Alere Determine™ HIV-1/2 Ag/Ab Combo Memo

Link: Alere Determine HIV-1/2 Ag/Ab Combo Memo


This memo is intended to update Arizona clinicians and HIV testers on the accuracy of the
Alere Determine HIV-1/2 Ag/Ab Combo Rapid Test. The Determine Combo received its
FDA approval in August 2013 and CLIA (Clinical Laboratory Improvement Amendments)
waiver in December 2014, making it suitable for use as a point-of-care (POC) rapid HIV test
in clinics and outreach testing sites. The Determine Combo is designed to separately detect
HIV-1 p24 antigen and HIV-1/2 antibodies and can be used with plasma, serum or whole
blood specimens (including fingerstick). However, recent studies demonstrate that
Determine Combo is less sensitive during early HIV infection than laboratory-based Ag/Ab
combo tests, and rarely detects p24 antigen when used with whole blood specimens.
Therefore, the Determine Combo does not reliably screen for acute HIV-1 infection when
used with whole blood.

If you have questions or would like to request HIV training, please contact Alyssa Guido at: or (520) 626-0723.