CLIA Waiver for Trinity Biotech Uni-Gold Recombigen HIV Test

The FDA has approved a waiver under the Clinical Laboratory Improvements Amendments of 1988 (CLIA) for the Uni-Gold Recombigen HIV test.

Trinity Biotech’s Uni-Gold Recombigen HIV test was approved by the FDA on December 23rd 2003. The test which gives results within 10 minutes, is approved for the detection of antibodies to HIV in human serum, plasma and whole blood and is the only device to be approved for use with all three sample types. Uni-Gold Recombigen HIV is simple to use, requiring only one step and produces a result within 10 minutes.

The test is 100% sensitive and 99.7% specific. The product has been waived for use in detecting HIV-1 antibodies in venous whole blood samples. With this waiver, Uni-Gold Recombigen HIV can be used by almost 200,000 test sites in the US, including physician’s offices and clinics, in addition to its previously approved applicability in the hospital environment.

Approval is also expected shortly for a finger stick whole blood claim for the Uni-Gold HIV.