CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
April 24, 2020—Roche announced FDA approval of the Cobas HPV test for use on the fully automated, high-throughput Cobas 6800/8800 systems.
The Cobas HPV test is a qualitative in vitro test for the detection of human papillomavirus in cervical specimens collected by a clinician using an endocervical brush/spatula and placed in the ThinPrep Pap Test PreservCyt Solution. The test uses amplification of target DNA by the polymerase chain reaction and nucleic acid hybridization for the detection of 14 high-risk HPV types in a single analysis. The test specifically identifies types HPV 16 and HPV 18 while concurrently detecting the rest of the high-risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68).
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