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10.1371/journal.pone.0245914

http://scihub22266oqcxt.onion/10.1371/journal.pone.0245914
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33596236!7888604!33596236
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suck abstract from ncbi


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pmid33596236      PLoS+One 2021 ; 16 (2): e0245914
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  • Performance of SARS-CoV-2 serology tests: Are they good enough? #MMPMID33596236
  • Piec I; English E; Thomas MA; Dervisevic S; Fraser WD; John WG
  • PLoS One 2021[]; 16 (2): e0245914 PMID33596236show ga
  • In the emergency of the SARS-CoV-2 pandemic, great efforts were made to quickly provide serology testing to the medical community however, these methods have been introduced into clinical practice without the complete validation usually required by the regulatory organizations. SARS-CoV-2 patient samples (n = 43) were analyzed alongside pre-pandemic control specimen (n = 50), confirmed respiratory infections (n = 50), inflammatory polyarthritis (n = 22) and positive for thyroid stimulating immunoglobulin (n = 30). Imprecision, diagnostic sensitivity and specificity and concordance were evaluated on IgG serologic assays from EuroImmun, Epitope Diagnostics (EDI), Abbott Diagnostics and DiaSorin and a rapid IgG/IgM test from Healgen. EDI and EuroImmun imprecision was 0.02-14.0% CV. Abbott and DiaSorin imprecision (CV) ranged from 5.2%-8.1% and 8.2%-9.6% respectively. Diagnostic sensitivity of the assays was 100% (CI: 80-100%) for Abbott, EDI and EuroImmun and 95% (CI: 73-100%) for DiaSorin at >/=14 days post PCR. Only the Abbott assay had a diagnostic specificity of 100% (CI: 91-100%). EuroImmun cross-reacted in 3 non-SARS-CoV-2 respiratory infections and 2 controls. The DiaSorin displayed more false negative results and cross-reacted in six cases across all conditions tested. EDI had one cross-reactive sample. The Healgen rapid test showed excellent sensitivity and specificity. Overall, concordance of the assays ranged from 76.1% to 97.9%. Serological tests for SARS-CoV-2 showed good analytical performance. The head-to-head analysis of samples revealed differences in results that may be linked to the use of nucleocapsid or spike proteins. The point of care device tested demonstrated adequate performance for antibody detection.
  • |Antibodies, Viral/blood[MESH]
  • |Brazil/epidemiology[MESH]
  • |COVID-19 Serological Testing/*methods/trends[MESH]
  • |COVID-19/*diagnosis/epidemiology/immunology/virology[MESH]
  • |Clinical Laboratory Techniques/methods[MESH]
  • |Cross Reactions[MESH]
  • |Humans[MESH]
  • |Immunoglobulin G/blood[MESH]
  • |Immunoglobulin M/blood[MESH]
  • |Pandemics[MESH]
  • |Point-of-Care Systems[MESH]
  • |SARS-CoV-2/*immunology/isolation & purification[MESH]


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