Evaluation of the analytical performance of anti-SARS-CoV-2 antibody test kits distributed or developed in Japan
Background: With the spread of COVID-19, anti-SARS-CoV-2 antibody tests have been utilized. Herein we evaluated the analytical performance of anti-SARS-CoV-2 antibody test kits using a new reference standard prepared from COVID-19 patient sera. Methods: Fifty-seven kits in total (16 immunochromatography types, 11 ELISA types and 30 types for automated analyzers) were examined. By measuring serially diluted reference standards, the maximum dilution factor showing a positive result and its precision were investigated. Results: The measured cut-off titers varied largely depending on the antibody kit; however, the variability was small, with the titers obtained by each kit being within twofold in most cases. Conclusion: The current results suggest that a suitable kit should be selected depending on the intended purpose.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:14 |
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| Enthalten in: |
Bioanalysis - 14(2022), 6 vom: 27. März, Seite 325-340 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Shibata, Hiroko [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 14.03.2022 Date Revised 14.03.2022 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.4155/bio-2021-0254 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM337657963 |
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| 100 | 1 | |a Shibata, Hiroko |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Evaluation of the analytical performance of anti-SARS-CoV-2 antibody test kits distributed or developed in Japan |
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| 500 | |a Date Completed 14.03.2022 | ||
| 500 | |a Date Revised 14.03.2022 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Background: With the spread of COVID-19, anti-SARS-CoV-2 antibody tests have been utilized. Herein we evaluated the analytical performance of anti-SARS-CoV-2 antibody test kits using a new reference standard prepared from COVID-19 patient sera. Methods: Fifty-seven kits in total (16 immunochromatography types, 11 ELISA types and 30 types for automated analyzers) were examined. By measuring serially diluted reference standards, the maximum dilution factor showing a positive result and its precision were investigated. Results: The measured cut-off titers varied largely depending on the antibody kit; however, the variability was small, with the titers obtained by each kit being within twofold in most cases. Conclusion: The current results suggest that a suitable kit should be selected depending on the intended purpose | ||
| 650 | 4 | |a Evaluation Study | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a ELISA | |
| 650 | 4 | |a analytical performance | |
| 650 | 4 | |a anti-SARS-CoV-2 antibody test | |
| 650 | 4 | |a antibody titer | |
| 650 | 4 | |a automated analyzer | |
| 650 | 4 | |a cut-off titer | |
| 650 | 4 | |a cut-off value | |
| 650 | 4 | |a immunochromatography | |
| 650 | 7 | |a Antibodies, Viral |2 NLM | |
| 650 | 7 | |a Immunoglobulin G |2 NLM | |
| 650 | 7 | |a Reagent Kits, Diagnostic |2 NLM | |
| 700 | 1 | |a Nishimura, Kazuko |e verfasserin |4 aut | |
| 700 | 1 | |a Maeda, Takuya |e verfasserin |4 aut | |
| 700 | 1 | |a Honma, Masamitsu |e verfasserin |4 aut | |
| 700 | 1 | |a Goda, Yukihiro |e verfasserin |4 aut | |
| 700 | 1 | |a Ishii-Watabe, Akiko |e verfasserin |4 aut | |
| 700 | 1 | |a Saito, Yoshiro |e verfasserin |4 aut | |
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