Classifications

• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
  • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
  • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
  • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
  • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
  • G01N33/54366—Apparatus specially adapted for solid-phase testing
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
  • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
  • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
  • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
  • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
  • G01N33/54306—Solid-phase reaction mechanisms
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
  • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
  • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
  • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
  • G01N33/558—Immunoassay; Biospecific binding assay; Materials therefor using diffusion or migration of antigen or antibody

Definitions

• the present invention relates to a lateral migration immunochromatographic device for the detection of an analyte in a liquid sample.
• Lateral migration immunochromatographic devices are for example described in patent EP 0 284 232. These devices implement a capillary diffusion means in the form of a porous solid support in which the sample and the reagents migrate by capillary diffusion. . These devices thus integrate a porous solid support (or immunochromatographic) comprising a first zone carrying in lyophilized or dehydrated form, a binding reagent conjugated to a particulate marker and a detection zone on which is immobilized a capture reagent specific for the analyte. . The reagent conjugated with the particulate marker is immobile in lyophilized form but becomes mobile in the solid support in the wet state.
• the solid support migrates by capillary diffusion in this support causing the binding reagent conjugated to the particulate marker.
• the sample and the labeled binding reagent migrate by capillary diffusion into the solid support to the detection zone carrying the immobilized capture reagent.
• the labeled binding reagent binds to the analyte while the analyte is immobilized on the solid support by the capture reagent. The presence or absence of the analyte in the sample is thus measured by the detection of the labeled reagent.
• EP 0291 194, EP 0 560411 and EP 0 560410 disclose devices in which the immunochromatographic solid support is incorporated in a housing provided with an opening for depositing the sample and an observation window for reading. results.
• these patents also disclose devices in which one end of the solid support protrudes permanently relative to the housing to facilitate the deposition of the liquid sample. This projecting end of the solid support can thus be directly brought into contact with a flow of urine for example.
• a second diffusion means in the form of an absorbent material is salient with respect to the housing and allows the deposit of the sample. This absorbent material being arranged in capillary continuity with the porous solid support carrying the reagents to allow the deposition and then the migration of the sample.
• the patent EP 1 091 808 describes improved devices also comprising a porous solid support integrated into a housing in which a movable capture member allows better collection of the sample.
• This capture member comprises an absorbent material on which the sample is deposited.
• the capture member is movable in translation relative to the housing.
• the capture member and the absorbent material remain integral with the housing and are not removable. Since the capture member is not removable and can not be completely detached from the housing, there is a risk of flooding the device when it is placed under a stream of urine for example.
• No. 5,900,379 discloses test devices in the form of reusable housings after replacement of the removable cassette placed in the housing.
• This cassette consists of a rigid support on which are affixed capillary diffusion means. It is in the form of an immunochromatographic strip. The entire immunochromatographic cassette or strip including the different reagents can be replaced to allow reuse of the housing.
• WO 98/19164 thus describes devices comprising a sampling member provided with an absorbent material on which reagents are deposited.
• a sampling member provided with an absorbent material on which reagents are deposited.
• absorbent material of the sample organ is placed under a flow of urine a fraction of the reagent deposited on this material is lost by a washing effect.
• the present invention proposes devices in which the sampling member consists of a gripping support and a capillary diffusion means comprising separate and opposite sampling and sample transfer zones.
• the binding reagent conjugated to the label is deposited downstream of the sample collection zone with respect to the direction of capillary diffusion to avoid any washing effect when sampling the sample.
• the sampling member removably assembles with the housing comprising the immunochromatographic support to allow easy and fast domestic use without risk of flooding the device during the deposit of the sample.
• this procedure also makes it possible to increase the sensitivity of the device with the (optional) possibility of leaving the sample and the reagent in contact for a certain time before starting the reaction.
• the device for determining an analyte in a liquid sample comprises: a first gripping support (1),
• the first gripping support (1) has two open ends (13) for passage on the one hand of the sampling zone (4) of the sample and on the other hand of the transfer zone (5) of the sample of the first capillary diffusion means (2)
• the second gripping support (7) is provided with an opening (14) for applying the sample to the collection zone (10) of the second capillary diffusion means (8)
• the first gripping support ( 1) being adapted to be detachably assembled in two inverted positions with respect to the reference direction (3) with the second gripping support (7) so that in the first position the sampling area (4) of the first means of capillary diffusion (2) is inserted in the second gripping medium (7) through the opening (14) while in the second position the transfer zone (5) of the first capillary diffusion means (2) is inserted into the second gripping support (7) through the opening (14) such that said transfer zone (5) of the first capillary diffusion means
• the second gripping support (7) is in the form of a housing provided with an opening (14) for the insertion of the sampling zone (4) or of the transfer zone (5) of the first gripping means. capillary diffusion (2), and an observation window (15) aligned with the detection zone (11) of the second capillary diffusion means (8).
• the second capillary diffusion means (8) is clamped and held inside the casing between ribs (16) extending parallel to the capillary diffusion direction.
• the second gripping support (7) is provided with guiding means (17) for the insertion of the sampling zone (4) or the transfer zone (5) of the first capillary diffusion means (2).
• the second capillary diffusion means (2) is in the form of an immunochromatographic strip.
• the binding reagent conjugated to a visible and / or measurable marker (6) is immobilized in the dry state in the transfer zone (5) of the first capillary diffusion means (2). ).
• the first gripping support (1) has the shape of a hollow body provided with two open ends (13) for the passage of the first capillary diffusion means (2).
• the first capillary diffusion means (2) in the form of an absorbent material elongated in the direction of capillary diffusion.
• the sampling zone (4) and the transfer zone (5) of the first capillary diffusion means (2) are projecting relative to the first gripping support (1).
• the device also comprises a removable cap (18) for protecting the sampling zone (4) or the transfer zone (5) protruding with respect to the first gripping support (1). ).
• the first capillary diffusion means (2) is movable and displaceable in translation relative to the first gripping support (1) parallel to the direction of capillary diffusion.
• the subject of the invention is also a method for detecting an analyte in a liquid sample comprising the following steps: a) a device according to the invention is available; b) depositing a liquid sample on the sampling zone (4) of the first capillary diffusion means (2); c) assembling the first and second gripping support (1, 7) to insert the transfer zone of the first capillary diffusion means
• step e) of the method the binding reagent conjugated to a visible and / or measurable marker (6) and the capture reagent (12) allow detection of the analyte in a sandwich test.
• step e) of the method the binding reagent conjugated to a visible and / or measurable marker (6) and the capture reagent (12) allow detection of the analyte in a competition test.
• the sampling zone (4) of the first capillary diffusion means (2) is placed under a stream of urine in step b) of the method for depositing the sample.
• analyte is meant any chemical, biochemical or biological entity that it is desired to detect in a sample.
• analytes detected by the devices and methods according to the present invention mention will in particular be made of proteins, peptides, antibodies, hormones, steroids, antigens derived from infectious agents or tumor cells, infectious agents such as bacteria, viruses or parasites, nucleic acids (DNA or RNA), therapeutic molecules, drugs or antibiotics.
• detect is meant the determination of the presence or absence of an analyte in a sample but also the measurement and quantification of an analyte in a sample. Indeed, the performance of the devices and methods according to the invention allow the realization of quantitative or semi-quantitative measurements.
• the analyte is hCG (choriogonadotropin hormone) or LH (luthinizing hormone).
• liquid sample any sample in which the desired analyte is in solution or suspension.
• This liquid sample may especially be any biological or body fluid.
• the liquid sample may also have been obtained directly or indirectly from a biological fluid or body fluid.
• the sample may also be a liquid extract of a solid sample.
• the liquid sample is urine, whole blood, plasma or serum.
• the liquid sample is urine and the sample is deposited by placing the sampling area of the sample of the first capillary diffusion means under a flow of water. 'urine.
• the devices according to the invention are thus particularly well suited for home use since only very simple manipulations are necessary.
• capillary diffusion means is meant a porous solid support allowing the migration of a liquid by simple capillary diffusion.
• the porosity of this support allows the capillary diffusion (or lateral migration) of the sample and / or reagents in the liquid or wet state.
• Such capillary diffusion means are very widely used in all lateral migration immunochromatography techniques in particular.
• capillary diffusion means used in the immunochromatographic tests according to the invention are well known to those skilled in the art (EP 0 284232).
• these capillary diffusion means may consist of various immunochromatographic supports, of cellulose, of nylon, of nitrocellulose, of polyethylene or of fiberglass.
• the capillary diffusion means may consist of one or more distinct parts.
• the different parts of the support can advantageously be made of different materials.
• these elements are arranged in such a way as to allow continuity of the capillary flow in the capillary diffusion means.
• the first capillary diffusion means makes it possible to capture the liquid sample and then to deposit it on the collection zone of the second capillary diffusion means.
• the first capillary diffusion means consists of a porous solid support elongated in the direction of capillary diffusion.
• the first capillary diffusion means consists of an absorbent material.
• the first capillary diffusion means comprises a sample collection zone and a sample transfer zone.
• the sampling zone and the transfer zone are two distinct zones separated from the first capillary diffusion means. These zones are arranged to allow continuity of the capillary flow from the sampling zone to the transfer zone in a reference direction. Typically, each of these areas corresponds to one of the opposite ends of the first capillary diffusion means.
• the first capillary diffusion means is thus for example constituted of an absorbent material elongated in the direction of capillary diffusion having a proximal end and a distal end respectively constituting the sampling zone and the transfer zone of the sample.
• the sampling zone of the first capillary diffusion means is intended to be brought into contact with a flow of urine for example. We will choose a suitable absorbent material. These materials are well known to those skilled in the art.
• the first capillary diffusion means carries the conjugated binding reagent to a visible and / or measurable marker.
• This labeled binding reagent is immobilized in the dry state in the first capillary diffusion means but is free to migrate by capillary diffusion in the wet state.
• This reagent is located downstream of the sampling zone to avoid any loss of reagent by a washing effect during sampling of the sample.
• the labeled binding reagent is immobilized in the transfer zone of the first capillary diffusion means.
• the deposition of the labeled binding reagent on this absorbent material allows a better dosage of the reagent.
• This dosage of the reagent is more difficult to achieve when the reagent is deposited on the second capillary diffusion means generally consisting of a chromatographic strip.
• the sampling zone of the first capillary diffusion means is brought into contact with a liquid sample (a flow of urine for example) and then the sample migrates by capillary diffusion to the transfer zone through the first means of diffusion. capillary scattering then driving the binding reagent conjugated to a marker.
• the second means of capillary diffusion of the devices according to the invention is a porous solid support in the form of a band or an immunochromatographic strip.
• the second capillary diffusion means is typically in the form of an immunochromatographic strip consisting of several superimposed or overlapping strips.
• the second capillary diffusion means comprises a sample collection zone and a detection zone carrying the capture reagent. These zones are arranged to allow continuity of the capillary flow from the collection zone to the detection zone in a reference direction.
• the collection zone and the detection zone are two distinct zones separated from the second capillary diffusion means.
• the sample and the labeled binding reagent migrate through the second capillary diffusion means from the collection zone to the detection zone.
• the second capillary diffusion means is for example constituted by an immunochromatographic strip, one end of which constitutes the collection zone, the detection zone being situated near the other end of the strip.
• These zones may for example be present in the same plane on a strip made of a single material.
• a specific material corresponds to each zone of the second capillary diffusion means.
• a porous absorbent material may for example be used for the collection area of the sample.
• the detection zone of the second capillary diffusion means comprises a capture reagent for the detection and / or quantification of the analyte.
• This capture reagent is immobilized in the detection zone of the second capillary diffusion means.
• the detection zone of the second capillary diffusion means may also comprise a second capture reagent immobilized on the porous support downstream of the first capture reagent.
• This second immobilized capture reagent usually makes it possible to control the smooth running of the test by checking, for example, the migration of the conjugated binding reagent to the marker in the capillary diffusion means.
• the second capture reagent is, for example, an antibody specific for the binding reagent.
• the first and second capillary diffusion means are respectively secured to a first and second gripping support. These gripping supports facilitate the handling of the capillary diffusion means and can also protect them including moisture.
• the gripping support can partially or completely wrap the capillary diffusion means.
• the gripping support may be made of various materials such as cardboard, plasticized cardboard or more preferably plastics.
• the gripping support is made of a rigid and impermeable material.
• the first gripping support covers only partially. the first capillary diffusion means.
• the first gripping support has the shape of a hollow body provided with two open ends for the passage of the sampling zone and the transfer zone of the first capillary diffusion support. These zones are therefore salient with respect to the first gripping support and are directly accessible. The sampling zone can thus be directly brought into contact with the liquid sample.
• the first gripping support and the first capillary diffusion means thus form a sample collection or collection member.
• this sample collection member takes the form of a rectangular hollow body open at both ends in which is inserted an absorbent member having an elongated shape. Both ends of the absorbent element protrude from the hollow body. These two projecting ends respectively constitute the sampling zone and the transfer zone of the sample.
• the device according to the invention also comprises a removable cap for protecting the projecting ends of the first capillary diffusion means.
• This cap covers one or other of the ends of the first capillary diffusion means according to the assembly of the device in two inverted positions.
• the second capillary diffusion means is integrated in the second support for gripping.
• the second gripping support is in the form of a housing in which the second capillary diffusion means is fixed.
• the device is in the form of a housing in which is immobilized an immunochromatographic strip.
• the second holder or housing is provided with an opening for application of the sample to the collection area of the second capillary delivery means. This opening allows the insertion of the projecting ends of the first capillary diffusion means in the housing.
• the second gripping support is also provided with at least one observation window for observing the detection zone of the second capillary diffusion means.
• the first and second gripping supports are adapted to be removably assembled in two inverted positions.
• the first and second gripping support can snap removably.
• the first and second gripping support can therefore fit together to be assembled and can be separated and moved.
• the first gripping support and the first capillary diffusion means thus form a removable sampling member which can be entirely separated from the second gripping support (or housing). This sampling member can be handled independently of the remainder of the device for sampling.
• the removable assembly of the two gripping supports makes it possible to avoid any flooding of the entire device and in particular of the immunochromatographic strip during the application of the liquid sample.
• the first gripping support is adapted to be removably assembled in two inverted positions relative to the direction of capillary diffusion with the second gripping support so that in the first position the sampling zone of the first diffusion means capillary is inserted into the second gripping support by the opening while in the second position the transfer zone of the first capillary diffusion means is inserted into the second gripping support by the opening such that said transfer zone of the first capillary diffusion means is in capillary continuity with the collection zone of the second capillary diffusion means.
• This possibility of assembly in two inverted positions facilitates manipulation by the user. This characteristic also makes it possible to avoid any loss of reagent by washing during the application of the liquid sample.
• the user has a device assembled so that the sampling area of the first capillary diffusion means is inserted into the second gripping support by the opening.
• the sampling zone of the first capillary diffusion means is exposed and the user can apply the sample by placing the sampling zone under a flow of water. urine for example.
• this reagent is not deposited on the sampling area.
• this reagent is deposited on the transfer zone of the first capillary diffusion means which is protected by a cap. After the application of the liquid sample, the user moves the cap on the sampling zone of the first capillary diffusion means.
• the displacement of the cap exposes the transfer zone of the first capillary diffusion means.
• the user can then re-assemble the first and second gripping support in an inverted position relative to the starting position. In this position, the transfer zone of the first capillary diffusion means is inserted into the second gripping support by the opening in such a way that said transfer zone of the first capillary diffusion means is in capillary continuity with the collection zone of the second means of capillary diffusion.
• the migration of the reagents and the sample takes place and the user only has to observe the result of the test.
• the invention therefore also relates to a method for detecting an analyte in a liquid sample comprising the following steps: a) a device according to the invention is assembled so that the sampling zone of the first means of capillary diffusion is inserted into the second gripping support by the opening; b) separating the first and the second gripping support thus exposing the sampling zone of the first capillary diffusion means; c) depositing a liquid sample on the sampling zone of the first capillary diffusion means; d) moving the cap on the sampling zone of the first capillary diffusion means exposing the transfer zone of the first capillary diffusion means; e) assembling the first and second gripping supports to insert the transfer zone of the first capillary diffusion means into the second gripping support so that the transfer zone of the first capillary diffusion means is in flow continuity capillary with the collection zone of the second capillary diffusion means; f) a sufficiently long time is allowed to allow the sample to migrate in the first capillary diffusion means from the sampling zone to the transfer zone, resulting in the binding
• binding reagent conjugated to a visible and / or measurable label and the capture reagent are specific for the desired analyte in the sample.
• the binding reagent conjugated to a visible and / or measurable marker and the capture reagent immobilized in the detection zone of the second capillary diffusion means enable the analyte to be detected by a test. sandwich.
• the binding reagent conjugated to a visible and / or measurable marker and the capture reagent specific for the immobilized analyte in the detection zone of the second capillary diffusion means make it possible to detect the analyte by a competition test.
• Sandwich tests and competitive tests are well known to those skilled in the art.
• the analyte-specific capture reagent and the labeled binding reagent are predetermined to bind respectively and specifically with the analyte, for example at two epitopic sites, identical to or different from the analyte.
• the labeled binding reagent is identical or analogous to the analyte, to bind with the capture reagent, in competition with the analyte.
• capture reagent any biochemical or biological chemical entity capable of binding specifically with the analyte.
• the capture reagent also binds to the binding reagent.
• the analyte and the capture reagent typically form a ligand / anti-ligand, antigen / antibody, DNA / RNA or DNA / DNA pair.
• the capture reagent is for example an antibody specific for the analyte.
• the capture reagent is the antigen recognized by the antibody or an antibody specifically recognizing the analyte.
• the capture reagent is for example a complementary DNA probe.
• the immobilized capture reagent is preferably a polyclonal or monoclonal antibody having a high affinity for the analyte and more preferentially it is a monoclonal antibody.
• the capture reagent specific for the analyte is immobilized in the detection zone of the second capillary diffusion means according to techniques known to those skilled in the art.
• This capture reagent is immobilized so that it is not mobile in the wet state. This immobilization can be carried out for example by absorption or by covalent coupling.
• the capture reagent is a nucleic acid, it is for example fixed on a nitrocellulose type support by UV treatment or by any other technique known to those skilled in the art.
• binding reagent is meant any biochemical or biological chemical entity capable of binding specifically with the analyte or with the capture reagent in competition with the analyte.
• binding or “binding” is meant any strong binding, for example covalent or any weak binding, for example of the antigen / antibody or avidin / streptavidin type.
• the binding reagent is for example an antibody, an antigen or a nucleic acid.
• binding reagent any other binding reagent known to those skilled in the art may be used such as monoclonal antibody (or antibodies) to antibiotin, avidin, streptovidine, or polytroptavidin. These reagents can be native or recombinant.
• the binding reagent is for example the analyte itself or an appropriate analogue of the analyte.
• appropriate analogue of the analyte is meant an analogue specifically binding to the specific capture reagent of the analyte.
• the labeled binding reagent is therefore the analyte conjugated to a visible and / or measurable marker or an analogue of the analyte conjugated to a visible and / or measurable marker.
• the binding reagent specifically binds to the analyte.
• the labeled binding reagent is, for example, an antibody specific for the analyte conjugated to a visible and / or measurable marker.
• the binding reagent is conjugated to a visible and / or measurable marker allowing measurement or direct observation of the test result.
• the marker can be observed directly to the naked eye when it is concentrated in the detection zone of the second capillary diffusion means.
• the marker can be measured directly with the naked eye or with a measuring device. This measurement is done by direct observation that does not require additional manipulation.
• the devices according to the present invention comprise a binding reagent conjugated to a particulate marker.
• the particulate markers consist of small particles insoluble in water and which therefore form suspensions in the liquid phase that is to say a dispersion of solid particles in a liquid.
• Particulate markers are well known to those skilled in the art.
• colored or fluorescent particle markers are known.
• the markers allowing direct observation with the naked eye are also the markers of the dextran type (Hansen TM, IVD Technology 4, 35-40, 2003).
• the binding reagent is then conjugated to a dextran chain (polysaccharide derivative) carrying fluorophores.
• the binding reagent is conjugated to the visible marker and / or measurable according to known techniques.
• the invention is described in more detail with reference to the following figures:
• Figure 1 shows in perspective a device according to a particular embodiment of the invention.
• the first and second gripping support and the cap are not assembled.
• Figure 2 shows the device of Figure 1.
• the first and second gripping support and the cap are assembled.
• Figure 3 shows a top view of the first gripping support.
• Figure 4 shows a cross-sectional view of the first gripping support.
• FIG. 5 represents an exploded perspective view of the device represented in FIG.
• Figures 6-10 show the different steps of the method of use of the device of Figure 1.
• a device according to one particular embodiment of the invention, comprises:
• a first holding support (1) having the shape of a hollow body provided with two open ends (13) for the passage of the two projecting ends of the first capillary diffusion means (2), this hollow body is provided with means of assembly (19) for removable assembly with the cap (18) and with the second gripping support (7);
• a first capillary diffusion means (2) having the form of a porous solid support of elongated absorbent material in the direction of capillary diffusion having a proximal end and an opposite distal end respectively forming the sampling zone of the sample (4); ) and the sample transfer zone (5); the sample transfer zone (5) is located downstream of the sampling zone (4) relative to the reference direction (3) of capillary diffusion; this first capillary diffusion means (2) is integral with the first support gripper (1) having the shape of a hollow body so that the sampling zone (4) and the transfer zone (5) are projecting;
• a second holding support (7) in the form of a hollow housing comprising at one end an opening (14) for the passage of one or the other of the projecting ends of the first capillary diffusion means (2) , this housing being provided with an observation window (15) for the direct reading of the result of the diagnostic test, and assembly means (21) for the removable assembly with the first support (1).
• Figure 2 shows the same assembled device.
• the hollow body 1 holding support (1) can be assembled with the housing of the second gripping support (7) in two inverted positions.
• the hollow body In the first position, the hollow body is assembled with the housing so that the sampling area of the sample (4) of the first capillary diffusion means (2) is inserted into the housing through the opening (14) then the removable cap (18) protects the sample transfer zone (5) from the first capillary diffusion means (2).
• the hollow body is assembled with the housing, so that the sample transfer zone (4) of the first capillary diffusion means (2) is inserted into the housing through the opening (14). while the removable cap (18) protects the sampling area of the sample (4) from the first capillary diffusion means (2).
• the transfer zone (5) of the first capillary diffusion means (2) is in capillary continuity with the collection zone (10) of the second capillary diffusion means (8).
• FIG. 3 represents a view from above of the first holding support (1) having the shape of a hollow body provided with two ends open (13) and assembly means (19) for removable assembly with the cap (18) on the one hand and the housing on the other hand.
• Figure 4 shows a cross-sectional view of the first gripping support (1) having the shape of a hollow body. Ribs (21) make it possible to hold and immobilize the first capillary diffusion means (2) by clamping.
• the first capillary diffusion means (2) can be movable and displaceable in translation relative to the hollow body. The displacement of the first capillary diffusion means (2) takes place under the pressure exerted on the removable cap during assembly of the device.
• the device represented in FIG. 1 also comprises:
• a second capillary diffusion means (8) in the form of an immunochromatographic strip integrated in the casing; this strip comprises a collection area (10) of the sample accessible externally through the opening (14) in the housing for depositing the sample by means of the first capillary diffusion means (2); the detection zone (11) is located downstream of the collection zone (10) with respect to the capillary diffusion reference direction (9); the detection zone (11) is positioned in the housing so that it is aligned with the observation window (15) for the direct reading of the test result;
• the user has an assembled device as shown in FIG. 2 so that the sampling zone of the sample (4) of the first capillary diffusion means (2) is inserted into the hollow housing, while the removable cap (18) protects the transfer zone (5) of the first capillary diffusion means (2) ( Figure 6).
• the first gripping support (1), the hollow housing and the cap (18) are removably assembled.
• the user separates the first gripping support (1) from the hollow casing (7).
• the sampling zone (4) of the first capillary diffusion means (2) protruding with respect to the first gripping support (1) becomes accessible.
• the sampling zone (4) of the first capillary diffusion means (1) made of absorbent material is then placed under a flow of urine or soaked in a liquid. Since the housing is separated from the sample collection member (hollow body and first capillary diffusion means) any risk of flooding of the housing is discarded ( Figure 7).
• the user separates the removable cap (18) and moves it on the sampling zone (4) of the first capillary diffusion means (2).
• the sample transfer zone (5) of the first capillary diffusion means (2) protruding with respect to the first gripping support (1) then becomes accessible (FIG. 8).
• the user inserts the transfer zone (5) of the first capillary diffusion means (2) in the housing through the opening (14) provided for this purpose so that the transfer zone (5) of the first means capillary diffusion (2) is in capillary flow continuity with the collection zone (10) of the immunochromatographic strip (8).
• the first gripping means (1) is then assembled with the housing (7) in the inverted position relative to the initial assembly (FIGS. 9 and 10).
• the lateral migration immunochromatographic test then proceeds without further user intervention (Figure 10).
• the liquid sample migrates by capillary diffusion in the reference direction (3) from the sampling zone (4) to the transfer zone (5) of the first capillary diffusion means (2) consisting of an absorbent material.
• the sample then drives the labeled binding reagent (6) which is mobile in the wet state.
• the sample and the labeled binding reagent (6) then migrate from the transfer zone (5) of the first capillary diffusion means (2) into the collection area (10) of the immunochromatographic strip (8) and then within from this strip in the reference direction (9) to the detection zone (11) carrying the immobilized capture reagent (12).
• the reactions are carried out and the result is directly visible to the naked eye by the observation window (15).
• the device being disposable it can then be discarded by the user.
• the device consists of a pregnancy test that detects HCG hormone.
• the transfer zone of the first capillary diffusion means then comprises 20 ⁇ l of particulate marker with concentrated colloidal gold on which is absorbed a mouse anti-HCG antibody (this marker is then dried).
• the detection zone of the second capillary diffusion means comprises two immobilized reagents deposited along a test line and a control line.
• the capture reagent constitutes the test line, it is typically an immobilized anti-HCG polyclonal or monoclonal antibody (approximately 1 ⁇ g / test).
• a second immobilized reagent consisting of a polyclonal anti-mouse immunoglobulin antibody (approximately 1 ⁇ g / test) constitutes the control line.
• This embodiment is similar to the rapid tests embodiments known housing or strip format I one skilled in the art, the difference being the positioning of the particulate label, it is no longer disposed on the inner strip itself same (second capillary diffusion means) but on the first removable capillary diffusion means.

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• 2004
  • 2004-07-13 FR FR0407815A patent/FR2873208B1/fr not_active Expired - Fee Related
• 2005
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