U.S. patent application number 15/274292 was filed with the patent office on 2017-01-12 for assembly for determining the presence or absence of an analyte in a blood sample and analysis unit comprising such an assembly.
This patent application is currently assigned to BIOMERIEUX. The applicant listed for this patent is BIOMERIEUX. Invention is credited to Bruno COLIN, Michel GOUDARD, Cecile PARIS.
Application Number | 20170007164 15/274292 |
Document ID | / |
Family ID | 47089060 |
Filed Date | 2017-01-12 |
United States Patent
Application |
20170007164 |
Kind Code |
A1 |
COLIN; Bruno ; et
al. |
January 12, 2017 |
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.
Inventors: |
COLIN; Bruno; (Marcy
l'Etoile, FR) ; PARIS; Cecile; (Bessenay, FR)
; GOUDARD; Michel; (Saint Genis Les Ollieres,
FR) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
BIOMERIEUX |
Marcy-l'Etoile |
|
FR |
|
|
Assignee: |
BIOMERIEUX
Marcy-l'Etoile
FR
|
Family ID: |
47089060 |
Appl. No.: |
15/274292 |
Filed: |
September 23, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
14350238 |
Apr 7, 2014 |
9480428 |
|
|
PCT/FR2012/052237 |
Oct 3, 2012 |
|
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15274292 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 5/1411 20130101;
A61B 5/150343 20130101; A61B 5/150022 20130101; A61B 5/150305
20130101; B01L 2300/0816 20130101; F04C 2270/0421 20130101; A61B
5/15117 20130101; A61B 2562/0295 20130101; A61B 5/150442 20130101;
A61B 5/150717 20130101; A61B 5/150412 20130101; A61B 5/15142
20130101; A61B 5/15113 20130101; G01N 33/558 20130101; A61B
5/150503 20130101; A61B 5/15105 20130101; A61B 5/150618 20130101;
G01N 33/50 20130101; B01L 3/5023 20130101; A61B 5/150549 20130101;
B01L 2300/0825 20130101; A61B 5/150358 20130101; B01L 2300/0672
20130101; A61B 5/150824 20130101; G01N 2333/16 20130101; A61B 5/157
20130101; A61B 5/145 20130101; A61B 5/150267 20130101; A61J 1/05
20130101 |
International
Class: |
A61B 5/157 20060101
A61B005/157; A61B 5/145 20060101 A61B005/145; G01N 33/50 20060101
G01N033/50; A61B 5/151 20060101 A61B005/151; B01L 3/00 20060101
B01L003/00; A61J 1/05 20060101 A61J001/05; A61B 5/15 20060101
A61B005/15 |
Foreign Application Data
Date |
Code |
Application Number |
Oct 5, 2011 |
FR |
1158998 |
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
[0001] This is a Continuation of application Ser. No. 14/350,238
filed Apr. 7, 2014, which is a PCT National Stage of
PCT/FR2012/052237 filed Oct. 3, 2012, which claims priority to FR
1158998 filed Oct. 5, 2011, The disclosures of the prior
applications are hereby incorporated by reference herein in their
entireties.
[0002] The present invention relates to an assembly for carrying
out an assay referred to as rapid test with a view to determining
the presence or absence of at least one analyte in a sample of
human or animal blood. Furthermore, the present invention relates
to an analysis unit comprising such an assembly. The present
invention is particularly used in the field of clinical and
industrial analyses.
[0003] Rapid tests or lateral flow tests are frequently used in the
clinical, food, pharmaceutical and chemical fields for determining
the presence or absence of various analytes, such as antibodies,
antigens, hormones, proteins and chemical molecules in liquid
samples, such as blood samples. Rapid tests are commercialized
either in the form of simple strips comprising all the physical and
biological elements required for the analysis, or in the form of a
cassette in which the flow test is included.
[0004] By way of example patent application US2006172435A1
describes a rapid test for carrying out an assay with a view to
determining the presence or absence of an analyte in a human or
animal blood sample. The rapid test of document US2006172435A1
includes a hand transportable casing and a strip which is attached
to the casing and which exhibits an application area for applying
the blood sample. The strip comprises a reagent suitable for
reacting in presence of the analyte, so as to modify the visual
aspect of a test area of the strip.
[0005] In practice, in order to carry out an assay called rapid
test, there are several prior actions to be performed in hygienic
and safe conditions: local disinfecting of the collecting area,
making available the piercing member kept in sterile conditions,
pricking the patient or animal in order to collect the sample to be
analyzed, depositing the sample at the analysis strip in an
adequate area called application area for applying the sample.
[0006] Thus, as described in the aforementioned patent application,
the user implements a needle, for piercing the skin and a blood
vessel, and a container for storing the blood sample in order to
apply it on the application area.
[0007] However, the drawbacks pertaining to the practices of the
prior art are many:
[0008] the user must have: [0009] the actual rapid test, [0010] the
piercing and collecting members of the sample, and [0011] the
container for collecting the sample,
[0012] thus requiring several, different packages for each
aforementioned member; moreover, each of the aforementioned members
must be perfectly calibrated according to the analysis to be
carried out, and
[0013] in addition, the user must obtain an independent means for
locally sterilizing the piercing area of the patient or animal.
[0014] Generally, a rapid test of the prior art requires that the
user ensures that good hygiene and safety practices are followed.
However, in some deficient organizations, precarious economies,
etc. . . . , these good practices of hygiene and safety may not be
followed, thus leading to significant cross-contamination
risks.
[0015] The purpose of the present invention is particularly to
resolve the aforementioned problems.
[0016] To this end, the invention relates to an assembly, for
carrying out an assay with a view to determining the presence or
absence of at least one analyte in a sample of human or animal
blood, the assembly comprising at least: [0017] a hand
transportable support; [0018] 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 the analysis;
[0019] a piercing member, such as a tip, preferably sterile,
connected to the support and suitable for piercing the skin and a
blood vessel; and [0020] a container calibrated and suitable for
collecting, storing and returning the blood sample, the piercing
member being inserted either totally or partially into the
container, said container being removably connected to the support
in such a manner that the container may be alternatively arranged
in a storage configuration and in a use configuration in which the
container may be placed close to the application area.
[0021] In other words, the support, the strip, the piercing member
and the container are attached or connected together such as to
form an autonomous assembly.
[0022] According to an embodiment of the invention, the assembly
further comprises a piece of fabric soaked in disinfectant product
and which extends over an outer surface of the support, preferably
on the surface opposite to the application area, the assembly
further comprising a sealed film, detachable and watertight, the
film being arranged such as to cover the piece of fabric in the
storage configuration.
[0023] In a preferential embodiment, the piece of fabric is folded
at the outer surface of the support opposite to the application
area.
[0024] Thus, such a piece of fabric allows the user, before and
after the prick, to disinfect the skin at the place of the prick
and the tip if need be. In folded position, the piece of fabric
represents an insignificant encumbrance.
[0025] Thus, such an assembly allows to gather all the components
required for the analysis assay, particularly their packaging and
transport may be carried out by means of a unique pack.
Furthermore, the connection between the piercing member and the
support prevents losing the needle and improves the handling of the
assembly. Finally, such an assembly allows to meet all hygiene and
safety requirements, avoid cross-contamination issues and ensure a
blood collecting of which the volume is perfectly calibrated.
[0026] In an embodiment of the invention, the sterile piercing
member is obtained by overmolding and remains sterile until its
use, particularly when the container is not detached from the
support. In other words, the piercing member is sterilized during
its overmolding, at more than 120.degree. C. or even higher than
150.degree. C., by the plastic material forming the container, that
is to say its walls and/or its sub plate.
[0027] Thus, the piercing member is sterilized during the
manufacture of the assembly, thus avoiding to provide an additional
sterilization step.
[0028] In the present application, the term "assembly" designates a
group of components which are necessary to achieve an assay with a
view to determining the presence or absence of at least one analyte
in a sample of human or animal blood.
[0029] In the present application, the term "connect" and its
derivatives designate a material or mechanical, direct or indirect
connection between two members. In other words, two members may be
mechanically connected together or by means of a third member.
[0030] In the present application, the term "piercing member"
designates a tip, needle, blade or any other equivalent member
suitable for piercing the skin and a blood vessel. In the present
application, the term "pierce" and its derivatives designates the
actions consisting of perforating or cutting.
[0031] In the present application, the term "container" designates
a hollow object capable of containing a liquid, for example a blood
sample. In other words, the container essentially defines a cavity
in which the liquid may be contained.
[0032] In the present application, the expression "calibrated and
suitable for collecting, storing and returning the sample of human
or animal blood" indicates that the user may collect and store a
volume of blood adequate and necessary for the analysis by placing
the container close to the prick, then return this volume to the
application area of the strip.
[0033] In the present application, the term "inserted" and its
derivatives designates the insertion of the piercing member into
the container, that is to say either inside the hollow volume
defined by the container, or fitted into the container (that is to
say on a sub plate or a wall of this container).
[0034] According to an embodiment of the invention, in the storage
configuration, the container is attached to the support and the
piercing member is attached to the support.
[0035] In other words, the container is directly connected to the
support and the piercing member is directly connected to the
support.
[0036] According to another embodiment of the invention, in the
storage configuration, the container surrounds all or part of the
piercing member, the container being totally or partially inserted
into the support.
[0037] Thus, such an arrangement allows to achieve a compact
assembly in the storage configuration, as the piercing member is
housed in the volume of the container.
[0038] According to another embodiment of the invention, in the
storage configuration, the container is connected to the support by
means of a compression means, such as a spring, retained by a
blocking means, said compression means also being in connection
with the piercing member.
[0039] Such a compression means may be formed by an elastic return
member, such as a spring. Thus, such a compression means and such a
blocking means allow to handle the container easily.
[0040] According to an alternative embodiment of the invention, the
piercing member is movable between a storage configuration, in
which the piercing member is arranged inside the support, and a
piercing configuration, in which the piercing member is arranged
protruding over an edge of the support.
[0041] Thus, such a movable piercing member allows to form a secure
and compact assembly, because the piercing member is not arranged
protruding over an edge of the support; and because a user is not
likely to be pricked unexpectedly.
[0042] According to an alternative embodiment, the piercing member
is movable between the storage configuration, in which the piercing
member is located inside the support, set back in the support or
level with an outer surface of the support, and the use
configuration in which the piercing member is partially protruding
out with respect to an outer surface of the support.
[0043] According to another alternative embodiment of the
invention, the piercing member is movable between the storage
configuration, in which the piercing member is set back inside the
support, and the use configuration, in which the piercing member is
partially protruding out with respect to the support by release
under the action by expansion of a compression member.
[0044] Such a compression member may be formed by an elastic return
means, such as a spring.
[0045] According to an alternative embodiment of the invention, the
assembly comprises a control button arranged on the support such as
to free the compression member. The control button may for example
cooperate by elastically snap-fitting with the compression
member.
[0046] According to an embodiment of the invention, in the storage
configuration, the container is connected to the support by means
of the piercing member, the piercing member being attached to the
support, the assembly comprising a sub plate which is fitted onto
the piercing member, the container being attached onto the sub
plate.
[0047] Thus, such a sub plate allows to protect a user, for example
the medical staff, from an unexpected prick, because the piercing
member is fitted onto the sub plate. Moreover, such a sub plate
allows the user to easily handle the container.
[0048] According to an embodiment of the invention, the sub plate
is formed by a cap arranged for blocking an end of the container,
the cap being made of a resilient material such as to be able to be
fitted onto the piercing member.
[0049] Thus, such a cap allows to block the container and rapidly
and removably attach the sub plate, hence the container, onto the
piercing member.
[0050] According to an embodiment of the invention, the support is
formed by a casing, such as an essentially parallelepiped cassette,
and the strip, preferably porous, is arranged inside the 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 the test area.
[0051] Thus, such a casing and such a strip allow to carry out
assays for most of the analytes to be sought for.
[0052] According to an alternative embodiment of the invention, the
casing is formed of two half-shells comprising means for attaching
a half-shell on the other half-shell.
[0053] Thus, such a casing allows an easy mounting of the strip in
a half-shell and it ensures an effective watertightness of the
inner volume where the strip is mounted.
[0054] According to an embodiment of the invention, the piercing
member is arranged protruding over an edge of the support.
[0055] Thus, such an arrangement allows to use the piercing member
directly, which avoids handling the assembly in order to bring the
piercing member out.
[0056] According to an embodiment of the invention, the piercing
member is formed of a needle or a blade.
[0057] Thus, such a needle allows to perforate the skin and a blood
vessel, which can be carried out by a user without qualifications,
for example by the person from whom the sample is taken.
[0058] According to an embodiment of the invention, the container
generally has the shape of a tube, preferably with a circular
base.
[0059] Thus, such a container is simple to handle and manufacture
and is well suited to gather a blood sample.
[0060] According to an embodiment of the invention, the container
is made from a translucent material, preferably from a transparent
material.
[0061] Thus, such a container allows to view the volume of blood,
hence to collect the required volume.
[0062] According to an embodiment of the invention, the container
has a volume ranging between 30 microliters and 200 microliters,
preferably between 60 microliters and 100 microliters.
[0063] Thus, such a volume allows to carry out assays for most of
the analytes to be sought for.
[0064] According to an alternative embodiment of the invention, the
container may comprise a level mark.
[0065] Thus, such a mark allows to indicate to the user when the
collected volume is sufficient for determining the presence or
absence of the analyte.
[0066] According to an alternative embodiment of the invention, the
assembly further comprises a rigid portion protruding over an edge
of the support, such as to allow the detachment from the detachable
film.
[0067] Such a rigid portion allows to easily detach the detachable
film.
[0068] Furthermore, the present invention relates to an analysis
unit, for carrying out an assay with a view to determining the
presence or absence of at least one analyte in a sample of human or
animal blood, the analysis unit comprising an assembly according to
the invention and a sterile packaging, the assembly being arranged
in the sterile packaging.
[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 mm.times.35 mm.times.6 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.
* * * * *