Assembly for determining the presence or absence of an analyte in a blood sample and analysis unit comprising such an assembly

• US 9,480,428 B2
• Filed: 10/03/2012
• Issued: 11/01/2016
• Est. Priority Date: 10/05/2011
• Status: Active Grant

• Current Assignee: Biomerieux B.V. (Compagnie Merieux Alliance SAS)
• Original Assignee: Biomerieux B.V. (Compagnie Merieux Alliance SAS)
• Inventors: Colin, Bruno, Paris, Ccile, Goudard, Michel
• Primary Examiner(s): Crawford, Erik B
• Application Number:
  US14/350,238
• Publication Number:
  US 20140235970A1
• Time in Patent Office: 1,490 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150267 Modular design or construction, i.e. subunits are assembled separately before being joined together or the device comprises interchangeable or detachable modules
• CPC Class Codes: A61B 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• CPC Class Codes: A61B 5/150343 Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes sampling from within body cavities A61B5/150015, A61B5/150045
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150442 Blade-like piercing elements, e.g. blades, cutters, knives, for cutting the skin
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150549 Protectors removed by rotational movement, e.g. torsion or screwing
• CPC Class Codes: A61B 5/150618 Integrally moulded protectors, e.g. protectors simultaneously moulded together with a further component, e.g. a hub, of the piercing element
• CPC Class Codes: A61B 5/150717 manually removed
• CPC Class Codes: A61B 5/150824 by visual feedback
• CPC Class Codes: A61B 5/15105 Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
• CPC Class Codes: A61B 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61J 1/05 : for collecting, storing or administering blood, plasma or medical fluids multiple bags systems for separating or storing blood components A61M1/0209; Infusion or perfusion containers
• CPC Class Codes: B01L 2300/0672 : Integrated piercing tool
• CPC Class Codes: B01L 2300/0816 : Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/0825 : Test strips
• CPC Class Codes: B01L 3/5023 : with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: F04C 2270/0421 : Controlled or regulated
• CPC Class Codes: G01N 2333/16 : HIV-1, HIV-2
• CPC Class Codes: G01N 33/50 : Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing measuring or testing processes involving enzymes or microorganisms, compositions or test papers therefor; processes for forming such compositions, condition responsive control in microbiological or enzymological processes C12Q
• CPC Class Codes: G01N 33/54388 : based on lateral flow
• CPC Class Codes: G01N 33/558 : using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387

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 for assaying the presence or absence of at least one analyte in a sample of human or animal blood obtained by piercing skin or a blood vessel of the human or animal, the assembly comprising at least:

a hand transportable support;

a strip which is attached to the support and which includes an application area for applying the blood sample and at least one reagent required for a blood analysis;

a container configured to collect, store and provide the blood sample to the strip, said container being removably connected to the support in such a manner that the container may be alternatively arranged either in a storage configuration or in a use configuration in which the container may be placed close to the application area; and

a piercing member configured to pierce the skin or the blood vessel, the piercing member being inserted either totally or partially into the container and the piercing member being non-removably attached to the support while in use.

2. The assembly according to claim 1, further comprising:

a piece of fabric which is soaked in disinfectant product and which extends over an outer surface of the support; 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 attached to the support.

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 support.

5. The assembly according to claim 1, configured such that when the container is arranged in the storage configuration, the container is connected to the support by a compression means, said 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 support 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 support is formed by a casing, the casing exhibiting at least one aperture to clear the application area and at least one aperture to view the result of the assay at a test area; and

the strip is arranged inside the casing.

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

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 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 support 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 8, wherein the casing is an essentially parallelepiped cassette.

18. The assembly according to claim 8, wherein the strip is porous.

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

20. The assembly according to claim 13, wherein the container has a volume ranging between 60 microliters and 100 microliters.

21. The assembly according to claim 15, wherein the piece of fabric is folded at the outer surface of the support opposite to the application area.

22. An assay method that uses the assembly according to claim 1, the method comprising at least:

removing the container from the support 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.

23. An assembly for assaying the presence or absence of at least one analyte in a sample of human or animal blood obtained by piercing skin or a blood vessel of the human or animal, the assembly comprising at least:

a hand transportable support;

a strip which is attached to the support and which includes an application area for applying the blood sample and at least one reagent required for a blood analysis;

a container configured to collect, store and provide the blood sample to the strip, said container being removably connected to the support in such a manner that the container may be alternatively arranged either in a storage configuration or in a use configuration in which the container may be placed close to the application area;

a piercing member configured to pierce the skin or the blood vessel, the piercing member being inserted either totally or partially into the container;

a piece of fabric which is soaked in disinfectant product and which extends over an outer surface of the support; 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.

24. An assembly for assaying the presence or absence of at least one analyte in a sample of human or animal blood obtained by piercing skin or a blood vessel of the human or animal, the assembly comprising at least:

a hand transportable support;

a strip which is attached to the support and which includes an application area for applying the blood sample and at least one reagent required for a blood analysis;

a container configured to collect, store and provide the blood sample to the strip, said container being removably connected to the support in such a manner that the container may be alternatively arranged either in a storage configuration or in a use configuration in which the container may be placed close to the application area; and

a piercing member configured to pierce the skin or the blood vessel, the piercing member being non-removably attached to the support while in use.

25. An assay method that uses the assembly according to claim 24, the method comprising at least:

removing the container from the support 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.