November 20, 2020

Multi-center nationwide comparison of seven serology assays reveals a SARS-CoV-2 non-responding seronegative subpopulation

Category: Article Summary

Topic: Testing and Treatment

Keywords (Tags): testing

• Significant performance differences were observed in commercially available serologic assays for antibodies against SARS-CoV-2. In a multi-center clinical and analytical validation of seven commercially available automated serology assays, samples from 2391 SARS-CoV-2 negative individuals and 698 SARS-CoV-2 PCR positive patients (collected between March and May 2020) were analyzed. Significant performance differences were observed with major impacts on the positive predictive values of the tests (probability of a true positive given a positive test) in low prevalence scenarios. A subgroup of symptomatic patients (~ 5%) remained seronegative across a wide range of antigens, isotypes, and technologies.

Oved et al. (Nov 19, 2020). Multi-center nationwide comparison of seven serology assays reveals a SARS-CoV-2 non-responding seronegative subpopulation. EClinicalMedicine. https://doi.org/10.1016/j.eclinm.2020.100651