ABBREVIATIONSNRnonreactiveRRrepeat reactiveWBWestern blotScreening for human T‐lymphotropic virus (HTLV) antibodies in the United States was mandated by the Food and Drug Administration (FDA) in 1988 (first for HTLV‐1 followed by HTLV‐2 in 1998). In the United States, HTLV prevalence is relatively low at 3.37 per 100,000 donations collected from 2011 to 2012. HTLV screening has used a dual‐testing algorithm beginning with either a chemiluminescent immunoassay or an enzyme‐linked immunosorbent screening assay (ELISA). Before the availability of a licensed supplemental assay, repeat‐reactive (RR) samples on a first assay (Assay 1) were retested with a second screening assay (Assay 2). Donors with RR results by Assay 2 were deferred from blood donation and further tested using an unlicensed supplemental test to confirm reactivity while nonreactive (NR) donors remained eligible for donation until RR on a subsequent donation. This “dual‐test” algorithm was replaced in May 2016 with the FDA requirement (Federal Register 29842; May 22, 2015) that all RRs by Assay 1 be further tested by a licensed HTLV supplemental test (Western blot [WB]). In this study, we have requalified the dual‐test algorithm using the available licensed HTLV WB.MATERIALS AND METHODSStudy protocolThis postmarket, open‐label, single‐center clinical study involved testing 100 randomly selected HTLV
Transfusion – Wiley
Published: Jan 1, 2018
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