New combination test for hepatitis C virus genotype and viral load determination using Amplicor GT HCV MONITOR test v2.0

Figure 1 HCV Guideline test flow.

Figure 2 Strategy of HCV Guideline test. Step 1: The PCR product (here genotype 1) was hybridized to the specific capture probe, immobilized on a micro-plate. Other PCR products (e.g. of genotype 2) did not hybridize to the immobilized probe and were captured by the competitive oligonucleotide probes. The genotype specific-hybridized PCR product is retained on the micro-plate, while other PCR products were washed out from the plate. Step 2: Additional universal biotin-labeled-probes hybridized to the specific PCR product resulting in signal amplification. Step 3: Biotin reacted with streptavidine which was conjugated to the horseradish-peroxidase (HRP) enzyme. The color reaction was measured after the addition of enzyme specific substrates.

Figure 3 Specificity of HCV Guideline test. 36 anti-HCV-positive samples and 36 anti-HCV-negative samples were used to determine the specificity of the HCV Guideline test. All the anti-HCV-positive samples showed an absorbance greater than 0.2, whereas all anti-HCV-negative samples showed an absorbance below 0.2.