Whose blood is safer? The effect of the stage of the epidemic on screening for HIV.
BACKGROUND
With improvements in HIV antibody test (ELISA) performance, the window 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 inherent 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 seronegative 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 prevalence 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.
Litvak
E
E
Department of Health Policy and Management, Harvard School of Public Health, Boston, MA 02115, USA. litvak@hsph.harvard.edu
Siegel
J E
JE
Pauker
S G
SG
Lallemant
M
M
Fineberg
H V
HV
Weinstein
M C
MC
D001771:Blood Banks; D001782:Blood Donors; D003661:Decision Support Techniques; D003951:Diagnostic Errors; D004797:Enzyme-Linked Immunosorbent Assay; D005188:False Negative Reactions; D015658:HIV Infections / Q000453:epidemiology / Q000517:prevention & control*; D006679:HIV Seropositivity / Q000453:epidemiology; D006801:Humans; D008403:Mass Screening / Q000379:methods*; D015995:Prevalence; D018570:Risk Assessment; D012680:Sensitivity and Specificity; D013997:Time Factors; D014481:United States / Q000453:epidemiology