical procedure. In still another of these embodiments, providing functionality for process control in diagnostic instrumentation by affixing a radio frequency identification tag 102 to a sample and storing data on and retrieving data from the radio frequency
identification tag 102 allows for a level of process control not readily available in most diagnostic systems.
[0073] Having discussed embodiments of the systems and methods for verifying, via a radio-frequency identification tag, completeness of an analysis of a sample in a chemical analytical procedure, it may be helpful to also discuss the computing environments in which some such embodiments may be deployed. A computing device may be deployed as and/or executed on any type and form of computing device, such as a computer, network device or appliance capable of communicating on any type and form of network and performing the operations described herein. FIGs. 3A and 3B depict block diagrams of a computing device 100 useful for practicing an embodiment of the methods and systems described herein. As shown in FIGs. 3 A and 3B, a computing device 100 includes a central processing unit 321 and a main memory unit 322. As shown in FIG. 3 A, a computing device 100 may include a storage device 328, an installation device 316, a network interface 318, an I/O controller 323, display devices 324a-n, a keyboard 326 and a pointing device 327, such as a mouse. The storage device 328 may include, without limitation, an operating system and one or more software application programs. As shown in FIG. 3B, each computing device 100 may also include additional optional elements, such as a memory port 303, a bridge 370, one or more input/output devices 330a-330n (generally referred to using reference numeral 330), and a cache memory 340 in communication with the central processing unit 321.
[0074] The central processing unit 321 is any logic circuitry that responds to and processes instructions fetched from the main memory unit 322. In many embodiments, the central processing unit 321 is provided by a microprocessor unit, such as: those manufactured by Intel Corporation of Mountain View, California; those manufactured by Motorola
Corporation of Schaumburg, Illinois; those manufactured by Transmeta Corporation of Santa Clara, California; the RS/6000 processor, those manufactured by International Business Machines of White Plains, New York; or those manufactured by Advanced Micro Devices of Sunnyvale, California. The computing device 100 may be based on any of these processors, or any other processor capable of operating as described herein. [0075] Main memory unit 322 may be one or more memory chips capable of storing data and allowing any storage location to be directly accessed by the microprocessor 321, such as static random access memory (SRAM), Burst SRAM or SynchBurst SRAM
(BSRAM), Dynamic random access memory (DRAM), Fast Page Mode DRAM (FPM DRAM), Enhanced DRAM (EDRAM), Extended Data Output RAM (EDO RAM), Extended Data Output DRAM (EDO DRAM), Burst Extended Data Output DRAM (BEDO DRAM), Enhanced DRAM (EDRAM), synchronous DRAM (SDRAM), JEDEC SRAM, PC 100 SDRAM, Double Data Rate SDRAM (DDR SDRAM), Enhanced SDRAM (ESDRAM), SyncLink DRAM (SLDRAM), Direct Rambus DRAM (DRDRAM), or Ferroelectric RAM (FRAM). The main memory 322 may be based on any of the above described memory chips, or any other available memory chips capable of operating as described herein. In the embodiment shown in FIG. 3 A, the processor 321 communicates with main memory 322 via a system bus 350 (described in more detail below). FIG. 3B depicts an embodiment of a computing device 100 in which the processor communicates directly with main memory 322 via a memory port 303. For example, in FIG. 3B the main memory 322 may be DRDRAM.
[0076] FIG. 3B depicts an embodiment in which the main processor 321
communicates directly with cache memory 340 via a secondary bus, sometimes referred to as a backside bus. In other embodiments, the main processor 321 communicates with cache memory 340 using the system bus 350. Cache memory 340 typically has a faster response time than main memory 322 and is typically provided by SRAM, BSRAM, or EDRAM. In the embodiment shown in FIG. 3 A, the processor 321 communicates with various I/O devices 330 via a local system bus 350. Various buses may be used to connect the central processing unit 321 to any of the I/O devices 330, including a VESA VL bus, an ISA bus, an EISA bus, a MicroChannel Architecture (MCA) bus, a PCI bus, a PCI-X bus, a PCI-Express bus, or a NuBus. For embodiments in which the I/O device is a video display 324, the processor 321 may use an Advanced Graphics Port (AGP) to communicate with the display 324. FIG. 3B depicts an embodiment of a computer 100 in which the main processor 321 communicates directly with I/O device 330b via HYPERTRANSPORT, RAPIDIO, or INFINIBAND communications technology. FIG. 3B also depicts an embodiment in which local buses and direct communication are mixed: the processor 321 communicates with I/O device 330a using a local interconnect bus 350 while communicating with I/O device 330b directly. [0077] A wide variety of I/O devices 330a-330n may be present in the computing device 100. Input devices include keyboards, mice, trackpads, trackballs, microphones, and drawing tablets. Output devices include video displays, speakers, inkjet printers, laser printers, and dye-sublimation printers. The I/O devices may be controlled by an I/O controller 323 as shown in FIG. 3A. The I/O controller may control one or more I/O devices such as a keyboard 326 and a pointing device 327, e.g., a mouse or optical pen. Furthermore, an I/O device may also provide storage and/or an installation medium 316 for the computing device 100. In still other embodiments, the computing device 100 may provide USB connections (not shown) to receive handheld USB storage devices such as the USB Flash Drive line of devices manufactured by Twintech Industry, Inc. of Los Alamitos, California.
[0078] Referring again to FIG. 3 A, the computing device 100 may support any suitable installation device 316, such as a floppy disk drive for receiving floppy disks such as 3.5-inch, 5.25-inch disks or ZIP disks, a CD-ROM drive, a CD-R/RW drive, a DVD-ROM drive, tape drives of various formats, USB device, hard-drive or any other device suitable for installing software application programs. The computing device 300 may further comprise a storage device, such as one or more hard disk drives or redundant arrays of independent disks, for storing an operating system and other related software, and for storing software application programs. Optionally, any of the installation devices 316 could also be used as the storage device. Additionally, the operating system and the software can be run from a bootable medium, for example, a bootable CD, such as K OPPIX, a bootable CD for GNU/Linux that is available as a GNU/Linux distribution from knoppix.net.
[0079] Furthermore, the computing device 100 may include a network interface 318 to interface to a network 304 (described in greater detail below in connection with FIG. 3C) through a variety of connections including, but not limited to, standard telephone lines, LAN or WAN links (e.g., 802.1 1 , Tl , T3, 56kb, X.25, SNA, DECNET), broadband connections (e.g., ISDN, Frame Relay, ATM, Gigabit Ethernet, Ethernet-over- SONET), wireless connections, or some combination of any or all of the above. Connections can be established using a variety of communication protocols (e.g., TCP/IP, IPX, SPX, NetBIOS, Ethernet, ARCNET, SONET, SDH, Fiber Distributed Data Interface (FDDI), RS232, IEEE 802.1 1 , IEEE 802.1 la, IEEE 802.1 lb, IEEE 802.1 lg, CDMA, GSM, WiMax and direct
asynchronous connections). In one embodiment, the computing device 100 communicates with other computing devices 100' via any type and/or form of gateway or tunneling protocol such as Secure Socket Layer (SSL) or Transport Layer Security (TLS). The network interface 318 may comprise a built-in network adapter, network interface card, PCMCIA network card, card bus network adapter, wireless network adapter, USB network adapter, modem or any other device suitable for interfacing the computing device 100 to any type of network capable of communication and performing the operations described herein.
[0080] In some embodiments, the computing device 100 may comprise or be connected to multiple display devices 324a-324n, which each may be of the same or different type and/or form. As such, any of the I/O devices 330a-330n and/or the I/O controller 323 may comprise any type and/or form of suitable hardware, software, or combination of hardware and software to support, enable or provide for the connection and use of multiple display devices 324a-324n by the computing device 100. For example, the computing device 100 may include any type and/or form of video adapter, video card, driver, and/or library to interface, communicate, connect or otherwise use the display devices 324a-324n. In one embodiment, a video adapter may comprise multiple connectors to interface to multiple display devices 324a-324n. In other embodiments, the computing device 100 may include multiple video adapters, with each video adapter connected to one or more of the display devices 324a-324n. In some embodiments, any portion of the operating system of the computing device 100 may be configured for using multiple displays 324a-324n. In other embodiments, one or more of the display devices 324a-324n may be provided by one or more other computing devices, such as computing devices 100a and 100b connected to the computing device 100, for example, via a network. These embodiments may include any type of software designed and constructed to use another computer's display device as a second display device 324a for the computing device 100. One ordinarily skilled in the art will recognize and appreciate the various ways and embodiments that a computing device 100 may be configured to have multiple display devices 324a-324n.
[0081] In further embodiments, an I/O device 330 may be a bridge between the system bus 350 and an external communication bus, such as a USB bus, an Apple Desktop Bus, an RS-232 serial connection, a SCSI bus, a Fire Wire bus, a Fire Wire 800 bus, an Ethernet bus, an AppleTalk bus, a Gigabit Ethernet bus, an Asynchronous Transfer Mode bus, a HIPPI bus, a Super HIPPI bus, a SerialPlus bus, a SCI/LAMP bus, a FibreChannel bus, or a Serial Attached small computer system interface bus. [0082] A computing device 100 of the sort depicted in FIGs. 3 A and 3B typically operates under the control of an operating system, which controls scheduling of tasks and access to system resources. The computing device 100 can be running any operating system such as any of the versions of the MICROSOFT WINDOWS operating systems, the different releases of the Unix and Linux operating systems, any version of the MAC OS for Macintosh computers, any embedded operating system, any real-time operating system, any open source operating system, any proprietary operating system, any operating systems for mobile computing devices, or any other operating system capable of running on the computing device and performing the operations described herein. Typical operating systems include, but are not limited to: WINDOWS 3.x, WINDOWS 95, WINDOWS 98, WINDOWS 2000, WINDOWS NT 3.51, WINDOWS NT 4.0, WINDOWS CE, WINDOWS XP, and
WINDOWS VISTA, all of which are manufactured by Microsoft Corporation of Redmond, Washington; MAC OS, manufactured by Apple Inc., of Cupertino, California; OS/2, manufactured by International Business Machines of Armonk, New York; and Linux, a freely-available operating system distributed by Caldera Corp. of Salt Lake City, Utah, or any type and/or form of a Unix operating system, among others.
[0083] The computing device 100 can be any workstation, desktop computer, laptop or notebook computer, server, handheld computer, mobile telephone or other portable telecommunication device, media playing device, a gaming system, mobile computing device, or any other type and/or form of computing, telecommunications or media device that is capable of communication and that has sufficient processor power and memory capacity to perform the operations described herein.
[0084] In some embodiments, the computing device 100 may have different processors, operating systems, and input devices consistent with the device. In other embodiments, the computing device 100 is a smart phone. In still other embodiments, the computing device 100 comprises a combination of devices, such as a mobile phone combined with a digital audio player or portable media player. Moreover, the computing device 100 can be any workstation, desktop computer, laptop or notebook computer, server, handheld computer, mobile telephone, any other computer, or other form of computing or
telecommunications device that is capable of communication and that has sufficient processor power and memory capacity to perform the operations described herein. [0085] Referring now to FIG. 3C, an embodiment of a network environment is depicted. In brief overview, the network environment comprises one or more clients 302a- 302n (also generally referred to as local machine(s) 302, client(s) 302, client node(s) 302, client machine(s) 302, client computer(s) 302, client device(s) 302, endpoint(s) 302, or endpoint node(s) 302) in communication with one or more remote machines 306a-306n (also generally referred to as server(s) 306 or remote machine(s) 306) via one or more networks 304. In some embodiments, a client 302 has the capacity to function as both a client node seeking access to resources provided by a server and as a server providing access to hosted resources for other clients 302a-302n. A client 302 may execute, operate or otherwise provide an application, which can be any type and/or form of software, program, or executable instructions such as any type and/or form of web browser, web-based client, client-server application, a thin-client computing client, an ActiveX control, or a Java applet, or any other type and/or form of executable instructions capable of executing on client 302.
[0086] Although FIG. 3C shows a network 304 between the clients 302 and the remote machines 306, the clients 302 and the remote machines 306 may be on the same network 304. The network 304 can be a local-area network (LAN), such as a company Intranet, a metropolitan area network (MAN), or a wide area network (WAN), such as the Internet or the World Wide Web. In some embodiments, there are multiple networks 304 between the clients 302 and the remote machines 306. In one of these embodiments, a network 304' (not shown) may be a private network and a network 304 may be a public network. In another of these embodiments, a network 304 may be a private network and a network 304' a public network. In still another embodiment, networks 304 and 304' may both be private networks. In yet another embodiment, networks 304 and 304' may both be public networks.
[0087] The network 304 may be any type and/or form of network and may include any of the following: a point to point network, a broadcast network, a wide area network, a local area network, a telecommunications network, a data communication network, a computer network, an ATM (Asynchronous Transfer Mode) network, a SONET
(Synchronous Optical Network) network, a SDH (Synchronous Digital Hierarchy) network, a wireless network and a wireline network. In some embodiments, the network 304 may comprise a wireless link, such as an infrared channel or satellite band. The topology of the network 304 may be a bus, star, or ring network topology. The network 304 may be of any such network topology as known to those ordinarily skilled in the art capable of supporting the operations described herein. The network may comprise mobile telephone networks utilizing any protocol or protocols used to communicate among mobile devices, including AMPS, TDMA, CDMA, GSM, GPRS or UMTS. In some embodiments, different types of data may be transmitted via different protocols. In other embodiments, the same types of data may be transmitted via different protocols.
[0088] In some embodiments, the system may include multiple, logically-grouped remote machines 306. In one of these embodiments, the logical group of remote machines may be referred to as a server farm 38. In another of these embodiments, the remote machines 306 may be geographically dispersed. In other embodiments, a server farm 38 may be administered as a single entity. In still other embodiments, the server farm 38 comprises a plurality of server farms 38. The remote machines 306 within each server farm 38 can be heterogeneous - one or more of the remote machines 306 can operate according to one type of operating system platform (e.g., WINDOWS NT, WINDOWS 2003, WINDOWS 2008, manufactured by Microsoft Corp. of Redmond, Washington), while one or more of the other remote machines 306 can operate on according to another type of operating system platform (e.g., Unix or Linux).
[0089] The remote machines 306 of each server farm 38 do not need to be physically proximate to another remote machine 306 in the same server farm 38. Thus, the group of remote machines 306 logically grouped as a server farm 38 may be interconnected using a wide-area network (WAN) connection or a metropolitan-area network (MAN) connection. For example, a server farm 38 may include remote machines 306 physically located in different continents or different regions of a continent, country, state, city, campus, or room. Data transmission speeds between remote machines 306 in the server farm 38 can be increased if the remote machines 306 are connected using a local-area network (LAN) connection or some form of direct connection.
[0090] A remote machine 306 may be a file server, application server, web server, proxy server, appliance, network appliance, gateway, application gateway, gateway server, virtualization server, deployment server, SSL VPN server, or firewall. In some
embodiments, a remote machine 306 provides a remote authentication dial-in user service, and is referred to as a RADIUS server. In other embodiments, a remote machine 306 is a blade server. In still other embodiments, a remote machine 306 executes a virtual machine providing, to a user or client computer 302, access to a computing environment.
[0091] It should be understood that the systems described above may provide multiple ones of any or each of those components and these components may be provided on either a standalone machine or, in some embodiments, on multiple machines in a distributed system. The systems and methods described above may be implemented as a method, apparatus or article of manufacture using programming and/or engineering techniques to produce software, firmware, hardware, or any combination thereof. In addition, the systems and methods described above may be provided as one or more computer-readable programs embodied on or in one or more articles of manufacture. The term "article of manufacture" as used herein is intended to encompass code or logic accessible from and embedded in one or more computer-readable devices, firmware, programmable logic, memory devices (e.g., EEPROMs, ROMs, PROMs, RAMs, SRAMs, etc.), hardware (e.g., integrated circuit chip, Field Programmable Gate Array (FPGA), Application Specific Integrated Circuit (ASIC), etc.), electronic devices, a computer readable non-volatile storage unit (e.g., CD-ROM, floppy disk, hard disk drive, etc.). The article of manufacture may be accessible from a file server providing access to the computer-readable programs via a network transmission line, wireless transmission media, signals propagating through space, radio waves, infrared signals, etc. The article of manufacture may be a flash memory card or a magnetic tape. The article of manufacture includes hardware logic as well as software or programmable code embedded in a computer readable medium that is executed by a processor. In general, the computer-readable programs may be implemented in any programming language, such as LISP, PERL, C, C++, C#, PROLOG, or in any byte code language such as JAVA. The software programs may be stored on or in one or more articles of manufacture as object code.
[0092] Having described certain embodiments of methods and systems for verifying, via a radio-frequency identification tag, completeness of an analysis of a sample in a chemical analytical procedure, it will now become apparent to one of skill in the art that other embodiments incorporating the concepts of the disclosure may be used. Therefore, the disclosure should not be limited to certain embodiments, but rather should be limited only by the spirit and scope of the following claims.

Claims

CLAIMS What is claimed is:
1. A method for verifying, via a radio-frequency identification tag, completeness of an analysis of a sample in a chemical analytical procedure, the method comprising: storing, by a radio-frequency identification tag, an indication of completion of at least one of a plurality of steps in a chemical analytical procedure;
receiving, by a computing device, a request for initiation of a subsequent step in the plurality of steps in the chemical analytical procedure;
requesting, by the computing device, from the radio-frequency identification tag, an identification of a number of completed steps in the plurality of steps in the chemical analytical procedure; and
authorizing, by the computing device, initiation of the subsequent step in the plurality of steps in the chemical analytical procedure, responsive to receiving the identification of the number of completed steps in the plurality of steps.
2. The method of claim 1, wherein storing further comprises storing, by the radio- frequency identification tag, an indication of completion of an analysis of a test sample.
3. The method of claim 1, wherein storing further comprises storing, by the radio- frequency identification tag, an indication of completion of an analysis of a control sample.
4. The method of claim 1, wherein storing further comprises storing, by the radio- frequency identification tag, an indication of completion of a temperature control process.
5. The method of claim 1 further comprising authorizing, by the computing device, initiation of the subsequent step in the plurality of steps in the chemical analytical procedure, responsive to confirming an association between the radio-frequency identification tag and a patient identifier.
6. The method of claim 1 further comprising authorizing, by the computing device, initiation of the subsequent step in the plurality of steps in the chemical analytical procedure, responsive to confirming an association between the radio-frequency identification tag and a sample cell identifier.
7. The method of claim 1 further comprising authorizing, by the computing device, initiation of the subsequent step in the plurality of steps in the chemical analytical procedure, responsive to confirming an association between the radio-frequency identification tag with a test sample identifier.
8. The method of claim 1 further comprising authorizing, by the computing device, initiation of the subsequent step in the plurality of steps in the chemical analytical procedure, responsive to confirming an association between the radio-frequency identification tag with a control sample identifier.
9. The method of claim 1 further comprising determining, by the computing device, that an analysis of a sample during a chemical analytical procedure has occurred, responsive to information retrieved from the radio-frequency identification tag.
10. The method of claim 1 further comprising preventing, by the computing device, initiation of the subsequent step in the plurality of steps in the chemical analytical procedure, responsive to receiving an indication of completion of the at least one of the plurality of steps.
11. A system for verifying, via a radio-frequency identification tag, completeness of an analysis of a sample in a chemical analytical procedure comprising:
a radio-frequency identification tag storing an indication of completion of at least one of a plurality of steps in a chemical analytical procedure; and a computing device i) receiving a request for initiation of a subsequent step in the plurality of steps in the chemical analytical procedure, ii) requesting, from the radio-frequency identification tag, an identification of a number of completed steps in the plurality of steps in the chemical analytical procedure and iii) authorizing initiation of the subsequent step in the plurality of steps in the chemical analytical procedure, responsive to receiving the identification of the number of completed steps in the plurality of steps.
12. The system of claim 11, wherein the radio-frequency identification tag further
comprises a radio-frequency identification label.
13. The system of claim 11, wherein the system further comprises a radio-frequency
identification tag reader in communication with the radio-frequency identification tag.
14. The system of claim 11, wherein the computing device further comprises a receiver receiving, from the radio-frequency identification tag, an indication that the at least one of the plurality of steps in the chemical analytical procedure is complete.
15. The system of claim 11, wherein the computing device further comprises an
application receiving the indication of completion of the at least one of the plurality of steps in the chemical analytical procedure and transmitting, to the radio-frequency identification tag, the indication of completion of the at least one of a plurality of steps in the chemical analytical procedure.
16. The system of claim 11, wherein the computing device further comprises an
application receiving the request for initiation of the subsequent step in the plurality of steps in the chemical analytical procedure and transmitting, to the radio-frequency identification tag, a request for the identification of the number of completed steps in the plurality of steps in the chemical analytical procedure.
17. The system of claim 11 further comprising a chemical analysis component receiving, from the computing device, an instruction to initiate the second of the plurality of steps in the chemical analytical procedure.
18. The system of claim 11 further comprising a temperature control device receiving, from the computing device, an instruction to initiate the second of the plurality of steps in the chemical analytical procedure.
19. The system of claim 11, wherein the computing device further comprises means for determining, responsive to information received from the radio-frequency
identification tag, that the one of the plurality of steps in the chemical analytical procedure is incomplete.
20. The system of claim 11, wherein the computing device further comprises means for determining, responsive to information received from the radio-frequency
identification tag, that the sample cell previously underwent spectral analysis.
21. A system for verifying, via a radio-frequency identification tag, completeness of an analysis of a sample in a chemical analytical procedure, comprising:
means for transmitting, to a radio-frequency identification tag, an indication of completion of at least one of a plurality of steps in a chemical analytical procedure;
means for receiving, by a computing device, a request for initiation of a subsequent step in the plurality of steps in the chemical analytical procedure; means for requesting, by the computing device, from the radio-frequency identification tag, an indication of a number of completed steps in the plurality of steps in the chemical analytical procedure; and
means for authorizing, by the computing device, initiation of the subsequent step in the plurality of steps in the chemical analytical procedure, responsive to receiving the identification of the number of completed steps in the plurality of steps.
22. The system of claim 21 further comprising means for associating the radio-frequency identification tag with a sample cell identifier.
23. The system of claim 21 further comprising means for associating the radio-frequency identification tag with a patient identifier.
24. The system of claim 21 further comprising means for associating the radio-frequency identification tag with a test sample identifier.
25. The system of claim 21 further comprising means for associating the radio-frequency identification tag with a control sample identifier.
26. The system of claim 21 further comprising means for determining, by the computing device, that an analysis of the sample cell during a chemical analytical procedure has occurred, responsive to information received from the radio-frequency identification tag.
27. The system of claim 21 further comprising means for storing, by the radio-frequency identification tag, the transmitted indication.
28. The system of claim 21 further comprising means for authorizing, by the computing device, initiation of the subsequent step in the plurality of steps in the chemical analytical procedure, responsive to confirming an association between the radio- frequency identification tag and a sample cell identifier.
29. The system of claim 21 further comprising means for authorizing, by the computing device, initiation of the subsequent step in the plurality of steps in the chemical analytical procedure, responsive to confirming an association between the radio- frequency identification tag and a patient identifier.
30. The system of claim 21 further comprising means for authorizing, by the computing device, initiation of the subsequent step in the plurality of steps in the chemical analytical procedure, responsive to confirming an association between the radio- frequency identification tag with a control sample.
31. The system of claim 21 further comprising means for authorizing, by the computing device, initiation of the subsequent step in the plurality of steps in the chemical analytical procedure, responsive to confirming an association between the radio- frequency identification tag with a test sample.
32. The system of claim 21 further comprising means for determining, by the computing device, that an analysis of a sample during a chemical analytical procedure has occurred, responsive to information retrieved from the radio-frequency identification tag.
33. The system of claim 21 further comprising means for preventing, by the computing device, initiation of the subsequent step in the plurality of steps in the chemical analytical procedure, responsive to receiving an indication of a lack of completion of the at least one of the plurality of steps.
PCT/US2010/051126 2009-10-06 2010-10-01 Verifying, via radio-frequency identification, completeness of a sample analysis in a chemical analytical procedure WO2011043996A1 (en)

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