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Streamlined workflow for Roche HPV test, 8/13:86

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The FDA has approved a workflow process for Roche Diagnostics’ Cobas HPV test that allows sample processing from the primary sample collection vial after it has been used for cytology (Pap) testing. Labs can load the same vial used for a ThinPrep Pap test directly onto the Cobas 4800 system for high-risk HPV and individual HPV 16 and 18 genotype testing. The workflow option uses a special primary vial rack for the Cobas 4800.

The Cobas HPV test, approved by the FDA in 2011, is the first HPV test to receive FDA approval for loading a Pap sample vial directly onto an automated system and for the use of primary vial samples after cytology processing on either the ThinPrep 3000 (T3000) system or ThinPrep 2000 (T2000) system.

Roche Diagnostics, 317-521-3966

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