Performance evaluation of Espline HTLV-I/II, a newly developed rapid immunochromatographic antibody test for different diagnostic situations

ABSTRACT Antibody screening tests for human T-cell leukemia virus type 1 (HTLV-1) are performed based on methods such as chemiluminescent enzyme immunoassay (CLEIA), chemiluminescence immunoassay (CLIA), electrochemiluminescence immunoassay, and particle agglutination (PA). Espline HTLV-I/II, a commercially available, easy-to-use, and rapid immunochromatographic antibody test (IC), was developed for situations where expensive instruments and laboratory equipment are not available. In this report, we compared the performance of IC with the above existing tests using diverse samples derived from asymptomatic HTLV-1 carriers and patients with HTLV-1-associated diseases in collaboration with 11 Japanese institutes. We found that IC detected HTLV-1 infection in all samples from HTLV-1-associated diseases, including adult T-cell leukemia, HTLV-1-associated myelopathy, and HTLV-1 uveitis (200/200). The sensitivity of IC compared with CLIA, CLEIA, and PA was 99.2% (363/366), 100% (241/241), and 100% (47/47), respectively, and the specificity was 99.4% (994/1000), 100% (60/60), and 100% (40/40), respectively. The positive and negative predictive values of IC were 99.7% [95% confidence interval (CI): 99.12–99.92] and 99.5% (95% CI: 98.82–99.75), respectively. However, IC had difficulty in correctly judging samples that were diagnosed as seroreactive in other first screening tests but negative by a confirmatory test; for example, of 612 confirmed negative samples that were CLIA seroreactive, 332 samples were IC positive. These results confirmed that IC has sufficient sensitivity and specificity as a screening test for HTLV-1, although, like the other screening tests, it also requires a confirmatory test to determine HTLV-1 infection correctly. IMPORTANCE The World Health Organization estimated that 5–10 million people are infected with human T-cell leukemia virus type 1 (HTLV-1). This number is likely to be underestimated because reliable endemic data are available for only approximately 1.5 billion people worldwide. The point-of-care test is a powerful tool for the easy and quick detection of infections without the requirement for expensive instruments and laboratory equipment. Espline HTLV-I/II, a newly developed rapid immunochromatographic antibody test that was evaluated in this study, might significantly advance our understanding of the global epidemiology of HTLV-1 infection. Ausführliche Beschreibung

Gespeichert in:

Autor*in:	Madoka Kuramitsu [verfasserIn] Haruka Momose [verfasserIn] Yuichiro Uchida [verfasserIn] Kenji Ishitsuka [verfasserIn] Ryuji Kubota [verfasserIn] Masahito Tokunaga [verfasserIn] Atae Utsunomiya [verfasserIn] Kunihiko Umekita [verfasserIn] Yuuki Hashikura [verfasserIn] Kisato Nosaka [verfasserIn] Ki-Ryang Koh [verfasserIn] Hitomi Nakamura [verfasserIn] Yasuko Sagara [verfasserIn] Rieko Sobata [verfasserIn] Masahiro Satake [verfasserIn] Koh Nagata [verfasserIn] Yuri Hasegawa [verfasserIn] Daisuke Sasaki [verfasserIn] Hiroo Hasegawa [verfasserIn] Tomoo Sato [verfasserIn] Yoshihisa Yamano [verfasserIn] Kou Hiraga [verfasserIn] Kenta Tezuka [verfasserIn] Emi Ikebe [verfasserIn] Sahoko Matsuoka [verfasserIn] Kazu Okuma [verfasserIn] Toshiki Watanabe [verfasserIn] Kiyonori Miura [verfasserIn] Isao Hamaguchi [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2023

Schlagwörter:	immunochromatographic antibody test point-of-care test HTLV-1 sensitivity specificity

Übergeordnetes Werk:	In: Microbiology Spectrum - American Society for Microbiology, 2022, 11(2023), 6
Übergeordnetes Werk:	volume:11 ; year:2023 ; number:6

Links:	Link aufrufen Link aufrufen Link aufrufen Journal toc

DOI / URN:	10.1128/spectrum.02078-23

Katalog-ID:	DOAJ099352559

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520			\|a ABSTRACT Antibody screening tests for human T-cell leukemia virus type 1 (HTLV-1) are performed based on methods such as chemiluminescent enzyme immunoassay (CLEIA), chemiluminescence immunoassay (CLIA), electrochemiluminescence immunoassay, and particle agglutination (PA). Espline HTLV-I/II, a commercially available, easy-to-use, and rapid immunochromatographic antibody test (IC), was developed for situations where expensive instruments and laboratory equipment are not available. In this report, we compared the performance of IC with the above existing tests using diverse samples derived from asymptomatic HTLV-1 carriers and patients with HTLV-1-associated diseases in collaboration with 11 Japanese institutes. We found that IC detected HTLV-1 infection in all samples from HTLV-1-associated diseases, including adult T-cell leukemia, HTLV-1-associated myelopathy, and HTLV-1 uveitis (200/200). The sensitivity of IC compared with CLIA, CLEIA, and PA was 99.2% (363/366), 100% (241/241), and 100% (47/47), respectively, and the specificity was 99.4% (994/1000), 100% (60/60), and 100% (40/40), respectively. The positive and negative predictive values of IC were 99.7% [95% confidence interval (CI): 99.12–99.92] and 99.5% (95% CI: 98.82–99.75), respectively. However, IC had difficulty in correctly judging samples that were diagnosed as seroreactive in other first screening tests but negative by a confirmatory test; for example, of 612 confirmed negative samples that were CLIA seroreactive, 332 samples were IC positive. These results confirmed that IC has sufficient sensitivity and specificity as a screening test for HTLV-1, although, like the other screening tests, it also requires a confirmatory test to determine HTLV-1 infection correctly. IMPORTANCE The World Health Organization estimated that 5–10 million people are infected with human T-cell leukemia virus type 1 (HTLV-1). This number is likely to be underestimated because reliable endemic data are available for only approximately 1.5 billion people worldwide. The point-of-care test is a powerful tool for the easy and quick detection of infections without the requirement for expensive instruments and laboratory equipment. Espline HTLV-I/II, a newly developed rapid immunochromatographic antibody test that was evaluated in this study, might significantly advance our understanding of the global epidemiology of HTLV-1 infection.
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allfields	10.1128/spectrum.02078-23 doi (DE-627)DOAJ099352559 (DE-599)DOAJcf6ba8e318c54103a74069a7e46c0125 DE-627 ger DE-627 rakwb eng QR1-502 Madoka Kuramitsu verfasserin aut Performance evaluation of Espline HTLV-I/II, a newly developed rapid immunochromatographic antibody test for different diagnostic situations 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier ABSTRACT Antibody screening tests for human T-cell leukemia virus type 1 (HTLV-1) are performed based on methods such as chemiluminescent enzyme immunoassay (CLEIA), chemiluminescence immunoassay (CLIA), electrochemiluminescence immunoassay, and particle agglutination (PA). Espline HTLV-I/II, a commercially available, easy-to-use, and rapid immunochromatographic antibody test (IC), was developed for situations where expensive instruments and laboratory equipment are not available. In this report, we compared the performance of IC with the above existing tests using diverse samples derived from asymptomatic HTLV-1 carriers and patients with HTLV-1-associated diseases in collaboration with 11 Japanese institutes. We found that IC detected HTLV-1 infection in all samples from HTLV-1-associated diseases, including adult T-cell leukemia, HTLV-1-associated myelopathy, and HTLV-1 uveitis (200/200). The sensitivity of IC compared with CLIA, CLEIA, and PA was 99.2% (363/366), 100% (241/241), and 100% (47/47), respectively, and the specificity was 99.4% (994/1000), 100% (60/60), and 100% (40/40), respectively. The positive and negative predictive values of IC were 99.7% [95% confidence interval (CI): 99.12–99.92] and 99.5% (95% CI: 98.82–99.75), respectively. However, IC had difficulty in correctly judging samples that were diagnosed as seroreactive in other first screening tests but negative by a confirmatory test; for example, of 612 confirmed negative samples that were CLIA seroreactive, 332 samples were IC positive. These results confirmed that IC has sufficient sensitivity and specificity as a screening test for HTLV-1, although, like the other screening tests, it also requires a confirmatory test to determine HTLV-1 infection correctly. IMPORTANCE The World Health Organization estimated that 5–10 million people are infected with human T-cell leukemia virus type 1 (HTLV-1). This number is likely to be underestimated because reliable endemic data are available for only approximately 1.5 billion people worldwide. The point-of-care test is a powerful tool for the easy and quick detection of infections without the requirement for expensive instruments and laboratory equipment. Espline HTLV-I/II, a newly developed rapid immunochromatographic antibody test that was evaluated in this study, might significantly advance our understanding of the global epidemiology of HTLV-1 infection. immunochromatographic antibody test point-of-care test HTLV-1 sensitivity specificity Microbiology Haruka Momose verfasserin aut Yuichiro Uchida verfasserin aut Kenji Ishitsuka verfasserin aut Ryuji Kubota verfasserin aut Masahito Tokunaga verfasserin aut Atae Utsunomiya verfasserin aut Kunihiko Umekita verfasserin aut Yuuki Hashikura verfasserin aut Kisato Nosaka verfasserin aut Ki-Ryang Koh verfasserin aut Hitomi Nakamura verfasserin aut Yasuko Sagara verfasserin aut Rieko Sobata verfasserin aut Masahiro Satake verfasserin aut Koh Nagata verfasserin aut Yuri Hasegawa verfasserin aut Daisuke Sasaki verfasserin aut Hiroo Hasegawa verfasserin aut Tomoo Sato verfasserin aut Yoshihisa Yamano verfasserin aut Kou Hiraga verfasserin aut Kenta Tezuka verfasserin aut Emi Ikebe verfasserin aut Sahoko Matsuoka verfasserin aut Kazu Okuma verfasserin aut Toshiki Watanabe verfasserin aut Kiyonori Miura verfasserin aut Isao Hamaguchi verfasserin aut In Microbiology Spectrum American Society for Microbiology, 2022 11(2023), 6 (DE-627)816693293 (DE-600)2807133-5 21650497 nnns volume:11 year:2023 number:6 https://doi.org/10.1128/spectrum.02078-23 kostenfrei https://doaj.org/article/cf6ba8e318c54103a74069a7e46c0125 kostenfrei https://journals.asm.org/doi/10.1128/spectrum.02078-23 kostenfrei https://doaj.org/toc/2165-0497 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_213 GBV_ILN_230 GBV_ILN_252 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 11 2023 6
spelling	10.1128/spectrum.02078-23 doi (DE-627)DOAJ099352559 (DE-599)DOAJcf6ba8e318c54103a74069a7e46c0125 DE-627 ger DE-627 rakwb eng QR1-502 Madoka Kuramitsu verfasserin aut Performance evaluation of Espline HTLV-I/II, a newly developed rapid immunochromatographic antibody test for different diagnostic situations 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier ABSTRACT Antibody screening tests for human T-cell leukemia virus type 1 (HTLV-1) are performed based on methods such as chemiluminescent enzyme immunoassay (CLEIA), chemiluminescence immunoassay (CLIA), electrochemiluminescence immunoassay, and particle agglutination (PA). Espline HTLV-I/II, a commercially available, easy-to-use, and rapid immunochromatographic antibody test (IC), was developed for situations where expensive instruments and laboratory equipment are not available. In this report, we compared the performance of IC with the above existing tests using diverse samples derived from asymptomatic HTLV-1 carriers and patients with HTLV-1-associated diseases in collaboration with 11 Japanese institutes. We found that IC detected HTLV-1 infection in all samples from HTLV-1-associated diseases, including adult T-cell leukemia, HTLV-1-associated myelopathy, and HTLV-1 uveitis (200/200). The sensitivity of IC compared with CLIA, CLEIA, and PA was 99.2% (363/366), 100% (241/241), and 100% (47/47), respectively, and the specificity was 99.4% (994/1000), 100% (60/60), and 100% (40/40), respectively. The positive and negative predictive values of IC were 99.7% [95% confidence interval (CI): 99.12–99.92] and 99.5% (95% CI: 98.82–99.75), respectively. However, IC had difficulty in correctly judging samples that were diagnosed as seroreactive in other first screening tests but negative by a confirmatory test; for example, of 612 confirmed negative samples that were CLIA seroreactive, 332 samples were IC positive. These results confirmed that IC has sufficient sensitivity and specificity as a screening test for HTLV-1, although, like the other screening tests, it also requires a confirmatory test to determine HTLV-1 infection correctly. IMPORTANCE The World Health Organization estimated that 5–10 million people are infected with human T-cell leukemia virus type 1 (HTLV-1). This number is likely to be underestimated because reliable endemic data are available for only approximately 1.5 billion people worldwide. The point-of-care test is a powerful tool for the easy and quick detection of infections without the requirement for expensive instruments and laboratory equipment. Espline HTLV-I/II, a newly developed rapid immunochromatographic antibody test that was evaluated in this study, might significantly advance our understanding of the global epidemiology of HTLV-1 infection. immunochromatographic antibody test point-of-care test HTLV-1 sensitivity specificity Microbiology Haruka Momose verfasserin aut Yuichiro Uchida verfasserin aut Kenji Ishitsuka verfasserin aut Ryuji Kubota verfasserin aut Masahito Tokunaga verfasserin aut Atae Utsunomiya verfasserin aut Kunihiko Umekita verfasserin aut Yuuki Hashikura verfasserin aut Kisato Nosaka verfasserin aut Ki-Ryang Koh verfasserin aut Hitomi Nakamura verfasserin aut Yasuko Sagara verfasserin aut Rieko Sobata verfasserin aut Masahiro Satake verfasserin aut Koh Nagata verfasserin aut Yuri Hasegawa verfasserin aut Daisuke Sasaki verfasserin aut Hiroo Hasegawa verfasserin aut Tomoo Sato verfasserin aut Yoshihisa Yamano verfasserin aut Kou Hiraga verfasserin aut Kenta Tezuka verfasserin aut Emi Ikebe verfasserin aut Sahoko Matsuoka verfasserin aut Kazu Okuma verfasserin aut Toshiki Watanabe verfasserin aut Kiyonori Miura verfasserin aut Isao Hamaguchi verfasserin aut In Microbiology Spectrum American Society for Microbiology, 2022 11(2023), 6 (DE-627)816693293 (DE-600)2807133-5 21650497 nnns volume:11 year:2023 number:6 https://doi.org/10.1128/spectrum.02078-23 kostenfrei https://doaj.org/article/cf6ba8e318c54103a74069a7e46c0125 kostenfrei https://journals.asm.org/doi/10.1128/spectrum.02078-23 kostenfrei https://doaj.org/toc/2165-0497 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_213 GBV_ILN_230 GBV_ILN_252 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 11 2023 6
allfields_unstemmed	10.1128/spectrum.02078-23 doi (DE-627)DOAJ099352559 (DE-599)DOAJcf6ba8e318c54103a74069a7e46c0125 DE-627 ger DE-627 rakwb eng QR1-502 Madoka Kuramitsu verfasserin aut Performance evaluation of Espline HTLV-I/II, a newly developed rapid immunochromatographic antibody test for different diagnostic situations 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier ABSTRACT Antibody screening tests for human T-cell leukemia virus type 1 (HTLV-1) are performed based on methods such as chemiluminescent enzyme immunoassay (CLEIA), chemiluminescence immunoassay (CLIA), electrochemiluminescence immunoassay, and particle agglutination (PA). Espline HTLV-I/II, a commercially available, easy-to-use, and rapid immunochromatographic antibody test (IC), was developed for situations where expensive instruments and laboratory equipment are not available. In this report, we compared the performance of IC with the above existing tests using diverse samples derived from asymptomatic HTLV-1 carriers and patients with HTLV-1-associated diseases in collaboration with 11 Japanese institutes. We found that IC detected HTLV-1 infection in all samples from HTLV-1-associated diseases, including adult T-cell leukemia, HTLV-1-associated myelopathy, and HTLV-1 uveitis (200/200). The sensitivity of IC compared with CLIA, CLEIA, and PA was 99.2% (363/366), 100% (241/241), and 100% (47/47), respectively, and the specificity was 99.4% (994/1000), 100% (60/60), and 100% (40/40), respectively. The positive and negative predictive values of IC were 99.7% [95% confidence interval (CI): 99.12–99.92] and 99.5% (95% CI: 98.82–99.75), respectively. However, IC had difficulty in correctly judging samples that were diagnosed as seroreactive in other first screening tests but negative by a confirmatory test; for example, of 612 confirmed negative samples that were CLIA seroreactive, 332 samples were IC positive. These results confirmed that IC has sufficient sensitivity and specificity as a screening test for HTLV-1, although, like the other screening tests, it also requires a confirmatory test to determine HTLV-1 infection correctly. IMPORTANCE The World Health Organization estimated that 5–10 million people are infected with human T-cell leukemia virus type 1 (HTLV-1). This number is likely to be underestimated because reliable endemic data are available for only approximately 1.5 billion people worldwide. The point-of-care test is a powerful tool for the easy and quick detection of infections without the requirement for expensive instruments and laboratory equipment. Espline HTLV-I/II, a newly developed rapid immunochromatographic antibody test that was evaluated in this study, might significantly advance our understanding of the global epidemiology of HTLV-1 infection. immunochromatographic antibody test point-of-care test HTLV-1 sensitivity specificity Microbiology Haruka Momose verfasserin aut Yuichiro Uchida verfasserin aut Kenji Ishitsuka verfasserin aut Ryuji Kubota verfasserin aut Masahito Tokunaga verfasserin aut Atae Utsunomiya verfasserin aut Kunihiko Umekita verfasserin aut Yuuki Hashikura verfasserin aut Kisato Nosaka verfasserin aut Ki-Ryang Koh verfasserin aut Hitomi Nakamura verfasserin aut Yasuko Sagara verfasserin aut Rieko Sobata verfasserin aut Masahiro Satake verfasserin aut Koh Nagata verfasserin aut Yuri Hasegawa verfasserin aut Daisuke Sasaki verfasserin aut Hiroo Hasegawa verfasserin aut Tomoo Sato verfasserin aut Yoshihisa Yamano verfasserin aut Kou Hiraga verfasserin aut Kenta Tezuka verfasserin aut Emi Ikebe verfasserin aut Sahoko Matsuoka verfasserin aut Kazu Okuma verfasserin aut Toshiki Watanabe verfasserin aut Kiyonori Miura verfasserin aut Isao Hamaguchi verfasserin aut In Microbiology Spectrum American Society for Microbiology, 2022 11(2023), 6 (DE-627)816693293 (DE-600)2807133-5 21650497 nnns volume:11 year:2023 number:6 https://doi.org/10.1128/spectrum.02078-23 kostenfrei https://doaj.org/article/cf6ba8e318c54103a74069a7e46c0125 kostenfrei https://journals.asm.org/doi/10.1128/spectrum.02078-23 kostenfrei https://doaj.org/toc/2165-0497 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_213 GBV_ILN_230 GBV_ILN_252 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 11 2023 6
allfieldsGer	10.1128/spectrum.02078-23 doi (DE-627)DOAJ099352559 (DE-599)DOAJcf6ba8e318c54103a74069a7e46c0125 DE-627 ger DE-627 rakwb eng QR1-502 Madoka Kuramitsu verfasserin aut Performance evaluation of Espline HTLV-I/II, a newly developed rapid immunochromatographic antibody test for different diagnostic situations 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier ABSTRACT Antibody screening tests for human T-cell leukemia virus type 1 (HTLV-1) are performed based on methods such as chemiluminescent enzyme immunoassay (CLEIA), chemiluminescence immunoassay (CLIA), electrochemiluminescence immunoassay, and particle agglutination (PA). Espline HTLV-I/II, a commercially available, easy-to-use, and rapid immunochromatographic antibody test (IC), was developed for situations where expensive instruments and laboratory equipment are not available. In this report, we compared the performance of IC with the above existing tests using diverse samples derived from asymptomatic HTLV-1 carriers and patients with HTLV-1-associated diseases in collaboration with 11 Japanese institutes. We found that IC detected HTLV-1 infection in all samples from HTLV-1-associated diseases, including adult T-cell leukemia, HTLV-1-associated myelopathy, and HTLV-1 uveitis (200/200). The sensitivity of IC compared with CLIA, CLEIA, and PA was 99.2% (363/366), 100% (241/241), and 100% (47/47), respectively, and the specificity was 99.4% (994/1000), 100% (60/60), and 100% (40/40), respectively. The positive and negative predictive values of IC were 99.7% [95% confidence interval (CI): 99.12–99.92] and 99.5% (95% CI: 98.82–99.75), respectively. However, IC had difficulty in correctly judging samples that were diagnosed as seroreactive in other first screening tests but negative by a confirmatory test; for example, of 612 confirmed negative samples that were CLIA seroreactive, 332 samples were IC positive. These results confirmed that IC has sufficient sensitivity and specificity as a screening test for HTLV-1, although, like the other screening tests, it also requires a confirmatory test to determine HTLV-1 infection correctly. IMPORTANCE The World Health Organization estimated that 5–10 million people are infected with human T-cell leukemia virus type 1 (HTLV-1). This number is likely to be underestimated because reliable endemic data are available for only approximately 1.5 billion people worldwide. The point-of-care test is a powerful tool for the easy and quick detection of infections without the requirement for expensive instruments and laboratory equipment. Espline HTLV-I/II, a newly developed rapid immunochromatographic antibody test that was evaluated in this study, might significantly advance our understanding of the global epidemiology of HTLV-1 infection. immunochromatographic antibody test point-of-care test HTLV-1 sensitivity specificity Microbiology Haruka Momose verfasserin aut Yuichiro Uchida verfasserin aut Kenji Ishitsuka verfasserin aut Ryuji Kubota verfasserin aut Masahito Tokunaga verfasserin aut Atae Utsunomiya verfasserin aut Kunihiko Umekita verfasserin aut Yuuki Hashikura verfasserin aut Kisato Nosaka verfasserin aut Ki-Ryang Koh verfasserin aut Hitomi Nakamura verfasserin aut Yasuko Sagara verfasserin aut Rieko Sobata verfasserin aut Masahiro Satake verfasserin aut Koh Nagata verfasserin aut Yuri Hasegawa verfasserin aut Daisuke Sasaki verfasserin aut Hiroo Hasegawa verfasserin aut Tomoo Sato verfasserin aut Yoshihisa Yamano verfasserin aut Kou Hiraga verfasserin aut Kenta Tezuka verfasserin aut Emi Ikebe verfasserin aut Sahoko Matsuoka verfasserin aut Kazu Okuma verfasserin aut Toshiki Watanabe verfasserin aut Kiyonori Miura verfasserin aut Isao Hamaguchi verfasserin aut In Microbiology Spectrum American Society for Microbiology, 2022 11(2023), 6 (DE-627)816693293 (DE-600)2807133-5 21650497 nnns volume:11 year:2023 number:6 https://doi.org/10.1128/spectrum.02078-23 kostenfrei https://doaj.org/article/cf6ba8e318c54103a74069a7e46c0125 kostenfrei https://journals.asm.org/doi/10.1128/spectrum.02078-23 kostenfrei https://doaj.org/toc/2165-0497 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_213 GBV_ILN_230 GBV_ILN_252 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 11 2023 6
allfieldsSound	10.1128/spectrum.02078-23 doi (DE-627)DOAJ099352559 (DE-599)DOAJcf6ba8e318c54103a74069a7e46c0125 DE-627 ger DE-627 rakwb eng QR1-502 Madoka Kuramitsu verfasserin aut Performance evaluation of Espline HTLV-I/II, a newly developed rapid immunochromatographic antibody test for different diagnostic situations 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier ABSTRACT Antibody screening tests for human T-cell leukemia virus type 1 (HTLV-1) are performed based on methods such as chemiluminescent enzyme immunoassay (CLEIA), chemiluminescence immunoassay (CLIA), electrochemiluminescence immunoassay, and particle agglutination (PA). Espline HTLV-I/II, a commercially available, easy-to-use, and rapid immunochromatographic antibody test (IC), was developed for situations where expensive instruments and laboratory equipment are not available. In this report, we compared the performance of IC with the above existing tests using diverse samples derived from asymptomatic HTLV-1 carriers and patients with HTLV-1-associated diseases in collaboration with 11 Japanese institutes. We found that IC detected HTLV-1 infection in all samples from HTLV-1-associated diseases, including adult T-cell leukemia, HTLV-1-associated myelopathy, and HTLV-1 uveitis (200/200). The sensitivity of IC compared with CLIA, CLEIA, and PA was 99.2% (363/366), 100% (241/241), and 100% (47/47), respectively, and the specificity was 99.4% (994/1000), 100% (60/60), and 100% (40/40), respectively. The positive and negative predictive values of IC were 99.7% [95% confidence interval (CI): 99.12–99.92] and 99.5% (95% CI: 98.82–99.75), respectively. However, IC had difficulty in correctly judging samples that were diagnosed as seroreactive in other first screening tests but negative by a confirmatory test; for example, of 612 confirmed negative samples that were CLIA seroreactive, 332 samples were IC positive. These results confirmed that IC has sufficient sensitivity and specificity as a screening test for HTLV-1, although, like the other screening tests, it also requires a confirmatory test to determine HTLV-1 infection correctly. IMPORTANCE The World Health Organization estimated that 5–10 million people are infected with human T-cell leukemia virus type 1 (HTLV-1). This number is likely to be underestimated because reliable endemic data are available for only approximately 1.5 billion people worldwide. The point-of-care test is a powerful tool for the easy and quick detection of infections without the requirement for expensive instruments and laboratory equipment. Espline HTLV-I/II, a newly developed rapid immunochromatographic antibody test that was evaluated in this study, might significantly advance our understanding of the global epidemiology of HTLV-1 infection. immunochromatographic antibody test point-of-care test HTLV-1 sensitivity specificity Microbiology Haruka Momose verfasserin aut Yuichiro Uchida verfasserin aut Kenji Ishitsuka verfasserin aut Ryuji Kubota verfasserin aut Masahito Tokunaga verfasserin aut Atae Utsunomiya verfasserin aut Kunihiko Umekita verfasserin aut Yuuki Hashikura verfasserin aut Kisato Nosaka verfasserin aut Ki-Ryang Koh verfasserin aut Hitomi Nakamura verfasserin aut Yasuko Sagara verfasserin aut Rieko Sobata verfasserin aut Masahiro Satake verfasserin aut Koh Nagata verfasserin aut Yuri Hasegawa verfasserin aut Daisuke Sasaki verfasserin aut Hiroo Hasegawa verfasserin aut Tomoo Sato verfasserin aut Yoshihisa Yamano verfasserin aut Kou Hiraga verfasserin aut Kenta Tezuka verfasserin aut Emi Ikebe verfasserin aut Sahoko Matsuoka verfasserin aut Kazu Okuma verfasserin aut Toshiki Watanabe verfasserin aut Kiyonori Miura verfasserin aut Isao Hamaguchi verfasserin aut In Microbiology Spectrum American Society for Microbiology, 2022 11(2023), 6 (DE-627)816693293 (DE-600)2807133-5 21650497 nnns volume:11 year:2023 number:6 https://doi.org/10.1128/spectrum.02078-23 kostenfrei https://doaj.org/article/cf6ba8e318c54103a74069a7e46c0125 kostenfrei https://journals.asm.org/doi/10.1128/spectrum.02078-23 kostenfrei https://doaj.org/toc/2165-0497 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_213 GBV_ILN_230 GBV_ILN_252 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 11 2023 6
language	English
source	In Microbiology Spectrum 11(2023), 6 volume:11 year:2023 number:6
sourceStr	In Microbiology Spectrum 11(2023), 6 volume:11 year:2023 number:6
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	immunochromatographic antibody test point-of-care test HTLV-1 sensitivity specificity Microbiology
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container_title	Microbiology Spectrum
authorswithroles_txt_mv	Madoka Kuramitsu @@aut@@ Haruka Momose @@aut@@ Yuichiro Uchida @@aut@@ Kenji Ishitsuka @@aut@@ Ryuji Kubota @@aut@@ Masahito Tokunaga @@aut@@ Atae Utsunomiya @@aut@@ Kunihiko Umekita @@aut@@ Yuuki Hashikura @@aut@@ Kisato Nosaka @@aut@@ Ki-Ryang Koh @@aut@@ Hitomi Nakamura @@aut@@ Yasuko Sagara @@aut@@ Rieko Sobata @@aut@@ Masahiro Satake @@aut@@ Koh Nagata @@aut@@ Yuri Hasegawa @@aut@@ Daisuke Sasaki @@aut@@ Hiroo Hasegawa @@aut@@ Tomoo Sato @@aut@@ Yoshihisa Yamano @@aut@@ Kou Hiraga @@aut@@ Kenta Tezuka @@aut@@ Emi Ikebe @@aut@@ Sahoko Matsuoka @@aut@@ Kazu Okuma @@aut@@ Toshiki Watanabe @@aut@@ Kiyonori Miura @@aut@@ Isao Hamaguchi @@aut@@
publishDateDaySort_date	2023-01-01T00:00:00Z
hierarchy_top_id	816693293
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Espline HTLV-I/II, a commercially available, easy-to-use, and rapid immunochromatographic antibody test (IC), was developed for situations where expensive instruments and laboratory equipment are not available. In this report, we compared the performance of IC with the above existing tests using diverse samples derived from asymptomatic HTLV-1 carriers and patients with HTLV-1-associated diseases in collaboration with 11 Japanese institutes. We found that IC detected HTLV-1 infection in all samples from HTLV-1-associated diseases, including adult T-cell leukemia, HTLV-1-associated myelopathy, and HTLV-1 uveitis (200/200). The sensitivity of IC compared with CLIA, CLEIA, and PA was 99.2% (363/366), 100% (241/241), and 100% (47/47), respectively, and the specificity was 99.4% (994/1000), 100% (60/60), and 100% (40/40), respectively. The positive and negative predictive values of IC were 99.7% [95% confidence interval (CI): 99.12–99.92] and 99.5% (95% CI: 98.82–99.75), respectively. However, IC had difficulty in correctly judging samples that were diagnosed as seroreactive in other first screening tests but negative by a confirmatory test; for example, of 612 confirmed negative samples that were CLIA seroreactive, 332 samples were IC positive. These results confirmed that IC has sufficient sensitivity and specificity as a screening test for HTLV-1, although, like the other screening tests, it also requires a confirmatory test to determine HTLV-1 infection correctly. IMPORTANCE The World Health Organization estimated that 5–10 million people are infected with human T-cell leukemia virus type 1 (HTLV-1). This number is likely to be underestimated because reliable endemic data are available for only approximately 1.5 billion people worldwide. The point-of-care test is a powerful tool for the easy and quick detection of infections without the requirement for expensive instruments and laboratory equipment. 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callnumber-first	Q - Science
author	Madoka Kuramitsu
spellingShingle	Madoka Kuramitsu misc QR1-502 misc immunochromatographic antibody test misc point-of-care test misc HTLV-1 misc sensitivity misc specificity misc Microbiology Performance evaluation of Espline HTLV-I/II, a newly developed rapid immunochromatographic antibody test for different diagnostic situations
authorStr	Madoka Kuramitsu
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topic_title	QR1-502 Performance evaluation of Espline HTLV-I/II, a newly developed rapid immunochromatographic antibody test for different diagnostic situations immunochromatographic antibody test point-of-care test HTLV-1 sensitivity specificity
topic	misc QR1-502 misc immunochromatographic antibody test misc point-of-care test misc HTLV-1 misc sensitivity misc specificity misc Microbiology
topic_unstemmed	misc QR1-502 misc immunochromatographic antibody test misc point-of-care test misc HTLV-1 misc sensitivity misc specificity misc Microbiology
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title	Performance evaluation of Espline HTLV-I/II, a newly developed rapid immunochromatographic antibody test for different diagnostic situations
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title_full	Performance evaluation of Espline HTLV-I/II, a newly developed rapid immunochromatographic antibody test for different diagnostic situations
author_sort	Madoka Kuramitsu
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author_browse	Madoka Kuramitsu Haruka Momose Yuichiro Uchida Kenji Ishitsuka Ryuji Kubota Masahito Tokunaga Atae Utsunomiya Kunihiko Umekita Yuuki Hashikura Kisato Nosaka Ki-Ryang Koh Hitomi Nakamura Yasuko Sagara Rieko Sobata Masahiro Satake Koh Nagata Yuri Hasegawa Daisuke Sasaki Hiroo Hasegawa Tomoo Sato Yoshihisa Yamano Kou Hiraga Kenta Tezuka Emi Ikebe Sahoko Matsuoka Kazu Okuma Toshiki Watanabe Kiyonori Miura Isao Hamaguchi
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author-letter	Madoka Kuramitsu
doi_str_mv	10.1128/spectrum.02078-23
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title_sort	performance evaluation of espline htlv-i/ii, a newly developed rapid immunochromatographic antibody test for different diagnostic situations
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title_auth	Performance evaluation of Espline HTLV-I/II, a newly developed rapid immunochromatographic antibody test for different diagnostic situations
abstract	ABSTRACT Antibody screening tests for human T-cell leukemia virus type 1 (HTLV-1) are performed based on methods such as chemiluminescent enzyme immunoassay (CLEIA), chemiluminescence immunoassay (CLIA), electrochemiluminescence immunoassay, and particle agglutination (PA). Espline HTLV-I/II, a commercially available, easy-to-use, and rapid immunochromatographic antibody test (IC), was developed for situations where expensive instruments and laboratory equipment are not available. In this report, we compared the performance of IC with the above existing tests using diverse samples derived from asymptomatic HTLV-1 carriers and patients with HTLV-1-associated diseases in collaboration with 11 Japanese institutes. We found that IC detected HTLV-1 infection in all samples from HTLV-1-associated diseases, including adult T-cell leukemia, HTLV-1-associated myelopathy, and HTLV-1 uveitis (200/200). The sensitivity of IC compared with CLIA, CLEIA, and PA was 99.2% (363/366), 100% (241/241), and 100% (47/47), respectively, and the specificity was 99.4% (994/1000), 100% (60/60), and 100% (40/40), respectively. The positive and negative predictive values of IC were 99.7% [95% confidence interval (CI): 99.12–99.92] and 99.5% (95% CI: 98.82–99.75), respectively. However, IC had difficulty in correctly judging samples that were diagnosed as seroreactive in other first screening tests but negative by a confirmatory test; for example, of 612 confirmed negative samples that were CLIA seroreactive, 332 samples were IC positive. These results confirmed that IC has sufficient sensitivity and specificity as a screening test for HTLV-1, although, like the other screening tests, it also requires a confirmatory test to determine HTLV-1 infection correctly. IMPORTANCE The World Health Organization estimated that 5–10 million people are infected with human T-cell leukemia virus type 1 (HTLV-1). This number is likely to be underestimated because reliable endemic data are available for only approximately 1.5 billion people worldwide. The point-of-care test is a powerful tool for the easy and quick detection of infections without the requirement for expensive instruments and laboratory equipment. Espline HTLV-I/II, a newly developed rapid immunochromatographic antibody test that was evaluated in this study, might significantly advance our understanding of the global epidemiology of HTLV-1 infection.
abstractGer	ABSTRACT Antibody screening tests for human T-cell leukemia virus type 1 (HTLV-1) are performed based on methods such as chemiluminescent enzyme immunoassay (CLEIA), chemiluminescence immunoassay (CLIA), electrochemiluminescence immunoassay, and particle agglutination (PA). Espline HTLV-I/II, a commercially available, easy-to-use, and rapid immunochromatographic antibody test (IC), was developed for situations where expensive instruments and laboratory equipment are not available. In this report, we compared the performance of IC with the above existing tests using diverse samples derived from asymptomatic HTLV-1 carriers and patients with HTLV-1-associated diseases in collaboration with 11 Japanese institutes. We found that IC detected HTLV-1 infection in all samples from HTLV-1-associated diseases, including adult T-cell leukemia, HTLV-1-associated myelopathy, and HTLV-1 uveitis (200/200). The sensitivity of IC compared with CLIA, CLEIA, and PA was 99.2% (363/366), 100% (241/241), and 100% (47/47), respectively, and the specificity was 99.4% (994/1000), 100% (60/60), and 100% (40/40), respectively. The positive and negative predictive values of IC were 99.7% [95% confidence interval (CI): 99.12–99.92] and 99.5% (95% CI: 98.82–99.75), respectively. However, IC had difficulty in correctly judging samples that were diagnosed as seroreactive in other first screening tests but negative by a confirmatory test; for example, of 612 confirmed negative samples that were CLIA seroreactive, 332 samples were IC positive. These results confirmed that IC has sufficient sensitivity and specificity as a screening test for HTLV-1, although, like the other screening tests, it also requires a confirmatory test to determine HTLV-1 infection correctly. IMPORTANCE The World Health Organization estimated that 5–10 million people are infected with human T-cell leukemia virus type 1 (HTLV-1). This number is likely to be underestimated because reliable endemic data are available for only approximately 1.5 billion people worldwide. The point-of-care test is a powerful tool for the easy and quick detection of infections without the requirement for expensive instruments and laboratory equipment. Espline HTLV-I/II, a newly developed rapid immunochromatographic antibody test that was evaluated in this study, might significantly advance our understanding of the global epidemiology of HTLV-1 infection.
abstract_unstemmed	ABSTRACT Antibody screening tests for human T-cell leukemia virus type 1 (HTLV-1) are performed based on methods such as chemiluminescent enzyme immunoassay (CLEIA), chemiluminescence immunoassay (CLIA), electrochemiluminescence immunoassay, and particle agglutination (PA). Espline HTLV-I/II, a commercially available, easy-to-use, and rapid immunochromatographic antibody test (IC), was developed for situations where expensive instruments and laboratory equipment are not available. In this report, we compared the performance of IC with the above existing tests using diverse samples derived from asymptomatic HTLV-1 carriers and patients with HTLV-1-associated diseases in collaboration with 11 Japanese institutes. We found that IC detected HTLV-1 infection in all samples from HTLV-1-associated diseases, including adult T-cell leukemia, HTLV-1-associated myelopathy, and HTLV-1 uveitis (200/200). The sensitivity of IC compared with CLIA, CLEIA, and PA was 99.2% (363/366), 100% (241/241), and 100% (47/47), respectively, and the specificity was 99.4% (994/1000), 100% (60/60), and 100% (40/40), respectively. The positive and negative predictive values of IC were 99.7% [95% confidence interval (CI): 99.12–99.92] and 99.5% (95% CI: 98.82–99.75), respectively. However, IC had difficulty in correctly judging samples that were diagnosed as seroreactive in other first screening tests but negative by a confirmatory test; for example, of 612 confirmed negative samples that were CLIA seroreactive, 332 samples were IC positive. These results confirmed that IC has sufficient sensitivity and specificity as a screening test for HTLV-1, although, like the other screening tests, it also requires a confirmatory test to determine HTLV-1 infection correctly. IMPORTANCE The World Health Organization estimated that 5–10 million people are infected with human T-cell leukemia virus type 1 (HTLV-1). This number is likely to be underestimated because reliable endemic data are available for only approximately 1.5 billion people worldwide. The point-of-care test is a powerful tool for the easy and quick detection of infections without the requirement for expensive instruments and laboratory equipment. Espline HTLV-I/II, a newly developed rapid immunochromatographic antibody test that was evaluated in this study, might significantly advance our understanding of the global epidemiology of HTLV-1 infection.
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container_issue	6
title_short	Performance evaluation of Espline HTLV-I/II, a newly developed rapid immunochromatographic antibody test for different diagnostic situations
url	https://doi.org/10.1128/spectrum.02078-23 https://doaj.org/article/cf6ba8e318c54103a74069a7e46c0125 https://journals.asm.org/doi/10.1128/spectrum.02078-23 https://doaj.org/toc/2165-0497
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author2	Haruka Momose Yuichiro Uchida Kenji Ishitsuka Ryuji Kubota Masahito Tokunaga Atae Utsunomiya Kunihiko Umekita Yuuki Hashikura Kisato Nosaka Ki-Ryang Koh Hitomi Nakamura Yasuko Sagara Rieko Sobata Masahiro Satake Koh Nagata Yuri Hasegawa Daisuke Sasaki Hiroo Hasegawa Tomoo Sato Yoshihisa Yamano Kou Hiraga Kenta Tezuka Emi Ikebe Sahoko Matsuoka Kazu Okuma Toshiki Watanabe Kiyonori Miura Isao Hamaguchi
author2Str	Haruka Momose Yuichiro Uchida Kenji Ishitsuka Ryuji Kubota Masahito Tokunaga Atae Utsunomiya Kunihiko Umekita Yuuki Hashikura Kisato Nosaka Ki-Ryang Koh Hitomi Nakamura Yasuko Sagara Rieko Sobata Masahiro Satake Koh Nagata Yuri Hasegawa Daisuke Sasaki Hiroo Hasegawa Tomoo Sato Yoshihisa Yamano Kou Hiraga Kenta Tezuka Emi Ikebe Sahoko Matsuoka Kazu Okuma Toshiki Watanabe Kiyonori Miura Isao Hamaguchi
ppnlink	816693293
callnumber-subject	QR - Microbiology
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isOA_txt	true
hochschulschrift_bool	false
doi_str	10.1128/spectrum.02078-23
callnumber-a	QR1-502
up_date	2024-07-03T22:21:25.692Z
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