Local evaluation of a rapid HIV assay for use in developing countries

We present a research scheme for evaluating inexpensive HIV rapid tests in a developing country setting and assess the held validity of the Sero Strip HIV 1/2 rapid test. The research design features the random allocation of 100 true HIV-positive and 190 true HIV-negative serum specimens to 4 groups , followed by blind testing for HIV status. After one short training sessio n, laboratory technicians at 4 township hospitals (25-35 beds) located 20-5 0 km from Yangon, Myanmar were sent 800 sera labelled with only an identifi cation number and divided into four groups of 200 specimens each, half bein g HIV-positive and half HIV-negative. Testing was done in the field with th e Sero Strip HIV 1/2. Determination of the test's validity was based on 399 true HIV positive and 401 true HIV negative sera. All true positives were correctly identified, as were all but two of the true negatives. The sensit ivity (% of true positives that test positive) was 100%, and the specificit y (% of true negatives that test negative) was 99.5%. The research was comp leted by in-country scientists who are best suited to evaluate the validity of HIV tests conducted in local environments.