HCV Gen4 Ag & Ab Microlisa

Intended Use

HCV Gen4 Ag & Ab Microlisa is an in vitro qualitative enzyme immunoassay for the detection of anti-HCV antibodies and core antigen in human serum or plasma. It is intended for screening of blood donors and for clinical diagnostic testing.

Salient Features

• 4th Generation ELISA Test.
• Detection of HCV Core Antigen and Antibodies to HCV(Core ,NS3,NS4 & NS5) in Human serum/Plasma
• Significant reduction in window period by 5-7 weeks
• Detects all 8 HCV Genotypes
• Colour coded reagents to monitor the procedural steps
• Assay procedure: 150 minutes
• Use of only 1 Enzyme Conjugate
• Shelf life : 24 months at 2-8°C.
• NIB Evaluated with 100% Sensitivity and Specificity
• Easy to use on automated and semi-automatic processor
• Indigenously developed kit and more suitable for Indian Population.

Principle

HCV Gen4 Ag & Ab Microlisa test is a 4th Generation qualitative enzyme immunoassay. HCV recombinant antigen (NS3, NS4, NS5 and Core) and anti-HCV core antibodies are coated onto microtiter wells. Specimens and controls are added to the microtiter wells and incubated. The plate is then washed to remove unbound material. Horseradish peroxidase (HRP) conjugated to Antihuman IgG and anti-HCV antibodies is added to each well. This conjugate will bind to HCV antigenantibody or anti-HCV antibody-antigen complex present. Finally substrate solution containing chromogen and hydrogen peroxide is added to the wells and incubated.

A blue colour will develop in proportion to the amount of anti-HCV antibodies and/or HCV core antigen present in the specimen. The colour reaction is stopped by a stop solution. The enzyme substrate reaction is read by EIA reader for absorbance at a wavelength of 450 nm. If the sample does not contain anti-HCV antibodies and/or HCV core antigen then enzyme conjugate will not bind and the solution in the wells will be either colourless or only a faint background colour develops.

Ordering Information

Evaluation

Performance of the test with reference to sensitivity and specificity has been evaluated in-house with the panel of 91 negative samples and 28 HCV positive (6 HCV Antigen & 22 HCV Antibody) samples , 553 clinical patient samples and 12potentially cross-reacting specimen; HIV, HBsAg, Syphilis, RA, Dengue and ante-natal samples .The kit performance is also checked using Sero-conversion panels. The kit detects HCV infection earlier as compared to an anti-HCV antibody detection kit (anti-HCV kit) and results are as follows:
Sensitivity with HCV Antigen Positive samples : 100%
Sensitivity with HCV Antibody Positive samples -100%
Specificity with clinic samples and cross reacting samples: 100%