Performance of the Alere Determine™ HIV-1/2 Ag/Ab Combo Rapid Test with specimens from HIV-1 seroconverters from the US and HIV-2 infected individuals from Ivory Coast.

Abstract

BACKGROUND:

FDA-approved HIV Antigen/Antibody combo (4th generation) immunoassays (IAs) can identify HIV-1 infections before the Western blot (WB) becomes positive. In the US, increased detection of acute HIV infections has been facilitated by using 4th generation IAs, but there is no FDA-approved 4th generation rapid test (RT). The Alere Determine™ HIV-1/2 Ag/Ab Combo (Determine Combo) RT detects and distinguishes HIV p24 Antigen (Ag) from Antibody (Ab) to HIV-1+HIV-2 and thus has the potential to improve diagnosis of acute HIV infection.

OBJECTIVE:

To evaluate the ability of Determine Combo RT to detect acute/early HIV-1 infections and HIV-2 antibody in well-characterized plasma specimens.

STUDY DESIGN:

In HIV-1 seroconverters from the US, Determine Combo reactivity was evaluated by performing the 50% cumulative frequency analysis and by comparing with 3rd and 4th generation IAs' reactivity. HIV-2 plasma specimens from Ivory Coast were tested with Determine Combo.

RESULTS:

The 50% cumulative frequency analysis in 17 seroconverters placed Determine Combo (Ag+/Ab-, Ag+Ab+, Ag-/Ab+) and Ab-component reactivity at 15.5 and 7 days before WB positivity, respectively. In 26 seroconverters, Determine Combo was reactive in 99.0% and 92.5% of 3rd and 4th generation IAs-reactive specimens, respectively. All HIV-2 plasma specimens were Ab-reactive/Ag-non-reactive by Determine Combo.

CONCLUSIONS:

Based on previous results with the same seroconversion panels, combined Ag/Ab reactivity of the Determine Combo appears between FDA-approved 4th and 3rd generation laboratory IAs. These data indicate that this RT could detect HIV-1 infection earlier than other RTs and it performs well in HIV-2 specimens.

• Authors: Silvina Masciotra, Wei Luo, Ae S Youngpairoj, M Susan Kennedy, Susan Wells, Krystin Ambrose, Patrick Sprinkle, S Michele Owen
• Journal: Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology (J Clin Virol) Vol. 58 Suppl 1 Pg. e54-8 (Dec 2013) ISSN: 1873-5967 [Electronic] Netherlands
• PMID: 23911678 (Publication Type: Evaluation Study, Journal Article, Research Support, U.S. Gov't, P.H.S.)
• Copyright: Published by Elsevier B.V.

Chemical References

• HIV Antibodies
• HIV Antigens

Topics

• Algorithms
• Cote d'Ivoire
• Diagnostic Tests, Routine (methods)
• HIV Antibodies (blood)
• HIV Antigens (blood)
• HIV Infections (diagnosis, virology)
• HIV-1 (classification, genetics, immunology)
• HIV-2 (classification, genetics, immunology)
• Humans
• Immunoassay (methods)
• Sensitivity and Specificity
• Time Factors
• United States
• Virology (methods)