Establishment of a novel diagnostic test algorithm for human T-cell leukemia virus type 1 infection with line immunoassa
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Retrovirology Open Access
RESEARCH
Establishment of a novel diagnostic test algorithm for human T‑cell leukemia virus type 1 infection with line immunoassay replacement of western blotting: a collaborative study for performance evaluation of diagnostic assays in Japan Kazu Okuma1, Madoka Kuramitsu1, Toshihiro Niwa2, Tomokuni Taniguchi3, Yumiko Masaki4, Gohzoh Ueda5, Chieko Matsumoto6, Rieko Sobata6, Yasuko Sagara7, Hitomi Nakamura7, Masahiro Satake6, Kiyonori Miura8, Naoki Fuchi8, Hideaki Masuzaki8, Akihiko Okayama9, Kazumi Umeki9,10, Yoshihisa Yamano11,12, Tomoo Sato12, Masako Iwanaga13, Kaoru Uchimaru14,15, Makoto Nakashima14, Atae Utsunomiya16, Ryuji Kubota17, Kenji Ishitsuka18, Hiroo Hasegawa19, Daisuke Sasaki19, Ki‑Ryang Koh20, Mai Taki21, Kisato Nosaka22, Masao Ogata23, Isao Naruse24, Noriaki Kaneko24, Sara Okajima24, Kenta Tezuka1, Emi Ikebe1, Sahoko Matsuoka1, Kazuo Itabashi25, Shigeru Saito26, Toshiki Watanabe15,27 and Isao Hamaguchi1*
Abstract Background: The reliable diagnosis of human T-cell leukemia virus type 1 (HTLV-1) infection is important, particu‑ larly as it can be vertically transmitted by breast feeding mothers to their infants. However, current diagnosis in Japan requires a confirmatory western blot (WB) test after screening/primary testing for HTLV-1 antibodies, but this test often gives indeterminate results. Thus, this collaborative study evaluated the reliability of diagnostic assays for HTLV-1 infection, including a WB-based one, along with line immunoassay (LIA) as an alternative to WB for confirmatory testing. Results: Using peripheral blood samples from blood donors and pregnant women previously serologically screened and subjected to WB analysis, we analyzed the performances of 10 HTLV-1 antibody assay kits commercially avail‑ able in Japan. No marked differences in the performances of eight of the screening kits were apparent. However, LIA determined most of the WB-indeterminate samples to be conclusively positive or negative (an 88.0% detection rate). When we also compared the sensitivity to HTLV-1 envelope gp21 with that of other antigens by LIA, the sensitiv‑ ity to gp21 was the strongest. When we also compared the sensitivity to envelope gp46 by LIA with that of WB, LIA showed stronger sensitivity to gp46 than WB did. These findings indicate that LIA is an alternative confirmatory test to WB analysis without gp21. Therefore, we established a novel diagnostic test algorithm for HTLV-1 infection in Japan,
*Correspondence: [email protected] 1 Department of Safety Research on Blood and Biological Products, National Institute of Infectious Diseases, Tokyo, Japan Full list of author information is available at the end of the article © The Author(s) 2020. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if c
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