Diagnostic accuracy of Abbott Architect Assay as a screening tool for human T‐cell leukaemia virus type‐1 and type‐2 infection in a London teaching hospital with a large solid organ transplant centre

Abstract

In the United Kingdom, organ donors/recipients are screened for evidence of human T‐cell leukaemia virus type‐1 and type‐2 (HTLV‐1/2) infections. Since the United Kingdom is a low prevalence country for HTLV infections, a screening assay with high sensitivity and specificity is required. Samples with repeat reactivity on antibody testing are sent to a reference lab for confirmatory serological and molecular testing. In the case of donor screen, this leads to delays in the release of organs and can result in wastage. We aim to assess whether a signal/cut‐off (S/CO) ratio higher than the manufacturer's recommendation of 1.0 in the Abbott Architect antibody assay is a reliable measure of HTLV‐1/2 infection.