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FDA approves Roche’s HIV-1/HIV-2 test for use in cobas Systems

September 2, 2020

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Roche has received US Food and Drug Administration (FDA) approval for its cobas HIV-1/HIV-2 Qualitative test for use on fully automated cobas 6800/8800 Systems in the US.

The test is an in vitro nucleic acid amplification assay for the qualitative detection and differentiation of human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2) RNA in human serum and plasma.

It enables healthcare professionals to diagnose HIV with a single result. It also differentiates HIV-1 and HIV-2, offering appropriate treatment options for patients.

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