This highly sensitive test offers Roche’s fully automated real-time polymerase chain reaction (PCR) technology to achieve a broad range for the quantitative detection of hepatitis B virus DNA in patient plasma and serum.
According to the company, the Cobas AmpliPrep/Cobas TaqMan HBV Test v2.0 can detect genotypes A-H and pre-core mutants. It offers a broader range than previous generation tests, from as low as 20IU/ml and as high as 1.7E+08 IU/ml, enabling physicians to improve viral load monitoring. The assay offers both serum and plasma specimen type and only uses 650 microliters sample processing volume.
This test is designed for use on Roche’s automated platform that was CE Mark certified in 2005. The platform combines the Cobas AmpliPrep instrument for automated sample preparation and the Cobas TaqMan analyzer or the smaller Cobas TaqMan 48 analyzer for automated real-time PCR amplification and detection.
Teresa Wright, chief medical officer of Roche Molecular Diagnostics, said: “This test enables doctors to optimize patient treatment with standardized viral load measurements and enables laboratories to test efficiently with improved automation.”