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

Trombetta, Bianca A.; Kandigian, Savannah E.; Kitchen, Robert R.; Grauwet, Korneel; Webb, Pia Kivisäkk; Miller, Glenn A.; Jennings, Charles G.; Jain, Sejal; Miller, Samara; Kuo, Yikai; Sweeney, Thadryan; Gilboa, Tal; Norman, Maia; Simmons, Daimon P.; Ramirez, Christopher E.; Bedard, Melissa; Fink, Catherine; Ko, Jina; De León Peralta, Esmarline J.; Watts, Gerald; Gomez-Rivas, Emma; Davis, Vannessa; Barilla, Rocky M.; Wang, Jianing; Cunin, Pierre; Bates, Samuel; Morrison-Smith, Chevaun; Nicholson, Benjamin; Wong, Edmond; El-Mufti, Leena; Kann, Michael; Bolling, Anna; Fortin, Brooke; Ventresca, Hayden; Zhou, Wen; Pardo, Santiago; Kwock, Megan; Hazra, Aditi; Cheng, Leo; Ahmad, Q. Rushdy; Toombs, James A.; Larson, Rebecca; Pleskow, Haley; Luo, Nell Meosky; Samaha, Christina; Pandya, Unnati M.; De Silva, Pushpamali; Zhou, Sally; Ganhadeiro, Zakary; Yohannes, Sara; Gay, Rakeisha; Slavik, Jacqueline; Mukerji, Shibani S.; Jarolim, Petr; Walt, David R.; Carlyle, Becky C.; Ritterhouse, Lauren L.; Suliman, Sara

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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12879-021-06257-7.