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Journal of Clinical Microbiology, December 2008, p. 3946-3951, Vol. 46, No. 12
0095-1137/08/$08.00+0     doi:10.1128/JCM.01045-08
Copyright © 2008, American Society for Microbiology. All Rights Reserved.

Validation, Performance under Field Conditions, and Cost-Effectiveness of Capillus HIV-1/HIV-2 and Determine HIV-1/2 Rapid Human Immunodeficiency Virus Antibody Assays Using Sequential and Parallel Testing Algorithms in Tanzania{triangledown}

Meghan K. Mayhood,1 Isaac A. Afwamba,2 Christopher O. Odhiambo,2 Epimack Ndanu,3 Nathan M. Thielman,1,4 Anne B. Morrissey,1,2 John F. Shao,2,5 Brian Wells Pence,1,4,6,7 and John A. Crump1,2,4,5*

Duke University Medical Center, Durham, North Carolina,1 Kilimanjaro Christian Medical Centre, Moshi, Tanzania,2 Kikundi cha Wanawake Kilimanjaro Kupambana na UKIMWI (KIWAKKUKI; Women Against AIDS in Kilimanjaro), Moshi, Tanzania,3 Duke Global Health Institute, Duke University, Durham, North Carolina,4 Kilimanjaro Christian Medical College, Tumaini University, Moshi, Tanzania,5 Sanford Institute of Public Policy, Duke University, Durham, North Carolina,6 Center for Health Policy, Duke University, Durham, North Carolina7

Received 3 June 2008/ Returned for modification 26 July 2008/ Accepted 2 October 2008

Rapid human immunodeficiency virus (HIV) antibody tests support the effort to expand access to HIV testing and counseling services in remote, rural, and poor parts of the world. We validated the Capillus HIV-1/HIV-2 (Trinity Biotech PLC, Bray, County Wicklow, Ireland) and Determine HIV-1/2 (Abbott Laboratories, Abbott Park, IL) rapid tests in a reference laboratory using patient samples from Tanzania and evaluated the performance of the tests under field conditions in northern Tanzania. We used the resulting data to study sequential and parallel testing algorithms. In the validation study, sensitivity, specificity, the predictive value of a positive test (PV+), and the predictive value of a negative test (PV–) were all 100% for Capillus and Determine. In the field evaluation among 12,737 clients, sensitivity, specificity, PV+, and PV– were 99.7%, 99.8%, 98.7%, and 99.9%, respectively, for Capillus and 99.6%, 99.9%, 99.5%, and 99.9%, respectively, for Determine. A sequential testing algorithm that did not confirm a negative initial Capillus result with a Determine result cost $7.77 per HIV diagnosis but missed 0.3% of HIV infections. A sequential testing algorithm that did not confirm a negative initial Determine result with a Capillus result cost $7.64 per HIV diagnosis but missed 0.4% of HIV infections. A parallel testing algorithm cost $13.46 per HIV diagnosis but detected more HIV-infected clients.

* Corresponding author. Mailing address: Division of Infectious Diseases and International Health, Department of Medicine, Duke University Medical Center, Box 3867, Durham, NC 27710. Phone: (919) 684-2660. Fax: (919) 684-8902. E-mail: crump017{at}mc.duke.edu

{triangledown} Published ahead of print on 15 October 2008.

Journal of Clinical Microbiology, December 2008, p. 3946-3951, Vol. 46, No. 12
0095-1137/08/$08.00+0     doi:10.1128/JCM.01045-08
Copyright © 2008, American Society for Microbiology. All Rights Reserved.





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