According to the Centers for Disease Control and Prevention (CDC), there are approximately 1.1 million Americans living with HIV. The U.S. Food and Drug Administration (FDA) has recently granted a Clinical Laboratory Improvement Amendments (CLIA) Waiver for the Alere Determine HIV-1/2 Ag/Ab Combo test. The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). Any person or facility that performs laboratory tests on human specimens for the purpose of diagnosis and/or treatment is required by federal law to have a CLIA certificate. The objective of CLIA program is to ensure quality laboratory testing.
This fourth-generation Alere Determine HIV-1/2 Ag/Ab Combo Test can independently distinguish results for HIV-1 p24 antigen and HIV antibodies in a single test. It can identify HIV infection early as it detects p24 antigen, which usually appears a few days after the infection.
Early detection of HIV infection allows healthcare providers to
- Improve clinical outcomes through early diagnosis and treatment
- Reduce additional HIV transmission
Approved by the FDA in August 2013, this HIV Combo test was initially only permitted for use inside healthcare facilities and laboratories licensed to conduct tests that are of “moderate complexity”. With the CLIA approval, the test will now be available for use in physician offices, clinics and other public healthcare settings as well.