Clinical Use of the Calypte~(TM) HIV-1 Urine EIA-PRC

Objective To evaluate the specificity and sensitivity of the Calypte?HIV-1 Urine EIA-PRC. Methods The specificity of CalypteTM HIV-1 Urine EIA-PRC was tested at one site which routinely performs HIV antibody determination on urine and serum specimens collected from healthy Blood donors. The sensitivity of Calypte?HIV-1 Urine EIA-PRC was evaluated by assaying 48 paired urine and serum specimens obtained from subjects with a clinical diagnosis of AIDS. Results When the urine EIA results were compared to the serum ELA results,in all five thousand(5000) urine specimens, 54 specimens tested were urine initially reactive and all repeated tests were negative. The specificity of Calypte橦IV-l Urine EIA-PRC in this study was estimated to be 98. 92% (4946/5000). In all 48 AIDS patients specimens,48 of the 48 urine specimens were repeatedly reactive. In this population the sensitivity of the Calypte?HIV-1 Urine EIA-PRC was 100% (48/48). Conclusion Detection of urine HIV-1 antibody is worthy developing to the clinic,especially facilitating surveillance and screening for HIV infection.