HIV Combo Test Receives CLIA Waiver

A rapid point-of-care test that detects both human immunodeficiency virus (HIV-1/2) antibodies and free HIV-1 p24 antigen has been granted a Clinical Laboratory Improvement Amendments (CLIA) Waiver.

The test has been available for sale in the USA to health facilities and laboratories licensed to conduct tests of moderate complexity and now with this approval, the test will now be available for use in physician offices, clinics and other public health settings as well.


The US Food and Drug Administration (FDA; Silver Springs, MD, USA) have granted a CLIA Waiver for the fourth generation Alere Determine HIV-1/2 Ag/Ab Combo test (Alere; San Diego, CA, USA). The capability of the test to detect p24 antigen, which can appear in only days after infection and before the HIV antibody is detectable, may detect HIV infection earlier in the course of the disease. Earlier detection allows healthcare providers to improve clinical outcomes through earlier diagnosis and treatment of patients who test positive for HIV.

Eugene Martin, PhD, professor of pathology and laboratory medicine at Rutgers University (Piscataway Township, NJ, USA) said, “I'm excited to learn that Alere Determine HIV-1/2 Ag/Ab Combo has been granted CLIA waiver and will be available for broader use in HIV screening. The promise of a fourth-generation, rapid HIV test is one that we all look forward to since it will allow screening locations to potentially identify early HIV infections, and to steer those who are most at risk of infecting others into treatment sooner.”

Avi Pelossof, global president of infectious disease at Alere, said, “The CLIA Waiver of the Alere Determine HIV-1/2 Ag/Ab Combo will help facilitate accurate and early detection of HIV, which is critical to stemming the spread of HIV/AIDS in the United States, and will have a positive economic impact by bringing a critical healthcare service nearer to patients. Broadening the test's availability to laboratories, physician offices, clinics and other public health settings, advances Alere's commitment to delivering reliable and actionable information through rapid diagnostics.”

Related Links:
US Food and Drug Administration
Alere 
Rutgers University