Evaluation of serological lateral flow assays for severe acute respiratory syndrome coronavirus-2
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 inte...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Bianca A. Trombetta [verfasserIn] Savannah E. Kandigian [verfasserIn] Robert R. Kitchen [verfasserIn] Korneel Grauwet [verfasserIn] Pia Kivisäkk Webb [verfasserIn] Glenn A. Miller [verfasserIn] Charles G. Jennings [verfasserIn] Sejal Jain [verfasserIn] Samara Miller [verfasserIn] Yikai Kuo [verfasserIn] Thadryan Sweeney [verfasserIn] Tal Gilboa [verfasserIn] Maia Norman [verfasserIn] Daimon P. Simmons [verfasserIn] Christopher E. Ramirez [verfasserIn] Melissa Bedard [verfasserIn] Catherine Fink [verfasserIn] Jina Ko [verfasserIn] Esmarline J. De León Peralta [verfasserIn] Gerald Watts [verfasserIn] Emma Gomez-Rivas [verfasserIn] Vannessa Davis [verfasserIn] Rocky M. Barilla [verfasserIn] Jianing Wang [verfasserIn] Pierre Cunin [verfasserIn] Samuel Bates [verfasserIn] Chevaun Morrison-Smith [verfasserIn] Benjamin Nicholson [verfasserIn] Edmond Wong [verfasserIn] Leena El-Mufti [verfasserIn] Michael Kann [verfasserIn] Anna Bolling [verfasserIn] Brooke Fortin [verfasserIn] Hayden Ventresca [verfasserIn] Wen Zhou [verfasserIn] Santiago Pardo [verfasserIn] Megan Kwock [verfasserIn] Aditi Hazra [verfasserIn] Leo Cheng [verfasserIn] Q. Rushdy Ahmad [verfasserIn] James A. Toombs [verfasserIn] Rebecca Larson [verfasserIn] Haley Pleskow [verfasserIn] Nell Meosky Luo [verfasserIn] Christina Samaha [verfasserIn] Unnati M. Pandya [verfasserIn] Pushpamali De Silva [verfasserIn] Sally Zhou [verfasserIn] Zakary Ganhadeiro [verfasserIn] Sara Yohannes [verfasserIn] Rakeisha Gay [verfasserIn] Jacqueline Slavik [verfasserIn] Shibani S. Mukerji [verfasserIn] Petr Jarolim [verfasserIn] David R. Walt [verfasserIn] Becky C. Carlyle [verfasserIn] Lauren L. Ritterhouse [verfasserIn] Sara Suliman [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2021 |
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| Übergeordnetes Werk: |
In: BMC Infectious Diseases - BMC, 2003, 21(2021), 1, Seite 14 |
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| Übergeordnetes Werk: |
volume:21 ; year:2021 ; number:1 ; pages:14 |
| Links: |
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| DOI / URN: |
10.1186/s12879-021-06257-7 |
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| Katalog-ID: |
DOAJ076887995 |
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| 520 | |a 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. | ||
| 650 | 4 | |a SARS-CoV-2 | |
| 650 | 4 | |a Coronavirus | |
| 650 | 4 | |a COVID-19 | |
| 650 | 4 | |a Antibodies | |
| 650 | 4 | |a Lateral flow assays | |
| 653 | 0 | |a Infectious and parasitic diseases | |
| 700 | 0 | |a Savannah E. Kandigian |e verfasserin |4 aut | |
| 700 | 0 | |a Robert R. Kitchen |e verfasserin |4 aut | |
| 700 | 0 | |a Korneel Grauwet |e verfasserin |4 aut | |
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| 700 | 0 | |a Nell Meosky Luo |e verfasserin |4 aut | |
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10.1186/s12879-021-06257-7 doi (DE-627)DOAJ076887995 (DE-599)DOAJ019aff5557364e74bdca28b0b1adff41 DE-627 ger DE-627 rakwb eng RC109-216 Bianca A. Trombetta verfasserin aut Evaluation of serological lateral flow assays for severe acute respiratory syndrome coronavirus-2 2021 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. SARS-CoV-2 Coronavirus COVID-19 Antibodies Lateral flow assays Infectious and parasitic diseases Savannah E. Kandigian verfasserin aut Robert R. Kitchen verfasserin aut Korneel Grauwet verfasserin aut Pia Kivisäkk Webb verfasserin aut Glenn A. Miller verfasserin aut Charles G. Jennings verfasserin aut Sejal Jain verfasserin aut Samara Miller verfasserin aut Yikai Kuo verfasserin aut Thadryan Sweeney verfasserin aut Tal Gilboa verfasserin aut Maia Norman verfasserin aut Daimon P. Simmons verfasserin aut Christopher E. Ramirez verfasserin aut Melissa Bedard verfasserin aut Catherine Fink verfasserin aut Jina Ko verfasserin aut Esmarline J. De León Peralta verfasserin aut Gerald Watts verfasserin aut Emma Gomez-Rivas verfasserin aut Vannessa Davis verfasserin aut Rocky M. Barilla verfasserin aut Jianing Wang verfasserin aut Pierre Cunin verfasserin aut Samuel Bates verfasserin aut Chevaun Morrison-Smith verfasserin aut Benjamin Nicholson verfasserin aut Edmond Wong verfasserin aut Leena El-Mufti verfasserin aut Michael Kann verfasserin aut Anna Bolling verfasserin aut Brooke Fortin verfasserin aut Hayden Ventresca verfasserin aut Wen Zhou verfasserin aut Santiago Pardo verfasserin aut Megan Kwock verfasserin aut Aditi Hazra verfasserin aut Leo Cheng verfasserin aut Q. Rushdy Ahmad verfasserin aut James A. Toombs verfasserin aut Rebecca Larson verfasserin aut Haley Pleskow verfasserin aut Nell Meosky Luo verfasserin aut Christina Samaha verfasserin aut Unnati M. Pandya verfasserin aut Pushpamali De Silva verfasserin aut Sally Zhou verfasserin aut Zakary Ganhadeiro verfasserin aut Sara Yohannes verfasserin aut Rakeisha Gay verfasserin aut Jacqueline Slavik verfasserin aut Shibani S. Mukerji verfasserin aut Petr Jarolim verfasserin aut David R. Walt verfasserin aut Becky C. Carlyle verfasserin aut Lauren L. Ritterhouse verfasserin aut Sara Suliman verfasserin aut In BMC Infectious Diseases BMC, 2003 21(2021), 1, Seite 14 (DE-627)326645381 (DE-600)2041550-3 14712334 nnns volume:21 year:2021 number:1 pages:14 https://doi.org/10.1186/s12879-021-06257-7 kostenfrei https://doaj.org/article/019aff5557364e74bdca28b0b1adff41 kostenfrei https://doi.org/10.1186/s12879-021-06257-7 kostenfrei https://doaj.org/toc/1471-2334 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 21 2021 1 14 |
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10.1186/s12879-021-06257-7 doi (DE-627)DOAJ076887995 (DE-599)DOAJ019aff5557364e74bdca28b0b1adff41 DE-627 ger DE-627 rakwb eng RC109-216 Bianca A. Trombetta verfasserin aut Evaluation of serological lateral flow assays for severe acute respiratory syndrome coronavirus-2 2021 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. SARS-CoV-2 Coronavirus COVID-19 Antibodies Lateral flow assays Infectious and parasitic diseases Savannah E. Kandigian verfasserin aut Robert R. Kitchen verfasserin aut Korneel Grauwet verfasserin aut Pia Kivisäkk Webb verfasserin aut Glenn A. Miller verfasserin aut Charles G. Jennings verfasserin aut Sejal Jain verfasserin aut Samara Miller verfasserin aut Yikai Kuo verfasserin aut Thadryan Sweeney verfasserin aut Tal Gilboa verfasserin aut Maia Norman verfasserin aut Daimon P. Simmons verfasserin aut Christopher E. Ramirez verfasserin aut Melissa Bedard verfasserin aut Catherine Fink verfasserin aut Jina Ko verfasserin aut Esmarline J. De León Peralta verfasserin aut Gerald Watts verfasserin aut Emma Gomez-Rivas verfasserin aut Vannessa Davis verfasserin aut Rocky M. Barilla verfasserin aut Jianing Wang verfasserin aut Pierre Cunin verfasserin aut Samuel Bates verfasserin aut Chevaun Morrison-Smith verfasserin aut Benjamin Nicholson verfasserin aut Edmond Wong verfasserin aut Leena El-Mufti verfasserin aut Michael Kann verfasserin aut Anna Bolling verfasserin aut Brooke Fortin verfasserin aut Hayden Ventresca verfasserin aut Wen Zhou verfasserin aut Santiago Pardo verfasserin aut Megan Kwock verfasserin aut Aditi Hazra verfasserin aut Leo Cheng verfasserin aut Q. Rushdy Ahmad verfasserin aut James A. Toombs verfasserin aut Rebecca Larson verfasserin aut Haley Pleskow verfasserin aut Nell Meosky Luo verfasserin aut Christina Samaha verfasserin aut Unnati M. Pandya verfasserin aut Pushpamali De Silva verfasserin aut Sally Zhou verfasserin aut Zakary Ganhadeiro verfasserin aut Sara Yohannes verfasserin aut Rakeisha Gay verfasserin aut Jacqueline Slavik verfasserin aut Shibani S. Mukerji verfasserin aut Petr Jarolim verfasserin aut David R. Walt verfasserin aut Becky C. Carlyle verfasserin aut Lauren L. Ritterhouse verfasserin aut Sara Suliman verfasserin aut In BMC Infectious Diseases BMC, 2003 21(2021), 1, Seite 14 (DE-627)326645381 (DE-600)2041550-3 14712334 nnns volume:21 year:2021 number:1 pages:14 https://doi.org/10.1186/s12879-021-06257-7 kostenfrei https://doaj.org/article/019aff5557364e74bdca28b0b1adff41 kostenfrei https://doi.org/10.1186/s12879-021-06257-7 kostenfrei https://doaj.org/toc/1471-2334 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 21 2021 1 14 |
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10.1186/s12879-021-06257-7 doi (DE-627)DOAJ076887995 (DE-599)DOAJ019aff5557364e74bdca28b0b1adff41 DE-627 ger DE-627 rakwb eng RC109-216 Bianca A. Trombetta verfasserin aut Evaluation of serological lateral flow assays for severe acute respiratory syndrome coronavirus-2 2021 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. SARS-CoV-2 Coronavirus COVID-19 Antibodies Lateral flow assays Infectious and parasitic diseases Savannah E. Kandigian verfasserin aut Robert R. Kitchen verfasserin aut Korneel Grauwet verfasserin aut Pia Kivisäkk Webb verfasserin aut Glenn A. Miller verfasserin aut Charles G. Jennings verfasserin aut Sejal Jain verfasserin aut Samara Miller verfasserin aut Yikai Kuo verfasserin aut Thadryan Sweeney verfasserin aut Tal Gilboa verfasserin aut Maia Norman verfasserin aut Daimon P. Simmons verfasserin aut Christopher E. Ramirez verfasserin aut Melissa Bedard verfasserin aut Catherine Fink verfasserin aut Jina Ko verfasserin aut Esmarline J. De León Peralta verfasserin aut Gerald Watts verfasserin aut Emma Gomez-Rivas verfasserin aut Vannessa Davis verfasserin aut Rocky M. Barilla verfasserin aut Jianing Wang verfasserin aut Pierre Cunin verfasserin aut Samuel Bates verfasserin aut Chevaun Morrison-Smith verfasserin aut Benjamin Nicholson verfasserin aut Edmond Wong verfasserin aut Leena El-Mufti verfasserin aut Michael Kann verfasserin aut Anna Bolling verfasserin aut Brooke Fortin verfasserin aut Hayden Ventresca verfasserin aut Wen Zhou verfasserin aut Santiago Pardo verfasserin aut Megan Kwock verfasserin aut Aditi Hazra verfasserin aut Leo Cheng verfasserin aut Q. Rushdy Ahmad verfasserin aut James A. Toombs verfasserin aut Rebecca Larson verfasserin aut Haley Pleskow verfasserin aut Nell Meosky Luo verfasserin aut Christina Samaha verfasserin aut Unnati M. Pandya verfasserin aut Pushpamali De Silva verfasserin aut Sally Zhou verfasserin aut Zakary Ganhadeiro verfasserin aut Sara Yohannes verfasserin aut Rakeisha Gay verfasserin aut Jacqueline Slavik verfasserin aut Shibani S. Mukerji verfasserin aut Petr Jarolim verfasserin aut David R. Walt verfasserin aut Becky C. Carlyle verfasserin aut Lauren L. Ritterhouse verfasserin aut Sara Suliman verfasserin aut In BMC Infectious Diseases BMC, 2003 21(2021), 1, Seite 14 (DE-627)326645381 (DE-600)2041550-3 14712334 nnns volume:21 year:2021 number:1 pages:14 https://doi.org/10.1186/s12879-021-06257-7 kostenfrei https://doaj.org/article/019aff5557364e74bdca28b0b1adff41 kostenfrei https://doi.org/10.1186/s12879-021-06257-7 kostenfrei https://doaj.org/toc/1471-2334 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 21 2021 1 14 |
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10.1186/s12879-021-06257-7 doi (DE-627)DOAJ076887995 (DE-599)DOAJ019aff5557364e74bdca28b0b1adff41 DE-627 ger DE-627 rakwb eng RC109-216 Bianca A. Trombetta verfasserin aut Evaluation of serological lateral flow assays for severe acute respiratory syndrome coronavirus-2 2021 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. SARS-CoV-2 Coronavirus COVID-19 Antibodies Lateral flow assays Infectious and parasitic diseases Savannah E. Kandigian verfasserin aut Robert R. Kitchen verfasserin aut Korneel Grauwet verfasserin aut Pia Kivisäkk Webb verfasserin aut Glenn A. Miller verfasserin aut Charles G. Jennings verfasserin aut Sejal Jain verfasserin aut Samara Miller verfasserin aut Yikai Kuo verfasserin aut Thadryan Sweeney verfasserin aut Tal Gilboa verfasserin aut Maia Norman verfasserin aut Daimon P. Simmons verfasserin aut Christopher E. Ramirez verfasserin aut Melissa Bedard verfasserin aut Catherine Fink verfasserin aut Jina Ko verfasserin aut Esmarline J. De León Peralta verfasserin aut Gerald Watts verfasserin aut Emma Gomez-Rivas verfasserin aut Vannessa Davis verfasserin aut Rocky M. Barilla verfasserin aut Jianing Wang verfasserin aut Pierre Cunin verfasserin aut Samuel Bates verfasserin aut Chevaun Morrison-Smith verfasserin aut Benjamin Nicholson verfasserin aut Edmond Wong verfasserin aut Leena El-Mufti verfasserin aut Michael Kann verfasserin aut Anna Bolling verfasserin aut Brooke Fortin verfasserin aut Hayden Ventresca verfasserin aut Wen Zhou verfasserin aut Santiago Pardo verfasserin aut Megan Kwock verfasserin aut Aditi Hazra verfasserin aut Leo Cheng verfasserin aut Q. Rushdy Ahmad verfasserin aut James A. Toombs verfasserin aut Rebecca Larson verfasserin aut Haley Pleskow verfasserin aut Nell Meosky Luo verfasserin aut Christina Samaha verfasserin aut Unnati M. Pandya verfasserin aut Pushpamali De Silva verfasserin aut Sally Zhou verfasserin aut Zakary Ganhadeiro verfasserin aut Sara Yohannes verfasserin aut Rakeisha Gay verfasserin aut Jacqueline Slavik verfasserin aut Shibani S. Mukerji verfasserin aut Petr Jarolim verfasserin aut David R. Walt verfasserin aut Becky C. Carlyle verfasserin aut Lauren L. Ritterhouse verfasserin aut Sara Suliman verfasserin aut In BMC Infectious Diseases BMC, 2003 21(2021), 1, Seite 14 (DE-627)326645381 (DE-600)2041550-3 14712334 nnns volume:21 year:2021 number:1 pages:14 https://doi.org/10.1186/s12879-021-06257-7 kostenfrei https://doaj.org/article/019aff5557364e74bdca28b0b1adff41 kostenfrei https://doi.org/10.1186/s12879-021-06257-7 kostenfrei https://doaj.org/toc/1471-2334 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 21 2021 1 14 |
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10.1186/s12879-021-06257-7 doi (DE-627)DOAJ076887995 (DE-599)DOAJ019aff5557364e74bdca28b0b1adff41 DE-627 ger DE-627 rakwb eng RC109-216 Bianca A. Trombetta verfasserin aut Evaluation of serological lateral flow assays for severe acute respiratory syndrome coronavirus-2 2021 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. SARS-CoV-2 Coronavirus COVID-19 Antibodies Lateral flow assays Infectious and parasitic diseases Savannah E. Kandigian verfasserin aut Robert R. Kitchen verfasserin aut Korneel Grauwet verfasserin aut Pia Kivisäkk Webb verfasserin aut Glenn A. Miller verfasserin aut Charles G. Jennings verfasserin aut Sejal Jain verfasserin aut Samara Miller verfasserin aut Yikai Kuo verfasserin aut Thadryan Sweeney verfasserin aut Tal Gilboa verfasserin aut Maia Norman verfasserin aut Daimon P. Simmons verfasserin aut Christopher E. Ramirez verfasserin aut Melissa Bedard verfasserin aut Catherine Fink verfasserin aut Jina Ko verfasserin aut Esmarline J. De León Peralta verfasserin aut Gerald Watts verfasserin aut Emma Gomez-Rivas verfasserin aut Vannessa Davis verfasserin aut Rocky M. Barilla verfasserin aut Jianing Wang verfasserin aut Pierre Cunin verfasserin aut Samuel Bates verfasserin aut Chevaun Morrison-Smith verfasserin aut Benjamin Nicholson verfasserin aut Edmond Wong verfasserin aut Leena El-Mufti verfasserin aut Michael Kann verfasserin aut Anna Bolling verfasserin aut Brooke Fortin verfasserin aut Hayden Ventresca verfasserin aut Wen Zhou verfasserin aut Santiago Pardo verfasserin aut Megan Kwock verfasserin aut Aditi Hazra verfasserin aut Leo Cheng verfasserin aut Q. Rushdy Ahmad verfasserin aut James A. Toombs verfasserin aut Rebecca Larson verfasserin aut Haley Pleskow verfasserin aut Nell Meosky Luo verfasserin aut Christina Samaha verfasserin aut Unnati M. Pandya verfasserin aut Pushpamali De Silva verfasserin aut Sally Zhou verfasserin aut Zakary Ganhadeiro verfasserin aut Sara Yohannes verfasserin aut Rakeisha Gay verfasserin aut Jacqueline Slavik verfasserin aut Shibani S. Mukerji verfasserin aut Petr Jarolim verfasserin aut David R. Walt verfasserin aut Becky C. Carlyle verfasserin aut Lauren L. Ritterhouse verfasserin aut Sara Suliman verfasserin aut In BMC Infectious Diseases BMC, 2003 21(2021), 1, Seite 14 (DE-627)326645381 (DE-600)2041550-3 14712334 nnns volume:21 year:2021 number:1 pages:14 https://doi.org/10.1186/s12879-021-06257-7 kostenfrei https://doaj.org/article/019aff5557364e74bdca28b0b1adff41 kostenfrei https://doi.org/10.1186/s12879-021-06257-7 kostenfrei https://doaj.org/toc/1471-2334 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 21 2021 1 14 |
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Bianca A. Trombetta @@aut@@ Savannah E. Kandigian @@aut@@ Robert R. Kitchen @@aut@@ Korneel Grauwet @@aut@@ Pia Kivisäkk Webb @@aut@@ Glenn A. Miller @@aut@@ Charles G. Jennings @@aut@@ Sejal Jain @@aut@@ Samara Miller @@aut@@ Yikai Kuo @@aut@@ Thadryan Sweeney @@aut@@ Tal Gilboa @@aut@@ Maia Norman @@aut@@ Daimon P. Simmons @@aut@@ Christopher E. Ramirez @@aut@@ Melissa Bedard @@aut@@ Catherine Fink @@aut@@ Jina Ko @@aut@@ Esmarline J. De León Peralta @@aut@@ Gerald Watts @@aut@@ Emma Gomez-Rivas @@aut@@ Vannessa Davis @@aut@@ Rocky M. Barilla @@aut@@ Jianing Wang @@aut@@ Pierre Cunin @@aut@@ Samuel Bates @@aut@@ Chevaun Morrison-Smith @@aut@@ Benjamin Nicholson @@aut@@ Edmond Wong @@aut@@ Leena El-Mufti @@aut@@ Michael Kann @@aut@@ Anna Bolling @@aut@@ Brooke Fortin @@aut@@ Hayden Ventresca @@aut@@ Wen Zhou @@aut@@ Santiago Pardo @@aut@@ Megan Kwock @@aut@@ Aditi Hazra @@aut@@ Leo Cheng @@aut@@ Q. Rushdy Ahmad @@aut@@ James A. Toombs @@aut@@ Rebecca Larson @@aut@@ Haley Pleskow @@aut@@ Nell Meosky Luo @@aut@@ Christina Samaha @@aut@@ Unnati M. Pandya @@aut@@ Pushpamali De Silva @@aut@@ Sally Zhou @@aut@@ Zakary Ganhadeiro @@aut@@ Sara Yohannes @@aut@@ Rakeisha Gay @@aut@@ Jacqueline Slavik @@aut@@ Shibani S. Mukerji @@aut@@ Petr Jarolim @@aut@@ David R. Walt @@aut@@ Becky C. Carlyle @@aut@@ Lauren L. Ritterhouse @@aut@@ Sara Suliman @@aut@@ |
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Trombetta</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Evaluation of serological lateral flow assays for severe acute respiratory syndrome coronavirus-2</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2021</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">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. 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RC109-216 Evaluation of serological lateral flow assays for severe acute respiratory syndrome coronavirus-2 SARS-CoV-2 Coronavirus COVID-19 Antibodies Lateral flow assays |
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Bianca A. Trombetta Savannah E. Kandigian Robert R. Kitchen Korneel Grauwet Pia Kivisäkk Webb Glenn A. Miller Charles G. Jennings Sejal Jain Samara Miller Yikai Kuo Thadryan Sweeney Tal Gilboa Maia Norman Daimon P. Simmons Christopher E. Ramirez Melissa Bedard Catherine Fink Jina Ko Esmarline J. De León Peralta Gerald Watts Emma Gomez-Rivas Vannessa Davis Rocky M. Barilla Jianing Wang Pierre Cunin Samuel Bates Chevaun Morrison-Smith Benjamin Nicholson Edmond Wong Leena El-Mufti Michael Kann Anna Bolling Brooke Fortin Hayden Ventresca Wen Zhou Santiago Pardo Megan Kwock Aditi Hazra Leo Cheng Q. Rushdy Ahmad James A. Toombs Rebecca Larson Haley Pleskow Nell Meosky Luo Christina Samaha Unnati M. Pandya Pushpamali De Silva Sally Zhou Zakary Ganhadeiro Sara Yohannes Rakeisha Gay Jacqueline Slavik Shibani S. Mukerji Petr Jarolim David R. Walt Becky C. Carlyle Lauren L. Ritterhouse Sara Suliman |
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Elektronische Aufsätze |
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Bianca A. Trombetta |
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evaluation of serological lateral flow assays for severe acute respiratory syndrome coronavirus-2 |
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RC109-216 |
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Evaluation of serological lateral flow assays for severe acute respiratory syndrome coronavirus-2 |
| abstract |
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. |
| abstractGer |
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. |
| abstract_unstemmed |
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. |
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Evaluation of serological lateral flow assays for severe acute respiratory syndrome coronavirus-2 |
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https://doi.org/10.1186/s12879-021-06257-7 https://doaj.org/article/019aff5557364e74bdca28b0b1adff41 https://doaj.org/toc/1471-2334 |
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Savannah E. Kandigian Robert R. Kitchen Korneel Grauwet Pia Kivisäkk Webb Glenn A. Miller Charles G. Jennings Sejal Jain Samara Miller Yikai Kuo Thadryan Sweeney Tal Gilboa Maia Norman Daimon P. Simmons Christopher E. Ramirez Melissa Bedard Catherine Fink Jina Ko Esmarline J. De León Peralta Gerald Watts Emma Gomez-Rivas Vannessa Davis Rocky M. Barilla Jianing Wang Pierre Cunin Samuel Bates Chevaun Morrison-Smith Benjamin Nicholson Edmond Wong Leena El-Mufti Michael Kann Anna Bolling Brooke Fortin Hayden Ventresca Wen Zhou Santiago Pardo Megan Kwock Aditi Hazra Leo Cheng Q. Rushdy Ahmad James A. Toombs Rebecca Larson Haley Pleskow Nell Meosky Luo Christina Samaha Unnati M. Pandya Pushpamali De Silva Sally Zhou Zakary Ganhadeiro Sara Yohannes Rakeisha Gay Jacqueline Slavik Shibani S. Mukerji Petr Jarolim David R. Walt Becky C. Carlyle Lauren L. Ritterhouse Sara Suliman |
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Savannah E. Kandigian Robert R. Kitchen Korneel Grauwet Pia Kivisäkk Webb Glenn A. Miller Charles G. Jennings Sejal Jain Samara Miller Yikai Kuo Thadryan Sweeney Tal Gilboa Maia Norman Daimon P. Simmons Christopher E. Ramirez Melissa Bedard Catherine Fink Jina Ko Esmarline J. De León Peralta Gerald Watts Emma Gomez-Rivas Vannessa Davis Rocky M. Barilla Jianing Wang Pierre Cunin Samuel Bates Chevaun Morrison-Smith Benjamin Nicholson Edmond Wong Leena El-Mufti Michael Kann Anna Bolling Brooke Fortin Hayden Ventresca Wen Zhou Santiago Pardo Megan Kwock Aditi Hazra Leo Cheng Q. Rushdy Ahmad James A. Toombs Rebecca Larson Haley Pleskow Nell Meosky Luo Christina Samaha Unnati M. Pandya Pushpamali De Silva Sally Zhou Zakary Ganhadeiro Sara Yohannes Rakeisha Gay Jacqueline Slavik Shibani S. Mukerji Petr Jarolim David R. Walt Becky C. Carlyle Lauren L. Ritterhouse Sara Suliman |
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