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Journal of Clinical Microbiology, January 2005, p. 506-508, Vol. 43, No. 1
0095-1137/05/$08.00+0     doi:10.1128/JCM.43.1.506-508.2005
Copyright © 2005, American Society for Microbiology. All Rights Reserved.

Evaluation of an Ultrasensitive p24 Antigen Assay as a Potential Alternative to Human Immunodeficiency Virus Type 1 RNA Viral Load Assay in Resource-Limited Settings

Richard A. Respess,1* Ada Cachafeiro,2 David Withum,1 Susan A. Fiscus,2 Daniel Newman,1 Bernard Branson,1 Oliviero E. Varnier,3 Kim Lewis,1 and Timothy J. Dondero1

Centers for Disease Control and Prevention, Atlanta, Georgia,1 University of North Carolina, Chapel Hill, North Carolina,2 University of Genoa, Genoa, Italy3

Received 19 February 2004/ Returned for modification 5 May 2004/ Accepted 31 August 2004

An inexpensive enzyme-linked immunosorbent assay method for human immunodeficiency virus type 1 quantitation, ultrasensitive p24 antigen assay (Up24), was compared with RNA viral load assay (VL). Up24 had 100% sensitivity of detection at a viral load of ≥30,000, with sensitivity of 46.4% at a viral load of <30,000 (232 specimens from 65 seropositive subjects). The assay was highly reproducible, with excellent correlation between duplicates and among three laboratories.

* Corresponding author. Mailing address: Global AIDS Program, National Center for HIV, STD and TB Prevention, Center for Disease Control and Prevention, 1600 Clifton Rd., Mail Stop A-12, Atlanta, GA 30333. Phone: (404) 639-4573. Fax: (404) 639-2475. E-mail: rrespess{at}cdc.gov.

Journal of Clinical Microbiology, January 2005, p. 506-508, Vol. 43, No. 1
0095-1137/05/$08.00+0     doi:10.1128/JCM.43.1.506-508.2005
Copyright © 2005, American Society for Microbiology. All Rights Reserved.



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