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.

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.