PCR-Based HBV Diagnostic Kits

A new diagnostic kit based on polymerase chain reaction (PCR) for testing for the hepatitis B virus (HBV) is now available as a panel of three assays: HBV VL, designed to show if treatment is effective by monitoring viral load; HBV DE/3TC, for monitoring patients for lamivudine-resistant HBV; and HBV mutant VL, for measuring viral strains associated with BheAg-negative infection.

One common sample preparation serves all three assays. The first two assays have received the CE Mark and the third is under final review. The assays are part of the affigene line of Sangtee Molecular Diagnostics AB (Stockholm, Sweden), which notes that these diagnostic kits are the first to carry the CE label, which will be mandatory for all in vitro diagnostic products sold in Europe as of December 7, 2003.

"The affigene HBV concept offers a complete range of PCR assays for HBV diagnostics, to monitor HBV viral load, drug resistance, and precore/core promotor mutations in a standardized way. The concept is designed for routine clinical diagnostics with one common sample preparation,” said Therese Sundell, international product manager at Sangtee Molecular Diagnostics.




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