WO2008122908A1

WO2008122908A1 - Method and device for gathering a fluid sample for screening purposes

Info

Publication number: WO2008122908A1
Application number: PCT/IB2008/051186
Authority: WO
Inventors: Johannes W. Weekamp
Original assignee: Koninklijke Philips Electronics N.V.
Priority date: 2007-04-04
Filing date: 2008-03-31
Publication date: 2008-10-16

Abstract

The present invention relates to a fluid sample take-up device for collection in a fast and controlled way, fluid samples such as body fluid ready for testing. In a first aspect, the present invention provides a fluid sample take-up device comprising a hollow tube having a first portion and a second portion remote from the first portion, an absorbent pad, e.g. for taking up a fluid sample such as for example a bodily fluid sample, within the first portion of the hollow tube, and extraction means for squeezing sample fluid from the absorbent pad towards the hollow tube so as to guide the sample fluid to the second portion through the hollow tube. The fluid sample is squeezed through the absorbent pad into the hollow tube. An advantage thereof is that the fluid sample is filtered by the absorbent pad, which allows particles and/or large proteins to be removed from the fluid sample, so that only the low viscosity part of the fluid sample is guided through the hollow tube.

Description

Method and device for gathering a fluid sample for screening purposes

FIELD OF THE INVENTION

The present invention relates to the field of testing fluids, such as bodily fluids for the presence of a substance such as, for example drugs, toxins, alcohol, glucose, cholesterol, urea, an antigen or antibody, pregnancy hormone etc., Such testing can be used to detect a condition such as for example inability to drive a car, illness or pregnancy, pathogenic content of water supplies or bathing or swimming water. The testing methods can be used for forensic testing and investigation. In particular oral fluids may be used for such testing.

BACKGROUND OF THE INVENTION

The standard procedure followed when performing diagnostic tests, for example medical investigations or drug testing, is to collect a bodily fluid sample, for example a saliva sample, by means of an absorbent collection pad or swab.

In particular for such saliva investigation, current methods are based on taking up saliva with a swab: cotton wrapped around a small stick.

After the take-up, saliva may be "washed off' the absorbent collection pad in a separate vial containing a buffer/saline solution. After mixing, the liquid buffer is presumed to contain the sample and is transferred to the diagnostic kit either by pouring or by pipetting. It is a disadvantage of this saliva collection method that at least two separate devices and multiple steps are required to perform a single test. Furthermore, these actions take a considerable time and skills.

An alternative solution is to collect the sample by means of an absorbent collection pad and to squeeze sample off the pad and drop it directly onto a diagnostic kit. In this case, only a single device is needed. Nevertheless, this solution has the disadvantage that contamination which is present in the saliva and both high and low viscosity parts are removed from the swab by this squeezing and are brought onto the diagnostic kit, where they can lead to false test results. By an additional filtering step the particles can be removed from the saliva. Furthermore, the viscosity can be adjusted by adding reagents. But then again at least two separate devices and multiple steps are required to perform a test. SUMMARY OF THE INVENTION

It is an object of the present invention to collect, in a fast and controlled way, fluid samples such as bodily fluid samples ready for testing. This proves important in particular for on-site testing/forensic investigation of fluids such as bodily fluids for the presence of pre-determined substances, such as for example roadside drugs testing.

The above objective is accomplished by a method and device according to the present invention.

Particular and preferred aspects of the invention are set out in the accompanying independent and dependent claims. Features from the dependent claims may be combined with features of the independent claims and with features of other dependent claims as appropriate and not merely as explicitly set out in the claims.

In a first aspect, the present invention provides a fluid sample take-up device comprising a hollow tube having a first portion and a second portion remote from the first portion, an absorbent pad, e.g. for taking up a fluid sample such as for example a bodily fluid sample, within the first portion of the hollow tube, and extraction means for squeezing sample fluid from the absorbent pad towards the hollow tube so as to guide the sample fluid to the second portion through the hollow tube. The fluid sample is squeezed through the absorbent pad into the hollow tube. An advantage thereof is that the fluid sample is filtered by the absorbent pad, which allows particles and/or large proteins to be removed from the fluid sample, so that only the low viscosity part of the fluid sample is guided through the hollow tube.

A fluid sample take-up device according to embodiments of the present invention may further comprise a micro fluidic sensor chip at the second portion of the hollow tube. This way, a sensor is integrated in the take-up device, which avoids additional steps have to be taken to transfer collected fluid sample e.g. onto a biosensor device. The microfluidic sensor chip may comprise a sensor for detecting the presence of a substance, such as e.g. a drug, a drug of abuse, a toxin, an alcohol, glucose, cholesterol, urea, an antigen or antibody. The microfluidic sensor chip may comprise a connector for connection to a read- out device.

Alternatively, a fluid sample take-up device according to embodiments of the present invention may comprising a syringe head on the second portion of the hollow tube. This way, filtered fluid samples, e.g. bodily fluid samples, may be transferred e.g. to external sensor devices. It is advantageous that an easy extrication of collected fluid, e.g. collected bodily fluid, is obtained.

A fluid sample take-up device according to embodiments of the present invention may furthermore comprise an overflow chamber in the hollow tube. Such overflow chamber may be used for storing superfluous fluid sample, which is not necessary e.g. for a screening operation to be performed.

In a fluid sample take-up device according to embodiments of the present invention, the absorbent pad may have the ability to saturate itself when placed in contact with the fluid sample. The more hydrophilic the absorbent pad is, the better and faster the fluid sample collection will be, in particular for bodily fluid sample.

According to embodiments of the present invention, the absorbent pad may comprise or consist of hydrophilic material, such as e.g. cotton, cellulose, a gel, a foam, rayon, or another synthetic material.

According to embodiments of the present invention, the absorbent pad of the fluid sample take-up device may be a cotton swab.

According to embodiments of the present invention, the absorbent pad may be provided with a hydrophilic membrane. This, again, enhances collecting of fluid specimens, e.g. bodily fluid specimens.

According to embodiments of the present invention, the hollow tube preferably comprises an indicator for indicating saturation of the absorbent pad. This may give an indication of the end of a sample collection time, e.g. a visual indication, thus providing comfort both to the sample taker and, in case of a bodily fluid sample being taken, to a person or patient from whom a bodily fluid sample is taken.

According to embodiments of the present invention, the extraction means may comprise a pressure exerting means for exerting a pressure onto the absorbent pad. This way, the fluid sample taken is more easily transferred into the hollow tube. The extraction means may be formed by a cap snugly fitting onto a housing comprising or forming the hollow tube. This way, a clean and easy way of sample collection is obtained, with low, e.g. reduced, the risk of contamination of the collected fluid sample. The extraction means may further comprise fins for assisting in applying pressure onto the absorbent pad. This eases the transferral of the collected fluid sample into the hollow tube.

According to embodiments of the present invention, the hollow tube may furthermore comprise reagents for preparing the collected fluid sample for future processing. The reagents may be dry reagents. The reagents may be used to prepare the collected fluid sample for further measurements or investigations. The reagents may change properties of the collected fluid sample e.g. adjust its viscosity.

In a second aspect, the present invention provides a method for collecting a fluid sample. The method comprises gathering a fluid sample by means of an absorbent pad on an first extremity of a hollow tube, and squeezing the fluid sample from the absorbent pad through the hollow tube. Thus a filtering of the collected bodily fluid sample is obtained, without separated steps to be carried out. The method thus obtained is easy and fast, and does not require particular skills.

According to embodiments of the present invention, the method may comprise gathering a fluid sample by means of an absorbent pad on a rod, moving the rod into a hollow tube, and squeezing the fluid sample from the absorbent pad through the hollow tube.

A method according to embodiments of the present invention may furthermore comprise extracting the fluid sample from a second extremity of the hollow tube. The extracting may comprise moving the fluid sample towards a sensor of a microfluidic sensor chip integrated on the second extremity of the hollow tube. Alternatively, the method may furthermore comprise providing the extracted fluid sample to a microfluidic sensor chip remote from the absorbent pad.

According to embodiments of the present invention, squeezing fluid sample may comprise filtering the fluid sample through the absorbent pad. According to embodiments of the present invention, squeezing fluid sample may be performed by exerting pressure onto the absorbent pad.

In a third aspect, the present invention provides the use of a sample take-up device according to any of the embodiments of the first aspect of the present invention for collecting and filtering a fluid sample. The fluid sample may be a body fluid such as any of saliva, blood, serum, plasma, urine, sweat or tears. The use of the sample take-up device may be for testing the fluid sample for the presence of a particular substance, such as e.g. a drug, a drug of abuse, a toxin, an alcohol, glucose, cholesterol, urea, an antigen or antibody. It is an advantage of embodiments of the present invention that they reduce or even eliminate the possibility of contamination of gathered fluid samples, e.g. bodily fluid samples.

BRIEF DESCRIPTION OF THE DRAWINGS

Fig. 1 is a side elevation of a fluid sample take-up device according to a first embodiment of the present invention. Fig. 2 is a side elevation of a fluid sample take-up device according to a second embodiment of the present invention.

Fig. 3 is a flow chart of a method for collecting a fluid sample according to a first embodiment of the present invention. Fig. 4 is a flow chart of a method for collecting a fluid sample according to a second embodiment of the present invention.

Fig. 5 illustrates different stages during the use of a fluid sample take-up device in accordance with Fig. 2 for collecting a fluid sample.

Fig. 6 illustrates a sequence of steps performed in accordance with an embodiment of the present invention, after having taken a fluid sample.

Fig. 7 illustrates a plurality of reader shape options.

Fig. 8 illustrates a fluid sample take-up device according to a further embodiment of the present invention, during different stages of the use thereof.

Fig 9 illustrates a cross-section of a micro fluidic sensor chip of the sample take-up device, with micro fluidic channels being visible.

Fig. 10 is a schematic representation of a fluid sample take-up device according to a further embodiment of the present invention.

Dashed boxes in block schematic diagrams are not necessary for the invention, but may be provided in embodiments of the present invention. In the different figures, the same reference signs refer to the same or analogous elements.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention will be described with respect to particular embodiments and with reference to certain drawings but the invention is not limited thereto but only by the claims. Any reference signs in the claims shall not be construed as limiting the scope. The drawings described are only schematic and are non-limiting. In the drawings, the size of some of the elements may be exaggerated and not drawn on scale for illustrative purposes. Where the term "comprising" is used in the present description and claims, it does not exclude other elements or steps. Where an indefinite or definite article is used when referring to a singular noun e.g. "a" or "an", "the", this includes a plural of that noun unless something else is specifically stated. Furthermore, the terms first, second and the like in the description and in the claims, are used for distinguishing between similar elements and not necessarily for describing a sequence, either temporally, spatially, in ranking or in any other manner. It is to be understood that the terms so used are interchangeable under appropriate circumstances and that the embodiments of the invention described herein are capable of operation in other sequences than described or illustrated herein.

Moreover, the terms top, bottom, over, under and the like in the description and the claims are used for descriptive purposes and not necessarily for describing relative positions. It is to be understood that the terms so used are interchangeable under appropriate circumstances and that the embodiments of the invention described herein are capable of operation in other orientations than described or illustrated herein.

Reference throughout this specification to "one embodiment" or "an embodiment" means that a particular feature, structure or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, appearances of the phrases "in one embodiment" or "in an embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment, but may. Furthermore, the particular features, structures or characteristics may be combined in any suitable manner, as would be apparent to one of ordinary skill in the art from this disclosure, in one or more embodiments. Similarly it should be appreciated that in the description of exemplary embodiments of the invention, various features of the invention are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various inventive aspects. This method of disclosure, however, is not to be interpreted as reflecting an intention that the claimed invention requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed embodiment. Thus, the claims following the detailed description are hereby expressly incorporated into this detailed description, with each claim standing on its own as a separate embodiment of this invention. Furthermore, while some embodiments described herein include some but not other features included in other embodiments, combinations of features of different embodiments are meant to be within the scope of the invention, and form different embodiments, as would be understood by those in the art. For example, in the following claims, any of the claimed embodiments can be used in any combination. In the description provided herein, numerous specific details are set forth. However, it is understood that embodiments of the invention may be practiced without these specific details. In other instances, well-known methods, structures and techniques have not been shown in detail in order not to obscure an understanding of this description. In the following reference will be made to a fluid sample take-up device in accordance with the present invention. The device may advantageously be used for sampling body fluids such as saliva but the present invention is not limited thereto. The device can be used to sample any fluid such as water in swimming baths and in the sea, contaminating or polluting fluids such as aqueous spills, animal or plant fluids, etc. the device may be used for sampling as part of forensic investigations. Accordingly, although the present invention will mainly be described with reference to sampling body fluids, it should be understood that this is described for example only.

Figs. 1 and 2 illustrate elevational views of a fluid sample take-up device 10 in accordance with a first embodiment and a second embodiment, respectively, of the present invention. Fig. 10 is a schematic illustration of a fluid sample take-up device 90 according to a further embodiment of the present invention. The devices may advantageously be used for sampling body fluids such as saliva. Henceforth they will be described as a bodily fluid sample take-up devices.

The bodily fluid sample take-up device 10 illustrated in Fig. 1 and Fig. 2 comprises, inside a housing 17, a hollow tube 11 having a first extremity 12 and a second extremity 13. An absorbent pad 14 for taking up bodily fluid sample is provided within the first extremity 12 when in its retracted position. The bodily fluid sample take-up device 90 illustrated in Fig. 10 comprises a hollow tube formed by a housing 17, the hollow tube having a first extremity 12 and a second extremity 13. The first extremity 12 is provided with a hole 91 for allowing fluid to pass. An absorbent pad 14 for taking up bodily fluid sample is provided at the first extremity 12, at or partially within the hole 91.

Thus, in embodiments of the present invention the hollow tube may be the same as a tubular housing 17, as illustrated in the embodiment of Fig. 10. In the following embodiments both a hollow tube 11 and a hollow housing 17 are described separately but it should be understood that in accordance with any of the embodiments of the present invention the hollow tube 11 and the hollow housing 17 can be integrated into a single tubular structure.

The absorbent pad 14 has the ability to saturate itself when placed in contact with the bodily fluid sample to be tested. The absorbent pad 14 may comprise a fluid sample absorbing material, such as e.g. cotton, cellulose, a bodily fluid absorbing gel, a bodily fluid absorbing foam, rayon or another synthetic material. The absorbent pad 14 may be provided with a hydrophilic membrane in order to enhance collecting of bodily fluid samples. The pad 14 preferably has filtering properties for filtering particles and large proteins. In particular embodiments, as illustrated in Fig. 2, the absorbent pad 14 may for example be a cotton swab. A cotton swab consists of a small wad 15 of cotton wrapped around the end of a small rod 16. In embodiments of the present invention making use of a cotton swab, the small rod 16 of the cotton swap is a hollow rod as is known for absorbent tips or cotton swabs that go by the name of "Q-tips". In alternative embodiments, wads of other absorbing materials may be wrapped around the end of a small solid hollow rod 16.

The hollow tube 11 is adapted to provide a fluid path between the absorbent pad 14 when located in the first extremity 12, and the second extremity 13. More particularly, the fluid path is provided at the inside of the hollow tube 11. In case of the absorbent pad 14 being in the form of a cotton swab as in Fig. 2, the fluid path between the absorbent pad, more particularly the cotton wad 15 thereof, and the second extremity, is via the hollow rod 16 and/or the hollow tube 11.

The hollow tube 11 may be provided in a housing 17, e.g. a tubular housing. The housing may be provided with a cap 18 to provide an environmental covering over the absorbent pad 14. Cap 18 may also be so arranged that movement of the cap breaks a seal and gives a clear indication that the device has been used. By this means re-use of the device can be prevented.

The housing 17 may be provided, as in the embodiments illustrated in Figs. 1, 2 and 10, with a micro fluidic sensor chip 20 connected to the second extremity 13 of the hollow tube 11. The micro fluidic sensor chip 20 comprises a sensor 21 and at least one connector 22 for being connected with read-out circuitry (not illustrated in Figs. 1 or 2, but reader 60 in Fig. 6). The microfluidic sensor chip 20 may be any suitable type of micro fluidic sensor chip, such as e.g. a microfluidic sensor chip based on magnetic effects or detection, on optical/visual effects or detection, etc. In the microfluidic sensor chip 20, a channel may be provided for flowing received bodily fluid sample towards a measuring chamber, where actual screening of the bodily fluid sample is performed. A schematic illustration of a microfluidic sensor chip 20 is illustrated in Fig. 9.

In use, a fluid such as a bodily fluid sample taken up by the absorbent pad 14 is squeezed through the absorbent pad 14, from the first extremity 12, through the hollow tube 11 towards the second extremity 13 thereof, where it may be applied to the sensor 21 of the micro fluidics sensor chip 20.

In embodiments of the present invention, a bodily fluid sample take-up device 10 may be provided with an overflow chamber 26 storing excessive bodily fluid sample not necessary for performing a analytical or diagnostic screening.

Fig. 3 is a flow chart of a method in accordance with embodiments of the present invention. In a first step 30, a bodily fluid sample is collected on an absorbent pad 14. This may for example be performed by collecting saliva from a test person's mouth. Alternatively, the absorbent pad 14 may be rubbed against a subject's body, e.g. along a subject's arm, to collect a sweat sample, or put into contact with the material or sample (urine, blood or other bodily fluids) to be tested.

In step 31 , an optional determination is made as to whether or not enough sample of bodily fluid has been collected. As soon as enough sample is collected on the absorbent pad 14, the absorbent pad 14 may be removed from the collection area, for example the absorbent pad may be removed from the test person's mouth. Determination of the sufficiency of the amount of bodily fluid sample present on the absorbent pad may be done by means of an indicator 19 or filter integrated in or co-operating with the absorbent pad 14, which indicates that sufficient bodily fluid sample has been collected. For example, an indicator 19 may be provided in the hollow tube 11, which changes properties, preferably visual properties such as colour, upon wetting. Alternatively, if the absorbent pad 14 itself is a combination of a hollow rod 16 and a wad 15 of absorbing material, the filter or indicator 19 may be integrated in or on the hollow rod 16. A fluid path is provided between the wad 15 or the absorbent pad 14 and the indicator 19, and the fluid path preferably is adapted so as to not directly come into contact with the bodily fluid sample, but so as to come into contact with bodily fluid sample only after it has been absorbed by the absorbent pad 14 or wad 15.

Once enough sample is collected, the sample take-up device 10, provided with a sensor as in the embodiments of Fig. 1 and Fig. 2 may be placed in a reader device, step 32. Although this is not strictly necessary for the present invention, preferably the reader device is calibrated for the measurement to be carried out, step 33. Thereafter, in step 34, the bodily fluid sample is squeezed through the absorbent pad 14 and through the hollow tube 11, towards the second extremity of the hollow tube 11. In order to perform such squeezing action, any pressure device, exerting a pressure force on the absorbent pad 14 so as to squeeze droplets of bodily fluid towards and into the hollow tube 11 may be used. Preferably, the pressure device is substantially sterile and does not contaminate the bodily fluid sample connected onto the absorbent pad 14. In embodiments of the present invention, cap 18 may be used as such a pressure device. Cap 18 may be formed so as to snugly fit in or over the housing 17. When sliding the cap 18 in or over the housing 17 towards the second extremity 13, the absorbent pad 14 may be compressed by the top 23 of the cap 18 and bodily fluid sample may be released from it, the bodily fluid sample, in accordance with the present invention, being pushed into the interior of the hollow tube 11. In case the absorbent pad 14 consists of an absorbent wad 15 and a hollow rod 16, the hollow rod 16 may be pressed into the hollow tube 11, dimensions of hollow rod 16 and hollow tube 11 being adapted to each other. The top 23 of cap 18 may optionally be provided with a stop 27, preferably a flexible stop 27 such as e.g. a rubber stop. Such flexible stop 27 acts as a soft pad to better squeeze the bodily fluid through the absorbent pad 14.

The hollow tube 11 may be provided at its first extremity 12 with a counter pressure plate or box 24, against which the absorbent pad 14 or wad 15 may be pressed in order to extricate drops of bodily fluid. The counter pressure plate or box 24 may have a shape adapted to the shape of the absorbent pad 14, for example it may be conical.

The cap 18 and/or the housing 17 may be provided with protrusions extending from a wall thereof, and allowing easier application of pressure so as to squeeze the absorbent pad 14. In the embodiment illustrated in Figs. 1 and 2, fins 28 are provided on the cap 18, which allow a user to hook two fingers around the fins 28, while at the same time hooking the thumb around the bottom of the bodily fluid take-up device 10, where the microfluidics sensor chip 20 is present. When moving fingers and thumb towards each other, the absorbent pad 14 is squeezed. According to alternative embodiments (not illustrated), the housing 17 can be provided with fins around which a user can hook the fingers, while at the same time hooking the thumb around the top 23 of the cap 18. Here again, when moving fingers and thumb towards each other, the absorbent pad 14 is squeezed. According to yet other embodiments (not illustrated) both housing 17 and cap 18 can be provided with one or more fins for applying a force to the absorbent pad 14.

By pressing the bodily fluid sample through the absorbent pad 14, particles and large molecule fractions are filtered out by the absorbent pad 14 and remain on the outside thereof. Only the low viscosity part without particles is pressed through the channel in the hollow tube 11. In embodiments of the present invention, dry reagents 25 may be provided in the absorbent pad 14 or at the inside of the tube 11 to prepare the bodily fluid sample for further measurements or investigations or to preserve the sample, for example.

In the embodiments illustrated in Figs. 1 and 2, bodily fluid sample pushed through the hollow tube 11 may be provided to a microfluidics sensor chip 20 where it is subject to an operation such as testing or screening, step 35. The operation may be testing for the presence of particular substances, such as e.g. a drug, a drug of abuse, a toxin, an alcohol, glucose, cholesterol, urea, an antigen or an antibody, etc. The operation may be a reaction such as an enzymatic reaction. The test results may be read out, step 36, by a reader adapted to cooperate with the micro fluidic sensor chip 20, as known to a person skilled in the art.

Fig. 4 illustrates a more elaborated flow chart of a method in accordance with embodiments of the present invention. As an illustration only, take-up devices in accordance with Fig. 1 may be used in such methods, but the invention is not limited thereto. Different method steps in accordance with the method set out in the flow chart of Fig. 4 have been illustrated in Fig. 5, relating to the take-up device of Fig. 2.

The left hand part of Fig. 5 illustrates a fresh sample take-up device 10, i.e. a sample take-up device 10 which has not been used for sample taking yet. The sample take-up device 10 is provided with a protective cap 18 over the absorbent pad 14, which cap 18 protects the absorbent pad 14 from contaminations.

In a first step 40, the cap 18 may be moved away or removed from the housing 17, thus revealing the absorbent pad 14. In preferred embodiments, the cap 18 may be placed on, e.g. slid over, the bottom part of the housing 17, e.g. over the micro fluidic sensor chip 20, step 41. By doing this, on the one hand contamination of the cap 18, as far as its inner side is concerned, is avoided, and on the other hand also destruction of the microfluidics sensor chip 20 during sample taking is avoided. The sample take-up device 10 with the cap 18 slid over the bottom part of the housing 17, revealing the absorbent pad 14, is illustrated in the middle part of Fig. 5.

The thus revealed absorbent pad 14 may be used for collection of bodily fluids, step 30, e.g. for collection of saliva from a test person's mouth. Such collection of bodily fluids is carried out until, step 31, for example an optional a determination is made that enough sample is present on the absorbent pad 14. It has been described above how such determination may be made. As soon as enough bodily fluid sample is present on the absorbent pad 14, the cap 18 may be placed back onto the housing 17, i.e. placed over the absorbent pad 14, step 42. This way, contamination of the sample taken is avoided.

Next, the sample take-up device 10 may be placed in a reader device, step 32. The reader may be calibrated for the measurement to be performed, step 33.

Thereafter, as in the previously described method embodiment, bodily fluid sample is squeezed through the absorbent pad 14 and through the hollow tube 11 , towards the second extremity 13 of the hollow tube 11, step 34. In order to perform such squeezing action, any pressure device, exerting a pressure force on the absorbent pad 14 so as to squeeze droplets of bodily fluid towards and into the hollow tube 11 may be used. The application of pressure is preferably done in such a way as to avoid contamination of the sample. Hence the application of pressure is preferably done without contamination with an additional fluid. Hence the application of pressure is preferably by a dry clean surface. In particularly preferred embodiments, the pressure is exerted by pushing the cap 18 onto the absorbent pad 14. In the embodiments illustrated in the right hand side of Fig. 5, the absorbent pad 14, consisting of a wad 15 and a hollow rod 16, is pushed with the hollow rod 16 into the hollow tube 11, until the wad 15 hits the counter pressure plates 24, e.g. having a conical or funnel shape. When pushing the cap 18 onto the absorbent pad 14 while the absorbent pad 14 is held by the counter pressure plates 24, bodily fluid sample is pushed through the absorbent pad 14 into the hollow tube 11. Particles and optionally a large molecule fraction are filtered out by the absorbent pad 14 and remain on the outside thereof. Only the liquid, e.g. low viscosity part without particles is pressed through the channel in the hollow tube 11.

Bodily fluid sample may be pushed through the hollow tube 11 until the sample is provided to or reaches a microfluidics sensor chip 20 where it is subject to another operation. The operation may be such as being tested, screened, investigated, step 35, for the presence of particular substances, such as e.g. a drug, a drug of abuse, a toxin, an alcohol, glucose, cholesterol, urea, an antigen or an antibody, etc.

The test results may be read out, step 36, by a reader adapted to cooperate with the microfluidic sensor chip 20, as known to a person skilled in the art. The bodily fluid sample take-up device may be removed from the reader and may be destroyed. The bodily fluid sample take-up devices in accordance with embodiments of the present invention preferably are disposables. The process between when the sample has been taken until after the screening result has been read out is illustrated in Fig. 6. In a first step, a sample take-up device 10 is loaded into a reader 60, which is provided with a loading port adapted for receiving at least the micro fluidics sensor chip 20. Once loaded, the reader 60 is calibrated. Thereafter, the bodily fluid sample is squeezed into the microfluidics sensor chip 20, and a measurement if performed, during which the sample is screened for the presence of pre-determined substances, such as e.g. a drug, a drug of abuse, a toxin, an alcohol, glucose, cholesterol, urea, an antigen, an antibody or the like. After performing the measurement or screening, the bodily fluid sample take-up device may be removed from the reader 60 and discarded. For the reader 60, different shapes are possible, having their loading ports for receiving at least the microfluidics sensor chip 20 at any suitable side thereof. A few examples are illustrated in Fig. 7, but the invention is not limited thereto.

In accordance with the embodiments of the present invention as described above, sample taking, optionally sample preparation and sample screening are all integrated into one single bodily fluid sample take-up device 10.

According to other embodiments of the present invention, sample screening is performed on a screening device separate from the bodily fluid sample take-up device. In that case, the sample take-up device 10 is not provided with a microfluidics sensor chip 20 but rather with a reservoir (not illustrated) and/or a syringe type of exit. Such sample take-up device 80 is illustrated in Fig. 8.

The basics of the bodily fluid sample take-up device 80 are as for the previously explained embodiments. Elements with like reference numbers refer to like or analogous elements. In this embodiment again, the bodily fluid sample take-up device 80 comprises a hollow tube 11 having a first extremity 12 and a second extremity 13. An absorbent pad 14 for taking up bodily fluid sample is provided within the first extremity 12. The absorbent pad 14 may be, but does not need to be, in the form of a wad 15 of absorbent material wrapped around the end of a small rod 16, as is the case in the embodiment illustrated in Fig. 8. The rod may be hollow. The hollow tube 11 is adapted to provide a fluid path between the absorbent pad 14 at the first extremity 12 and the second extremity 13. The hollow tube 11 may be provided in a housing 17, which may be provided with a cap 18 for covering the absorbent pad 14.

Contrary to the previous embodiments, in this embodiment the housing 17 is provided with a syringe type of outlet 81 connected to the second extremity 13 of the hollow tube 11. In use, bodily fluid sample taken up by the absorbent pad 14 is squeezed through the absorbent pad 14, from the first extremity 12, through the hollow tube 11 towards the second extremity 13 thereof, where it may be applied to the sensor of an external screening device (not illustrated) through the syringe type outlet 81. Again, the sample is filtered by the absorbent pad 14. Particles and optionally a large molecule fractions are filtered out by the absorbent pad 14 and remain on the outside thereof. Only the liquid, e.g. low viscosity part without particles is pressed through the channel in the hollow tube 11.

As in the previous embodiments, the bodily fluid sample take-up device 80 of this embodiment may be provided optionally with an indicator 19 or filter integrated in or co- operating with the absorbent pad 14, which indicates that sufficient bodily fluid sample has been collected.

As in the previous embodiments, the hollow tube 11 may be provided at its first extremity 12 with a counter pressure plate or box 24, against which the absorbent pad 14 or wad 15 may be pressed in order to extricate drops of bodily fluid. The counter pressure plate or box 24 may have a shape adapted to the shape of the absorbent pad 14, e.g. it may be conical or funnel shaped.

The cap 18 and/or the housing 17 may be provided with protrusions 28 extending from a wall thereof, and allowing easier application of pressure so as to squeeze the absorbent pad 14. In embodiments of the present invention, dry reagents 25 may be provided in the absorbent pad 14 or at the inside of the tube 11 to prepare the bodily fluid sample for further measurements.

Different method steps in accordance with the basics of the methods set out in the flow charts of Fig. 3 and Fig. 4, which are also applicable for the bodily fluid take-up devices in accordance with embodiments of the present invention, i.e. the flow charts referred to, but omitting the boxes relating to the reader, are illustrated in Fig. 8.

The left hand part of Fig. 8 illustrates a fresh sample take-up device 80, i.e. a sample take-up device 80 which is ready for use, but has not been used for sample taking yet. The sample take-up device 80 is provided with a protective cap 18 which has been put over the syringe type outlet 81.

The middle part of Fig. 8 illustrates a bodily fluid sample take-up device 80 after a sample has been taken, but before the sample is squeezed into the hollow tube 11. The protective cap 18 has been placed back over the absorbent pad 14. It can be seen, in particular from the middle part of Fig. 8, that in the embodiment illustrated the fins 28 are part of the syringe tip. The cap 18 may be provided with small protrusions 85. The fins 28 and the protrusions 85 may be used to squeeze the sample take-up device 80 between fingers.

The right hand part of Fig. 8 illustrates the situation when bodily fluid sample is squeezed out of the absorbent pad 14 and through the hollow tube 11, thus extricating drops of bodily fluid sample from the second extremity 13 of the hollow tube 11, for example for application to a sensor of an external diagnostic screening device (not illustrated).

The above-described embodiment thus relates to a bodily fluid syringe, e.g. a saliva syringe, with integrated filter, formed by the absorbent pad 14, and optionally provided with reagents for preparing the bodily fluid sample for further measurements. It is an advantage of embodiments of the present invention that bodily fluid take-up devices are provided which can be used for on-site or roadside screening of bodily fluid samples for presence of pre-determined substances, e.g. for on-site or roadside drug testing. However, the devices according to embodiments of the present invention are not limited to these application, but can more generally be used in all types of forensic, chemical, biological or medical testing where fluids are involved. Collection of fluids of any type and preparing them for processing, testing, screening, etc. according to embodiments of the present invention, is easy to perform and does not require particular skills of the person collecting the fluid samples.

It is to be understood that although preferred embodiments, specific constructions and configurations, as well as materials, have been discussed herein for devices according to the present invention, various changes or modifications in form and detail may be made without departing from the scope and spirit of this invention. For example, other materials may be used of the absorbent pad 14. Housing 17 and cap 18 may have a different shape than the shapes illustrated in the drawings. They may interact in a different way than illustrated in the drawings, e.g. the housing may slide over the cap, rather than the cap over the housing. Protrusions for exerting pressure may or may not be provided, and if they are provided, they may be provided in a different shape and/or in a different number and/or on a different location than illustrated in the appended drawings.

Claims

CLAIMS:

1. Fluid sample take-up device (10, 80, 90) comprising a hollow tube (11, 17) having a first portion (12) and a second portion (13) remote from the first portion (12) an absorbent pad (14) within the first portion (12) of the hollow tube (11, 17), extraction means (18) for squeezing sample fluid from the absorbent pad (14) towards the hollow tube (11, 17) so as to guide the sample fluid to the second portion (13) through the hollow tube (11, 17).

2. Fluid sample take-up device (10, 90) according to claim 1, further comprising a microfluidic sensor chip (20) at the second portion (13) of the hollow tube (11, 17).

3. Fluid sample take-up device (10, 90) according to claim 2, wherein the microfluidic sensor chip (20) comprises a sensor (21) for detecting the presence of a substance.

4. Fluid sample take-up device according to any of claims 2 or 3, wherein the microfluidic sensor chip (20) comprises a connector (22) for connection to a read-out device (60).

5. Fluid sample take-up device (80) according to claim 1, further comprising a syringe head (81) on the second portion (13) of the hollow tube (11, 17).

6. Fluid sample take-up device (10, 80, 90) according to any of the previous claims, furthermore comprising an overflow chamber (26) in the hollow tube (11, 17).

7. Fluid sample take-up device (10, 80, 90) according to any of the previous claims, wherein the absorbent pad (14) comprises a hydrophilic material.

8. Fluid sample take-up device (10, 80, 90) according to any of the previous claims, wherein the absorbent pad (14) is provided with a hydrophilic membrane.

9. Fluid sample take-up device (10, 80, 90) according to any of the previous claims, wherein the hollow tube (11, 17) comprises an indicator (19) for indicating saturation of the absorbent pad (14).

10. Fluid sample take-up device (10, 80) according to any of the previous claims, wherein the extraction means comprises a pressure exerting means for exerting a pressure onto the absorbent pad (14).

11. Fluid sample take-up device (10, 80) according to claim 10, wherein the extraction means is formed by a cap (18) snugly fitting onto a housing (17) comprising or forming the hollow tube (11, 17).

12. Fluid sample take-up device (10, 80) according to any of the previous claims, wherein the hollow tube (11, 17) furthermore comprises reagents (25) for preparing the collected fluid sample for future processing.

13. A method for collecting a fluid sample, comprising gathering (30) a fluid sample by means of an absorbent pad (14) on an first extremity of a hollow tube (11, 16, 17), and squeezing (34) the fluid sample from the absorbent pad (14) through the hollow tube (11, 16, 17).

14. A method according to claim 13, wherein gathering a fluid sample comprises gathering a fluid sample by means of an absorbent pad (14) on an first extremity of a rod (16), and moving the rod (16) into a hollow tube (11, 17).

15. A method according to claim 13, furthermore comprising providing the extracted fluid sample to a micro fluidic sensor chip remote from the absorbent pad (14).

16. A method according to any of claims 13 to 15, wherein squeezing (34) fluid sample comprises filtering the fluid sample through the absorbent pad (14).

17. Use of a fluid sample take-up device (10, 80) according to any of claims 1 to

12 for collecting and filtering a fluid sample.

18. Use according to claim 17 for testing the fluid sample for the presence of a particular substance.

19. Use according to claim 18, wherein the substance is a drug, a drug of abuse, a toxin, an alcohol, glucose, cholesterol, urea, an antigen or antibody.