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Notice to Readers: Potential Shortage of Supplemental 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 human immunodeficiency virus (HIV) antibodies in specimens obtained from either patients or blood and plasma
donors. On April 17, 2002, Calypte Biomedical Corporation (Alameda, California) announced the company might
stop manufacturing the Cambridge Biotech HIV-1 Western blot kit. The distributor, bioMérieux, Inc. (Durham, North
Carolina), immediately notified customers that it no longer would be able to distribute the Cambridge Biotech HIV-1 Western blot kit.
The Cambridge kit is one of two HIV-1 Western blot (WB) kits licensed by the Food and Drug Administration (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 made by
BioRad Laboratories, Inc. (Hercules, California). A third,
OraSure® HIV-1 Western blot kit made by OraSure Technologies,
Inc. (Bethlehem, Pennsylvania) and 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. However, use of oral fluid specimens is
not approved for screening and supplemental testing of blood and plasma donors.
The algorithm for HIV testing in the United States begins with an initial screening enzyme immunoassay (EIA). If
reactive, the EIA is repeated in duplicate on the same specimen. If repeatedly reactive, the specimen is tested with a more
specific supplemental test to validate the true-positive EIA results and to prevent notification based on false-positive results that
might occur during the screening tests. Supplemental tests include the WB test or the indirect immunofluorescence assay (IFA).
This algorithm is used with serum, plasma, dried whole-blood spots, and oral fluid specimens
(1--9).
Some laboratories are experiencing delays in obtaining WB supplemental test kits, and the potential exists for future
delays in supplemental testing. Persons being tested for HIV might need to be counseled that they might experience delays
in receiving their HIV test results.
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 about the availability of the test kit is available by telephone, 800-224-6723, or at
http://www.biorad.com.
Supplemental testing can be performed on serum, plasma, and dried whole-blood spots using the
Fluorognost™ HIV-1 IFA kit made by Sanochemia (Vienna, Austria) and distributed by Home Access Health (Hoffman Estates,
Illinois). Information about the availability of this product is available by telephone, 203-227-6880, or at
http://www.fluorognost.com. Sanochemia provides a self-taught course on performing the HIV-1 IFA and a proficiency
panel free of charge.
Patient (but 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, Inc. 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 by telephone, 800-869-3538, or at
http://www.orasure.com. Information about the availability of the oral fluid EIA and WB kits can be obtained
from bioMérieux, Inc., telephone 800-682-2666.
The period during which kits might be in short supply is uncertain. CDC and FDA have contacted all the companies
listed above 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, telephone 404-639-4581.
The Consortium for Retrovirus Serology. Serological diagnosis of human immunodeficiency virus infection by Western blot testing.
JAMA 1988;260:674--9.
Dodd RY, Fang CT. The western immunoblot procedure for HIV antibodies and its interpretation. Arch Pathol Lab Med 1990;114:240--5.
Sullivan PT, Mucke H, Kadey SD, Fang CT, Williams AE. Evaluation of an indirect immunofluoresence assay for confirmation of
human immunodeficiency virus type 1 antibody in U.S. blood donor sera. J Clin Micro 1992;30:2509--10.
Iltis JP, Patel NM, Lee SR, Barmat SL, Wallen WC. Comparative evaluation of an immunofluorescent antibody test, enzyme immunoassay,
and western blot for the detection of HIV-1 antibody. Intervirology 1990;31:122--8.
Stramer SL, Sapan CV, Henderson SE, et al. Commercial HIV-immunofluorescence assay (IFA) in confirmatory algorithms for HIV-1/2
EIA. Meeting of the International Society of Blood Transfusion, Amsterdam, The Netherlands, 1994
Gallo D, George JR, Fitchen JH, Goldstein AS, Hindahl MS. Evaluation of a system using oral mucosal transudate for HIV-1 antibody screening
and confirmatory testing. JAMA 1997;277:254--8.
Cordeiro ML, Turpin CS, McAdams SA. A comparative study of saliva and OraSure oral fluid. Ann N Y Acad Sci 1993;694:330--1.
Granade TC, Phillips SK, Parekh B, et al. Detection of antibodies to human immunodeficiency virus type 1 in oral fluids: a large-scale evaluation
of immunoassay performance. Clin Diag Lab Immunol 1998;5:171--5.
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