Rapid return: SUDS HIV test not washed up

Popular post-exposure test rebounds

The original rapid HIV test is back on the market, the Food and Drug Administration (FDA) recently announced.

Infection control professionals had grown accustomed to the quick results in guiding decisions on post-exposure prophylaxis following needlesticks. However, on Oct. 18, 2000, Abbott Diagnostics reported that Single Use Diagnostic System (SUDS) HIV-1 test, the only rapid HIV test licensed for the U.S. market, would not be available for an undetermined period due to manufacturing problems related to the failure to meet certain panel and negative control specifications. Abbott conducted an extensive investigation in an effort to identify all potential problems related to the production of the SUDS test. After reviewing lot release data submitted by Abbott Murex for five consecutive lots of its test kit, the FDA Center for Biologics Evaluation and Research (CBER) determined that the SUDS test may be released for clinical use.

In the interim, however, other rapid HIV tests have made inroads into the U.S. market on trial approval, including the Uni-Gold HIV test by Trinity Biotech in Dublin, Ireland. (See Hospital Infection Control, April 2001, under archives at www.HIConline.com.)

[Editor’s note: ICPs with questions, concerns, or suggestions regarding the rapid test can contact CBER’s Consumer Affairs Branch, Office of Communication, Training and Manufacturer Assistance at (800) 835-4709 or (301) 827-1800.]