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Journal of Clinical Microbiology, December 2005, p. 5950-5956, Vol. 43, No. 12
0095-1137/05/$08.00+0     doi:10.1128/JCM.43.12.5950-5956.2005
Copyright © 2005, American Society for Microbiology. All Rights Reserved.

Comparison of Two Human Immunodeficiency Virus (HIV) RNA Surrogate Assays to the Standard HIV RNA Assay

Cheryl Jennings,1* Susan A. Fiscus,2 Suzanne M. Crowe,3 Aleksandra D. Danilovic,1 Ralph J. Morack,1 Salvatore Scianna,1 Ada Cachafeiro,2 Donald J. Brambilla,4 Jorg Schupbach,5 Wendy Stevens,6 Richard Respess,7 Oliviero E. Varnier,8 Gary E. Corrigan,9 J. Simon Gronowitz,10 Michael A. Ussery,11 and James W. Bremer1

Rush Medical College, Chicago, Illinois,1 University of North Carolina at Chapel Hill, Chapel Hill, North Carolina,2 The Macfarlane Burnet Institute for Medical Research and Public Health, Melbourne, Australia,3 New England Research Institute, Watertown, Massachusetts,4 University of Zurich, Zurich, Switzerland,5 University of Witwatersrand and National Health Laboratory Services, Parktown, South Africa,6 Center for Disease Control and Prevention, Atlanta, Georgia,7 Institute of Microbiology, Medical School, University of Genoa, Genoa, Italy,8 MTC/SMI, Karolinska Institute, Stockholm, Sweden,9 Uppsala University, Uppsala, Sweden,10 National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland,11

Received 3 February 2005/ Returned for modification 20 July 2005/ Accepted 21 September 2005

Human immunodeficiency virus (HIV) RNA testing is the gold standard for monitoring antiretroviral therapy in HIV-infected patients. However, equipment and reagent costs preclude widespread use of the assay in resource-limited settings. The Perkin-Elmer Ultrasensitive p24 assay and the Cavidi Exavir Load assay both offer potentially simpler, less costly technologies for monitoring viral load. These assays were compared to the Roche Amplicor HIV-1 Monitor Test, v1.5, using panels of clinical samples (subtype B) from HIV-positive subjects and HIV-spiked samples (subtypes A, C, D, CRF_01AE, CRF_02AG, and F). The Ultrasensitive p24 assay detected 100% of the spiked samples with virus loads of >250,000copies/ml and 61% of the clinical samples with virus loads of 219 to 288,850 copies/ml. Detection rates were improved substantially if an external lysis buffer was added to the procedure. The Cavidi assay detected 54 to 100% of spiked samples with virus loads >10,000 copies/ml and 68% of the clinical samples. These detection rates were also greatly improved with a newly implemented version of this kit. Coefficients of variation demonstrate good reproducibility for each of these kits. The results from the Cavidi v1.0, Cavidi v2.0, and Perkin-Elmer, and the Perkin-Elmer Plus external buffers all correlated well with the results from the Roche Monitor Test (r = 0.83 to 0.96, r = 0.84 to 0.99, r = 0.58 to 0.67, and r = 0.59 to 0.95, respectively). Thus, the use of these two assays for monitoring patients, together with less-frequent confirmation testing, offers a feasible alternative to frequent HIV RNA testing in resource-limited settings.

* Corresponding author. Mailing address: Rush Medical College, Department of Immunology/Microbiology, 1653 W. Congress Parkway, Chicago, IL 60612. Phone: (312) 942-5954. Fax: (312) 942-6787. E-mail: cjenning{at}rush.edu.

Journal of Clinical Microbiology, December 2005, p. 5950-5956, Vol. 43, No. 12
0095-1137/05/$08.00+0     doi:10.1128/JCM.43.12.5950-5956.2005
Copyright © 2005, American Society for Microbiology. All Rights Reserved.



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