Validation of a new automated chemiluminescent anti-SARS-CoV-2 IgM and IgG antibody assay system detecting both N and S proteins in Japan
PCR methods are presently the standard for the diagnosis of Coronavirus disease 2019 (COVID-19), but additional methodologies are needed to complement PCR methods, which have some limitations. Here, we validated and investigated the usefulness of measuring serum antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using the iFlash3000 CLIA analyzer. We measured IgM and IgG titers against SARS-CoV-2 in sera collected from 26 PCR-positive COVID-19 patients, 53 COVID-19-suspected but PCR-negative patients, and 20 and 100 randomly selected non-COVID-19 patients who visited our hospital in 2020 and 2017, respectively. The repeatability and within-laboratory precision were obviously good in validations, following to the CLSI document EP15-A3. Linearity was also considered good between 0.6 AU/mL and 112.7 AU/mL for SARS-CoV-2 IgM and between 3.2 AU/mL and 55.3 AU/mL for SARS-CoV-2 IgG, while the linearity curves plateaued above the upper measurement range. We also confirmed that the seroconversion and no-antibody titers were over the cutoff values in all 100 serum samples collected in 2017. These results indicate that this measurement system successfully detects SARS-CoV-2 IgM/IgG. We observed four false-positive cases in the IgM assay and no false-positive cases in the IgG assay when 111 serum samples known to contain autoantibodies were evaluated. The concordance rates of the antibody test with the PCR test were 98.1% for SARS-CoV-2 IgM and 100% for IgG among PCR-negative cases and 30.8% for SARS-CoV-2 IgM and 73.1% for SARS-CoV-2 IgG among PCR-positive cases. In conclusion, the performance of this new automated method for detecting antibody against both N and S proteins of SARS-CoV-2 is sufficient for use in laboratory testing.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:16 |
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| Enthalten in: |
PloS one - 16(2021), 3 vom: 05., Seite e0247711 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Yokoyama, Rin [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 16.03.2021 Date Revised 16.03.2021 published: Electronic-eCollection Citation Status MEDLINE |
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| doi: |
10.1371/journal.pone.0247711 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM322193893 |
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| 100 | 1 | |a Yokoyama, Rin |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Validation of a new automated chemiluminescent anti-SARS-CoV-2 IgM and IgG antibody assay system detecting both N and S proteins in Japan |
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| 500 | |a Date Revised 16.03.2021 | ||
| 500 | |a published: Electronic-eCollection | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a PCR methods are presently the standard for the diagnosis of Coronavirus disease 2019 (COVID-19), but additional methodologies are needed to complement PCR methods, which have some limitations. Here, we validated and investigated the usefulness of measuring serum antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using the iFlash3000 CLIA analyzer. We measured IgM and IgG titers against SARS-CoV-2 in sera collected from 26 PCR-positive COVID-19 patients, 53 COVID-19-suspected but PCR-negative patients, and 20 and 100 randomly selected non-COVID-19 patients who visited our hospital in 2020 and 2017, respectively. The repeatability and within-laboratory precision were obviously good in validations, following to the CLSI document EP15-A3. Linearity was also considered good between 0.6 AU/mL and 112.7 AU/mL for SARS-CoV-2 IgM and between 3.2 AU/mL and 55.3 AU/mL for SARS-CoV-2 IgG, while the linearity curves plateaued above the upper measurement range. We also confirmed that the seroconversion and no-antibody titers were over the cutoff values in all 100 serum samples collected in 2017. These results indicate that this measurement system successfully detects SARS-CoV-2 IgM/IgG. We observed four false-positive cases in the IgM assay and no false-positive cases in the IgG assay when 111 serum samples known to contain autoantibodies were evaluated. The concordance rates of the antibody test with the PCR test were 98.1% for SARS-CoV-2 IgM and 100% for IgG among PCR-negative cases and 30.8% for SARS-CoV-2 IgM and 73.1% for SARS-CoV-2 IgG among PCR-positive cases. In conclusion, the performance of this new automated method for detecting antibody against both N and S proteins of SARS-CoV-2 is sufficient for use in laboratory testing | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a Validation Study | |
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| 650 | 7 | |a Coronavirus Nucleocapsid Proteins |2 NLM | |
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| 650 | 7 | |a Immunoglobulin M |2 NLM | |
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| 650 | 7 | |a spike protein, SARS-CoV-2 |2 NLM | |
| 700 | 1 | |a Kurano, Makoto |e verfasserin |4 aut | |
| 700 | 1 | |a Morita, Yoshifumi |e verfasserin |4 aut | |
| 700 | 1 | |a Shimura, Takuya |e verfasserin |4 aut | |
| 700 | 1 | |a Nakano, Yuki |e verfasserin |4 aut | |
| 700 | 1 | |a Qian, Chungen |e verfasserin |4 aut | |
| 700 | 1 | |a Xia, Fuzhen |e verfasserin |4 aut | |
| 700 | 1 | |a He, Fan |e verfasserin |4 aut | |
| 700 | 1 | |a Kishi, Yoshiro |e verfasserin |4 aut | |
| 700 | 1 | |a Okada, Jun |e verfasserin |4 aut | |
| 700 | 1 | |a Yoshikawa, Naoyuki |e verfasserin |4 aut | |
| 700 | 1 | |a Nagura, Yutaka |e verfasserin |4 aut | |
| 700 | 1 | |a Okazaki, Hitoshi |e verfasserin |4 aut | |
| 700 | 1 | |a Moriya, Kyoji |e verfasserin |4 aut | |
| 700 | 1 | |a Seto, Yasuyuki |e verfasserin |4 aut | |
| 700 | 1 | |a Kodama, Tatsuhiko |e verfasserin |4 aut | |
| 700 | 1 | |a Yatomi, Yutaka |e verfasserin |4 aut | |
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