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. 2021 May 18;155(6):773-775.
doi: 10.1093/ajcp/aqab033.

Unexpected False-Positive Rates in Pediatric SARS-CoV-2 Serology Using the EUROIMMUN Anti-SARS-CoV-2 ELISA IgG Assay

Daniel Geisler  1 , Megan Culler Freeman  2 , Glenn J Rapsinski  2   3 , Sarah E Wheeler  4
Affiliations

Unexpected False-Positive Rates in Pediatric SARS-CoV-2 Serology Using the EUROIMMUN Anti-SARS-CoV-2 ELISA IgG Assay

Daniel Geisler et al. Am J Clin Pathol. .

Abstract

Objectives: Serologic assay performance studies for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-​2) in pediatric populations are lacking, and few seroprevalence studies have routinely incorporated orthogonal testing to improve accuracy.

Methods: Remnant serum samples for routine bloodwork from 2,338 pediatric patients at UPMC Children's Hospital of Pittsburgh were assessed using the EUROIMMUN Anti-SARS-CoV-2 ELISA IgG (EuroIGG) assay. Reactive cases with sufficient volume were also tested using 3 additional commercial assays.

Results: Eighty-five specimens were reactive according to the EuroIGG, yielding 3.64% (95% confidence interval [CI], 2.91%-4.48%) seropositivity, of which 73 specimens had sufficient remaining volume for confirmation by orthogonal testing. Overall, 19.18% (95% CI, 10.18%-28.18%) of samples were positive on a second and/or third orthogonal assay. This 80.82% false positivity rate is disproportionate to the expected false positivity rate of 50% given our pediatric population prevalence and assay performance.

Conclusions: In pediatric populations, false-positive SARS-CoV-2 serology may be more common than assay and prevalence parameters would predict, and further studies are needed to establish the performance of SARS-CoV-2 serology in children.

Keywords: Orthogonal testing; Pediatric population; SARS-CoV-2; Seroprevalence.

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Comment in

  • False-Positive Rates in Pediatric SARS-CoV-2 Serology Testing.
    Henry BM, Benoit SW, Lippi G, Sabalza M, Venkataraman I, Geisler D, Freeman MC, Rapsinski GJ, Wheeler SE. Henry BM, et al. Am J Clin Pathol. 2022 Feb 3;157(2):314-316. doi: 10.1093/ajcp/aqab118. Am J Clin Pathol. 2022. PMID: 34480168 Free PMC article. No abstract available.

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