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Journal of Clinical Microbiology, March 2001, p. 1017-1020, Vol. 39, No. 3
0095-1137/01/$04.00+0   DOI: 10.1128/JCM.39.3.1017-1020.2001
Copyright © 2001, American Society for Microbiology. All rights reserved.

Evaluation of United States-Licensed Human Immunodeficiency Virus Immunoassays for Detection of Group M Viral Variants

Walter H. Koch,1,* Patrick S. Sullivan,2 Charles Roberts,1 Kori Francis,1 Robert Downing,3 Timothy D. Mastro,4 John Nkengasong,5 Dale Hu,2 Silvina Masciotra,6,7 Charles Schable,6 and Renu B. Lal6

Office of Blood Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland1; Surveillance and Epidemiology, Division of HIV/AIDS Prevention, National Center for HIV, STD, and TB Prevention,2 and Division of AIDS, STD, and TB Laboratory Research, National Center for Infectious Diseases,6 Centers for Disease Control and Prevention, Atlanta, Georgia; Uganda Virus Research Institute, Entebbe, Uganda3; HIV/AIDS Collaboration, Nonthaburi, Thailand4; Projet RETRO-CI, Abidjan, Côte d'Ivoire5; and Laboratorio Central y Seccion de Infectiologia, Hospital de Italiano de Buenos Aires, Buenos Aires, Argentina7

Received 13 September 2000/Returned for modification 28 November 2000/Accepted 27 December 2000

Six Food and Drug Administration (FDA)-licensed human immunodeficiency virus type 1 (HIV-1) and HIV-1/2 immunoassays, including five enzyme immunoassays and one rapid test, were challenged with up to 250 serum samples collected from various global sites. The serum samples were from individuals known to be infected with variants of HIV-1 including group M subtypes A, B, B', C, D, E, F, and G and group O. All immunoassays detected the vast majority of samples tested. Three samples produced low signal over cutoff values in one or more tests: a clade B sample, an untypeable sample with a low antibody titer, and a group O sample. It is concluded that HIV-1 immunoassays used in the United States are capable of detecting most HIV-1 group M variants.

* Corresponding author. Present address: Roche Molecular Systems, 1145 Atlantic Ave., Alameda, CA 94501. Phone: (510) 814-2987. Fax: (510) 522-1285. E-mail: walter_h.koch{at}roche.com.

Journal of Clinical Microbiology, March 2001, p. 1017-1020, Vol. 39, No. 3
0095-1137/01/$04.00+0   DOI: 10.1128/JCM.39.3.1017-1020.2001
Copyright © 2001, American Society for Microbiology. All rights reserved.


This article has been cited by other articles:

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