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Dx Focus: Roche's Cobas TaqMan HIV-1 Test 2.0

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Roche this week announced the US availability of the Cobas TaqMan HIV-1 Test v2.0 for use with the High Pure System.

Approved by the US Food and Drug Administration in July, the test is based on the company's proprietary dual-target approach, and enables labs to combine the FDA-approved High Pure process for manual viral nucleic acid preparation with the Cobas TaqMan 48 automated real-time PCR analyzer for amplification and detection.

The assay targets two highly conserved regions of the HIV-1 genome and avoids any regions that are current drug targets, thus providing reliable test results even when mutations are present, Roche said.

The new test completes Roche's High Pure System, which also provides FDA-approved processes for manual specimen preparation for hepatitis C and hepatitis B testing via automated real-time PCR. Labs can now consolidate HIV-1 amplification and detection on the Cobas TaqMan 48 along with HCV and HBV viral load monitoring assays.

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