Roche Launches Hepatitis B Viral Load Assay in CE Mark Countries

Roche’s cobas HBV quantitative nucleic acid test is now available for use on the cobas 6800/8000 systems in all countries that observe the CE mark. The new assay covers all hepatitis B genotypes — A through H — with high sensitivity, the Swiss firm said Monday.

The assay builds on the viral load monitoring portfolio of the cobas HIV-1, hepatitis C and cytomegalovirus assays. The assays and the 6800/8800 systems are designed to improve lab efficiency while providing the rapid results needed to make informed treatment decisions, Roche said.

“With the cobas HBV assay, laboratories now have a highly robust and sensitive assay for quantifying HBV DNA, with a lower sample requirement that provides a new standard of flexibility," said Roland Diggelmann, chief operating officer of Roche Diagnostics.

The systems produce up to 96 results in less than 3.5 hours, for a total of 384 and 960 results for the 6800 and 8800 systems over an eight-hour shift. Both systems allow for mixed batching, meaning labs can perform up to three tests in the same run without needing to presort, Roche said.

Neither system nor the HBV assay are available in the U.S. — Kellen Owings