Performance of Commercially Available Rapid Serological Assays for the Detection of SARS-CoV-2 Antibodies.

Anwar M Hashem; Rowa Y Alhabbab; Abdullah Algaissi; Mohamed A Alfaleh; Sharif Hala; Turki S Abujamel; M-Zaki ElAssouli; Afrah A AL-Somali; Fadwa S Alofi; Asim A Khogeer; Almohanad A Alkayyal; Ahmad Bakur Mahmoud; Naif A M Almontashiri; Arnab Pain

doi:10.3390/pathogens9121067

Performance of Commercially Available Rapid Serological Assays for the Detection of SARS-CoV-2 Antibodies.

Anwar M Hashem, Rowa Y Alhabbab, Abdullah Algaissi, Mohamed A Alfaleh, Sharif Hala, Turki S Abujamel, M-Zaki ElAssouli, Afrah A AL-Somali, Fadwa S Alofi, Asim A Khogeer, Almohanad A Alkayyal, Ahmad Bakur Mahmoud, Naif A M Almontashiri, Arnab Pain

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Abstract

The coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), continues to spread globally. Although several rapid commercial serological assays have been developed, little is known about their performance and accuracy in detecting SARS-CoV-2-specific antibodies in COVID-19 patient samples. Here, we have evaluated the performance of seven commercially available rapid lateral flow immunoassays (LFIA) obtained from different manufacturers, and compared them to in-house developed and validated ELISA assays for the detection of SARS-CoV-2-specific IgM and IgG antibodies in RT-PCR-confirmed COVID-19 patients. While all evaluated LFIA assays showed high specificity, our data showed a significant variation in sensitivity of these assays, which ranged from 0% to 54% for samples collected early during infection (3-7 days post symptoms onset) and from 54% to 88% for samples collected at later time points during infection (8-27 days post symptoms onset). Therefore, we recommend prior evaluation and validation of these assays before being routinely used to detect IgM and IgG in COVID-19 patients. Moreover, our findings suggest the use of LFIA assays in combination with other standard methods, and not as an alternative.

Original language	English (US)
Pages (from-to)	1067
Journal	Pathogens (Basel, Switzerland)
Volume	9
Issue number	12
DOIs	https://doi.org/10.3390/pathogens9121067
State	Published - Dec 23 2020

Bibliographical note

KAUST Repository Item: Exported on 2020-12-28
Acknowledged KAUST grant number(s): BAS/1/1020/01/01
Acknowledgements: The authors extend their appreciation to the deputyship for Research and Innovation, Ministry of Education in Saudi Arabia for funding this research work through the project number (436) to AMH. AP and SH are supported by a faculty baseline funding by KAUST to AP (BAS/1/1020/01/01) and the R3T initiative of KAUST.

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https://repository.kaust.edu.sa/bitstream/10754/664431/4/performance%20of%20commercially.pdf

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Hashem, A. M., Alhabbab, R. Y., Algaissi, A., Alfaleh, M. A., Hala, S., Abujamel, T. S., ElAssouli, M.-Z., AL-Somali, A. A., Alofi, F. S., Khogeer, A. A., Alkayyal, A. A., Mahmoud, A. B., Almontashiri, N. A. M., & Pain, A. (2020). Performance of Commercially Available Rapid Serological Assays for the Detection of SARS-CoV-2 Antibodies. Pathogens (Basel, Switzerland), 9(12), 1067. https://doi.org/10.3390/pathogens9121067

@article{3fff5933f646437891c8f49eb48db411,

title = "Performance of Commercially Available Rapid Serological Assays for the Detection of SARS-CoV-2 Antibodies.",

abstract = "The coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), continues to spread globally. Although several rapid commercial serological assays have been developed, little is known about their performance and accuracy in detecting SARS-CoV-2-specific antibodies in COVID-19 patient samples. Here, we have evaluated the performance of seven commercially available rapid lateral flow immunoassays (LFIA) obtained from different manufacturers, and compared them to in-house developed and validated ELISA assays for the detection of SARS-CoV-2-specific IgM and IgG antibodies in RT-PCR-confirmed COVID-19 patients. While all evaluated LFIA assays showed high specificity, our data showed a significant variation in sensitivity of these assays, which ranged from 0% to 54% for samples collected early during infection (3-7 days post symptoms onset) and from 54% to 88% for samples collected at later time points during infection (8-27 days post symptoms onset). Therefore, we recommend prior evaluation and validation of these assays before being routinely used to detect IgM and IgG in COVID-19 patients. Moreover, our findings suggest the use of LFIA assays in combination with other standard methods, and not as an alternative.",

author = "Hashem, {Anwar M} and Alhabbab, {Rowa Y} and Abdullah Algaissi and Alfaleh, {Mohamed A} and Sharif Hala and Abujamel, {Turki S} and M-Zaki ElAssouli and AL-Somali, {Afrah A} and Alofi, {Fadwa S} and Khogeer, {Asim A} and Alkayyal, {Almohanad A} and Mahmoud, {Ahmad Bakur} and Almontashiri, {Naif A M} and Arnab Pain",

note = "KAUST Repository Item: Exported on 2020-12-28 Acknowledged KAUST grant number(s): BAS/1/1020/01/01 Acknowledgements: The authors extend their appreciation to the deputyship for Research and Innovation, Ministry of Education in Saudi Arabia for funding this research work through the project number (436) to AMH. AP and SH are supported by a faculty baseline funding by KAUST to AP (BAS/1/1020/01/01) and the R3T initiative of KAUST.",

year = "2020",

month = dec,

day = "23",

doi = "10.3390/pathogens9121067",

language = "English (US)",

volume = "9",

pages = "1067",

journal = "Pathogens (Basel, Switzerland)",

issn = "2076-0817",

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Hashem, AM, Alhabbab, RY, Algaissi, A, Alfaleh, MA, Hala, S, Abujamel, TS, ElAssouli, M-Z, AL-Somali, AA, Alofi, FS, Khogeer, AA, Alkayyal, AA, Mahmoud, AB, Almontashiri, NAM & Pain, A 2020, 'Performance of Commercially Available Rapid Serological Assays for the Detection of SARS-CoV-2 Antibodies.', Pathogens (Basel, Switzerland), vol. 9, no. 12, pp. 1067. https://doi.org/10.3390/pathogens9121067

TY - JOUR

T1 - Performance of Commercially Available Rapid Serological Assays for the Detection of SARS-CoV-2 Antibodies.

AU - Hashem, Anwar M

AU - Alhabbab, Rowa Y

AU - Algaissi, Abdullah

AU - Alfaleh, Mohamed A

AU - Hala, Sharif

AU - Abujamel, Turki S

AU - ElAssouli, M-Zaki

AU - AL-Somali, Afrah A

AU - Alofi, Fadwa S

AU - Khogeer, Asim A

AU - Alkayyal, Almohanad A

AU - Mahmoud, Ahmad Bakur

AU - Almontashiri, Naif A M

AU - Pain, Arnab

N1 - KAUST Repository Item: Exported on 2020-12-28 Acknowledged KAUST grant number(s): BAS/1/1020/01/01 Acknowledgements: The authors extend their appreciation to the deputyship for Research and Innovation, Ministry of Education in Saudi Arabia for funding this research work through the project number (436) to AMH. AP and SH are supported by a faculty baseline funding by KAUST to AP (BAS/1/1020/01/01) and the R3T initiative of KAUST.

PY - 2020/12/23

Y1 - 2020/12/23

N2 - The coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), continues to spread globally. Although several rapid commercial serological assays have been developed, little is known about their performance and accuracy in detecting SARS-CoV-2-specific antibodies in COVID-19 patient samples. Here, we have evaluated the performance of seven commercially available rapid lateral flow immunoassays (LFIA) obtained from different manufacturers, and compared them to in-house developed and validated ELISA assays for the detection of SARS-CoV-2-specific IgM and IgG antibodies in RT-PCR-confirmed COVID-19 patients. While all evaluated LFIA assays showed high specificity, our data showed a significant variation in sensitivity of these assays, which ranged from 0% to 54% for samples collected early during infection (3-7 days post symptoms onset) and from 54% to 88% for samples collected at later time points during infection (8-27 days post symptoms onset). Therefore, we recommend prior evaluation and validation of these assays before being routinely used to detect IgM and IgG in COVID-19 patients. Moreover, our findings suggest the use of LFIA assays in combination with other standard methods, and not as an alternative.

AB - The coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), continues to spread globally. Although several rapid commercial serological assays have been developed, little is known about their performance and accuracy in detecting SARS-CoV-2-specific antibodies in COVID-19 patient samples. Here, we have evaluated the performance of seven commercially available rapid lateral flow immunoassays (LFIA) obtained from different manufacturers, and compared them to in-house developed and validated ELISA assays for the detection of SARS-CoV-2-specific IgM and IgG antibodies in RT-PCR-confirmed COVID-19 patients. While all evaluated LFIA assays showed high specificity, our data showed a significant variation in sensitivity of these assays, which ranged from 0% to 54% for samples collected early during infection (3-7 days post symptoms onset) and from 54% to 88% for samples collected at later time points during infection (8-27 days post symptoms onset). Therefore, we recommend prior evaluation and validation of these assays before being routinely used to detect IgM and IgG in COVID-19 patients. Moreover, our findings suggest the use of LFIA assays in combination with other standard methods, and not as an alternative.

UR - http://hdl.handle.net/10754/664431

UR - https://www.mdpi.com/2076-0817/9/12/1067

U2 - 10.3390/pathogens9121067

DO - 10.3390/pathogens9121067

M3 - Article

C2 - 33352788

SN - 2076-0817

VL - 9

SP - 1067

JO - Pathogens (Basel, Switzerland)

JF - Pathogens (Basel, Switzerland)

IS - 12

ER -

Performance of Commercially Available Rapid Serological Assays for the Detection of SARS-CoV-2 Antibodies.

Abstract

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