Virology - Assay Development

Virology

HBV rt204 drug resistant mutant detection assay (ultrasensitive*; quantitative or qualitative);
HBV basal core promoter (BCP) 1762T/1764A mutation assay (ultrasensitive*; quantitative or qualitative);
HBV precore 1896A mutation assay (ultrasensitive*; quantitative or qualitative);
HBV Genotyping;
HBV total viral load assay (high sensitivity: 40 copies of viral DNA per ml of blood);

* sensitivity level: 0.001% mutant.

The analytical sensitivity of a mutant PCR assay is measured in two ways: the minimal copy of mutant DNA detectable and the minimal mutant:WT ratio at which the mutant remains detectable. The minimal copy of mutant DNA detectable is in a close range of 5-30 for all the PCR-based assays. However, the minimal mutant:WT ratio may vary widely. Regular DNA sequencing has a mutation-detection sensitivity of 1:4 mutant:WT ratio or 20% mutant.