Alere: FDA Grants CLIA Waiver For Alere Determine HIV-1/2 Ag/Ab Combo Test

(RTTNews) - Alere Inc (ALR), a leader in rapid diagnostic tests, Tuesday announced that the U.S. Food and Drug Administration has granted CLIA (Clinical Laboratory Improvement Amendments) Waiver for the Alere Determine HIV-1/2 Ag/Ab Combo test.

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

Alere Determine HIV 1-2 Ag/Ab Combo was FDA-approved in August 2013 as the first fourth-generation, rapid point-of-care test that detects both HIV-1/2 antibodies and free HIV-1 p24 antigen.

Due to its capability to detect p24 antigen, which can appear in only days after infection and before the HIV antibody is detectable, Alere Determine HIV-1/2 Ag/Ab Combo may detect HIV infection earlier in the course of the disease.