Document 2693 DOCN M94A2693 TI Evaluation of a rapid and simple HIV-1 assay. DT 9412 AU Zhang X; Constantine NT; Dept. Pathology, Univ. of Maryland Sch. of Med., Balto. SO Int Conf AIDS. 1994 Aug 7-12;10(1):246 (abstract no. PB0413). Unique Identifier : AIDSLINE ICA10/94369882 AB OBJECTIVES: To evaluate the performance of the Health Test HIV-1 rapid assay when testing sera from inner-city hospital patients in the US, and to determine concordance with a routine FDA-licensed ELISA. METHODS: 850 serum samples were collected from sequential cases received at the Clinical Immunology Laboratory at the University of Maryland Medical System/Hospital in Baltimore. All samples were centrifuged, stored at 4 degrees C, and tested using an HIV-1/2 ELISA (Genetic Systems) and the Health Test HIV-1 assay (Akers Laboratories, USA) as recommended by the manufacturers. Any samples yielding a reactive result were retested by the respective test and confirmed by Western blot (BioRad). Samples which exhibited discrepant results were retested by all assays to ensure that technical error had not occurred. RESULTS: Of the 850 sera, 56 (6.6%) produced reactive results by both tests and were confirmed by Western blot (WB). There were 11 false positive results and one positive sample which was difficult to read by the Health Test as compared with ELISA and WB. Except for the one sample that was difficult to interpret, the sensitivity was 100%, and the specificity was 98.8%. DISCUSSION AND CONCLUSIONS: The Health Test HIV-1 assay is a very simple, rapid, and economical test for detecting HIV antibodies. It requires only one minute for completion and the test strips can be kept for permanent records. We are currently investigating the cause of the one sample which was difficult to interpret. DE AIDS Serodiagnosis/*METHODS Baltimore Blotting, Western Comparative Study Enzyme-Linked Immunosorbent Assay/*METHODS Human HIV Antibodies/*BLOOD HIV Seropositivity/*DIAGNOSIS/IMMUNOLOGY HIV-1/*IMMUNOLOGY Predictive Value of Tests *Urban Population MEETING ABSTRACT SOURCE: National Library of Medicine. NOTICE: This material may be protected by Copyright Law (Title 17, U.S.Code).