Journal article
Head-to-Head Comparison of Two SARS-CoV-2 Serology Assays
The journal of applied laboratory medicine, Vol.5(6), pp.1351-1357
11/01/2020
DOI: 10.1093/jalm/jfaa125
PMID: 32717056
Abstract
Background: While molecular techniques remain the gold standard for diagnosis of acute SARS-CoV-2 infection, serological tests have the unique potential to ascertain how much of the population has been exposed to the COVID-19 pathogen. There have been limited published studies to date documenting the performance of SARS-CoV-2 antibody assays.
Methods: We compared the DiaSorin Liaison SARS-CoV-2 S1/S2 IgG and Roche Diagnostics Elecsys Anti-SARS-CoV-2 assays using 228 samples spanning patients with positive PCR for SARS-CoV-2, patients with compatible symptoms but negative PCR, pre-COVID specimens, and potential cross-reactives.
Results: Both assays detected antibodies in 18/19 samples collected at least one week after a positive PCR result. Neither method consistently detected antibodies in specimens collected within one week of a positive PCR result (sensitivity < 50%), but antibodies were detected by only Roche in four samples in this time frame. Using 139 pre-COVID and 35 PCR-negative samples, the Roche and DiaSorin assays demonstrated specificities of 100.0% and 98.9%, respectively. Neither assay demonstrated cross-reactivity from other coronaviruses (229E, HKU1, NL63, OC43), respiratory pathogens (adenovirus, metapneumovirus, rhinovirus/enterovirus), or antibodies to other viruses (HIV, EBV, CMV, HBV, HCV, HAV).
Discussion: Overall, the qualitative interpretations afforded by the Roche and DiaSorin assays agreed for 97% of samples evaluated. Minor discrepancies in sensitivity and specificity were observed between methods, with the differences in specificity more clinically significant for our low-prevalence population. For the DiaSorin assay, all disagreements with the Roche assay occurred in samples with quantitative signals near the cut-off determining positivity.
Keywords: COVID-19; SARS-CoV-2; immunoassay; serology.
© American Association for Clinical Chemistry 2020. All rights reserved. For permissions, please email: journals.permissions@oup.com.
Details
- Title: Subtitle
- Head-to-Head Comparison of Two SARS-CoV-2 Serology Assays
- Creators
- Anna E Merrill - University of Iowa Hospitals and ClinicsJ Brooks Jackson - University of Iowa Hospitals and ClinicsAlexandra Ehlers - University of Iowa Hospitals and ClinicsDena Voss - University of Iowa Hospitals and ClinicsMatthew D Krasowski - University of Iowa Hospitals and Clinics
- Resource Type
- Journal article
- Publication Details
- The journal of applied laboratory medicine, Vol.5(6), pp.1351-1357
- DOI
- 10.1093/jalm/jfaa125
- PMID
- 32717056
- NLM abbreviation
- J Appl Lab Med
- ISSN
- 2576-9456
- eISSN
- 2475-7241
- Publisher
- Oxford University Press
- Language
- English
- Date published
- 11/01/2020
- Academic Unit
- Pathology; Injury Prevention Research Center; VPMA - Administration
- Record Identifier
- 9984186499802771
Metrics
18 Record Views