Elecsys HIV Duo

STN: 125778
Proper Name: Elecsys HIV Duo
Tradename: Elecsys HIV Duo
Manufacturer: Roche Diagnostics
Indication:

• Elecsys HIV Duo is an in vitro immunoassay for the simultaneous qualitative detection and differentiation of HIV-1 p24 antigen and antibodies to HIV, HIV-1 (groups M and O) and HIV-2 in human serum and plasma.
• Elecsys HIV Duo is intended to screen individual human donors, including volunteer donors of whole blood, blood components and source plasma.
• The assay is also intended to be used to screen organ, tissue and cell donors, when donor samples are obtained while the donor's heart is still beating and in testing serum specimens to screen cadaveric donors when specimens are obtained after the donor’s heart has stopped beating.
• It is not intended for use on cord blood specimens.
• The electrochemiluminescence immunoassay “ECLIA” is intended for use with cobas pro serology solution equipped with cobas e 801 analytical unit.

Product Information

• Package Insert - Elecsys HIV Duo
• Package Insert - PreciControl HIV Gen II
• Package Insert - PreciControl HIV. HIV-2+GprO
• Package Insert - PreciControl Release HIV Gen II

Supporting Documents

• March 31, 2026 Approval Letter - Elecsys HIV Duo
• June 13, 2023 Approval Letter - Elecsys HIV Duo
• June 12, 2023 Summary Basis for Regulatory Action - Elecsys HIV Duo