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
  • G01N33/54386—Analytical elements
  • G01N33/54387—Immunochromatographic test strips
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
  • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
  • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
  • B01L3/5023—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures with a sample being transported to, and subsequently stored in an absorbent for analysis
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L2300/00—Additional constructional details
  • B01L2300/08—Geometry, shape and general structure
  • B01L2300/0809—Geometry, shape and general structure rectangular shaped
  • B01L2300/0825—Test strips
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L2300/00—Additional constructional details
  • B01L2300/08—Geometry, shape and general structure
  • B01L2300/0809—Geometry, shape and general structure rectangular shaped
  • B01L2300/0829—Multi-well plates; Microtitration plates

Definitions

• VIDAS® device which is a multi-parameter automated device for immunoassays. This device is composed of an analytical module which automatically takes care of all the stages of the analysis until the complete edition of the results.
• the principle of the VIDAS® test is based on the use of a cone and a reaction bar:
• the cone is the solid phase of the reaction, and includes the recognition antibodies coated on its wall. It is for single use and acts as a sampling needle. During the test, it is subjected to injection / aspiration steps in order to bring the multiple test reagents into contact successively.
• the reaction strip contains all the reagents ready for use, distributed in the various wells of the strip, and in particular the detection antibodies.
• a well also allows the deposit of the sample that one wishes to analyze.
• the cone sucks and delivers the reagent contained in the various wells of the strip several times until the final stage of the analysis.
• the last well of the bar is the reading tank where the final intensity of the reaction is measured in fluorescence.
• the control can also be carried out by pressure sensors, placed within the automaton, in order to detect whether the sample, or the reagent has indeed been injected. This however increases the cost of manufacturing the machines.
• the present invention proposes to solve all the drawbacks of the state of the art by improving the current control systems of automatic dosing machines. by presenting a very simple and rapid control system, allowing a visual interpretation of the results, at low cost, without requiring a total calibration of the automatic biological assay. Before going further, a few definitions are given in order to facilitate understanding of the description of the invention.
• biological fluid any Hquide in which it is desired to demonstrate the presence of a given antigen (or of an antibody).
• This liquid can thus be a clinical sample of blood, urine, saliva, plasma ...
• This Hquide can also be a food sample of water, drinks, in which one wishes to determine the presence of an organism ( bacteria, parasites, viruses ).
• the present invention relates to a reaction module comprising at least one reaction well for biological analysis comprising the injection of biological fluid and / or of reagent allowing a determined biological reaction and at least one means of controlling the quantity of biological fluid and / or injected reagent, characterized in that the control means is a caHbred colorimetric strip.
• FIG. 1 represents a first embodiment of the invention.
• FIG. 1a represents a side view of a reaction module, which is a reaction bar (1) comprising a control means (2) according to the invention.
• This control means is a strip of absorbent paper, comprising a charred volumetric drop (4).
• the injection of biological Hquide and / or of reagent takes place through an orifice (3), and the Hquide diffuses along the volumetric scale.
• the charred volumetric flow (4) is integrated into the bar so that the user is not in direct contact with the biological fluid and / or the reagent which is absorbed by the control means (2). This is important especially when the biological Hquide is likely to be contaminated.
• This strip includes 8 reaction wells (5).
• FIG. 1b represents a top view of a reaction bar (1) comprising the control means as defined above.
• FIG. 2 shows in a more detailed manner the control means (2) presented in FIG. 1.
• a first absorbent layer (7) is deposited on the bar (1).
• This first layer comprises a dried dye.
• a second layer (8) of absorbent paper but not comprising dye is placed above.
• This first and second layer make it possible to obtain a simple and inexpensive means of control: when a Hquide is in contact with the second layer (8), it diffuses through to the first layer (7) by rehydrating the dye. which in turn diffuses within the second layer (8).
• the second layer (8) is colored, this means for the user that an injection of Hquide has taken place.
• a last layer which is a protective means (9) such as a plastic film makes it possible to isolate the control means (2).
• FIG. 3 represents different successive steps carried out during an immunological test.
• FIG. 3a represents the first step of an immunological test such as a Vidas® test in which a reaction cone (10) sucks in the first well of the bar a determined volume of biological fluid.
• This reaction cone (10) comprises, on its wall, recognition antibodies, which form, with the target antigens of the biological fluid, an antigen - antibody complex.
• FIG. 3b represents the second step of the test which consists in aspirating and discharging a reagent, such as in particular a washing liquid contained in a second well, in order to remove the target antigens which would have been badly fixed on the recognition antibodies.
• the cone (10) automatically passes from the first well of the bar to the second well.
• a control step is carried out in order to determine whether the aspiration / injection steps have been carried out correctly.
• the automaton withdraws by the cone (10) a determined volume of Hquide (which can be a biological Hquide, a reagent, or a simple aqueous solution) in the last well of the reaction bar, and deposits this volume on the means of control (2).
• Hquide then diffuses within the second layer as shown in Figure 2 until reaching the first layer comprising a dye.

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• Health & Medical Sciences (AREA)
• Immunology (AREA)
• Life Sciences & Earth Sciences (AREA)
• Chemical & Material Sciences (AREA)
• Engineering & Computer Science (AREA)
• Hematology (AREA)
• Biomedical Technology (AREA)
• Molecular Biology (AREA)
• Urology & Nephrology (AREA)
• General Health & Medical Sciences (AREA)
• Analytical Chemistry (AREA)
• Food Science & Technology (AREA)
• General Physics & Mathematics (AREA)
• Medicinal Chemistry (AREA)
• Physics & Mathematics (AREA)
• Cell Biology (AREA)
• Biochemistry (AREA)
• Biotechnology (AREA)
• Microbiology (AREA)
• Pathology (AREA)
• Clinical Laboratory Science (AREA)
• Chemical Kinetics & Catalysis (AREA)
• Apparatus Associated With Microorganisms And Enzymes (AREA)
• Automatic Analysis And Handling Materials Therefor (AREA)
• Investigating Or Analysing Materials By The Use Of Chemical Reactions (AREA)

Applications Claiming Priority (2)

Publications (1)

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ID=33306205

Family Applications (1)

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Family Cites Families (10)

• 2003
  • 2003-05-07 FR FR0305544A patent/FR2854695B1/fr not_active Expired - Fee Related
• 2004
  • 2004-05-06 WO PCT/FR2004/050181 patent/WO2004099525A2/fr active Application Filing
  • 2004-05-06 EP EP04742862A patent/EP1620724A2/de not_active Withdrawn

Non-Patent Citations (1)

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