Journal of clinical microbiology 2017 05 03() pii 10.1128/JCM.00169-17
Screening of blood for human T-cell lymphotropic virus type I and type II (HTLV-I/II) is important to diagnose and prevent infection and ensure the safety of blood supplies. The Elecsys® HTLV-I/II assay is a newly developed, electrochemiluminescence screening assay for the detection of HTLV-I/II infection. The sensitivity and specificity of the Elecsys® HTLV-I/II assay were determined using well-characterized HTLV-I/II-positive serum and plasma samples, and routine diagnostic and blood donor samples expected to be HTLV-negative, respectively. These results were compared with those for at least one of the following CE-marked assays at seven independent laboratories and the Roche Diagnostics facility in Penzberg, Germany: Abbott Architect® rHTLV-I/II; Ortho Avioq® HTLV-I/II Microelisa System; Abbott Prism® HTLV-I/HTLV-II; and DiaSorin Murex® HTLV I+II. Fujirebio INNO-LIA® HTLV-I/II Score was used as a confirmatory assay. The Elecsys® HTLV-I/II, Abbott Architect® rHTLV-I/II, and Abbott Prism® HTLV-I/HTLV-II assays detected all HTLV-I/II-positive samples (sensitivity 100%). Sensitivity for Ortho Avioq® HTLV-I/II was 98.63%. The Elecsys® HTLV-I/II assay had a specificity of 99.95% in blood donor samples which was comparable to results for the other assays (range 99.91-100%). In routine diagnostic samples, the specificity of the Elecsys® HTLV-I/II assay was 99.83%, compared with 99.70% for Abbott Architect® rHTLV-I/II. Specificity for the Elecsys® HTLV-I/II assay in potentially cross-reactive samples was 100%, compared with 99.0% for Ortho Avioq® HTLV-I/II and 99.2% for DiaSorin Murex® HTLV I+II. The Elecsys® HTLV-I/II assay has the sensitivity and specificity to support its use as a routine screening assay for detecting HTLV infection.