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Evaluation of serological lateral flow assays for severe acute respiratory syndrome coronavirus-2 #MMPMID34134647
Trombetta BA; Kandigian SE; Kitchen RR; Grauwet K; Webb PK; Miller GA; Jennings CG; Jain S; Miller S; Kuo Y; Sweeney T; Gilboa T; Norman M; Simmons DP; Ramirez CE; Bedard M; Fink C; Ko J; De Leon Peralta EJ; Watts G; Gomez-Rivas E; Davis V; Barilla RM; Wang J; Cunin P; Bates S; Morrison-Smith C; Nicholson B; Wong E; El-Mufti L; Kann M; Bolling A; Fortin B; Ventresca H; Zhou W; Pardo S; Kwock M; Hazra A; Cheng L; Ahmad QR; Toombs JA; Larson R; Pleskow H; Luo NM; Samaha C; Pandya UM; De Silva P; Zhou S; Ganhadeiro Z; Yohannes S; Gay R; Slavik J; Mukerji SS; Jarolim P; Walt DR; Carlyle BC; Ritterhouse LL; Suliman S
BMC Infect Dis 2021[Jun]; 21 (1): 580 PMID34134647show ga
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 mug/mL), followed by a similar LOD of 1.5 mug/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.
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BMC+Infect+Dis 2021 ; 21 (1): 580
