Rapid HIV test pulled from market temporarily
December 1, 2000 3 minutes read
Rapid HIV test pulled from market temporarily
FDA recommends alternatives for fast results
Production of the only rapid HIV test currently licensed for the U.S. market has been suspended while the manufacturer, Abbott Diagnostics of Abbott Park, IL, struggles to resolve manufacturing problems.
In an Oct. 18 letter to customers, Abbott stated that the Abbott/Murex Single Use Diagnostic System (SUDS) HIV-1 test failed "to meet certain panel and negative control specifications."
"As part of this investigation, all product components are being evaluated as a potential cause for this problem," vice president Gene Cartwright, PhD, stated in the letter. While the company gave no time line for restarting production of the rapid HIV test, it could be as soon as 30 days, he added.
Hospitals may continue to safely use their current supply of the SUDS test, says Food and Drug Administration (FDA) spokeswoman Lanessa Banks.
The sudden suspension of production highlighted the importance of a swift and well-informed response to needlestick exposures. The SUDS test provided an initial result on the HIV status of source patients within 10 minutes. However, some concerns had surfaced about the accuracy of the rapid test.
At PEPline, a national post-exposure hotline for clinicians and health care workers, recommendations for PEP are based on risk factors and an assessment of the exposure, says Ronald H. Goldschmidt, MD, professor of family and community medicine at the University of California-San Francisco and co-director of PEPline. PEP can be discontinued within a few days if tests show the patient is HIV negative, he says.
The suspension of the rapid test "reemphasizes how important it is to have HIV tests done accurately and in the context of proper counseling," says Goldschmidt. "Falsely positive tests are phenomenally traumatic and create major medical problems [from PEP side effects]. Falsely negative tests can leave people without proper care and lead to inadvertent infection of other persons."
As an interim measure, the FDA recommended using enzyme-linked immunoassays (EIA). "Typically, samples are tested in batches so that 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," the FDA reported.
The agency also recommended testing three batches with the EIA at one time to avoid the delay of retesting after a needlestick. "Repeatedly reactive samples would be those found reactive in at least two of the three replicate tests."
The Sano Chemia (originally Waldheim) Fluo-rognost HIV-1 Indirect Immunofluorescence Assay could be used as an alternative to the EIA and, with proper equipment and a well-trained technician, could be available within 100 minutes, the FDA stated.
Regardless of the screening test used, it should be confirmed by a supplemental test, the FDA said. "The long-range solution to this problem will include the availability of multiple rapid HIV tests. FDA continues to encourage the development of rapid HIV tests and has recently taken action to facilitate approval of rapid HIV tests."
[Editor’s note: For more information on the SUDS test suspension and interim measures, contact the FDA’s 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. A list of licensed HIV tests is available at www.fda.gov/cber/products/testkits.htm.]
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