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DIAGNOSTICS OF HEPATITIS C
DIA-HCV-III, DIA-HCV – the enzyme immunoassay test system for the detection of antibodies to the hepatitis C virus
Scientific industrial enterprise
“Diaproph-Med” manufacturers two test kits for screening of
antibodies to hepatitis C virus: DIA-HÑV-²²² and DIA-HÑV. The
difference between kits is the composition of recombinant
proteins the microplate is coated with.
Principle of the method: two stage procedure based on indirect solid ELISA
Clinical materials: human serum or plasma
Detecting of specific
antibodies to proteins of hepatitis C virus both at early stages of
seroconversion and chronic disease course
Immunosorbent:
DIA-HCV-III – recombinant proteins – analogues of antigens
of hepatitis C virus: NS3, NS4ab, NS5, core, and chimeric protein
NÑ34ab (NS3, NS4ab, core); DIA-HCV – recombinant protein NS3 and
chimeric protein NÑ34ab
Conjugate – high specific monoclonal antibodies to human IgG conjugated with horseradish peroxidase
Packing configuration:
- Strip (lockwell) and monolith
- 96 or 192 tests
- TMB chromogen
Incubation time: 2 hours
Shelf life: 14 months
Sensitivity DIA-HCV-III 100 % (95 samples from BBI and BCPI panels, USA; MBC, Russia and 347 serum samples from patients with chronic hepatitis C)
Specificity DIA-HCV-III 99,3% (8 869 serum samples of blood donors)
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Assay principle |
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Wells coated with recombinant proteins
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Adding of sera
Incubation for 60 minutes,37°Ñ
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Adding of conjugate
Incubation for 30 minutes, 37°Ñ
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Adding of chromogen
Incubation for 30 minutes, 18-25°Ñ
Reaction termination
Result reading
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Dynamics of serological markers under viral hepatitis C
Time after infection
DIA-HCV-different
– Enzyme immunoassay for the differential detection of antibodies
to hepatitis Ñ virus (NS3, NS4, NS5, core)
Principle of the method: two stage procedure based on indirect solid ELISA
Clinical materials: human serum or plasma
Separate determining of IgG antibodies to core and non-structural (NS3, NS4, NS5) antigens of hepatitis C virus
Using as a confirmatory test for results of screening investigations during ELISA diagnostics of hepatitis C
Immunosorbent – strips are separately coated with recombinant proteins NS3, NS4ab, NS5, core
Conjugate – high specific monoclonal antibodies to human IgG conjugated with horseradish peroxidase
Packing configuration:
- Lockwell strip microplate
- 24 or 48 test
- TMB chromogen
Incubation time: 2 hours
Shelf life: 12 months
Results of testing of
DIA-HCV-different test kit in serum panels: HCV 6212 (BCPI, USA);
PHV-105, PHV-906, PHV-907, PHV-910 (BBI, USA) were in compliance with
the data sheets of those panels
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Assay principle |
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wells coated with recombinant proteins NS3, NS4, NS5, core
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Adding of sera
Incubation for 60 minutes, 37°Ñ
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Adding of conjugate
Incubation for 30 minutes, 37°Ñ
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adding of chromogen
Incubation for 30 minutes, 18-25°Ñ
Reaction termination
Result reading
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Evaluation of sensitivity for
DIA-HCV è DIA-HCV-²²² test kits |
Detection of antibodies to separate proteins of hepatitis C virus at the early seroconversion DIA-HCV-different |
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Anti - HCV Seroconversion Panel PHV -90 6 , BBI
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Anti - HCV Seroconversion Panel PHV -907, BBI
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Anti - HCV Seroconversion Panel PHV -910, BBI
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Company
