COBAS AmpliPrep/COBAS TaqMan dual-PCR HIV-1 test approved
COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, v2.0, by Roche Molecular Diagnostics
The FDA has approved the COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, v2.0, a dual-PCR target HIV-1 viral load test from Roche Molecular Diagnostics. The COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, v2.0, has the ability to detect HIV-1 RNA (Group M and O) down to 20 copies per milliliter in EDTA plasma. This test is intended for use in conjunction with clinical presentation and other laboratory markers of disease progress for the clinical management of HIV-1 infected patients. The test can be used to assess patient prognosis by measuring the baseline HIV-1 RNA level or to monitor the effects of antiretroviral therapy by measuring changes in EDTA plasma HIV-1 RNA levels during the course of antiretroviral treatment.