AlereAlere Inc, Waltham, Mass, has received FDA approval of its pre-market application (PMA) for Alere Determine™ HIV 1/2 Ag/Ab Combo in the United States for the detection of HIV-1 p24 antigen and antibodies to HIV-1/HIV-2.

This is the first and only FDA-approved rapid point-of-care test that detects both HIV-1/2 antibodies and the HIV-1 p24 antigen, which can appear days after infection and prior to1,2 HIV-1/2 antibodies, according to the company.

Alere can market the test as a CLIA (Clinical Laboratory Improvement Amendments) moderately complex medical device, says Avi Pelossof, the company’s global president of infectious disease.

“The Alere Determine™ Combo can help to identify additional cases that would not be detected using second- and third-generation antibody-only tests, Pelossof says.”4

The company plans to complete the CLIA waiver trials, aiming to submit the data in late 2013 or early 2014.

According to the Centers of Disease Control and Prevention (CDC), there are 1.4 million Americans living with HIV, and approximately 207,000 (18%) whose infections have not been diagnosed.3

[Source: Alere Inc]

1. Gurtler?L, Muhlbacher A, Michl U, Hofmann H, Paggi GG, Bossi V, Thorstensson R, G-Villaescusa R, Eiras A, Hernandez JM, Melchior W, Donie F, Weber B. Reduction of the diagnostic window with a new combined p24 antigen and human immunodeficiency virus antibody screen assay. J Virol Methods. 1998 Nov;75(1):27-38.

2. Burst S, Duttmann H, Feldner J, Gurtler L, Thorstensson R, Simon F. Shortening of the diagnostic window with a new combined HIV p24 antigen and antibody HIV1/2/O screening test. J Virol Methods. 2000 Nov;90(2):153-65

3. Centers for Disease Control and Prevention. Monitoring selected national HIV prevention and care objectives by using HIV surveillance data—United States and 6 U.S. dependent areas—2010. HIV Surveillance Supplemental Report 2012;17(No. 3, part A). Published June 2012.

4. Masciotra, S. Performance of the Alere Determine HIV-1/2 Combo Rapid Test with Specimens from U.S. HIV-1 Seroconvertes and HIV-2 Positive Specimens from Ivory Coast.2012 HIV Diagnostics Conference; Atlanta.