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10.1016/j.jcv.2021.104797

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suck abstract from ncbi


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pmid33770657      J+Clin+Virol 2021 ; 138 (ä): 104797
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  • An evaluation of 4 commercial assays for the detection of SARS-CoV-2 antibodies in a predominantly mildly symptomatic low prevalence Australian population #MMPMID33770657
  • Wehrhahn MC; Brown SJ; Newcombe JP; Chong S; Evans J; Figtree M; Hainke L; Hueston L; Khan S; Marland E; O'Sullivan MVN; Powell H; Roy J; Waring L; Yu M; Robson J
  • J Clin Virol 2021[May]; 138 (ä): 104797 PMID33770657show ga
  • A total of 1080 individual patient samples (158 positive serology samples from confirmed, predominantly mildly symptomatic COVID-19 patients and 922 serology negative including 496 collected pre-COVID) from four states in Australia were analysed on four commercial SARS-CoV-2 serological assays targeting antibodies to different antigens (Roche Elecsys and Abbott Architect: nucleocapsid; Diasorin Liaison and Euroimmun: spike). A subset was compared to immunofluorescent antibody (IFA) and micro-neutralisation. Sensitivity and specificity of the Roche (n = 1033), Abbott (n = 806), Diasorin (n = 1034) and Euroimmun (n = 175) were 93.7 %/99.5 %, 90.2 %/99.4 %, 88.6 %/98.6 % and 91.3 %/98.8 %, respectively. ROC analysis with specificity held at 99 % increased the sensitivity for the Roche and Abbott assays from 93.7% to 98.7% (cut-off 0.21) and 90.2 % to 94.0 % (cut-off 0.91), respectively. Overall seropositivity of samples increased from a maximum of 23 % for samples 0-7 days-post-onset of symptoms (dpos), to 61 % from samples 8-14dpos and 93 % from those >14dpos. IFA and microneutralisation values correlated best with assays targeting antibodies to spike protein with values >80 AU/mL on the Diasorin assay associated with neutralising antibody. Detectable antibody was present in 22/23 (96 %), 20/23 (87 %), 15/23 (65 %) and 9/22 (41 %) patients with samples >180dpos on the Roche, Diasorin, Abbott and microneutralisation assays respectively. Given the low prevalence in this community, two-step algorithms on initial positive results saw an increase in the positive predictive value (PPV) of positive samples (39 %-65 % to >/=98 %) for all combinations. Similarly accuracy increased from a range of 98.5 %-99.4 % to >/=99.8 % assuming a 1 % seroprevalence. Negative predictive value (NPV) was high (>/=99.8 %) regardless of which assay was used initially.
  • |*Reagent Kits, Diagnostic[MESH]
  • |Adolescent[MESH]
  • |Adult[MESH]
  • |Aged[MESH]
  • |Aged, 80 and over[MESH]
  • |Antibodies, Viral/*blood[MESH]
  • |Australia/epidemiology[MESH]
  • |COVID-19 Serological Testing/*methods[MESH]
  • |COVID-19/*diagnosis/epidemiology[MESH]
  • |Child[MESH]
  • |Coronavirus Nucleocapsid Proteins/immunology[MESH]
  • |Female[MESH]
  • |Humans[MESH]
  • |Immunoglobulin Isotypes/blood[MESH]
  • |Male[MESH]
  • |Middle Aged[MESH]
  • |Phosphoproteins/immunology[MESH]
  • |Prevalence[MESH]
  • |Sensitivity and Specificity[MESH]
  • |Seroepidemiologic Studies[MESH]
  • |Spike Glycoprotein, Coronavirus/immunology[MESH]


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