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
Abstract 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 scre...
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2020-08-01
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Series: | Retrovirology |
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Online Access: | http://link.springer.com/article/10.1186/s12977-020-00534-0 |
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English |
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DOAJ |
author |
Kazu Okuma Madoka Kuramitsu Toshihiro Niwa Tomokuni Taniguchi Yumiko Masaki Gohzoh Ueda Chieko Matsumoto Rieko Sobata Yasuko Sagara Hitomi Nakamura Masahiro Satake Kiyonori Miura Naoki Fuchi Hideaki Masuzaki Akihiko Okayama Kazumi Umeki Yoshihisa Yamano Tomoo Sato Masako Iwanaga Kaoru Uchimaru Makoto Nakashima Atae Utsunomiya Ryuji Kubota Kenji Ishitsuka Hiroo Hasegawa Daisuke Sasaki Ki-Ryang Koh Mai Taki Kisato Nosaka Masao Ogata Isao Naruse Noriaki Kaneko Sara Okajima Kenta Tezuka Emi Ikebe Sahoko Matsuoka Kazuo Itabashi Shigeru Saito Toshiki Watanabe Isao Hamaguchi |
spellingShingle |
Kazu Okuma Madoka Kuramitsu Toshihiro Niwa Tomokuni Taniguchi Yumiko Masaki Gohzoh Ueda Chieko Matsumoto Rieko Sobata Yasuko Sagara Hitomi Nakamura Masahiro Satake Kiyonori Miura Naoki Fuchi Hideaki Masuzaki Akihiko Okayama Kazumi Umeki Yoshihisa Yamano Tomoo Sato Masako Iwanaga Kaoru Uchimaru Makoto Nakashima Atae Utsunomiya Ryuji Kubota Kenji Ishitsuka Hiroo Hasegawa Daisuke Sasaki Ki-Ryang Koh Mai Taki Kisato Nosaka Masao Ogata Isao Naruse Noriaki Kaneko Sara Okajima Kenta Tezuka Emi Ikebe Sahoko Matsuoka Kazuo Itabashi Shigeru Saito Toshiki Watanabe Isao Hamaguchi 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 Retrovirology HTLV-1 infection HTLV-1 antibody Diagnostic algorithm Confirmatory test WB LIA |
author_facet |
Kazu Okuma Madoka Kuramitsu Toshihiro Niwa Tomokuni Taniguchi Yumiko Masaki Gohzoh Ueda Chieko Matsumoto Rieko Sobata Yasuko Sagara Hitomi Nakamura Masahiro Satake Kiyonori Miura Naoki Fuchi Hideaki Masuzaki Akihiko Okayama Kazumi Umeki Yoshihisa Yamano Tomoo Sato Masako Iwanaga Kaoru Uchimaru Makoto Nakashima Atae Utsunomiya Ryuji Kubota Kenji Ishitsuka Hiroo Hasegawa Daisuke Sasaki Ki-Ryang Koh Mai Taki Kisato Nosaka Masao Ogata Isao Naruse Noriaki Kaneko Sara Okajima Kenta Tezuka Emi Ikebe Sahoko Matsuoka Kazuo Itabashi Shigeru Saito Toshiki Watanabe Isao Hamaguchi |
author_sort |
Kazu Okuma |
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_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_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_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 |
publisher |
BMC |
series |
Retrovirology |
issn |
1742-4690 |
publishDate |
2020-08-01 |
description |
Abstract 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. |
topic |
HTLV-1 infection HTLV-1 antibody Diagnostic algorithm Confirmatory test WB LIA |
url |
http://link.springer.com/article/10.1186/s12977-020-00534-0 |
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doaj-85f6e42c134e41579196a4552b8847082020-11-25T03:01:11ZengBMCRetrovirology1742-46902020-08-0117111210.1186/s12977-020-00534-0Establishment 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 JapanKazu Okuma0Madoka Kuramitsu1Toshihiro Niwa2Tomokuni Taniguchi3Yumiko Masaki4Gohzoh Ueda5Chieko Matsumoto6Rieko Sobata7Yasuko Sagara8Hitomi Nakamura9Masahiro Satake10Kiyonori Miura11Naoki Fuchi12Hideaki Masuzaki13Akihiko Okayama14Kazumi Umeki15Yoshihisa Yamano16Tomoo Sato17Masako Iwanaga18Kaoru Uchimaru19Makoto Nakashima20Atae Utsunomiya21Ryuji Kubota22Kenji Ishitsuka23Hiroo Hasegawa24Daisuke Sasaki25Ki-Ryang Koh26Mai Taki27Kisato Nosaka28Masao Ogata29Isao Naruse30Noriaki Kaneko31Sara Okajima32Kenta Tezuka33Emi Ikebe34Sahoko Matsuoka35Kazuo Itabashi36Shigeru Saito37Toshiki Watanabe38Isao Hamaguchi39Department of Safety Research on Blood and Biological Products, National Institute of Infectious DiseasesDepartment of Safety Research on Blood and Biological Products, National Institute of Infectious DiseasesResearch and Development Division, Fujirebio Inc.Protein Technology, Engineering 1, Sysmex CorporationRoche Diagnostics K.K.Abbott Japan LLCCentral Blood Institute, Blood Service Headquarters, Japanese Red Cross SocietyCentral Blood Institute, Blood Service Headquarters, Japanese Red Cross SocietyDepartment of Quality, Japanese Red Cross Kyushu Block Blood CenterDepartment of Quality, Japanese Red Cross Kyushu Block Blood CenterCentral Blood Institute, Blood Service Headquarters, Japanese Red Cross SocietyDepartment of Obstetrics and Gynecology, Nagasaki University Graduate School of Biomedical SciencesDepartment of Obstetrics and Gynecology, Nagasaki University Graduate School of Biomedical SciencesDepartment of Obstetrics and Gynecology, Nagasaki University Graduate School of Biomedical SciencesDepartment of Rheumatology, Infectious Diseases and Laboratory Medicine, University of MiyazakiDepartment of Rheumatology, Infectious Diseases and Laboratory Medicine, University of MiyazakiDivision of Neurology, Department of Internal Medicine, St. Marianna University School of MedicineDepartment of Rare Diseases Research, Institute of Medical Science, St. Marianna University School of MedicineDepartment of Clinical Epidemiology, Nagasaki University Graduate School of Biomedical SciencesDepartment of Computational Biology and Medical Sciences, Graduate School of Frontier Sciences, The University of TokyoDepartment of Computational Biology and Medical Sciences, Graduate School of Frontier Sciences, The University of TokyoDepartment of Hematology, Imamura General HospitalDivision of Neuroimmunology, Joint Research Center for Human Retrovirus Infection, Kagoshima UniversityDepartment of Hematology and Rheumatology, Kagoshima UniversityDepartment of Laboratory Medicine, Nagasaki University HospitalDepartment of Laboratory Medicine, Nagasaki University HospitalDepartment of Hematology, Osaka General Hospital of West Japan Railway CompanyRakuwakai Kyoto Medical Examination CenterDepartment of Hematology, Kumamoto University of MedicineDepartment of Hematology, Oita University HospitalDepartment of Infection and Immunology, SRL Inc.Department of Infection and Immunology, SRL Inc.Department of Infection and Immunology, SRL Inc.Department of Safety Research on Blood and Biological Products, National Institute of Infectious DiseasesDepartment of Safety Research on Blood and Biological Products, National Institute of Infectious DiseasesDepartment of Safety Research on Blood and Biological Products, National Institute of Infectious DiseasesDepartment of Pediatrics, Showa University School of MedicineDepartment of Obstetrics and Gynecology, University of ToyamaDepartment of Hematology and Oncology, Research Hospital, Institute of Medical Science, The University of TokyoDepartment of Safety Research on Blood and Biological Products, National Institute of Infectious DiseasesAbstract 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.http://link.springer.com/article/10.1186/s12977-020-00534-0HTLV-1 infectionHTLV-1 antibodyDiagnostic algorithmConfirmatory testWBLIA |