Dataset Information

Lessons learned: A look back at the performance of nine COVID-19 serologic assays and their proposed utility.

ABSTRACT:

Background

Serologic assays for the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have been proposed to assist with the acute diagnosis of infection, support epidemiological studies, identify convalescent plasma donors, and evaluate vaccine response.

Methods

We report an evaluation of nine serologic assays: Abbott (AB) and Epitope (EP) IgG and IgM, EUROIMMUN (EU) IgG and IgA, Roche anti-N (RN TOT) and anti-S (RS TOT) total antibody, and DiaSorin (DS) IgG. We evaluated 291 negative controls (NEG CTRL), 91 PCR positive (PCR POS) patients (179 samples), 126 convalescent plasma donors (CPD), 27 healthy vaccinated donors (VD), and 20 allogeneic hematopoietic stem cell transplant (HSCT) recipients (45 samples).

Results

We observed good agreement with the method performance claims for specificity (93-100%) in NEG CTRL but only 85% for EU IgA. The sensitivity claims in the first 2 weeks of symptom onset was lower (26-61%) than performance claims based on > 2 weeks since PCR positivity. We observed high sensitivities (94-100%) in CPD except for AB IgM (77%), EP IgM (0%). Significantly higher RS TOT was observed for Moderna vaccine recipients then Pfizer (p-values < 0.0001). A sustained RS TOT response was observed for the five months following vaccination. HSCT recipients demonstrated significantly lower RS TOT than healthy VD (p < 0.0001) at dose 2 and 4 weeks after.

Conclusions

Our data suggests against the use of anti-SARS-CoV-2 assays to aid in acute diagnosis. RN TOT and RS TOT can readily identify past-resolved infection and vaccine response in the absence of native infection. We provide an estimate of expected antibody response in healthy VD over the time course of vaccination for which to compare antibody responses in immunosuppressed patients.

SUBMITTER: Tolan NV

PROVIDER: S-EPMC9985916 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature

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Publications

Lessons learned: A look back at the performance of nine COVID-19 serologic assays and their proposed utility.

Tolan Nicole V NV DeSimone Mia S MS Fernandes Maria D MD Lewis Joshua E JE Simmons Daimon P DP Schur Peter H PH Brigl Manfred M Tanasijevic Milenko J MJ Desjardins Michaël M Sherman Amy C AC Baden Lindsey R LR Snyder Marion M Melanson Stacy Ef SE

Clinical biochemistry 20230305

<h4>Background</h4>Serologic assays for the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have been proposed to assist with the acute diagnosis of infection, support epidemiological studies, identify convalescent plasma donors, and evaluate vaccine response.<h4>Methods</h4>We report an evaluation of nine serologic assays: Abbott (AB) and Epitope (EP) IgG and IgM, EUROIMMUN (EU) IgG and IgA, Roche anti-N (RN TOT) and anti-S (RS TOT) total antibody, and DiaSorin (DS) IgG. We evaluat ...[more]

PMID: 36878344

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Dataset Information

Lessons learned: A look back at the performance of nine COVID-19 serologic assays and their proposed utility.

Background

Methods

Results

Conclusions

Publications

Lessons learned: A look back at the performance of nine COVID-19 serologic assays and their proposed utility.

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