Whose Blood Is Safer?

Abstract

Background. With improvements in HIV antibody test (ELISA) performance, the win dow of time between infection and seroconversion becomes a major source of error in HIV screening. The authors examined its impact on the false-reassurance rate (FRR). Methods. Test sensitivity was modeled as the product of two factors: the in herent sensitivity (sensitivity when antibody is present) and the probability that antibody is present in infected blood. A model of HIV and AIDS incidence was used to derive an estimate of the probability of remaining in the seronegative window ( pw) among those who are infected. With plausible assumptions, this probability approaches 0.03. The FRR was then estimated as a function of the probability of remaining in the se ronegative window, the prevalence of HIV, and the inherent sensitivity of the ELISA test were estimated. Results. The FRRs for two blood donor groups, one with an HIV prevalence of 0.004 and a typical probability of remaining in the seronegative window ( pw = 0.03) and the other with a higher prevalence of 0.017 but fewer donors in the window ( pw = 0.003), are equal (140 per million donors) if the blood is negative on a single ELISA test. After two negative tests or a single test that can detect antibody more reliably, however, the FRR is much higher in the group with the higher pw (= 120 per million compared with 50 per million), because the greater numbers of donors in the window more than offsets the lower prevalence. Conclusions. With improvements in inherent sensitivity of ELISA by virtue of technical progress or retesting, the preva lence of HIV infection may no longer play the critical role in degrading the results of blood screening. As inherent test performance improves, tests are increasingly likely to miss infected blood because of the seronegative-window error rather than because of measurement error. Window error plays a proportionally greater role during the early stages of HIV dissemination in a population where the incidence of new HIV infection is high relative to the incidence of AIDS. These findings may explain, in part, the recent observation that cases of transfusion of contaminated blood often take place in areas where AIDS epidemics have started recently. They also suggest that the traditional strategy of soliciting blood donors from low-prevalence populations may not always be optimal, unless such populations are truly low-risk. Key words: HIV; AIDS; prevalence; incidence; sensitivity; ELISA; predicted values; protocols of screening; false-reassur ance rate. (Med Decis Making 1997;17:455-463)