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10.1371/journal.pone.0247711

http://scihub22266oqcxt.onion/10.1371/journal.pone.0247711
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33661990!7932516!33661990
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suck abstract from ncbi


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pmid33661990      PLoS+One 2021 ; 16 (3): e0247711
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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 #MMPMID33661990
  • 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
  • PLoS One 2021[]; 16 (3): e0247711 PMID33661990show ga
  • 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.
  • |Antibodies, Viral/*blood/immunology[MESH]
  • |COVID-19 Serological Testing/*methods[MESH]
  • |COVID-19/blood/*diagnosis/epidemiology/immunology[MESH]
  • |Coronavirus Nucleocapsid Proteins/immunology/isolation & purification[MESH]
  • |Humans[MESH]
  • |Immunoglobulin G/*blood/immunology[MESH]
  • |Immunoglobulin M/*blood/immunology[MESH]
  • |Japan/epidemiology[MESH]
  • |Luminescent Measurements/methods[MESH]
  • |Phosphoproteins/immunology/isolation & purification[MESH]
  • |SARS-CoV-2/immunology/*isolation & purification[MESH]
  • |Sensitivity and Specificity[MESH]


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