Laboratory evaluation of three dual rapid diagnostic tests for HIV and syphilis in China and Nigeria
International Journal of Gynecology and Obstetrics
National Center for STD Control, Institute of Dermatology, Peking Union Medical College, 12 Jiangwangmiao Street, Nanjing, China; National AIDS and STIs Control Program, Federal Ministry of Health, Abuja, Nigeria; World Health Organization, Abuja, Nigeria
Abstract Objective To determine the laboratory-based performance and operational characteristics of three dual rapid diagnostic tests (RDTs) for testing HIV and syphilis. Methods Three dual RDTs (SD Bioline, Chembio, and MedMira) were evaluated using 1514 serum specimens archived at laboratories or collected from clinics in China and Nigeria to determine sensitivity and specificity, with 95% confidence intervals. Concordance of testing results read by two technicians, stability of testing results read at two time points, and test operation characteristics were also assessed. Results All three of the evaluated RDTs gave excellent performance with a combined sensitivity ranging from 99.0%-99.6% for HIV and 98.3%-99.0% for syphilis, and a combined specificity ranging from 97.9%-99.0% for HIV and 97.2%-99.6% for syphilis. Concordance of testing results between two technicians and stability of testing results read within and one hour past the recommended reading period showed excellent agreement, with Kappa greater than or equal to 0.98. Conclusions All the tests were found to be very or fairly easy to use and easy to interpret the results. Further evaluations of these dual RDTs with whole blood in field settings, and more studies on the implication of introduction of these tests in HIV and syphilis control programs are needed. © 2015 Published by Elsevier Ireland Ltd.
Human immunodeficiency virus antibody; Article; China; diagnostic test accuracy study; evaluation study; HIV rapid test; human; Human immunodeficiency virus infection; intermethod comparison; laboratory; Nigeria; performance; priority journal; sensitivity and specificity; syphilis; syphilis rapid test
World Health Organization; UNFPA, World Health Organization; WHO, World Health Organization