Evaluation of Sensitivity and Specificity Performance of Elecsys HTLV-I/II Assay in a Multicenter Study in Europe and Japan

Abstract

Screening of blood for human T-cell lymphotropic virus type 1 and type 2 (HTLV-1 and -2, respectively) 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-1/2 infection. The sensitivity and specificity of the Elecsys HTLV-I/II assay were determined using well-characterized HTLV-1/2-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-1/2-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 to 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.

Evaluation of Elecsys HTLV‐I/II assay in comparison with ARCHITECT rHTLV‐I/II assay with Korean samples

“…These findings correspond well with those reports from the prior multicenter study with the same anti‐HTLV assay . In the previous study, clinical sensitivity of Elecsys HTLV‐I/II was demonstrated at 100% (n = 1149) using clinical specimens from Japan, the United States, Europe, and the Middle East.…”

“…These findings correspond well with those reports from the prior multicenter study with the same anti-HTLV assay. 10 In the previous study, clinical sensitivity of Elecsys HTLV-I/II was demonstrated at 100% (n = 1149) using clinical specimens from Japan, the United States, Europe, and the Middle East. The clinical specificity was 99.95% (n = 11 575) from blood donors and 99.83% (n = 2399) from routine diagnostic samples, including pregnancies and specimens requested for hepatitis, HIV, HSV, EBV, and rubella virus testing.…”

A Nationwide Antenatal Human T-Cell Leukemia Virus Type-1 Antibody Screening in Japan

“…CLIA (Qiu et al, 2008), and ECLIA (Laperche et al, 2017). These assays are available in Japan because they are capable of processing large numbers of samples in a relatively short time.…”

Screening of human T‐lymphotropic virus among solid organ transplant candidates at a large transplant center

“…Human T-lymphotropic virus screening is performed routinely in our center in all the SOT candidates. AVIOQ ® HTLV-I/II Microelisa System, a highly specific and sensitive assay, 3 was the serologic test used in our study. False positivity is unlikely as the specificity of the assay is 99.95%.…”