Device Generic Name: Real-time HIV-1 PCR test
Tradename: cobas HIV - 1
Manufacturer: Roche Molecular Systems, Inc.
An in vitronucleic acid amplification test for the quantitation of human immunodeficiency virus type 1 (HIV-1) in EDTA plasma of HIV-1-infected individuals using the automated cobas 6800/8800 Systems for specimen processing, amplification and detection. The test can quantitate HIV-1 RNA over the range of 20-10,000,000 copies/mL (33 to 1.67 x 107 International Units/mL).This test is intended for use in conjunction with clinical presentation and other laboratory markers for the clinical management of HIV-1 infected patients. The test can be used to assess patient prognosis by measuring the baseline HIV-1 level or to monitor the effects of antiretroviral therapy by measuring changes in HIV-1 RNA levels during the course of antiretroviral treatment.
Approval Date: December 18, 2015