Availability of Abbott / Murex Single Use Diagnostic System (SUDS) HIV-1 Test
May 10, 2001
On October 18, 2000, Abbott Diagnostics informed their customers that the Abbott Murex Single Use Diagnostic System (SUDS) HIV-1 test, the only rapid HIV test currently 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. Additionally, as Abbott indicated, the firm conducted an extensive investigation in an effort to identify all potential problems related to the production of the SUDS HIV-1 test. At that time, the Center for Biologics Evaluation and Research (CBER) also put a notice on its Website regarding the unavailability of the SUDS HIV-1 test.
Prior to release to the public, CBER evaluates protocols for each lot of rapid HIV test kit with an indication for the screening of blood donors. This lot release mechanism is one of the methods used by FDA to ensure the safety, purity and potency of biological products. After reviewing lot release data submitted by Abbott Murex for five consecutive lots of its SUDS HIV-1 test kit, CBER has determined that the SUDS test may be released for clinical use.
FDA continues to encourage the development of rapid HIV tests and has recently taken action to facilitate approval of rapid HIV tests as evidenced by presentations made during recent Blood Products Advisory Committee Meetings (see transcripts of June 15 and September 15, 2000 BPAC http://www.fda.gov/ohrms/dockets/ac/cber00.htm).
Healthcare providers with questions, concerns, or suggestions should contact CBER's Consumer Affairs Branch, Office of Communication, Training and Manufacturer Assistance at 800-835-4709 or 301-827-1800.