This article is a Preprint
Preprints are preliminary research reports that have not been certified by peer review. They should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Preprints posted online allow authors to receive rapid feedback and the entire scientific community can appraise the work for themselves and respond appropriately. Those comments are posted alongside the preprints for anyone to read them and serve as a post publication assessment.
Evaluation of serological tests for SARS-CoV-2: Implications for serology testing in a low-prevalence setting (preprint)
medrxiv; 2020.
Preprint
in English
| medRxiv | ID: ppzbmed-10.1101.2020.05.31.20118273
ABSTRACT
Background:
Robust serological assays are essential for long-term control of the COVID-19 pandemic. Many recently released point-of-care (PoCT) serological assays have been distributed with little pre-market validation.Methods:
Performance characteristics for five PoCT lateral flow devices approved for use in Australia were compared to a commercial enzyme immunoassay (ELISA) and a recently described novel surrogate virus neutralisation test (sVNT).Results:
Sensitivities for PoCT ranged from 51.8% (95% CI 43.1 to 60.4%) to 67.9% (95% CI 59.4-75.6%), and specificities from 95.6% (95% CI 89.2-98.8%) to 100.0% (95% CI 96.1-100.0%). Overall ELISA sensitivity for either IgA or IgG detection was 67.9% (95% CI 59.4-75.6), increasing to 93.8% (95% CI 85.0-98.3%) for samples >14 days post symptom onset. Overall, sVNT sensitivity was 60.9% (95% CI 53.2-68.4%), rising to 91.2%% (95% CI 81.8-96.7%) for samples collected >14 days post-symptom onset, with a specificity 94.4% (95% CI 89.2-97.5%),Conclusion:
Performance characteristics for COVID-19 serological assays were generally lower than those reported by manufacturers. Timing of specimen collection relative to onset of illness or infection is crucial in the reporting of performance characteristics for COVID-19 serological assays. The optimal algorithm for implementing serological testing for COVID-19 remains to be determined, particularly in low-prevalence settings.
Full text:
Available
Collection:
Preprints
Database:
medRxiv
Main subject:
COVID-19
/
Infections
Language:
English
Year:
2020
Document Type:
Preprint
Similar
MEDLINE
...
LILACS
LIS