title: Use of seroconversion panels to estimate delay in detection of anti-human immunodeficiency virus antibodies by enzyme-linked immunosorbent assay of pooled compared to singleton serum samples.
abstract: The transfusion of unsafe blood worldwide accounts for 5 to 15% of new human immunodeficiency virus (HIV) infections, most of which occur in sub-Saharan Africa. While developed countries now apply PCR testing of pooled samples, some developing countries still do not have universal screening policies. More efficient low-cost procedures for the screening of pooled samples have the potential to encourage mass screening efforts in resource-poor settings. The aim of this study was to estimate the delay in the detection of HIV antibodies in pooled serum samples compared to that in singleton serum samples by enzyme-linked immunosorbent assay (ELISA) and to evaluate the risk of transfusion-transmitted HIV infection during the window period. Serial blood samples obtained from five HIV seroconversion panels were mixed with HIV-seronegative blood samples to create pools of 6, 12, 16, 24, 32, and 48 samples. The delay in detection of the first anti-HIV antibody-positive sample in tests with pooled samples was calculated for each pool size and compared to that obtained by testing of singleton samples and statistically evaluated by a robust log-linear regression analysis. The risk of a false-negative (FN) result caused by dilution was estimated by use of the incidence risk/window period model. The additional risk of transmission related to ELISA screening of pooled samples for HIV did not exceed 9% of the current risk of an FN result (estimated to be 1/1,067,000). The countries with virus prevalence rates in donors of less than 15% are expected to save up to 30% in the number of tests. ELISA screening of pooled samples could be considered in settings where the testing of blood supplies for HIV is not routinely done.
authors.affiliation: Department of Epidemiology and Health Services Evaluation, Ben-Gurion University of the Negev, P.O. Box 653, Beer-Sheva 84105, Israel.
authors.forename: Lena
authors.initials: L
authors.lastname: Novack
authors.forename: Noya
authors.initials: N
authors.lastname: Galai
authors.forename: Arieh
authors.initials: A
authors.lastname: Yaari
authors.forename: Mordechai
authors.initials: M
authors.lastname: Orgel
authors.forename: Eilat
authors.initials: E
authors.lastname: Shinar
authors.forename: Batia
authors.initials: B
authors.lastname: Sarov
mesh_terms: D001782:Blood Donors; D001803:Blood Transfusion; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D015483:HIV Antibodies / Q000097:blood*; D015658:HIV Infections / Q000517:prevention & control / Q000635:transmission*; D006679:HIV Seropositivity; D006801:Humans; D013997:Time Factors
chemical_list: D015483:HIV Antibodies