FDA Notification

Shortage of test kits for detecting HIV-1 antibodies

The Public Health Service has become aware of a potential shortage of supplemental test kits used for confirmatory testing of HIV antibodies in specimens obtained from either patients or blood and plasma donors.

On April 17, 2002, Calypte Biomedical Corp. in Alameda, CA, announced the company might stop manufacturing the Cambridge Biotech HIV-1 Western blot kit. The distributor, bioMérieux of Durham, NC, immediately notified customers that it no longer would be able to distribute the Cambridge kit, which is one of two HIV-1 Western blot kits licensed by the U.S. Food and Drug Administration (FDA) for supplemental testing of serum, plasma, and dried whole-blood spot specimens.

The period during which kits might be in short supply is uncertain. The Centers for Disease Control and Prevention and the FDA have contacted manufacturers about increasing production to ensure that sufficient quantities of supplemental test kits will be available for patient and donor screening. CDC is collaborating with FDA and other private and public health partners about the evaluation of alternative strategies for HIV diagnostic testing in case shortages of supplemental test kits continue. Laboratories experiencing difficulty obtaining manufactured kits for supplemental testing can contact CDC at (404) 639-4581.