Objective: To evaluate a combination of rapid tests as a strategy for screening and supplemental testing of serum for HIV-1 and/or HIV-2 antibodies.
Design: Cross-sectional evaluation.
Setting: Projet RETRO-CI, an AIDS research project in Abidjan, Côte d'Ivoire.
Methods: Serum specimens were collected from 1000 consecutive women giving birth in an Abidjan maternal and child health centre and from 185 hospitalized patients. All serum specimens were tested for HIV-1 and HIV-2 antibodies by whole-virus enzyme immunoassay; repeatedly reactive specimens were further tested by virus-specific Western blot and synthetic peptide-based tests. This was the reference strategy against which the algorithm under evaluation was compared. All specimens were subsequently tested by a mixed (HIV-1 and HIV-2) recombinant antigen-based test (Abbott Testpack), followed, if positive, by a rapid synthetic peptide-based test (Genetic Systems Genie) as a supplemental test.
Results: According to the reference strategy the prevalence of HIV-1 and/or HIV-2 infection was 13% among the pregnant women and 78% among the hospitalized patients. Compared with the reference strategy, the combination of rapid tests was associated with a sensitivity of 99.6%, a specificity of 99.9%, and positive and negative predictive values of 99.6 and 99.9%, respectively. Four per cent of HIV-2-positive and 1% of HIV-1-positive specimens were considered dually reactive by the rapid test combination.
Conclusions: Synthetic peptide-based tests provide an alternative to Western blots for supplemental testing for HIV-1 and HIV-2. This combination of rapid tests offers performance characteristics comparable to an enzyme immunoassay and Western blot-based strategy, without requiring running water, electricity, or a well-developed laboratory. High-quality serodiagnosis of HIV-1 and HIV-2 infections is possible at the most peripheral levels of the health-care system in developing countries, the limiting factors being the costs of tests and training of staff.
PIP: Researchers from an AIDS research project took blood samples from 1000 consecutive women during childbirth at a maternal and child health center in Abidjan, Cote d'Ivoire, and from 185 hospitalized patients to compare the results of a combination of synthetic peptide-based rapid tests (product names, Testpack and Genie), which check for HIV-1 and HIV-2 antibodies, with those of the Western Blot-based test. They also wanted to see whether the rapid test-based strategy could replace the Western Blot-based test as a supplemental test. The Western Blot indicated the HIV-1 and/or HIV-2 prevalence to be 13% among the new mothers and 78% among the hospitalized patients for an overall prevalence of 23%. 3.3% of all people were positive for both HIV-1 and HIV-2. 17.4% tested positive for just HIV-1. 2.1% were positive for HIV-2. The rapid tests had a sensitivity of 99.6% and a specificity of 99.9%. The positive predictive value was 99.6% and the negative predictive value was 99.9%. The rapid tests identified 4% of the HIV-2 positive samples and 1% of the HIV-1 samples to be dually reactive. These findings demonstrated that rapid synthetic peptide-based assays reliably detect HIV-1 and HIV-2 antibodies and can be supplemental tests. High quality HIV serology can be performed in a setting without running water and electricity which was the case in this study. A further advantage of this strategy is that each test takes only 10 minutes. These tests would have significant effects on HIV testing and counseling, diagnosis, and screening of blood for transfusion in rural areas of developing countries.