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Head-to-head evaluation of five automated SARS-CoV-2 serology immunoassays in various prevalence settings

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Head-to-head evaluation of five automated SARS-CoV-2 serology immunoassays in various prevalence settings

ANDREY, Diego Olivier, et al.

Abstract

To assess the diagnostic performances of five automated anti-SARS-CoV-2 immunoassays, Epitope (N), Diasorin (S1/S2), Euroimmun (S1), Roche N (N), and Roche S (S-RBD), and to provide a testing strategy based on pre-test probability.

ANDREY, Diego Olivier, et al . Head-to-head evaluation of five automated SARS-CoV-2 serology immunoassays in various prevalence settings. Journal of Clinical Medicine , 2021, vol. 10, no. 8, p. 1605

PMID : 33920076

DOI : 10.3390/jcm10081605

Available at:

http://archive-ouverte.unige.ch/unige:152342

Disclaimer: layout of this document may differ from the published version.

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1 Supplementary Table S1. ROC curves statistics (vs. COVID-19 cases/controls).

Assays Difference 95% CI SE Z p-Value Roche N–DiaSorin 0.063 0.033 to 0.094 0.0155 4.09 <0.0001

EIDiaSorin 0.052 0.022 to 0.082 0.0153 3.42 0.0006 Roche S1DiaSorin 0.047 0.020 to 0.075 0.0138 3.43 0.0006 EpitopeDiaSorin 0.040 0.009 to 0.072 0.0162 2.50 0.0123 Roche NEpitope 0.023 0.007 to 0.039 0.0081 2.83 0.0046 Roche NRoche S1 0.016 0.003 to 0.029 0.0065 2.44 0.0146 EIEpitope 0.012 −0.007 to 0.031 0.0097 1.22 0.2227 Roche NEI 0.011 0.001 to 0.021 0.0051 2.15 0.0319 Roche S1Epitope 0.007 −0.012 to 0.026 0.0098 0.71 0.4747 EIRoche S1 0.005 −0.006 to 0.015 0.0053 0.91 0.3635

Supplementary Table S2. ROC curves statistics (vs. rIFA).

Assays Difference 95% CI SE Z p-Value

Roche N–DiaSorin 0.033 0.010 to 0.056 0.0117 2.83 0.0046 Roche S1–DiaSorin 0.032 0.011 to 0.053 0.0108 2.96 0.0031

EI–DiaSorin 0.032 0.010 to 0.054 0.0112 2.83 0.0047 Roche N–Epitope 0.017 0.003 to 0.030 0.0068 2.46 0.0140

Epitope–DiaSorin 0.016 0.010 to 0.043 0.0135 1.22 0.2240 Roche S1–Epitope 0.015 0.001 to 0.031 0.0082 1.90 0.0578 EI–Epitope 0.015 0.000 to 0.030 0.0076 2.01 0.0446 Roche N–EI 0.001 0.003 to 0.005 0.0020 0.70 0.4821 Roche N–Roche S1 0.001 0.005 to 0.008 0.0033 0.39 0.6979 Roche S1–EI 0.000 0.007 to 0.007 0.0035 0.04 0.9713

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2 Supplementary Table S3. Sensitivity, specificity, PPV, NPV and accuracy of tested assays (COVID-19 cases versus controls).

Epitope * Diasorin * Roche N Roche S1 Euroimmun * rIFA

Value 95% CI Value 95% CI Value 95% CI Value 95% CI Value 95% CI Value 95% CI

Sensitivity 77.91% 70.96–83.87 69.19

%

61.71–

75.99 87.79% 81.94–92.28 92.44

% 87.42–95.91 89.53

% 83.97–93.68 93.60% 88.85–96.76 Specificity 99.46% 97.03–99.99 97.84

%

94.56–

99.41

100.00

%

98.03–

100.00

99.46

% 97.03–99.99 98.38

% 94.95–99.58 100.00

%

98.03–

100.00 PLR 144.13 20.38–1019.45 32.00 12.08–

84.79 NA 171.02 24.21–

1208.25 55.21 17.95–

169.82 NA

NLR 0.22 0.17–0.29 0.31 0.25–0.39 0.12 0.08–0.18 0.08 0.05–0.13 0.11 0.07–0.17 0.06 0.04–0.11 PPV 99.26% 94.99–99.89 96.75

%

91.82–

98.75

100.00

%

96.91–

100.00

99.38

% 95.75–99.91 98.09

% 94.08–99.51 100.00

%

97.10–

100.00 NPV 82.88% 78.52–86.51 77.35

%

73.17–

81.05 89.81% 85.51–92.93 93.40

% 89.35–95.98 91.13

% 86.91–94.09 94.39% 90.47–96.75

* Borderline samples were handled as negative. PLR, positive likelihood ratio; NLR, negative likelihood ratio; PPV, positive predictive value; NPV, negative predictive value

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