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DIAGNOSTICS OF HEPATITIS Â
DIA-HÂV – Enzyme immunoassay test system for the detection of hepatitis B virus surface antigen (HBsAg)
Principle of the method: one-stage procedure based on «sandwich»-ELISA
Clinical materials: human serum or plasma
Immunosorbent – monoclonal antibodies to HBsAg
Conjugate – monoclonal antibodies to HBsAg conjugated with horseradish peroxidase
Packing configuration:
- strip (lockwell) or monolith microplate
- 96 or 192 tests
- TMB chromogen
Incubation time: 2 hours
Shelf life: 14 months
Sensitivity:
- 0,3 ng/ml HBsAg – for kits packed with OPD
- 0,2 ng/ml HBsAg – for kits packed with TMB
Specificity – 99.2 % (8869 serum samples from blood donors)
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Assay principle |
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wells coated with monoclonal antibodies to HBsAg
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adding of controls, sera and conjugate
incubation for 120 minutes, 37 °Ñ
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adding of chromogen
incubation for 30 minutes at 18-25°Ñ
reaction termination
result reading
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DIA-Ñ-HÂV – Enzyme immunoassay test system for the confirming of hepatitis B virus surface antigen (HBsAg)

Principle
of the method: verification of results based on neutralization- binding
of conjugate with HBsAg by antibodies composing of neutralization
component
Clinical materials: human serum or plasma
Using high specific monoclonal antibodies to HBsAg composing of immunosorbent, neutralization component and peroxidase conjugate
Packing configuration:
- strip microplate
- 96 tests
- TMB chromogen
Incubation time: 2,5 hours
Shelf life: 12 months
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Assay principle |
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wells coated with monoclonal antibodies to HBsAg
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adding of sera, conjugate and neutralization component
incubation for 120 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 of HBV
Relative concentration

Time after infection
DIA-HBcore
– Enzyme immunoassay test system for the detection of IgG and
IgM-antibodies to the hepatitis B virus core protein

Principle
of the method: verification of results based on neutralization- binding
of conjugate with HBsAg by antibodies composing of neutralization
component
Clinical materials: human serum or plasma
Using high specific monoclonal antibodies to HBsAg composing of immunosorbent, neutralization component and peroxidase conjugate
Packing configuration:
- strip microplate
- 96 tests
- TMB chromogen
Incubation time: 2,5 hours
Shelf life: 12 months
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Assay principle |
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wells coated with recombinant HBsAg antigen
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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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