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BMC Infect Dis
. 2021 Jun 16;21(1):580.
doi: 10.1186/s12879-021-06257-7.
Evaluation of serological lateral flow assays for severe acute respiratory syndrome coronavirus-2
Bianca A Trombetta # 1 , Savannah E Kandigian # 1 , Robert R Kitchen # 2 3 , Korneel Grauwet # 4 , Pia Kivisäkk Webb 1 2 , Glenn A Miller 3 , Charles G Jennings 4 5 , Sejal Jain 6 7 , Samara Miller 2 8 9 10 , Yikai Kuo 1 4 , Thadryan Sweeney 4 , Tal Gilboa 11 12 , Maia Norman 11 12 13 , Daimon P Simmons 14 , Christopher E Ramirez 1 , Melissa Bedard 14 , Catherine Fink 15 , Jina Ko 11 16 , Esmarline J De León Peralta 17 18 19 , Gerald Watts 14 , Emma Gomez-Rivas 14 , Vannessa Davis 12 , Rocky M Barilla 20 , Jianing Wang 21 , Pierre Cunin 14 , Samuel Bates 22 , Chevaun Morrison-Smith 12 , Benjamin Nicholson 23 , Edmond Wong 23 , Leena El-Mufti 1 , Michael Kann 23 , Anna Bolling 1 , Brooke Fortin 1 , Hayden Ventresca 21 , Wen Zhou 24 , Santiago Pardo 1 , Megan Kwock 25 , Aditi Hazra 2 26 , Leo Cheng 27 , Q Rushdy Ahmad 11 , James A Toombs 28 , Rebecca Larson 29 30 , Haley Pleskow 23 31 , Nell Meosky Luo 32 , Christina Samaha 32 , Unnati M Pandya 2 33 , Pushpamali De Silva 18 , Sally Zhou 34 35 , Zakary Ganhadeiro 34 35 , Sara Yohannes 28 , Rakeisha Gay 28 35 , Jacqueline Slavik 28 , Shibani S Mukerji 1 , Petr Jarolim 7 12 , David R Walt 11 12 36 , Becky C Carlyle 1 2 , Lauren L Ritterhouse # 17 36 , Sara Suliman # 37 38
Affiliations
- PMID: 34134647
- DOI: 10.1186/s12879-021-06257-7
Abstract
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.