US approves 10-minute HIV test

3 February 2004. Related: Diagnostics.

Graham McKerrow, HIV i-Base

The US Food and Drug Administration has approved a new, single-use 10 dollar, 10 minute HIV-1 antibody test, the Uni-Gold Recombigen, made by the Irish company Trinity Biotech PLC. It is the first testing kit to be approved by the FDA for use in plasma, serum and whole blood (venipuncture). The 20-minute OraSure test can be used only on whole blood.

The device, which tests a single drop of whole blood, serum or plasma, is only allowed to be used by clinical laboratory professionals in facilities that have suitable quality assurance programmes and Trinity Biotech wants to sell it to government programmes, physicians and hospitals for use following needlestick injuries and to test pregnant women. People being tested must receive printed information and counselling, and positive tests require confirmation. The company hopes to sell nearly 500,000 in the US this year alone. The test is already sold in Africa and Asia.

The FDA based its approval on company research involving more than 9,000 patient samples that detected 100% of HIV-positive specimens, and was 99.7% accurate on the negative samples.

Links:

• Trinity Biotech
  http://www.trinitybiotech.com/EN/index.asp
• FDA
  http://www.fda.gov/
• Product labeling will be available at
  http://www.fda.gov/cber/products/testkits.htm