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Validation of a new automated chemiluminescent anti-SARS-CoV-2 IgM and IgG antibody assay system detecting both N and S proteins in Japan.
PLoS One. 2021; 16(3):e0247711.Plos

Abstract

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.

Authors+Show Affiliations

Department of Clinical Laboratory, The University of Tokyo Hospital, Tokyo, Japan.Department of Clinical Laboratory, The University of Tokyo Hospital, Tokyo, Japan. Department of Clinical Laboratory Medicine, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.Department of Clinical Laboratory, The University of Tokyo Hospital, Tokyo, Japan.Department of Clinical Laboratory, The University of Tokyo Hospital, Tokyo, Japan.Department of Clinical Laboratory, The University of Tokyo Hospital, Tokyo, Japan.The Key Laboratory for Biomedical Photonics of MOE at Wuhan National Laboratory for Optoelectronics-Hubei Bioinformatics & Molecular Imaging Key Laboratory, Systems Biology Theme, Department of Biomedical Engineering, College of Life Science and Technology, Huazhong University of Science and Technology, Hubei, P. R. China.Reagent R&D Center, Shenzhen YHLO Biotech Co., Ltd, Guangdong, P. R. China.Reagent R&D Center, Shenzhen YHLO Biotech Co., Ltd, Guangdong, P. R. China.Business Planning Department, Sales & Marketing Division, Medical & Biological Laboratories Co., Ltd, Tokyo, Japan.Business Planning Department, Sales & Marketing Division, Medical & Biological Laboratories Co., Ltd, Tokyo, Japan.Department of Clinical Laboratory, The University of Tokyo Hospital, Tokyo, Japan.Department of Blood Transfusion, The University of Tokyo Hospital, Tokyo, Japan.Department of Blood Transfusion, The University of Tokyo Hospital, Tokyo, Japan.Department of Infection Control and Prevention, The University of Tokyo, Tokyo, Japan.Department of Gastrointestinal Surgery, The University of Tokyo, Tokyo, Japan.Laboratory for Systems Biology and Medicine, The University of Tokyo, Tokyo, Japan.Department of Clinical Laboratory, The University of Tokyo Hospital, Tokyo, Japan. Department of Clinical Laboratory Medicine, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't
Validation Study

Language

eng

PubMed ID

33661990

Citation

Yokoyama, Rin, et al. "Validation of a New Automated Chemiluminescent anti-SARS-CoV-2 IgM and IgG Antibody Assay System Detecting Both N and S Proteins in Japan." PloS One, vol. 16, no. 3, 2021, pp. e0247711.
Yokoyama R, Kurano M, Morita Y, et al. Validation of a new automated chemiluminescent anti-SARS-CoV-2 IgM and IgG antibody assay system detecting both N and S proteins in Japan. PLoS One. 2021;16(3):e0247711.
Yokoyama, R., Kurano, M., Morita, Y., Shimura, T., Nakano, Y., Qian, C., Xia, F., He, F., Kishi, Y., Okada, J., Yoshikawa, N., Nagura, Y., Okazaki, H., Moriya, K., Seto, Y., Kodama, T., & Yatomi, Y. (2021). Validation of a new automated chemiluminescent anti-SARS-CoV-2 IgM and IgG antibody assay system detecting both N and S proteins in Japan. PloS One, 16(3), e0247711. https://doi.org/10.1371/journal.pone.0247711
Yokoyama R, et al. Validation of a New Automated Chemiluminescent anti-SARS-CoV-2 IgM and IgG Antibody Assay System Detecting Both N and S Proteins in Japan. PLoS One. 2021;16(3):e0247711. PubMed PMID: 33661990.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Validation of a new automated chemiluminescent anti-SARS-CoV-2 IgM and IgG antibody assay system detecting both N and S proteins in Japan. AU - Yokoyama,Rin, AU - Kurano,Makoto, AU - Morita,Yoshifumi, AU - Shimura,Takuya, AU - Nakano,Yuki, AU - Qian,Chungen, AU - Xia,Fuzhen, AU - He,Fan, AU - Kishi,Yoshiro, AU - Okada,Jun, AU - Yoshikawa,Naoyuki, AU - Nagura,Yutaka, AU - Okazaki,Hitoshi, AU - Moriya,Kyoji, AU - Seto,Yasuyuki, AU - Kodama,Tatsuhiko, AU - Yatomi,Yutaka, Y1 - 2021/03/04/ PY - 2020/07/14/received PY - 2021/02/11/accepted PY - 2021/3/4/entrez PY - 2021/3/5/pubmed PY - 2021/3/17/medline SP - e0247711 EP - e0247711 JF - PloS one JO - PLoS One VL - 16 IS - 3 N2 - 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. SN - 1932-6203 UR - https://www.unboundmedicine.com/medline/citation/33661990/Validation_of_a_new_automated_chemiluminescent_anti_SARS_CoV_2_IgM_and_IgG_antibody_assay_system_detecting_both_N_and_S_proteins_in_Japan_ L2 - https://dx.plos.org/10.1371/journal.pone.0247711 DB - PRIME DP - Unbound Medicine ER -