Performance of 4 Automated SARS-CoV-2 Serology Assay Platforms in a Large Cohort Including Susceptible COVID-19-Negative and COVID-19-Positive Patients.
J Appl Lab Med
; 6(4): 942-952, 2021 07 07.
Article
in English
| MEDLINE | ID: covidwho-1127352
ABSTRACT
BACKGROUND:
Anti-SARS-CoV-2 serological responses may have a vital role in controlling the spread of the disease. However, the comparative performance of automated serological assays has not been determined in susceptible patients with significant comorbidities.METHODS:
In this study, we used large numbers of samples from patients who were negative (n = 2030) or positive (n = 112) for COVID-19 to compare the performance of 4 serological assay platforms Siemens Healthineers Atellica IM Analyzer, Siemens Healthineers Dimension EXL Systems, Abbott ARCHITECT, and Roche cobas.RESULTS:
All 4 serology assay platforms exhibited comparable negative percentage of agreement with negative COVID-19 status ranging from 99.2% to 99.7% and positive percentage of agreement from 84.8% to 87.5% with positive real-time reverse transcriptase PCR results. Of the 2142 total samples, only 38 samples (1.8%) yielded discordant results on one or more platforms. However, only 1.1% (23/2030) of results from the COVID-19-negative cohort were discordant. whereas discordance was 10-fold higher for the COVID-19-positive cohort, at 11.3% (15/112). Of the total 38 discordant results, 34 were discordant on only one platform.CONCLUSIONS:
Serology assay performance was comparable across the 4 platforms assessed in a large population of patients who were COVID-19 negative with relevant comorbidities. The pattern of discordance shows that samples were discordant on a single assay platform, and the discordance rate was 10-fold higher in the population that was COVID-19 positive.Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Biological Assay
/
COVID-19 Serological Testing
/
SARS-CoV-2
/
COVID-19
/
Antibodies, Viral
Type of study:
Cohort study
/
Diagnostic study
/
Observational study
/
Prognostic study
Limits:
Aged
/
Female
/
Humans
/
Male
Country/Region as subject:
North America
Language:
English
Journal:
J Appl Lab Med
Year:
2021
Document Type:
Article
Affiliation country:
Jalm
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