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10.1093/clinchem/hvab045

http://scihub22266oqcxt.onion/10.1093/clinchem/hvab045
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suck abstract from ncbi


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pmid33720347      Clin+Chem 2021 ; 67 (7): 977-986
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  • Case-Control Study of Individuals with Discrepant Nucleocapsid and Spike Protein SARS-CoV-2 IgG Results #MMPMID33720347
  • Wang H; Wiredja D; Yang L; Bulterys PL; Costales C; Roltgen K; Manalac J; Yee J; Zehnder J; Shi RZ; Boyd SD; Pinsky BA
  • Clin Chem 2021[Jul]; 67 (7): 977-986 PMID33720347show ga
  • BACKGROUND: Laboratory-based methods for SARS-CoV-2 antibody detection vary widely in performance. However, there are limited prospectively-collected data on assay performance, and minimal clinical information to guide interpretation of discrepant results. METHODS: Over a 2-week period, 1080 consecutive plasma samples submitted for clinical SARS-CoV-2 IgG testing were tested in parallel for anti-nucleocapsid IgG (anti-N, Abbott) and anti-spike IgG (anti-S1, EUROIMMUN). Chart review was conducted for samples testing positive or borderline on either assay, and for an age/sex-matched cohort of samples negative by both assays. CDC surveillance case definitions were used to determine clinical sensitivity/specificity and conduct receiver operating characteristics curve analysis. RESULTS: There were 52 samples positive by both methods, 2 positive for anti-N only, 34 positive for anti-S1 only, and 27 borderline for anti-S1. Of the 34 individuals positive for anti-S1 alone, 8 (24%) had confirmed COVID-19. No anti-S1 borderline cases were positive for anti-N or had confirmed/probable COVID-19. The anti-N assay was less sensitive (84.2% [95% CI 72.1-92.5%] vs 94.7% [95% CI 85.4-98.9%]) but more specific (99.2% [95% CI 95.5-100%] vs 86.9% [95% CI 79.6-92.3%]) than anti-S1. Abbott anti-N sensitivity could be improved to 96.5% with minimal effect on specificity if the index threshold was lowered from 1.4 to 0.6. CONCLUSION: Real-world concordance between different serologic assays may be lower than previously described in retrospective studies. These findings have implications for the interpretation of SARS-CoV-2 IgG results, especially with the advent of spike antigen-targeted vaccination, as a subset of patients with true infection are anti-N negative and anti-S1 positive.
  • |Adult[MESH]
  • |Antibodies, Viral/*blood[MESH]
  • |Area Under Curve[MESH]
  • |COVID-19/*diagnosis/virology[MESH]
  • |Case-Control Studies[MESH]
  • |Enzyme-Linked Immunosorbent Assay[MESH]
  • |Female[MESH]
  • |Humans[MESH]
  • |Immunoglobulin G/*blood[MESH]
  • |Male[MESH]
  • |Middle Aged[MESH]
  • |Nucleocapsid/*immunology[MESH]
  • |ROC Curve[MESH]
  • |Reagent Kits, Diagnostic[MESH]
  • |Retrospective Studies[MESH]
  • |SARS-CoV-2/isolation & purification/*metabolism[MESH]


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