Clinical validation of the Roche cobas HPV test on the Roche cobas 6800 system for the purpose of cervical screening and qualification as a second-generation comparator test.

This study assessed the relative clinical sensitivity and specificity for cervical precancer of the Roche cobas HPV test when processed using the Roche cobas 6800 system using the Roche cobas 4800 HPV test as comparator. Intra- and inter-laboratory reproducibility were evaluated as well. The cobas HPV test run on the cobas 6800 platform demonstrated a relative clinical sensitivity of 1.