WO2008104081A1 - Dispositif de dosage immunologique parallèle - Google Patents

Dispositif de dosage immunologique parallèle Download PDF

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Publication number
WO2008104081A1
WO2008104081A1 PCT/CA2008/000391 CA2008000391W WO2008104081A1 WO 2008104081 A1 WO2008104081 A1 WO 2008104081A1 CA 2008000391 W CA2008000391 W CA 2008000391W WO 2008104081 A1 WO2008104081 A1 WO 2008104081A1
Authority
WO
WIPO (PCT)
Prior art keywords
test device
rapid test
disease
epitopes
porous membrane
Prior art date
Application number
PCT/CA2008/000391
Other languages
English (en)
Inventor
Richard A. Galli
John Huang
Original Assignee
Biolytical Laboratories Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Biolytical Laboratories Inc. filed Critical Biolytical Laboratories Inc.
Publication of WO2008104081A1 publication Critical patent/WO2008104081A1/fr

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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
    • G01N33/569—Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
    • G01N33/56983—Viruses
    • G01N33/56988—HIV or HTLV
    • 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
    • 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
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6854—Immunoglobulins
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/005—Assays involving biological materials from specific organisms or of a specific nature from viruses
    • G01N2333/08—RNA viruses
    • G01N2333/15—Retroviridae, e.g. bovine leukaemia virus, feline leukaemia virus, feline leukaemia virus, human T-cell leukaemia-lymphoma virus
    • G01N2333/155—Lentiviridae, e.g. visna-maedi virus, equine infectious virus, FIV, SIV
    • G01N2333/16—HIV-1, HIV-2
    • G01N2333/162—HIV-1, HIV-2 env, e.g. gp160, gp110/120, gp41, V3, peptid T, DC4-Binding site

Definitions

  • the rapid tests' ability to produce accurate and reliable results depends not only on the intrinsic quality of the tests themselves but also on the extrinsic factors such as the quality/type of biological specimens, the ability of the user to correctly perform the tests, and the prevalence rate of the target disease in a given population.
  • the probability that a single rapid test will accurately determine the true infection status of a person varies with the prevalence of the infectious disease in that population.
  • Strategy I Requires one test; for use in diagnostic testing in populations with an HIV prevalence >30% among persons with clinical signs or symptoms of HIV infection; for use in blood screening, for all prevalence rates; and for use in surveillance testing in populations with an HIV prevalence >10%.
  • Strategy II Requires up to two tests; for use in diagnostic testing in populations with an HIV prevalence ⁇ 30% among persons with clinical signs or symptoms of HIV infection or >10% among asymptomatic persons; and for use in surveillance testing in populations with an HIV prevalence ⁇ 10%.
  • Strategy III Requires up to three tests; and for use in diagnostic testing in populations with an HIV prevalence ⁇ 10% among asymptomatic persons.
  • Flow-through tests employ solid-phase capture technology, which involves the immobilization of antigens on a porous membrane.
  • the specimen flows through the membrane and is absorbed into an absorbent material on the opposite side.
  • a dot or a line visibly forms on the membrane when developed with a signal reagent (usually a colloidal gold or selenium conjugate).
  • Some tests allow the detection of multiple diseases or disease subtypes by immobilizing antigens from disease specific markers to different locations on the membrane.
  • One such example is Bio-Rad Laboratories' MultispotTM HIV-l/HiV-2 Rapid Test.
  • the flow-through tests usually require a few steps for the addition of specimen, wash buffer, and signal reagent.
  • flow-through devices include a procedural control on the membrane; the appearance of a colored dot or line at this location confirms the test has been performed correctly.
  • US Patent Publication No. 20030165970 and International Patent Publication No. WO 03098215 describe examples of flow-through devices.
  • Lateral-flow strips incorporate both antigen and signal reagent into a strip of porous membrane and absorbent materials.
  • the specimen sometimes followed by a buffer, is applied to the absorbent/sampling area of the device.
  • the specimen is diluted in a vial of buffer, into which the test device is inserted or from which a quantity is drawn out and applied to the test device.
  • the specimen combines with the signal reagent and laterally migrates through the porous membrane.
  • a positive reaction results in a visual line on the membrane where antigens have been applied.
  • a procedural control line is usually applied to the strip at a location beyond the antigen line.
  • test strip is encased in a plastic cartridge.
  • EP 0306772, GB 2204398, EP 38619, EP 0225054, EP 0183442, and EP 0186799 describe examples of lateral-flow devices.
  • the present invention relates to diagnostic test kit designs comprising multiple recombinant antigens, of different combinations of epitopes for the same disease marker, that are capable of accurate, simultaneous, parallel detection of the presence of disease specific antibodies in a single specimen applied to a single test device, thus avoiding the need to perform multiple rapid tests or to repeatedly collect specimens.
  • the present invention therefore greatly improves the accuracy of current immunoconcentration (flow-through) and immunochromatographic (lateral-flow) rapid tests.
  • the invention provides a rapid test device comprising a porous membrane, a procedural control applied to the porous membrane, and two or more recombinant antigens applied to the porous membrane.
  • the recombinant antigens comprise differing combinations of epitopes for a disease marker and are applied at visually distinct locations on the porous membrane to simultaneously capture antibodies specific to the disease marker in a single collected specimen.
  • the rapid test device is a flow-through rapid test device. In yet another aspect, the rapid test device is a lateral-flow test device. In one aspect, the differing combinations of epitopes are partially identical to one another in terms of their amino acid sequences and/or surface structures.
  • the specimen is of either human or animal origin and comprises one of the following: serum, plasma, whole blood, saliva, mucous, skin cells, and urine.
  • the invention provides a rapid test device comprising one or more porous membranes, a procedural control applied to the one or more porous membranes, and two or more recombinant antigens applied to the one or more porous membranes. At least one of the recombinant antigens are applied to each of the porous membranes.
  • the recombinant antigens comprise differing combinations of epitopes for a disease marker and are applied at visually distinct locations on the porous membranes to simultaneously capture antibodies to the disease marker in a single collected specimen.
  • Fig. 1 illustrates an example of a flow-through rapid test device according to an embodiment of the present invention
  • Fig. 2A and Fig. 2B illustrate examples of immobilizing a procedural control and three antigens of different combinations of epitopes of the same disease marker on four different locations on the same membrane in a single flow-through rapid test device according to an embodiment of the present invention
  • Fig. 3A and Fig. 3B illustrate examples of immobilizing a procedural control and two antigens of different combinations of epitopes of the same disease marker on three different locations on the same membrane in a single flow-through rapid test device according to an embodiment of the present invention
  • Fig. 4 illustrates an example of a lateral-flow rapid test device according to an embodiment of the present invention
  • Fig. 5A and Fig. 5B illustrate examples of immobilizing two antigens of different combinations of epitopes of the same disease marker on two different locations on the same membrane or two separate membranes in a single lateral-flow rapid test device according to an embodiment of the present invention
  • Fig. 6 illustrates an example of immobilizing antigens of different combinations of epitopes of the same disease marker on 2 separate membranes in a single lateral-flow rapid test device according to an embodiment of the present invention
  • Fig. 7A and Fig. 7B illustrate examples of test strips that are housed within the lateral-flow rapid test device in Fig. 6;
  • Fig. 8 is a diagram of a parallel testing algorithm sourced from Global AIDS Program, Centers for Disease Control and Prevention, USA;
  • Fig. 9 is a diagram of testing strategies adopted by of WHO/UNAIDS.
  • a flow-through rapid test device with a solid casing 4 composed of a well-shaped receptacle 2 into which specimen fluid and complementary buffers and reagents can be poured, a porous membrane 1 immediately at the bottom of the receptacle that comprises an immobilized procedural control and antigens of different combinations of epitopes of the same disease marker, and a reservoir 3 within which holds an absorbent material meant to collect and retain fluids that are flown through the membrane 1 and to support the membrane.
  • the flow-through rapid test device's porous membrane 1 comprises three immobilized antigens and one procedural control.
  • FIG. 2B show two examples of possible arrangements of the immobilized antigens and procedural control at four locations on the porous membrane 1.
  • One of the four locations at 6, 7, 8, or 9 shown in Fig. 2A comprises a quantity of immobilized procedural control.
  • Each of the three remaining locations, other than the location comprising the immobilized procedural control comprises a quantity of immobilized antigens.
  • Each of the three immobilized antigen locations comprises a recombinant or a multiplex antigen of a different combination of epitopes of the same disease marker.
  • the present invention may also use antigens comprising synthetic or naturally-occurring peptides.
  • each of the three different antigens can be applied at one of the four locations as a dot, line, or any visually distinguishable shapes.
  • the different combinations of epitopes may be partially identical to one another in terms of their amino acid sequences and/or surface structures.
  • the flow-through rapid test device's porous membrane 1 comprises two immobilized antigens and one procedural control.
  • Fig. 3A and Fig. 3B show two examples of possible arrangement of the immobilized antigens and procedural control at three locations on the porous membrane 1.
  • One of the three locations at 10, 11, or 12 shown in Fig. 3 A comprises a quantity of immobilized procedural control.
  • Each of the two remaining locations, other than the location comprising the immobilized procedural control comprises a quantity of immobilized antigens.
  • Each of the two immobilized antigen locations comprise a recombinant or a multiplex antigen of a different combination of epitopes for the same disease marker.
  • the procedural control and/or each of the two different antigens can be applied at one of the three locations as a dot, line, or any visually distinguishable shapes.
  • the flow-through test device contains two different recombinant antigens; each of the two different antigens has a different combination of epitopes of the disease marker gp41 from Human Immunodeficiency Virus Type 1. Both combinations of epitopes are capable of capturing antibodies specific to gp41 in an HIV-I infected patient's serum, plasma, or whole blood, but differ in sensitivity and specificity.
  • the arrangement of the locations on the porous membrane of the two immobilized antigens and the procedural control is similar to Fig. 3 A, where the procedural control is immobilized at 10, one of the recombinant antigens for HIV-I is immobilized at 11, and the other is immobilized at 12.
  • Fig. 3B shows another possible arrangement of the three locations.
  • the same flow-through test device in Example 1 also contains two immobilized recombinant antigens of different combinations of epitopes of the disease marker gp36 from Human Immunodeficiency Virus Type 2, that are separately immobilized at 11 and 12, that are capable of capturing antibodies specific to gp36 in an infected patient's serum, plasma, or whole blood, but differ in sensitivity and specificity.
  • the flow-through test device contains three different recombinant antigens; each of the three different antigens has a different combination of epitopes of the disease marker gp41 from Human Immunodeficiency Virus Type 1. All three combinations of epitopes are capable of capturing antibodies specific to gp41 in an HIV-I infected patient's serum, plasma, or whole blood, but differ in sensitivity and specificity.
  • the arrangement of the locations on the porous membrane of the three immobilized antigens and the procedural control is similar to Fig. 2A, where the procedural control is immobilized at 6 and the three antigens each occupies 7, 8, and 9.
  • Fig. 2B shows another possible arrangement of the four locations.
  • the same flow-through test device in Example 3 also contains three immobilized recombinant antigens of different combinations of epitopes of the disease marker gp36 from Human Immuno deficiency Virus Type 2 that are separately immobilized at 7,8, and 9 on the porous membrane. All three combinations of epitopes are capable of capturing antibodies, which can bind to the disease marker gp36 from Human Immunodeficiency Virus Type 2, in an infected patient's serum, plasma, or whole blood, but differ in sensitivity and specificity.
  • FIG. 4 an example of lateral-flow rapid test device with a solid casing 14 that houses a test strip composed of absorbent materials and a porous membrane 13 that contains an immobilized procedural control and antigens of different combinations of epitopes of the same disease marker.
  • the casing also has a receptacle 16 immediately above the absorbent materials 15 of the test strip into which specimen fluid and complementary buffers and reagents can be added, and a viewing window 17 immediately above the porous membrane 13 to allow visual reading of the testing result.
  • the lateral-flow rapid test device's porous membrane 13 contains two immobilized antigens and one procedural control.
  • Fig. 5 A shows an example of possible arrangement of the immobilized antigens and procedural control at three locations 18, 19, and 20 on the porous membrane.
  • One of the three locations shown in Fig. 5A contains a quantity of immobilized procedural control.
  • Each of the two remaining locations, other than the location containing the immobilized procedural control contains a quantity of immobilized antigens.
  • Each of the two immobilized antigens locations contains a recombinant or multiplex antigen of a different combination of epitopes of the same disease marker.
  • the present invention may also use antigens comprising synthetic or naturally-occurring peptides.
  • the procedural control and/or each of the two different antigens can be applied at one of the three locations as a dot, line, or any visually distinguishable shapes.
  • the different combinations of epitopes may be partially identical to one another in terms of their amino acid sequences and/or surface structures.
  • the modified lateral-flow rapid test has an additional porous membrane 21 containing one or more immobilized antigens and one optional procedural control.
  • the additional membrane 21 can be supported on the same test strip Fig. 7A or on a separate test strip Fig. 7B housed within a single casing 14.
  • the casing has a single receptacle 16 immediately above the absorbent materials 15 of the test strip(s) into which specimen fluid and complementary buffers and reagents can be added, two viewing windows 17 and 22 immediately above the porous membrane 13 and 21, which contain immobilized procedural control and antigens of different combinations of epitopes for the same disease marker. Further additional porous membranes may also be used.
  • the lateral-flow test device contains two different recombinant antigens on the same porous membrane 13; each of the two different antigens has a different combination of epitopes of the disease marker gp41 from Human Immunodeficiency Virus Type 1. Both combinations of epitopes are capable of capturing antibodies specific to gp41 in an HIV- 1 infected patient's serum, plasma, or whole blood, but differ in sensitivity and specificity.
  • the arrangement of the locations on the porous membrane of the two immobilized antigens and the procedural control is similar to Fig. 5A, where the procedural control is immobilized at 18, one of the two recombinant antigens for HIV-I is immobilized at 19, and the other is immobilized at 20.
  • the lateral-flow test device contains two different recombinant antigens on two separate porous membranes 13 and 21; each of the two different antigens has a different combination of epitopes of the disease marker gp41 from Human Immunodeficiency Virus Type 1. Both combinations of epitopes are capable of capturing antibodies specific to gp41 in an HIV-I infected patient's serum, plasma, or whole blood, but differ in sensitivity and specificity.
  • the arrangement of the locations on the porous membrane of the two immobilized antigens and the procedural control is similar to Fig. 5A and 5B, where the procedural control is immobilized at 18 and 23, while one antigen is immobilized at 19, and the other is immobilized at 22.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Hematology (AREA)
  • Chemical & Material Sciences (AREA)
  • Biomedical Technology (AREA)
  • Urology & Nephrology (AREA)
  • Food Science & Technology (AREA)
  • Pathology (AREA)
  • Microbiology (AREA)
  • Cell Biology (AREA)
  • Biotechnology (AREA)
  • General Physics & Mathematics (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • Virology (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • AIDS & HIV (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Peptides Or Proteins (AREA)

Abstract

L'invention concerne des dispositifs d'essai comprenant une membrane poreuse, une commande et des antigènes recombinés multiples appliqués de manière distincte, de différentes combinaisons d'épitopes pour le même marqueur de maladie, qui peuvent détecter de façon précise et parallèle la présence d'anticorps spécifiques de maladie dans un échantillon donné.
PCT/CA2008/000391 2007-03-01 2008-02-29 Dispositif de dosage immunologique parallèle WO2008104081A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CA2,578,313 2007-03-01
CA 2578313 CA2578313A1 (fr) 2007-03-01 2007-03-01 Dispositif de dosage immunologique parallele rapide et tres precis

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WO2008104081A1 true WO2008104081A1 (fr) 2008-09-04

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111837038A (zh) * 2018-02-01 2020-10-27 思迪亚生物科学公司 用于评估感染持续时间的快速定量分析
US11011278B1 (en) 2020-09-21 2021-05-18 Biolytical Laboratories Inc. Methods and rapid test kits facilitating epidemiological surveillance
CN113311159A (zh) * 2021-04-15 2021-08-27 南方医科大学 通过血清hiv-1抗体检测快速区分hiv近期和长期感染状态的试纸条及其制备方法

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016035099A1 (fr) * 2014-09-05 2016-03-10 Meril Diagnostics Private Limited Dispositif à flux traversant pour la détection de substances biologiques à analyser et procédé associé

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001095784A2 (fr) * 2000-06-14 2001-12-20 J.Mitra & Co. Ltd. Trousse de diagnostic destinee a la detection in vitro de l'hepatite c
DE10108680A1 (de) * 2001-02-23 2002-09-26 Biognostic Ag Affinitätsassay zur schnellen Untersuchung biologischer Materialien
CA2422942A1 (fr) * 2001-08-17 2003-03-19 Shanghai Health Digit Limited Kit de diagnostic pour la detection simultane d'une pluralite de maladies infectieuses et preparation de celui-ci
CN1773285A (zh) * 2005-11-02 2006-05-17 中国农业科学院生物技术研究所 一种联检epsps和bt蛋白的试剂盒及方法
WO2006062800A1 (fr) * 2004-12-04 2006-06-15 Freedom Health, Llc Anticorps monoclonaux et polyclonaux contre l'hemoglobine equine ainsi qu'appareil et procedes permettant d'utiliser ces anticorps et/ou des reactions de peroxydase dans l'identification et la localisation d'ulceres chez les chevaux
CA2575852A1 (fr) * 2004-07-29 2006-07-13 Siliang Zhou Systeme et dispositif d'analyse sur membrane
WO2007068310A1 (fr) * 2005-12-14 2007-06-21 The Jordanian Pharmaceutical Manufacturing Co. Dispositif destine a la detection immunochromatographique rapide et precoce de vih et son utilisation

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001095784A2 (fr) * 2000-06-14 2001-12-20 J.Mitra & Co. Ltd. Trousse de diagnostic destinee a la detection in vitro de l'hepatite c
DE10108680A1 (de) * 2001-02-23 2002-09-26 Biognostic Ag Affinitätsassay zur schnellen Untersuchung biologischer Materialien
CA2422942A1 (fr) * 2001-08-17 2003-03-19 Shanghai Health Digit Limited Kit de diagnostic pour la detection simultane d'une pluralite de maladies infectieuses et preparation de celui-ci
CA2575852A1 (fr) * 2004-07-29 2006-07-13 Siliang Zhou Systeme et dispositif d'analyse sur membrane
WO2006062800A1 (fr) * 2004-12-04 2006-06-15 Freedom Health, Llc Anticorps monoclonaux et polyclonaux contre l'hemoglobine equine ainsi qu'appareil et procedes permettant d'utiliser ces anticorps et/ou des reactions de peroxydase dans l'identification et la localisation d'ulceres chez les chevaux
CN1773285A (zh) * 2005-11-02 2006-05-17 中国农业科学院生物技术研究所 一种联检epsps和bt蛋白的试剂盒及方法
WO2007068310A1 (fr) * 2005-12-14 2007-06-21 The Jordanian Pharmaceutical Manufacturing Co. Dispositif destine a la detection immunochromatographique rapide et precoce de vih et son utilisation

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
BASKAR ET AL.: "Development and Evaluation of a Rapid Flow-Through Immuno Filtration Test Using Recombinant Filarial Antigen for Diagnosis of Brugian and Bancroftian Filariasis", MICROBIOL. IMMUNOL., vol. 48, no. 7, 2004, pages 519 - 525, XP008147870, DOI: doi:10.1111/j.1348-0421.2004.tb03547.x *
MODY ET AL.: "Development of Rapid Assays for Common Infections Diseases", J. COMMUN. DIS., vol. 38, no. 3, 2006, pages 299 - 304 *

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111837038A (zh) * 2018-02-01 2020-10-27 思迪亚生物科学公司 用于评估感染持续时间的快速定量分析
US20200355681A1 (en) * 2018-02-01 2020-11-12 Sedia Biosciences Corporation Rapid quantitative assay to assess duration of infection
US11011278B1 (en) 2020-09-21 2021-05-18 Biolytical Laboratories Inc. Methods and rapid test kits facilitating epidemiological surveillance
CN113311159A (zh) * 2021-04-15 2021-08-27 南方医科大学 通过血清hiv-1抗体检测快速区分hiv近期和长期感染状态的试纸条及其制备方法

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