FDA Approval for HIV Test Using Fingerstick Wholeblood

Trinity Biotech plc have received FDA approval for the use of its Uni-Gold™ Recombigen® HIV Test with fingerstick whole blood samples. The test, which gives results within 10 minutes, is now approved for the detection of antibodies to HIV in human serum, plasma, venous and fingerstick whole blood and is the first and only device to be approved for use with all four sample types.

Uni-Gold™ Recombigen® HIV is simple to use, provides rapid results and is 100% sensitive and 99.7% specific. The product has previously received CLIA waiver for use in detecting HIV 1 antibodies in venous whole blood samples and Trinity has already applied for CLIA waiver for fingerstick whole blood.

The fingerstick approval provides Trinity access to a whole new point of test market, such as doctor’s offices and other non-laboratory facilities.