WO2015070747A1

WO2015070747A1 - Test strip card

Info

Publication number: WO2015070747A1
Application number: PCT/CN2014/090850
Authority: WO
Inventors: 马义才; 顾敏; 马灵
Original assignee: 成都领御生物技术有限公司; 马义才
Priority date: 2013-11-14
Filing date: 2014-11-11
Publication date: 2015-05-21
Also published as: CN103675268A

Abstract

A test strip card capable of filtering a sample and provided with a storage medium (14) for storing information for detection, such as a standard curve or a coefficient parameter of a detected object. The test strip card comprises a card box (3) and a test strip (2) therein. A filter pad (5) used for filtering a sample is connected between a sample pad (4) and a marking pad (6) of the test strip (2). The storage medium (14) is mounted on the card box (3). When a sample is detected, a characteristic signal of a detection band (7) of the test strip (2) in the test strip card is acquired by an instrument with a signal detection function, and a standard curve or a coefficient parameter of a detected object is simultaneously read by the instrument from the storage medium (14), so as to calculate a single-component or multicomponent concentration of the sample. The test strip card has the characteristics of simplicity and quickness, high sensitivity, and flexibility in use when the test strip card is used for detecting a sample.

Description

Test strip card

Technical field

The invention belongs to the field of in vitro diagnosis, and particularly relates to a test information capable of filtering a sample by itself, storing a standard curve or a coefficient parameter of a test object with a storage medium 14 , and combining the instrument with the signal detection function to quickly detect a single sample Component or multi-component strip card.

Background technique

Immunochromatographic strip technology, which is mainly represented by colloidal gold strips, has been widely used in various aspects of immunoassays. The technology is simple and fast, and results are available in minutes. However, this technology has the following shortcomings:

(1) Blood samples need to be separated from the serum by instrumentation, and whole blood samples cannot be tested. Because: 1 red blood cells in the whole blood sample will prevent the smooth migration of the reactants on the test strip. 2 The red blood cell color (red) is similar to or the same as the colloidal gold display color (light red or purple), which may interfere with the detection result judgment. 3 Red blood cells interfere with many diagnostic assays. For example, in the detection of analytes, red blood cells may inhibit the binding between the paired components of specific structures; red blood cells have enzymatic activity, which may interfere with the detection signal. Utility Model Patent No. ZL03217482.9 discloses a technical solution for adding an erythrocyte filtration membrane between a colloidal gold conjugate of a colloidal gold test strip and a nitrocellulose membrane in an attempt to overcome the above-mentioned interference effect of red blood cells. : This technical measure is not overcome from the "source" component of the strip (sample pad 4), but the red blood cell filter membrane is introduced between the marker pad 6 of the colloidal gold test strip and the analysis membrane 8 ( That is, the "adhesive gold conjugate and the nitrocellulose membrane" of the test strip of the patent, the "improved" scheme for filtering red blood cells from the "downstream" component of the test strip does not effectively overcome the red blood cell pair marker pad 6 Interference with the binding reaction between the coating (gold standard-antigen/antibody) and the target analyte from the sample pad 4!

(2) The sample can only be qualitatively tested, and the sample cannot be quantitatively detected, and the multi-component quantitative detection of the sample cannot be realized. The solution disclosed in Patent No. ZL03217482.9 is the same as the prior art, and only the qualitative detection of the sample is realized, and the quantitative detection and multi-component simultaneous quantitative detection of the sample cannot be performed.

The use of the standard curve of the test substance to quantify the concentration of the test substance is the main method for quantifying the concentration of the sample in the current detection field. The standard curve is technically strong and the process is complicated, and it is inseparable from professional technicians. Recently developed storage media in the information field, such as RFID tags (also known as radio frequency identification tags), IC chips, magnetic codes, barcodes, etc., for information access identification is now widely used in computers, communications, electronics, commerce, transportation Control management and other fields. RFID tags, small size, large storage capacity, identification without manual intervention, is an ideal means of information access identification, but few people use it in biomedical testing.

In order to overcome the deficiencies of the prior art, the present invention provides a test information capable of filtering a sample by itself (the sample can be filtered when the whole blood is filtered), and using the self-contained storage medium 14 to store a standard curve or coefficient parameter of the test object. (The operator does not need to make the standard curve of the test object when testing the sample.) In combination with the instrument with signal detection function, the test strip for single-component or multi-component quantitative detection of the sample can be quickly realized. The invention is used for sample detection, and has the characteristics of simple and rapid, high sensitivity and objective result.

Summary of the invention

The technical scheme of the present invention is as follows:

The test strip card of the present invention comprises a cartridge 3 and a test strip 2 therein. The test strip 2 includes a sample pad 4, a filter pad 5, a marker pad 6, an analysis film 8, and an absorbent pad 9 which are sequentially attached to the substrate 1 by laps. The analysis membrane 7 has a detection strip 7. The detection belt 7 is one or many lines. The upper casing of the cartridge 3 is provided with a sample insertion hole 11 at a position corresponding to the test strip 4 of the test strip. The upper casing of the cartridge 3 is provided with a detection window 12 at a position corresponding to the test strip analysis film 8. A storage medium 14 is mounted on the cartridge 2.

The filter mat 5 of the test strip 2 includes a blood filter membrane.

The marker pad 6 of the test strip 2 is coated with a single specific molecule associated with a target analyte detected by a single marker, or a specific one associated with each target analyte coated with a marker corresponding to a different marker. a mixture of molecules.

The test strip 7 of the test strip 2 is coated with another specific molecule associated with detection of a certain target analyte, or a mixture of another specific molecule coated with detection of each target analyte.

The storage medium 14 on the cartridge 3 includes, but is not limited to, an RFID tag, an IC chip, a magnetic code, or a barcode. The storage medium 14 stores the standard curve or coefficient parameter of the sample for the quantitative sample concentration of the same batch test strip 2, the test strip batch number, the test strip validity period, the storage medium password, the clinical index reference value, and the test strip manufacturer information. Etc., and can read information such as the identity information of the object to be tested, the information of the detector, the name of the sample, the sample number, the date of detection, and the test result.

The standard curve of the sample stored in the storage medium 14 can be selected in various forms including, but not limited to, a corresponding relationship between the concentration of the sample standard series and the A _{detection zone} . The A _{detection zone is} defined as the detection zone signal strength measured by the concentration of the sample standard series.

After the absorbent pad 9 of the test strip 2 of the present invention, a test strip reaction end indicating label 10 can be overlapped. Correspondingly, the test strip reaction end point of the cartridge 3 indicates that the label 10 has a viewing window 13 corresponding thereto. The strip reaction end point indicator 10 includes, but is not limited to, a pH test strip having a discoloration range of 5-9.

The marking pad 6 of the test strip 2 of the present invention is a glass fiber membrane; the analysis membrane 8 of the test strip 2 is a nitrocellulose membrane, a nylon membrane, or a mixed membrane of nitrocellulose/cellulose acetate; The backing 1 is a polyester or plastic plate; the cartridge 3 is made of polyester, plastic, hard paper material, or other material.

The test strip 2 of the present invention is any test strip, including but not limited to a quantum dot label test strip, a colloidal gold label test strip, a colloidal selenium label strip, an upconversion phosphor label strip, and a nano rare earth fluorescent complex labeling test. Strips, nano-magnetic particle labeling strips, time-resolved chromatographic strips, chemiluminescent strips.

When the test strip of the present invention is used for sample detection, a liquid sample is applied to the sample insertion hole 11 of the test strip card. The liquid sample of the sample obtained by the sample pad 4 through the sample hole 11 is slowly pulled toward the rear end of the test strip 2 by capillary siphoning of the microporous filter under the pulling of the absorbent pad 9 at the other end of the test strip 2 ( The test strip reaction is completed by first reaching the marker pad 6 through the filter pad 5, reacting with the label conjugate of the marker pad 6, and continuing to migrate to the test strip 7 of the analysis membrane 8 to complete the strip reaction. During the osmosis process, the liquid sample is filtered in the filter pad area 5 after the "source" component (sample pad 4) of the test strip to prevent the interference in the sample from causing the test strip reaction to be performed after the filter mat 5 interference. A typical example is when the sample to be tested is a whole blood sample, the test strip filter pad 5 will prevent the red blood cells in the blood from passing through and only allow the serum to be filtered, and the filter pad 5 serves to separate the serum (red blood cells can not only Prevents the smooth migration of the sample on the test strip 2, and when the sample is tested with a colloidal gold test strip, the red color of the red blood cells will be affected by the red or magenta color displayed by the colloidal gold mark on the test strip. The authenticity and reliability of the results: When the test strip 2 is used for qualitative test of the sample, it will affect the observation and judgment of the test result; when the test strip 2 is used for quantitative test of the sample, it will affect the true signal strength of the test object accurately measured by the test instrument. , thereby affecting the quantitative concentration of the sample).

The test strip of the present invention collects the test strip in the test strip card by the instrument with the signal detection function (such as the reading instrument, the fluorescence detector, the magnetic signal detector, etc.) after the test strip is tested and the test strip is completed. The detection zone 7 characteristic signal is combined with the standard curve or coefficient parameter of the test object simultaneously read by the instrument from the storage medium 14 to calculate the single component or multi-component concentration of the sample.

The sample to be tested of the test strip card of the present invention may be from clinical or non-clinical blood, body fluid, urine, saliva, genital secretions or other liquid samples or viscous samples, wherein the clinical samples include infectious diseases, Samples of hormones, cardiovascular diseases, tumors, cancer, diabetes, autoimmune diseases, etc., non-clinical samples including food testing, environmental pollution testing, pesticide residue testing, biological contamination testing, biological agent testing, veterinary testing, drugs Samples such as detection.

Compared with the prior art, the present invention has the following beneficial effects:

(1) When the test strip card is used for sample detection, the sample can be filtered to reduce the interference effect of the components affected by the sample detection. For example, when the sample to be tested is a whole blood sample, the whole blood can be directly detected. When the existing test strip technology detects blood samples, it is necessary to separate the serum by using equipment such as a centrifuge or a centrifuge tube, and then perform detection, and the whole blood sample cannot be detected.

(2) Rapid and quantitative detection of sample components. A storage medium 14 is mounted on the test strip card of the present invention, and the storage medium 14 stores detection information such as a standard curve or a coefficient parameter of the test object. After the sample to be tested completes the chromatographic reaction on the test strip, the characteristic signal of the test strip 7 of the test strip 2 in the test strip card is collected by an instrument having a signal detecting function and is simultaneously read from the storage medium 14 by the instrument. The sample standard curve or coefficient parameter allows for rapid (in minutes) quantitative sample component concentration. Existing test strip technology does not have this function.

(3) When the test strip 2 in the test strip card of the invention adopts the quantum dot mark, the rapid and accurate quantitative detection of the sample multi-component can be simultaneously realized. Quantum Dots (QDs) are semiconductor nanocrystals with excellent spectral characteristics and photochemical stability developed in the 1990s. They have high fluorescence emission efficiency, wide excitation line range, narrow emission line range, and fluorescence lifetime. Long, Stokes displacement is large, the particle size is similar to biomolecules, and the surface can be multi-functional after modification. Quantum dots of different particle sizes, types and structures can produce sustained fluorescence peak spectra with different characteristic wavelengths, and the characteristic wavelength fluorescence peak spectra produced by the quantum dot mixture do not overlap. The corresponding reaction molecules of the test object are respectively labeled by using different quantum dots, and the mixture is coated on the test strip of the test strip of the present invention to react with the sample to be tested, and the specific fluorescent signal of the test strip can be measured within a few minutes. Quickly and accurately quantify sample multi-component concentrations. However, the existing test strip technology can only qualitatively detect samples, and can not achieve quantitative detection of samples, and can not achieve quantitative detection of multi-component samples.

(4) The reagents and materials in the test strip are not involved in activity inactivation and can be stored at room temperature for a long time.

DRAWINGS

Figure 1 is a top plan view of a preferred embodiment of the test strip card of the present invention (showing a test line in the inner test strip)

Figure 2 is a side view showing the structure of the test strip in the cartridge of the first preferred embodiment of the strip card of the present invention (the test strip adopts a test line)

Figure 3 is a top plan view of a preferred embodiment of the test strip card of the present invention (showing a plurality of test lines in the test strip)

Figure 4 is a side view showing the structure of the test strip in the cartridge of the first preferred embodiment of the test strip card of the present invention (the test strip adopts a plurality of test lines)

Figure 5 is a top plan view of another preferred embodiment of the test strip of the present invention (showing a test line in the test strip)

Figure 6 is a side elevational view of a test strip in another embodiment of the strip card of the present invention (the test strip adopts a test line). Figure 7: a plan view of another preferred embodiment of the test strip of the present invention Structure diagram (showing multiple test lines in the test strip)

Figure 8 is a side elevational view of the test strip of the cartridge in another preferred embodiment of the strip card of the present invention (the test strip uses a plurality of test lines).

1, underlay, 2, test strip, 3, cartridge, 4, sample pad, 5, filter pad, 6, marker pad, 7, test tape, 8, analysis membrane, 9, absorbent pad, 10, test strip reaction End point indicator label, 11, sample hole, 12, detection window, 13, observation window, 14, storage medium.

detailed description

The following embodiments and the accompanying drawings are only for further explanation of the present invention, and those skilled in the art should not limit the invention. Range of protection.

Embodiment 1

Figures 1-4 illustrate a first embodiment. Embodiment 1 is one of the preferred embodiments of the test strip card of the present invention.

In Figures 1-4, the strip card of the preferred embodiment includes a cartridge 3 and a strip 2 therein. The test strip 2 includes a sample pad 4, a filter pad 5, a marker pad 6, an analysis film 8, and an absorbent pad 9 which are sequentially attached to the substrate 1 by overlapping. The analysis membrane 8 has a detection strip 7. The upper casing of the cartridge 3 is provided with a sample insertion hole 11 at a position corresponding to the test strip 4 of the test strip. The upper casing of the cartridge 3 is provided with a detection window 12 at a position corresponding to the test strip analysis film 8. A storage medium 14 is mounted on the cartridge 3.

The filter mat 5 of the test strip 2 includes a blood filter membrane.

The test strip 7 of the test strip 2 may be one (shown in Figures 1 and 2) or a plurality of strips (shown in Figures 3 and 4). The test strip 7 is coated with another specific molecule associated with detection of a target analyte, or a mixture of another specific molecule coated with detection of each target analyte.

The marking pad 6 of the test strip 2 is a glass fiber membrane; the analysis membrane 8 of the test strip 2 is a nitrocellulose membrane, a nylon membrane, or a nitrocellulose/cellulose acetate mixed membrane; the bottom of the test strip 2 The liner 1 is a polyester or plastic plate; the cartridge 3 is made of polyester, plastic, hard paper material, or other material.

The test strip 2 is any test strip, which includes, but is not limited to, a quantum dot label test strip, a colloidal gold label test strip, a colloidal selenium label strip, an upconversion phosphor label strip, a nano rare earth fluorescent complex label strip, Nano magnetic particle labeling strip, time-resolved chromatographic strip, chemiluminescent strip.

When the test strip card is used for sample detection, the liquid sample is applied to the sample insertion hole 11 of the test strip card, and after the inner test strip 2 completes the reaction, the instrument with signal detection function (such as a reading instrument, fluorescence) The detector, the magnetic signal detector, etc.) collects the characteristic signal of the detection zone 7 of the test strip 2 in the test strip card and calculates the standard curve or coefficient parameter of the test object simultaneously read from the test strip card storage medium 14 by the instrument. A single component or multiple component concentration of the sample is obtained.

The sample to be tested of the test strip card may be from clinical or non-clinical blood, body fluid, urine, saliva, genital secretions or other liquid samples or viscous samples, wherein the clinical samples include infectious diseases, hormones, Samples of cardiovascular disease, cancer, cancer, diabetes, autoimmune diseases, etc., non-clinical samples including food testing, environmental pollution testing, pesticide residue testing, biological contamination testing, biological agent testing, veterinary testing, drug testing, etc. The sample inside.

Embodiment 2

Figures 5-8 illustrate a second embodiment. Embodiment 2 is another preferred embodiment of the test strip card of the present invention.

In Figures 5-8, the strip card of the preferred embodiment includes a cartridge 3 and a strip 2 therein. The test strip 2 includes a sample pad 4, a filter pad 5, a marker pad 6, an analysis film 8, an absorbent pad 9, and a test strip reaction end indicating label 10 which are sequentially attached to the substrate 1. The analysis membrane 8 has a detection strip 7. The upper surface of the cartridge 3 is opened at a position corresponding to the test strip 4 of the test strip. The sample hole 11 is added. The upper casing of the cartridge 3 is provided with a detection window 12 at a position corresponding to the test strip analysis film 8. The upper casing of the cartridge 3 is provided with an observation window 13 at a position corresponding to the test strip end point indicating label 10. A storage medium 14 is mounted on the cartridge 3.

The filter mat 5 of the test strip 2 includes a blood filter membrane.

The test strip 7 of the test strip 2 may be one (shown in FIGS. 5 and 6) or a plurality of strips (shown in FIGS. 7 and 8). The test strip 7 is coated with another specific molecule associated with detection of a target analyte, or a mixture of another specific molecule coated with detection of each target analyte.

The strip reaction end point indicator 10 includes, but is not limited to, a pH test strip having a discoloration range of 5-9. When the sample is tested, the test strip reaction end point on the test strip indicates that the label 10 can be colored according to the pH condition of the test strip reaction, to indicate whether the test strip reactant has sufficiently oozing through the test strip 7, indicating whether the strip reaction is sufficient, Whether the test result is valid.

When the test strip card is used for sample detection, the liquid sample is applied to the sample insertion hole 11 of the test strip card, and the test strip reaction end point label 10 of the inner test strip 2 indicates that the test strip 2 completes the reaction, and has The signal detection function instrument (such as the reading instrument, the fluorescence detector, the magnetic signal detector, etc.) collects the detection zone 7 characteristic signal of the test strip 2 in the test strip card and combines the instrument to simultaneously read from the test strip card storage medium 14 The sample standard curve or coefficient parameter is calculated to obtain a single component or multi-component concentration of the sample.

It should be noted that the test strip card of the present invention may have other improvements. For example, the storage medium 14 storing the detection information such as the standard curve of the test object may be mounted on the cartridge 3 of the test strip card. Directly installed on the test strip 2 in the test strip card; based on the same principle of the present invention, the test strip in the cartridge 3 can also be expanded and replaced with a biochip (including an antigen-antibody chip, a protein chip, a nucleic acid chip, a microfluidic chip), etc. Wait. Therefore, any other technical solutions formed by any equivalent replacement or equivalent transformation of the test strip of the present invention fall within the scope of protection of the present invention.

Claims

A test strip card comprising a cartridge (3) and a test strip (2) therein, the test strip (2) comprising a sample pad (4) and a marker pad (s) which are sequentially attached to the substrate (1) 6), the analysis membrane (8), the absorbent pad (9), the analysis membrane (8) has a detection belt (7), the detection belt (7) is one or more, and the upper casing of the cartridge (3) corresponds to A sample insertion hole (11) is opened at the position of the sample strip (4), and the upper surface of the cartridge (3) has a detection window (12) at a position corresponding to the analysis film (8) of the test strip, which is characterized in that :among them,

A filter pad (5) for filtering the sample is further connected between the sample pad (4) and the marking pad (6) of the test strip;

A storage medium (14) is also mounted on the cartridge (3).
The test strip according to claim 1, characterized in that the filter mat (5) of the test strip comprises a blood filter membrane.
The test strip of claim 1 wherein:

The marker pad (6) of the test strip (2) is coated with a single target molecule associated with a target analyte detected by a single marker, or: a target analyte coated with a marker corresponding to a different marker Detecting a mixture of related specific molecules;

The test strip (7) of the test strip (2) is coated with another specific molecule associated with detection of a target analyte, or a mixture of another specific molecule coated with detection of each target analyte.
A test strip according to claim 1, characterized in that the storage medium (14) on the cartridge (3) comprises an RFID tag, an IC chip, a magnetic code, or a barcode.
The test strip according to claim 1, wherein the storage medium (14) stores the same batch test strip (2) the sample standard curve or coefficient parameter for the quantitative sample concentration, and the test strip batch number. , test strip validity period, storage medium password, clinical index reference value, test strip manufacturer information, and can read the object identification information, detector information, sample name, sample number, date of detection, and test result information.
The test strip according to claim 5, characterized in that the standard curve of the test object stored in the storage medium (15) is available in various forms, including the concentration of the standard of the test object and the A test. Corresponding relationship curve between the bands ; the A detection band is defined as the detection band signal intensity measured by the concentration of the sample standard series.
The test strip of claim 1 wherein:

The marking pad (6) of the test strip (2) is a glass fiber membrane, and the analysis membrane (8) of the test strip (2) is a nitrocellulose membrane, a nylon membrane, or a nitrocellulose/cellulose acetate mixed membrane. ;

The underlayer (1) of the test strip (2) is a polyester or plastic plate;

The cartridge (3) is made of polyester, plastic, or a hard paper material.
The test strip according to claim 1, wherein the test strip (2) is any test strip comprising a quantum dot label test strip, a colloidal gold label test strip, a colloidal selenium label strip, and an upconversion. Phosphorescent labeling strip, nano rare earth fluorescent complex labeling strip, nano magnetic particle labeling strip, time-resolved chromatographic strip, chemiluminescent strip.
The test strip according to claim 1, wherein when the sample is detected, the instrument having the signal detecting function collects the test strip in the strip (2) the characteristic signal of the strip (7) and combines the instrument from the storage. The medium (14) is simultaneously read by the standard curve or coefficient parameter of the test object to calculate the single component or multi-component concentration of the sample.
A test strip according to claim 1, wherein the absorbent pad (9) of the test strip (2) is further overlapped with a test strip reaction end indicating label (10); 3) The test strip reaction end indication label (10) has an observation window (13) corresponding thereto.
The test strip according to claim 10, wherein said test strip reaction end point indicator (10) comprises a pH test strip having a discoloration range of 5-9.
A test strip according to claim 10, characterized in that the filter mat (5) of the test strip (2) comprises a blood filter membrane.
A test strip according to claim 10, wherein:

The marker pad (6) of the test strip (2) is coated with a single target molecule associated with a target analyte detected by a single marker, or: a target analyte coated with a marker corresponding to a different marker Detecting a mixture of related specific molecules;

The test strip (7) of the test strip (2) is coated with another specific molecule associated with detection of a target analyte, or a mixture of another specific molecule coated with detection of each target analyte.
A test strip according to claim 10, characterized in that the storage medium (14) on the cartridge (3) comprises an RFID tag, an IC chip, a magnetic code, or a barcode.
The test strip according to claim 10, characterized in that the storage medium (14) stores the same batch test strip (2) the sample standard curve or coefficient parameter for the quantitative sample concentration, and the test strip batch number , test strip validity period, storage medium password, clinical index reference value, test strip manufacturer information, and can read the object identification information, detector information, sample name, sample number, date of detection, and test result information.
The test strip according to claim 15, characterized in that the standard curve of the test object stored in the storage medium (14) has various forms to be selected, which includes the concentration of the test object standard series and the A test. Corresponding relationship curve between the bands ; the A detection band is defined as the detection band signal intensity measured by the concentration of the sample standard series.
A test strip according to claim 10, wherein:

The marking pad (6) of the test strip (2) is a glass fiber membrane, and the analysis membrane (8) of the test strip (2) is a nitrocellulose membrane, a nylon membrane, or a nitrocellulose/cellulose acetate mixed membrane. ;

The underlayer (1) of the test strip (2) is a polyester or plastic plate;

The cartridge (3) is made of polyester, plastic, or a hard paper material.
The test strip according to claim 10, wherein the test strip (2) is any test strip comprising a quantum dot label test strip, a colloidal gold label test strip, a colloidal selenium label strip, and an upconversion. Phosphorescent labeling strip, nano rare earth fluorescent complex labeling strip, nano magnetic particle labeling strip, time-resolved chromatographic strip, chemiluminescent strip.
The test strip according to claim 10, characterized in that, when the sample is detected, the test strip reaction end point indicating label (10) indicates that the sample is subjected to the test strip reaction on the test strip (2), and the instrument has a signal detecting function. Collecting the test strip in the test strip (2) detecting the characteristic signal of the strip (7) and calculating the single component or more of the sample by combining the standard curve or coefficient parameter of the test object read simultaneously from the storage medium (14) Component concentration.
A test strip according to claim 1 or 10, wherein the sample to be tested is from clinical or non-clinical Blood, body fluids, urine, saliva, genital tract secretions or other liquid samples or viscous samples, including clinical samples including infectious diseases, hormones, cardiovascular diseases, tumors, cancer, diabetes, autoimmune diseases Samples, non-clinical samples include food testing, environmental pollution testing, pesticide residue testing, biological contamination testing, biological agent testing, veterinary testing, drug testing.