Rapid HIV test runs off track in production
Interim measures proposed for PEP decisions
The only rapid HIV test currently licensed for the U.S. market will not be available for an undetermined period of time due to manufacturing problems, the Food and Drug Administration has announced.
While at least four other rapid HIV tests are in the research stage, only one such test has been approved by the FDA: the single-use diagnostic system (SUDS) distributed by Abbott Laboratories in Abbott Park, IL.
"Since the length of time that this test will not be available is not certain at this time, FDA recommends that health care providers implement one of the [following] suggested interim measures to replace the SUDS HIV-1 Test while it remains unavailable," the FDA announced.
Infection control professionals have hailed the benefits of the test, which can ease the emotional state of exposed workers quickly and guide decisions for post-exposure prophylaxis (PEP). (See Hospital Infection Control, November 1999.) Industry sources say the test is being purchased by some 1,400 hospitals and clinics nationally. In a letter dated Oct. 18, 2000, Abbott Diagnostics informed its customers of the problem. The FDA has received assurance from Abbott that the company is working to resolve the problems as quickly as possible. The FDA suggests ICPs consider the following interim measures for PEP of exposed health care workers:
• Provide immediate testing with one of the currently licensed enzyme-linked immunoassays (EIAs). Typically, samples are tested in batches, so results may not be available for several days. However, if health care providers arrange for the EIA tests to be performed on samples as needed, results could be available within 90 to 160 minutes.
To validate whether a reactive result is repeatedly reactive, any sample testing reactive on the initial assay (EIA or SUDS) normally would have to be repeated in duplicate in a separate assay. To avoid a lengthy delay due to a second round of testing of any initially reactive samples, performance of the initial assay in triplicate should be done. Repeatedly reactive samples would be those found reactive in at least two of the three replicate tests.
• Use the Sano Chemia (originally Waldheim) Fluorognost HIV-1 Indirect Immunofluorescence Assay, which is licensed as a screening test where EIAs are not practical. This test requires a fluorescence microscope and a well-trained technician and can be performed within about 100 minutes.
[Editor’s note: ICPs with questions about the situation can contact the FDA Center for Biologics Evaluation and Research’s Consumer Affairs Branch, Office of Communication, Training and Manufacturer Assistance at (800) 835-4709 or (301) 827-1800.]
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