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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

BACKGROUND: The reliable diagnosis of human T-cell leukemia virus type 1 (HTLV-1) infection is important, particularly 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/pr...

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Autores principales: Okuma, Kazu, Kuramitsu, Madoka, Niwa, Toshihiro, Taniguchi, Tomokuni, Masaki, Yumiko, Ueda, Gohzoh, Matsumoto, Chieko, Sobata, Rieko, Sagara, Yasuko, Nakamura, Hitomi, Satake, Masahiro, Miura, Kiyonori, Fuchi, Naoki, Masuzaki, Hideaki, Okayama, Akihiko, Umeki, Kazumi, Yamano, Yoshihisa, Sato, Tomoo, Iwanaga, Masako, Uchimaru, Kaoru, Nakashima, Makoto, Utsunomiya, Atae, Kubota, Ryuji, Ishitsuka, Kenji, Hasegawa, Hiroo, Sasaki, Daisuke, Koh, Ki-Ryang, Taki, Mai, Nosaka, Kisato, Ogata, Masao, Naruse, Isao, Kaneko, Noriaki, Okajima, Sara, Tezuka, Kenta, Ikebe, Emi, Matsuoka, Sahoko, Itabashi, Kazuo, Saito, Shigeru, Watanabe, Toshiki, Hamaguchi, Isao
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7444053/
https://www.ncbi.nlm.nih.gov/pubmed/32831150
http://dx.doi.org/10.1186/s12977-020-00534-0
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author Okuma, Kazu
Kuramitsu, Madoka
Niwa, Toshihiro
Taniguchi, Tomokuni
Masaki, Yumiko
Ueda, Gohzoh
Matsumoto, Chieko
Sobata, Rieko
Sagara, Yasuko
Nakamura, Hitomi
Satake, Masahiro
Miura, Kiyonori
Fuchi, Naoki
Masuzaki, Hideaki
Okayama, Akihiko
Umeki, Kazumi
Yamano, Yoshihisa
Sato, Tomoo
Iwanaga, Masako
Uchimaru, Kaoru
Nakashima, Makoto
Utsunomiya, Atae
Kubota, Ryuji
Ishitsuka, Kenji
Hasegawa, Hiroo
Sasaki, Daisuke
Koh, Ki-Ryang
Taki, Mai
Nosaka, Kisato
Ogata, Masao
Naruse, Isao
Kaneko, Noriaki
Okajima, Sara
Tezuka, Kenta
Ikebe, Emi
Matsuoka, Sahoko
Itabashi, Kazuo
Saito, Shigeru
Watanabe, Toshiki
Hamaguchi, Isao
author_facet Okuma, Kazu
Kuramitsu, Madoka
Niwa, Toshihiro
Taniguchi, Tomokuni
Masaki, Yumiko
Ueda, Gohzoh
Matsumoto, Chieko
Sobata, Rieko
Sagara, Yasuko
Nakamura, Hitomi
Satake, Masahiro
Miura, Kiyonori
Fuchi, Naoki
Masuzaki, Hideaki
Okayama, Akihiko
Umeki, Kazumi
Yamano, Yoshihisa
Sato, Tomoo
Iwanaga, Masako
Uchimaru, Kaoru
Nakashima, Makoto
Utsunomiya, Atae
Kubota, Ryuji
Ishitsuka, Kenji
Hasegawa, Hiroo
Sasaki, Daisuke
Koh, Ki-Ryang
Taki, Mai
Nosaka, Kisato
Ogata, Masao
Naruse, Isao
Kaneko, Noriaki
Okajima, Sara
Tezuka, Kenta
Ikebe, Emi
Matsuoka, Sahoko
Itabashi, Kazuo
Saito, Shigeru
Watanabe, Toshiki
Hamaguchi, Isao
author_sort Okuma, Kazu
collection PubMed
description BACKGROUND: The reliable diagnosis of human T-cell leukemia virus type 1 (HTLV-1) infection is important, particularly 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 available 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 sensitivity 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, including both the performance of a confirmatory test where LIA replaced WB on primary test-reactive samples and an additional decision based on a standardized nucleic acid detection step (polymerase chain reaction, PCR) on the confirmatory test-indeterminate samples. The final assessment of the clinical usefulness of this algorithm involved performing WB analysis, LIA, and/or PCR in parallel for confirmatory testing of known reactive samples serologically screened at clinical laboratories. Consequently, LIA followed by PCR (LIA/PCR), but neither WB/PCR nor PCR/LIA, was found to be the most reliable diagnostic algorithm. CONCLUSIONS: Because the above results show that our novel algorithm is clinically useful, we propose that it is recommended for solving the aforementioned WB-associated reliability issues and for providing a more rapid and precise diagnosis of HTLV-1 infection.
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spelling pubmed-74440532020-08-26 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 Okuma, Kazu Kuramitsu, Madoka Niwa, Toshihiro Taniguchi, Tomokuni Masaki, Yumiko Ueda, Gohzoh Matsumoto, Chieko Sobata, Rieko Sagara, Yasuko Nakamura, Hitomi Satake, Masahiro Miura, Kiyonori Fuchi, Naoki Masuzaki, Hideaki Okayama, Akihiko Umeki, Kazumi Yamano, Yoshihisa Sato, Tomoo Iwanaga, Masako Uchimaru, Kaoru Nakashima, Makoto Utsunomiya, Atae Kubota, Ryuji Ishitsuka, Kenji Hasegawa, Hiroo Sasaki, Daisuke Koh, Ki-Ryang Taki, Mai Nosaka, Kisato Ogata, Masao Naruse, Isao Kaneko, Noriaki Okajima, Sara Tezuka, Kenta Ikebe, Emi Matsuoka, Sahoko Itabashi, Kazuo Saito, Shigeru Watanabe, Toshiki Hamaguchi, Isao Retrovirology Research BACKGROUND: The reliable diagnosis of human T-cell leukemia virus type 1 (HTLV-1) infection is important, particularly 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 available 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 sensitivity 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, including both the performance of a confirmatory test where LIA replaced WB on primary test-reactive samples and an additional decision based on a standardized nucleic acid detection step (polymerase chain reaction, PCR) on the confirmatory test-indeterminate samples. The final assessment of the clinical usefulness of this algorithm involved performing WB analysis, LIA, and/or PCR in parallel for confirmatory testing of known reactive samples serologically screened at clinical laboratories. Consequently, LIA followed by PCR (LIA/PCR), but neither WB/PCR nor PCR/LIA, was found to be the most reliable diagnostic algorithm. CONCLUSIONS: Because the above results show that our novel algorithm is clinically useful, we propose that it is recommended for solving the aforementioned WB-associated reliability issues and for providing a more rapid and precise diagnosis of HTLV-1 infection. BioMed Central 2020-08-24 /pmc/articles/PMC7444053/ /pubmed/32831150 http://dx.doi.org/10.1186/s12977-020-00534-0 Text en © The Author(s) 2020 Open AccessThis 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 changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research
Okuma, Kazu
Kuramitsu, Madoka
Niwa, Toshihiro
Taniguchi, Tomokuni
Masaki, Yumiko
Ueda, Gohzoh
Matsumoto, Chieko
Sobata, Rieko
Sagara, Yasuko
Nakamura, Hitomi
Satake, Masahiro
Miura, Kiyonori
Fuchi, Naoki
Masuzaki, Hideaki
Okayama, Akihiko
Umeki, Kazumi
Yamano, Yoshihisa
Sato, Tomoo
Iwanaga, Masako
Uchimaru, Kaoru
Nakashima, Makoto
Utsunomiya, Atae
Kubota, Ryuji
Ishitsuka, Kenji
Hasegawa, Hiroo
Sasaki, Daisuke
Koh, Ki-Ryang
Taki, Mai
Nosaka, Kisato
Ogata, Masao
Naruse, Isao
Kaneko, Noriaki
Okajima, Sara
Tezuka, Kenta
Ikebe, Emi
Matsuoka, Sahoko
Itabashi, Kazuo
Saito, Shigeru
Watanabe, Toshiki
Hamaguchi, Isao
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7444053/
https://www.ncbi.nlm.nih.gov/pubmed/32831150
http://dx.doi.org/10.1186/s12977-020-00534-0
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