Alliance for Pandemic Preparedness

October 12, 2020

Diagnostic Accuracy of FDA Authorized Serology Tests to Detect SARS-CoV-2 Antibodies A Systematic Review and Meta-Analysis

Category:

Topic:

Keywords (Tags): , , ,

  • [Pre-print, not peer reviewed]A systematic review and meta-analysis of the diagnostic accuracy of seven different FDA-authorized tests for SARS-CoV-2 antibodies found that the pooled sensitivity was 87% and the pooled specificity was nearly 100%. Sensitivity increased with increased time between symptom onset and sample collection: at ≤ 7 days, sensitivity was 44%, for 8-14 days, sensitivity was 84%, and for blood draws ≥ 15 days after the onset of symptoms, sensitivity was 96%. The study found considerable heterogeneity between the tests and concluded that FDA authorized serology tests show high diagnostic accuracy for SARS-CoV-2 infection if performed under similar conditions.

Pandey et al. (Oct 11, 2020). Diagnostic Accuracy of FDA Authorized Serology Tests to Detect SARS-CoV-2 Antibodies A Systematic Review and Meta-Analysis. Pre-print downloaded Oct 12  https://doi.org/10.1101/2020.10.07.20208553