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# FDA Approves Roche’s 4th Generation HIV Assay
- URL: https://www.fdaweb.com/fda-approves-roches-4th-generation-hiv-assay/
- Published: 2017-06-23T12:00:00.000Z
- Updated: 2026-09-14T22:31:13.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139014

FDA has approved a Roche PMA for its fourth-generation HIV combination antigen-antibody assay, the Elecsys HIV combi PT assay. The assay is intended for the *in vitro* qualitative determination of HIV-1 p24 antigen and antibodies to HIV-1 (HIV-1 groups M and O) and HIV-2 in human serum and plasma, according to the company. It is also able to detect both antigen and antibodies simultaneously, it says.