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10.1093/jalm/jfab072

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34196711!8420636!34196711
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suck abstract from ncbi


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pmid34196711      J+Appl+Lab+Med 2021 ; 6 (6): 1561-1570
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  • Evaluation of Three Commercial and Two Non-Commercial Immunoassays for the Detection of Prior Infection to SARS-CoV-2 #MMPMID34196711
  • Nilles EJ; Karlson EW; Norman M; Gilboa T; Fischinger S; Atyeo C; Zhou G; Bennett CL; Tolan NV; Oganezova K; Walt DR; Alter G; Simmons DP; Schur P; Jarolim P; Woolley AE; Baden LR
  • J Appl Lab Med 2021[Nov]; 6 (6): 1561-1570 PMID34196711show ga
  • BACKGROUND: Serological testing provides a record of prior infection with SARS-CoV-2, but assay performance requires independent assessment. METHODS: We evaluated 3 commercial (Roche Diagnostics pan-IG, and Epitope Diagnostics IgM and IgG) and 2 non-commercial (Simoa and Ragon/MGH IgG) immunoassays against 1083 unique samples that included 251 PCR-positive and 832 prepandemic samples. RESULTS: The Roche assay registered the highest specificity 99.6% (3/832 false positives), the Ragon/MGH assay 99.5% (4/832), the primary Simoa assay model 99.0% (8/832), and the Epitope IgG and IgM 99.0% (8/830) and 99.5% (4/830), respectively. Overall sensitivities for the Simoa, Roche pan-IG, Epitope IgG, Ragon/MGH IgG, and Epitope IgM were 92.0%, 82.9%, 82.5%, 64.5% and 47.0%, respectively. The Simoa immunoassay demonstrated the highest sensitivity among samples stratified by days postsymptom onset (PSO), <8 days PSO (57.69%) 8-14 days PSO (93.51%), 15-21 days PSO (100%), and > 21 days PSO (95.18%). CONCLUSIONS: All assays demonstrated high to very high specificities while sensitivities were variable across assays.
  • |*COVID-19[MESH]
  • |*SARS-CoV-2[MESH]
  • |Antibodies, Viral[MESH]
  • |COVID-19 Serological Testing[MESH]
  • |Humans[MESH]
  • |Immunoassay[MESH]
  • |Immunoglobulin G[MESH]
  • |Immunoglobulin M[MESH]


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