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Evaluation of anti-SARS-CoV-2 antibody testing in asymptomatic or mild COVID-19 patients in outbreak on a cruise ship
Norihito Kaku; Fumitaka Nishimura; Yui Shigeishi; Rina Tachiki; Hironori Sakai; Daisuke Sasaki; Kenji Ota; Kei Sakamoto; Kosuke Kosai; Hiroo Hasegawa; Koichi Izumikawa; Koya Ariyoshi; Hiroshi Mukae; Jiro Yasuda; Kouichi Morita; Shigeru Kohno; Katsunori Yanagihara.
Afiliación
  • Norihito Kaku; Nagasaki University
  • Fumitaka Nishimura; Nagasaki University
  • Yui Shigeishi; Nagasaki University
  • Rina Tachiki; Nagasaki Univerisity
  • Hironori Sakai; Cellspect Co., Ltd
  • Daisuke Sasaki; Nagasaki University
  • Kenji Ota; Nagasaki University
  • Kei Sakamoto; Nagasaki University
  • Kosuke Kosai; Nagasaki University
  • Hiroo Hasegawa; Nagasaki University
  • Koichi Izumikawa; Nagasaki University
  • Koya Ariyoshi; Nagasaki University
  • Hiroshi Mukae; Nagasaki University
  • Jiro Yasuda; Nagasaki University
  • Kouichi Morita; Nagasaki University
  • Shigeru Kohno; Nagasaki University
  • Katsunori Yanagihara; Nagasaki University
Preprint en En | PREPRINT-MEDRXIV | ID: ppmedrxiv-21253064
ABSTRACT
BackgroundA few studies on antibody testing have focused on asymptomatic or mild coronavirus disease 2019 (COVID-19) patients with low initial anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody responses. Anti-SARS-CoV-2 antibody-testing performance was evaluated using blood samples from asymptomatic or mild COVID-19 patients. MethodsBlood samples were collected from 143 COVID-19 patients during an outbreak on a cruise ship 3 weeks after diagnosis. Simultaneously, a second SARS-CoV-2 genetic test was performed. Samples stored before the COVID-19 pandemic were also used to evaluate the lateral flow immunochromatographic assay (LFA) and electrochemiluminescence immunoassay (ECLIA). Titers of anti-SARS-CoV-2 IgM and IgG antibodies against the nucleocapsid and spike proteins were measured using the enzyme-linked immunosorbent assay to compare false-negative-with positive-result samples. ResultsSensitivity, specificity, positive-predictive, and negative-predictive values of LFA-detected IgM antibodies were 0.231, 1.000, 1.000, and 0.613, respectively; those of LFA-detected IgG antibodies were 0.483, 0.989, 0.972, and 0.601, respectively; and those of ECLIA-detected total antibodies were 0.783, 1.000, 1.000, and 0.848, respectively. IgM-, IgG-, and total-antibody positivity rates in the patients with negative results from the second genetic testing were 22.9%, 47.6%, and 72.4%, respectively. All antibody titers, especially those of the IgG antibody against nucleocapsid protein, were significantly lower in blood samples with false-negative results than in those with positive results. ConclusionsThese findings suggest that anti-SARS-CoV-2 antibody testing has lower performance in asymptomatic or mild COVID-19 patients than required in the guidelines, and situations in which it is useful are limited.
Licencia
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Texto completo: 1 Colección: 09-preprints Base de datos: PREPRINT-MEDRXIV Tipo de estudio: Diagnostic_studies / Experimental_studies / Prognostic_studies Idioma: En Año: 2021 Tipo del documento: Preprint
Texto completo: 1 Colección: 09-preprints Base de datos: PREPRINT-MEDRXIV Tipo de estudio: Diagnostic_studies / Experimental_studies / Prognostic_studies Idioma: En Año: 2021 Tipo del documento: Preprint