Two important changes have been made in the OraQuick Rapid HIV-1 Antibody Test procedure that were recently approved by the U.S Food and Drug Administration (FDA).

On September 5, the FDA approved the OraQuick test for use with venipuncture whole blood specimens. The expanded use will allow OraQuick testing on whole blood samples routinely drawn from patients by venipuncture. Final product labeling incorporating this new claim received FDA approval on Sept 30, 2003.

The maximum time for reading results of the OraQuick test has been reduced–from 60 minutes to 40 minutes. The maximum read time was reduced to 40 minutes in order to minimize the possibility of false positive test results. In clinical studies, there were occasional false positive results when the test was read between 40 and 60 minutes. The revised instructions indicate the test should be read no sooner than 20 minutes and no later than 40 minutes after the test device is inserted into the developer vial. The change applies to both fingerstick whole blood and venipuncture whole blood specimens.

OraQuick’s updated package insert includes step-by-step instructions on specimen collection and testing procedures for venipuncture whole blood. Links to the updated insert and the step-by-step instructions can be found at the CDC’s Rapid HIV Testing website: http://www.cdc.gov/hiv/