Qualification of the Geenius HIV 1/2 supplemental assay for use in the HIV blood donation screening algorithm.

Paula SaáRebecca L TownsendPeggy WellsMark A JanzenJaye P BrodskySusan L Stramer

Published in: Transfusion (2020)

Geenius FDA licensure (August 26, 2019) adding the HIV-1/HIV-2 differentiation/confirmation donation supplemental claim will enable replacement of previously used FDA-licensed supplemental assays while maintaining comparable sensitivity, avoiding thousands of unnecessary HIV-1-IFA, western blot, and HIV-2-EIA tests.

Keyphrases

antiretroviral therapy
hiv positive
hiv testing
hiv infected
human immunodeficiency virus
hepatitis c virus
hiv aids
men who have sex with men
south africa
machine learning
high throughput