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Abbott Receives Supplemental Approval for HIV-1 Viral Load Test

August 10, 2007

Abbott announced it received a supplemental premarket approval for its recently introduced RealTime HIV-1 viral load test.

The approval allows Abbott to market a number of enhancements to the test, including a feature that allows laboratories to perform HIV-1 viral load tests with smaller amounts (0.6 mL) of blood plasma.

The RealTime test is the most sensitive HIV-1 viral load test available and the only test of its kind validated to detect and precisely measure the common strains of HIV-1 as well as all known genetic variations of the virus, including group O, group N, and non-B subtypes, the company said.