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

Abstract

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.