Alliance for Pandemic Preparedness

July 6, 2020

Diagnostic Accuracy of Serological Tests for Covid-19: Systematic Review and Meta-Analysis

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  • The diagnostic accuracy of serological tests for SARS-CoV-2 antibodies was reviewed by Lisboa Bastos et al. based on 40 studies and 49 bias assessments. They found a high risk of patient selection bias in 98% (48/49) of assessments and high or unclear risk of bias regarding performance or interpretation of the serological test in 73% (36/49).  
  • The pooled sensitivity of ELISAs was 84.3% (95%CI 75.6-90.9%), of lateral flow immunoassays was 66.0% (49.3-79.3%), and of chemiluminescent immunoassays was 97.8% (46.2-100%). Sensitivity was higher at least three weeks after symptom onset (range 69.9-98.9%) compared with within the first week (range 13.4-50.3%). Among lateral flow assays, pooled sensitivity of commercial kits (65.0%, 49.0-78.2%) was lower than that of non-commercial tests (88.2%, 83.6-91.3%). Pooled specificities ranged from 96.6% to 99.7%, with a pooled specificity for lateral flow tests of 96.6-97.6%. 
  • The authors raised concerns about further use of existing point-of-care serological tests based on their limited sensitivity. 

Lisboa Bastos et al. (July 1, 2020). Diagnostic Accuracy of Serological Tests for Covid-19: Systematic Review and Meta-Analysis. BMJ (Clinical Research Ed.). https://doi.org/10.1136/bmj.m2516