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10.1128/JCM.01224-20

http://scihub22266oqcxt.onion/10.1128/JCM.01224-20
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32580948!7448652!32580948
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suck abstract from ncbi


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pmid32580948      J+Clin+Microbiol 2020 ; 58 (9): ä
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  • Clinical and Analytical Performance of an Automated Serological Test That Identifies S1/S2-Neutralizing IgG in COVID-19 Patients Semiquantitatively #MMPMID32580948
  • Bonelli F; Sarasini A; Zierold C; Calleri M; Bonetti A; Vismara C; Blocki FA; Pallavicini L; Chinali A; Campisi D; Percivalle E; DiNapoli AP; Perno CF; Baldanti F
  • J Clin Microbiol 2020[Aug]; 58 (9): ä PMID32580948show ga
  • In the coronavirus (CoV) disease 2019 (COVID-19) pandemic, highly selective serological testing is essential to define exposure to severe acute respiratory syndrome CoV 2 (SARS-CoV-2). Many tests have been developed, yet with variable speeds to first results, and are of unknown quality, particularly when considering the prediction of neutralizing capacity. The LIAISON SARS-CoV-2 S1/S2 IgG assay was designed to measure antibodies against the SARS-CoV-2 native S1/S2 proteins in a standardized automated chemiluminescence assay. The clinical and analytical performances of the test were validated in an observational study using residual samples (>1,500) with a positive or negative COVID-19 diagnosis. The LIAISON SARS-CoV-2 S1/S2 IgG assay proved to be highly selective and specific and offered semiquantitative measures of serum or plasma levels of anti-S1/S2 IgG with neutralizing activity. The assay's diagnostic sensitivities were 91.3% and 95.7% at >5 or >/=15 days from diagnosis, respectively, and 100% when assessed against a neutralizing assay. The assay's specificity ranged between 97% and 98.5%. The average imprecision of the assay was a <5% coefficient of variation. Assay performance at 2 different cutoffs was evaluated to optimize predictive values. The automated LIAISON SARS-CoV-2 S1/S2 IgG assay brings efficient, sensitive, specific, and precise serological testing to the laboratory, with the capacity to test large amounts of samples per day; first results are available within 35 min, with a throughput of 170 tests/hour. The semiquantitative results provided by the test also associate with the presence of neutralizing antibodies and may provide a useful tool for the large-scale screening of convalescent-phase plasma for safe therapeutic use.
  • |*Clinical Laboratory Techniques/methods/standards/statistics & numerical data[MESH]
  • |*Serologic Tests/methods/standards/statistics & numerical data[MESH]
  • |Antibodies, Neutralizing/blood[MESH]
  • |Antibodies, Viral/*blood[MESH]
  • |Automation, Laboratory[MESH]
  • |Betacoronavirus/*immunology[MESH]
  • |COVID-19[MESH]
  • |COVID-19 Testing[MESH]
  • |Coronavirus Infections/*diagnosis/immunology[MESH]
  • |Humans[MESH]
  • |Immunoglobulin G/blood[MESH]
  • |Pandemics[MESH]
  • |Pneumonia, Viral/*diagnosis/immunology[MESH]
  • |Reproducibility of Results[MESH]
  • |SARS-CoV-2[MESH]
  • |Sensitivity and Specificity[MESH]


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