ASSEMBLY FOR DETERMINING THE PRESENCE OR ABSENCE OF AN ANALYTE IN A BLOOD SAMPLE AND ANALYSIS UNIT COMPRISING SUCH AN ASSEMBLY

Abstract

This assembly includes: a transportable support; a strip attached to the support and including an application area for applying the sample and at least one reagent required for the analysis; a piercing member for piercing the skin and a blood vessel; and a container for collecting, storing and returning the sample of human or animal blood. The piercing member is inserted into the container. The tip is connected to the support. The container is connected to the support in a removable manner between a storage configuration and a use configuration, in which the container is placed close to the application area.

Claims

1. An assembly comprising: a casing configured to be transportable by hand; a strip attached to and arranged inside the casing, the strip comprising an application area for a blood sample and at least one reagent for a blood analysis; a piercing member connected to the casing and configured to pierce skin or a blood vessel; and a container configured to collect, store, and provide the blood sample to the strip, the container being removably connected to the casing such that the container may be alternatively arranged in a storage configuration or in a use configuration, in which the container may be placed close to the application area.

2. The assembly according to claim 1, further comprising: a piece of fabric which is soaked in disinfectant product and which is extends over an outer surface of the casing; and a sealed film, detachable and watertight, the film being arranged such as to cover the piece of fabric when the container is arranged in the storage configuration.

3. The assembly according to claim 1, configured such that when the container is arranged in the storage configuration, the container and the piercing member are each connected to the casing.

4. The assembly according to claim 3, configured such that when the container is arranged in the storage configuration, the piercing member is either totally or partially housed within a hollow volume of the container in which the sample may be contained, and the container is either totally or partially inserted into the casing.

5. The assembly according to claim 3, configured such that when the container is arranged in the storage configuration, the container is connected to the casing by a compression means, the compression means also being in connection with the piercing member.

6. The assembly according to claim 1, further comprising a sub plate which is fitted onto the piercing member, the container being attached onto the sub plate, wherein the assembly is configured such that when the container is arranged in the storage configuration, the container is connected to the casing by means of the piercing member.

7. The assembly according to claim 6, wherein the sub plate is formed by a cap arranged for blocking an end of the container, the cap being made of a resilient material so as to be able to be fitted onto the piercing member.

8. The assembly according to claim 1, wherein the casing has at least one aperture to clear the application area and at least one aperture to view a result of the blood analysis at a test area.

9. The assembly according to claim 1, wherein the piercing member is arranged protruding over an edge of the casing.

10. The assembly according to claim 1, wherein the piercing member is formed of a needle or a blade.

11. The assembly according to claim 1, wherein the container has essentially the form of a tube.

12. The assembly according to claim 1, wherein the container is made of a translucent or transparent material.

13. The assembly according to claim 1, wherein the container has a volume ranging between 30 microliters and 200 microliters.

14. An analysis unit comprising: a sterile packaging, and the assembly according to claim 1, the assembly being arranged in the sterile packaging.

15. The assembly according to claim 2, wherein the outer surface of the casing is a surface opposite to the application area.

16. The assembly according to claim 5, wherein the compression means is a spring.

17. The assembly according to claim 1, wherein the casing is an essentially parallelepiped cassette.

18. The assembly according to claim 1, wherein the strip is porous.

19. An assay method that uses the assembly according to claim 1, the method comprising: removing the container from the casing so that the container is in the use configuration; piercing skin or a blood vessel of a human or animal using the piercing member to obtain a blood sample; collecting the blood sample in the container; providing the blood sample from the container to the application area of the strip; and assaying for the presence or absence of at least one analyte in the blood sample.

Description

[0069] The present invention will be well understood and its advantages will become apparent in light of the following description, given only by way of non limiting example and with reference to the accompanying drawings in which:

[0070] FIG. 1 is a front view of an assembly according to the invention, in storage configuration;

[0071] FIG. 2 is a perspective view of the assembly of FIG. 1;

[0072] FIG. 3 is a view similar to FIG. 2 of the assembly of FIG. 2 in use configuration;

[0073] FIG. 4 is a view of the detail IV of FIG. 3;

[0074] FIG. 5 is a perspective view, according to an angle different from FIG. 2, of the assembly of FIG. 2, in storage configuration;

[0075] FIG. 6 is a view similar to FIG. 5 of the assembly of FIG. 5, in use configuration;

[0076] FIG. 7 is a view of a part of the assembly of FIG. 1, in the disassembled state;

[0077] FIG. 8 is a view similar to FIG. 3 of a part of an assembly according to an alternative embodiment of the invention, in storage configuration; and

[0078] FIG. 9 is a view of the assembly of FIG. 8 in use configuration.

[0079] FIGS. 1 and 2 illustrate an assembly 1 which has for function, in particular, to allow an assay with a view to determining the presence or absence of at least one analyte in a human or animal blood sample.

[0080] The assembly 1 comprises a support which is here defined by a casing 2 which is transportable by hand, for example by a user, as its encumbrance is low. In the example of FIGS. 1 and 2, the casing 2 forms an essentially parallelepiped cassette measuring around 70 mm35 mm6 mm.

[0081] Furthermore, the assembly 1 comprises a strip 4, for the analysis assay. The strip 4 is attached to the casing 4, as it is described hereinafter in association with FIG. 7. The strip 4 comprises an application area 6 where the blood sample is to be applied. The strip 4 is made from a porous material. The strip 4 further comprises at least one reagent required for the analysis. Such a reagent is suitable for reacting in presence of the analyte, such as to make appear the assay result at a test area 8 of the strip 4.

[0082] The assembly 1 further comprises a container 10 calibrated and suitable for collecting, storing and returning the sample of human or animal blood. To this end, the container 10 exhibits an aperture 10.1. Furthermore, the container has a volume of around 75 microliters. In the example of FIGS. 1 and 2, the container 10 has essentially the form of a tube with a circular base. The container 10 is composed of a translucent material, in this instance a transparent material.

[0083] As FIGS. 3 and 4 show, the assembly 1 further comprises a piercing member which is here defined by a needle 12 and which is suitable for piercing the skin and a blood vessel. To this end, the needle 12 exhibits a perforating end. The needle 12 may be for example made from a stainless steel.

[0084] Furthermore, the container 10 is removably connected to the casing 2 such that the container 10 may be arranged alternatively in a storage configuration (FIGS. 1 and 2) and a use configuration (FIGS. 3 and 4), in which the container 12 may be placed close to the application area 6.

[0085] The needle 12 is connected to the casing 2. In the example of FIGS. 3 and 4, the needle 12 is secured to a needle-holder 14 which belongs to the casing 2. The needle 12 is arranged protruding over an edge of the casing 2, in storage configuration (FIGS. 1 and 2) and in use configuration (FIGS. 3 and 4). The needle 12 is stationary or immovable with respect to the casing 2.

[0086] In storage configuration (FIGS. 1 and 2), the container 10 is connected to the casing 2 by means of the needle 12. In storage configuration (FIGS. 1 and 2), the container 10 is hence immobile with respect to the casing 2. To this end, the needle 12 is attached to the casing 2. The assembly 1 further comprises a sub plate for indirectly connecting the container 10 to the casing 2. The sub plate here is defined by a cap 16.

[0087] The cap 16 is attached to the container 10, for example with glue and the cap 16 is fitted onto the needle 12. Thus, the piercing member 12 is inserted (planted) into the cap 16 which belongs to the container 10.

[0088] The cap 16 is arranged in order to block an end 10.2 of the container 10. In the example of FIGS. 1 to 4, the cap 16 is made from a ductile material such that the cap 16 may be fitted onto the needle 12.

[0089] As FIGS. 5 and 6 show, the assembly 1 further comprises a piece of fabric 20 which is soaked in disinfectant product. The piece of fabric 20 is here formed by a wipe in a non-woven material. The piece of fabric 20 extends on the rear side 21 of the casing 2, that is to say, on the outer surface opposite the application area 6.

[0090] As FIG. 6 shows, the assembly 1 further comprises a detachable film 22 which is arranged such as to cover the piece of fabric 20. The detachable film 22 is watertight, particularly to disinfectant product. The detachable film 22 is here made from synthetic plastic material. In the example of FIG. 6, the piece of fabric 20 is folded at the outer surface 21 of the support 2 opposite the application area 6.

[0091] As FIG. 7 shows, the strip 4 is arranged inside the casing 2. The casing 2 exhibits an aperture for clearing the application area 6 and an opening for viewing the result of the assay at a test area 8.

[0092] The assembly 1 further comprises a rigid portion 24 which protrudes over an edge of the casing 2, such as to allow the detaching of the detachable film 22, hence the clearing of the piece of fabric 20. The rigid portion 24 may be formed by a band in synthetic or metallic material. The rigid portion 24 may be arranged between two strata of the detachable film 22. The rigid portion 24 may advantageously comprise an intelligible indication, written or by ideogram, to indicate to the user how to detach the detachable film 22.

[0093] As FIG. 7 shows, the casing 2 is formed of two half-shells, whereof one bears the reference 2.1 in FIG. 7. The half-shells 2.1 and equivalent delimit a hollow volume wherein the strip 4 and a portion of the needle 12 are housed.

[0094] Each half-shell 2.1 and equivalent comprises means for attaching a half-shell on the other half-shell, such as to assemble the casing 2. In the example of FIG. 7, the half-shell 2.1 comprises female snap-fitting portions 30 for elastically snap-fitting non represented male portions belonging to the non represented half-shell.

[0095] As FIG. 7 shows, the needle 12 is obtained by overmolding and remains sterile until its use, in particular when the container 10 is not detached from the support 2.

[0096] In service, a user has a non represented analysis unit in accordance with the invention. The user gets the assembly 1 out from its non represented sterile pack. In order to form an analysis unit in accordance with the invention, the assembly 1 is packed in a sterile environment.

[0097] Next, the user pulls the container 10 and the cap 16, such as to remove the needle 12. The user may place the container 10 and the cap 16 on a table beside the casing 2.

[0098] Then, the user pulls the rigid portion 24 to totally or partially detach the detachable film 22. The user may reach the thus cleared piece of fabric 20.

[0099] The user disinfects the skin at the place of the prick and the needle 12 if need be.

[0100] The user pricks the skin and a blood vessel using the needle 12, then collects, in the container 10, an adequate and required volume of blood for the analysis.

[0101] Next, the user places the container 10 close to the application area 6 such as to pour thereto the collected blood sample or return it.

[0102] Then, the blood sample becomes dispersed or migrates in the strip 4 to the reagent, which reacts if the analyte is present in the dispersed blood sample.

[0103] If possible, the user may view the result of the assay at the test area 8, depending on the presence or absence of an analyte in the collected blood sample.

[0104] Thus, the user can determine if the test is positive or negative.

[0105] FIGS. 8 and 9 illustrate an assembly 1 in accordance with an alternative embodiment of the invention. In as far as the assembly 1 of FIGS. 8 and 9 is similar to the assembly 1 of FIGS. 1 to 7, the description of the aforementioned assembly 1 in association with the FIGS. 1 to 7 may be transposed to the assembly 1 of FIGS. 8 and 9, except for the noticeable differences mentioned hereinafter.

[0106] The assembly 1 differs from the assembly 1, in particular, as in the assembly 1, the piercing member 12 is movable between the storage configuration (FIG. 8), in which the piercing member 12 is located inside the support 2, and the use configuration (FIG. 9), in which the piercing member 12 is partially brought out protruding with respect to an outer surface of the support 2. In the example of FIGS. 8 and 9, the piercing member 12 is arranged level with an outer surface of the support 2.

[0107] In addition, the assembly 1 differs from the assembly 1, as to move the piercing member 12 between the storage configuration (FIG. 8) and the use configuration (FIG. 9), the assembly 1 further comprises an elastic return member in compression, here symbolized by a helical spring 31, whereof the expansion releases the piercing member 12.

[0108] Furthermore, the assembly 1 comprises a control button 32 which is arranged on the support 2 such as to release the compression member (helical spring 31). The control button 32 cooperates for example by elastically snap-fitting with the compression member (helical spring 31).

[0109] In storage configuration, such as in the example of FIGS. 1 to 7, the container 10 is connected to the support by means of the piercing member 12, the piercing member 12 being slidingly connected to the support 2, the assembly 1 comprising a sub plate (cap 16) which is fitted, by overmolding, onto the piercing member 12, the container 10 being attached onto the sub plate (cap 16).

[0110] When the user presses the control button 32, the elastic snap-fitting releases the helical spring 31, which allows to move the piercing member 12 towards the use configuration (FIG. 9).

[0111] According to other advantageous but optional features, taken alone or according to any technically possible combination: [0112] The container is attached to the support and the piercing member is attached to the support, thus making a direct connection between the container and the support, alternatively to the indirect connection between the container 10 and the aforementioned casing 2. [0113] In storage configuration, the container may surround all or part of the piercing member, the container being totally or partially inserted in the support.