Evaluation of serological lateral flow assays for severe acute respiratory syndrome coronavirus-2

BMC Infect Dis. 2021 Jun 16;21(1):580. doi: 10.1186/s12879-021-06257-7.


Background: COVID-19 has resulted in significant morbidity and mortality worldwide. Lateral flow assays can detect anti-Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) antibodies to monitor transmission. However, standardized evaluation of their accuracy and tools to aid in interpreting results are needed.

Methods: We evaluated 20 IgG and IgM assays selected from available tests in April 2020. We evaluated the assays' performance using 56 pre-pandemic negative and 56 SARS-CoV-2-positive plasma samples, collected 10-40 days after symptom onset, confirmed by a molecular test and analyzed by an ultra-sensitive immunoassay. Finally, we developed a user-friendly web app to extrapolate the positive predictive values based on their accuracy and local prevalence.

Results: Combined IgG + IgM sensitivities ranged from 33.9 to 94.6%, while combined specificities ranged from 92.6 to 100%. The highest sensitivities were detected in Lumiquick for IgG (98.2%), BioHit for both IgM (96.4%), and combined IgG + IgM sensitivity (94.6%). Furthermore, 11 LFAs and 8 LFAs showed perfect specificity for IgG and IgM, respectively, with 15 LFAs showing perfect combined IgG + IgM specificity. Lumiquick had the lowest estimated limit-of-detection (LOD) (0.1 μg/mL), followed by a similar LOD of 1.5 μg/mL for CareHealth, Cellex, KHB, and Vivachek.

Conclusion: We provide a public resource of the accuracy of select lateral flow assays with potential for home testing. The cost-effectiveness, scalable manufacturing process, and suitability for self-testing makes LFAs an attractive option for monitoring disease prevalence and assessing vaccine responsiveness. Our web tool provides an easy-to-use interface to demonstrate the impact of prevalence and test accuracy on the positive predictive values.

Keywords: Antibodies; COVID-19; Coronavirus; Lateral flow assays; SARS-CoV-2.

MeSH terms

  • Adult
  • Aged
  • Antibodies, Viral / blood*
  • COVID-19 / blood
  • COVID-19 / diagnosis*
  • COVID-19 Serological Testing / methods*
  • Female
  • Humans
  • Immunoglobulin G / blood*
  • Immunoglobulin M / blood*
  • Limit of Detection
  • Male
  • Middle Aged
  • Predictive Value of Tests
  • Prevalence
  • SARS-CoV-2 / immunology*
  • Sensitivity and Specificity
  • User-Centered Design
  • User-Computer Interface


  • Antibodies, Viral
  • Immunoglobulin G
  • Immunoglobulin M