Sensitivity and specificity of HIV-1 testing of urine compared with serum specimens: Rakai, Uganda. The Rakai Project Team.

BACKGROUND AND OBJECTIVES: To evaluate a urine HIV-1 test. STUDY DESIGN: Paired urine and blood samples from a sample of 222 subjects were assayed for HIV-1 using Calypte HIV-1 Urine enzyme immunoassay (EIA) with Western blot (WB) confirmation, and sera were tested by EIA and WB. Masked assays were done on stored, refrigerated urine at Johns Hopkins University (JH), and on fresh specimens at the Rakai Project, Entebbe (RP). We assessed the sensitivity and specificity of the urine relative to serum assays. RESULTS: Compliance with provision of urine samples (95.0%) was higher than provision of serum (90.5%). Ninety-six sera were HIV-positive; 92 were HIV-positive on stored urine at JH (sensitivity 95.8%, CI 91.8-99.8%); and 94 (100%) were positive on fresh samples at the RP laboratory (sensitivity = 100.0%). Among serum HIV-negative subjects, all frozen urine were negative at JH and 97.7% of fresh samples were negative at RP. CONCLUSIONS: The Calypte urine HIV-1 EIA with WB is sensitive and specific. In this population, provision of urine was more acceptable than provision of blood samples.