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
Journal of Clinical Microbiology
Duke University Medical Center, Durham, NC, United States; Kilimanjaro Christian Medical Centre, Moshi, Tanzania; Kikundi Cha Wanawake Kilimanjaro Kupambana na UKIMWI (KIWAKKUKI; Women Against AIDS in Kilimanjaro), Moshi, Tanzania; Duke Global Health Institute, Duke University, Durham, NC, United States; Kilimanjaro Christian Medical College, Tumaini University, Moshi, Tanzania; Sanford Institute of Public Policy, Duke University, Durham, NC, United States; Center for Health Policy, Duke University, Durham, NC, United States; Division of Infectious Diseases and International Health, Department of Medicine, Duke University Medical Center, Box 3867, Durham, NC 27710, United States
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. Copyright © 2008, American Society for Microbiology. All Rights Reserved.
virus antibody; algorithm; article; controlled study; cost effectiveness analysis; human; Human immunodeficiency virus 1; Human immunodeficiency virus 2; Human immunodeficiency virus infection; immunoassay; performance measurement system; priority journal; sensitivity analysis; sensitivity and specificity; sequential analysis; Tanzania; validation study; Cost-Benefit Analysis; HIV Antibodies; HIV Infections; HIV-1; HIV-2; Humans; Immunoassay; Predictive Value of Tests; Sensitivity and Specificity; Tanzania; Human immunodeficiency virus; Human immunodeficiency virus 1; Human immunodeficiency virus 2