Shortage looming of HIV supplemental tests

Shortage looming of HIV supplemental tests

Clinicians are facing 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, the Centers for Disease Control and Prevention (CDC) warns. 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 Inc. in Durham, NC, immediately notified customers that it no longer would be able to distribute the Cambridge Biotech HIV-1 Western blot kit.

The period during which kits might be in short supply is uncertain. The CDC and the Food and Drug Administration (FDA) have contacted other companies about increasing production to ensure that sufficient quantities of supplemental test kits will be available for patient and donor screening. Laboratories experiencing difficulty obtaining manufactured kits for supplemental testing can contact the CDC at (404) 639-4581.

The Cambridge kit is one of two HIV-1 Western blot (WB) kits licensed by the FDA for supplemental testing of serum, plasma, and dried whole-blood spot specimens obtained for medical diagnosis or blood and plasma donor screening. The other WB test used for these purposes is the Genetic Systems Western blot kit (BioRad Laboratories Inc., Hercules, CA). A third, OraSure HIV-1 Western blot kit (OraSure Technologies Inc., Bethlehem, PA; distributed by bioMérieux Inc.) is approved for supplemental testing of oral fluid samples found reactive for antibodies to HIV-1 in screening tests performed on oral fluids. Use of oral fluid specimens is not approved for screening and supplemental testing of blood and plasma donors.

If the Cambridge Biotech HIV-1 Western blot kit is unavailable, three options exist for supplemental testing to detect HIV antibodies using manufactured test kits approved by FDA:

Supplemental testing can be performed on serum, plasma, and dried whole-blood spots using the Genetic Systems Western blot kit. Information on the availability of the test kit is available at (800) 224-6723, or www.biorad.com. Supplemental testing can be performed on serum, plasma, and dried whole-blood spots using the Fluorognost HIV-1 IFA kit (Sanochemia, Vienna, Austria; distributed by Home Access Health, Hoffman Estates, IL). Information on the availability of this product is available at (203) 227-6880, or www.fluorognost.com. Sanochemia provides a self-taught course on performing the HIV-1 IFA and a proficiency panel free of charge.

Patient (not blood or plasma donor) screening for antibodies to HIV can be performed on an oral fluid specimen collected with the OraSure HIV-1 oral fluid collection device made by OraSure Technologies Inc. using an approved EIA test kit (Oral Fluid Vironostika HIV-1 MicroElisa) manufactured by bioMérieux. Repeatedly EIA-reactive oral fluid samples can be tested further with the supplemental OraSure HIV-1 Western blot kit. Information about the availability of the OraSure HIV-1 collection device is available at (800) 869-3538, or www.orasure.com. Information about the availability of the oral fluid EIA and WB kits can be obtained from bioMérieux Inc. Phone: (800) 682-2666.