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Journal of Clinical Microbiology, October 2007, p. 3281-3285, Vol. 45, No. 10
0095-1137/07/$08.00+0     doi:10.1128/JCM.00894-07
Copyright © 2007, American Society for Microbiology. All Rights Reserved.

Large-Scale Human Immunodeficiency Virus Rapid Test Evaluation in a Low-Prevalence Ugandan Blood Bank Population{triangledown}

Leigh A. Eller,1,2* Michael A. Eller,1,2 Benson J. Ouma,1 Peter Kataaha,3 Bernard S. Bagaya,1 Robert L. Olemukan,1 Simon Erima,1 Lilian Kawala,1 Mark S. de Souza,2,4 Hannah Kibuuka,1 Fred Wabwire-Mangen,1 Sheila A. Peel,5 Robert J. O'Connell,5 Merlin L. Robb,6 and Nelson L. Michael5

Makerere University Walter Reed Project, Kampala, Uganda,1 U.S. Military Human Immunodeficiency Virus Research Program, Rockville, Maryland,2 Uganda National Blood Transfusion Service, Kampala, Uganda,3 Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand,4 Division of Retrovirology, Walter Reed Army Institute of Research, Rockville, Maryland,5 Henry M. Jackson Foundation, Rockville, Maryland6

Received 30 April 2007/ Returned for modification 11 July 2007/ Accepted 3 August 2007

The use of rapid tests for human immunodeficiency virus (HIV) has become standard in HIV testing algorithms employed in resource-limited settings. We report an extensive HIV rapid test validation study conducted among Ugandan blood bank donors at low risk for HIV infection. The operational characteristics of four readily available commercial HIV rapid test kits were first determined with 940 donor samples and were used to select a serial testing algorithm. Uni-Gold Recombigen HIV was used as the screening test, followed by HIV-1/2 STAT-PAK for reactive samples. OraQuick HIV-1 testing was performed if the first two test results were discordant. This algorithm was then tested with 5,252 blood donor samples, and the results were compared to those of enzyme immunoassays (EIAs) and Western blotting. The unadjusted algorithm sensitivity and specificity were 98.6 and 99.9%, respectively. The adjusted sensitivity and specificity were 100 and 99.96%, respectively. This HIV testing algorithm is a suitable alternative to EIAs and Western blotting for Ugandan blood donors.

* Corresponding author. Mailing address: Makerere University Faculty of Medicine, Pathology Building, A-10, Old Mulago Hill Rd., P.O. Box 16524, Kampala, Uganda. Phone: 256 772 221190. Fax: 256 414 534 586. E-mail: leller{at}muwrp.org

{triangledown} Published ahead of print on 15 August 2007.

Journal of Clinical Microbiology, October 2007, p. 3281-3285, Vol. 45, No. 10
0095-1137/07/$08.00+0     doi:10.1128/JCM.00894-07
Copyright © 2007, American Society for Microbiology. All Rights Reserved.





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