The efficacy of a malarial antibody enzyme immunoassay for establishing the reinstatement status of blood donors potentially exposed to malaria

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Abstract
Background and Objectives The two key objectives of the study were, first, to evaluate the sensitivity and specificity of a recombinant antigen‐based malarial enzyme‐linked immunoassay (EIA) and, second, to estimate the risk associated with implementing this test with a shortened cellular component restriction period (6 months rather than the standard 12–36 months) for blood donors with a malarial risk exposure. Materials and Methods Blood donors were recruited into four distinct groups [non‐exposed (control), malarial area ‘visitors’, ‘residents’ and ‘previous infection’) and screened by using the Newmarket malarial antibody EIA. Assay specificity was evaluated in unexposed blood donors, and sensitivity was determined in acute clinical samples. Results No parasitaemic donors were detected amongst 337 malarial ‘visitors’ who had returned from a malaria‐endemic area less than 6 months previously, or for 402 ‘visitors’ or ‘residents’ who had returned from a malaria‐endemic area more than 6 months previously. The incidence of malarial antibodies within the exposed blood donor groups was 1·33% (10/751). In acute clinical non‐donor samples, the Newmarket EIA detected 106/108 (98·1; 93·5–99·5%) ‘film’ positive Plasmodium falciparum infections and 12/12 (100, 75·7–100·0%) P. vivax infections. The estimated additional risk exposure of the proposed new strategy was one infectious P. falciparum donation per 175 years or 1 per 4·2 years for P. vivax. Conclusions The study findings support the efficacy and safety of a targeted screening strategy combining antibody screening with a 6‐month cellular component restriction period for donors with a declared malarial risk.

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