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