Assessing the performance of a serological point-of-care test in measuring detectable antibodies against SARS-CoV-2

Peter V. Coyle; Reham Awni El Kahlout; Soha R. Dargham; Hiam Chemaitelly; Mohamed Ali Ben Hadj Kacem; Naema Hassan Abdulla Al-Mawlawi; Imtiaz Gilliani; Nourah Younes; Zaina Al Kanaani; Abdullatif Al Khal; Einas Al Kuwari; Andrew Jeremijenko; Anvar Hassan Kaleeckal; Ali Nizar Latif; Riyazuddin Mohammad Shaik; Hanan F. Abdul Rahim; Gheyath K. Nasrallah; Hadi M. Yassine; Mohamed G. Al Kuwari; Hamad Eid Al Romaihi; Patrick Tang; Roberto Bertollini; Mohamed H. Al-Thani; Laith J. Abu-Raddad; Muhammed Elhadi

doi:10.1371/journal.pone.0262897

Assessing the performance of a serological point-of-care test in measuring detectable antibodies against SARS-CoV-2

Peter V. Coyle^*, Reham Awni El Kahlout, Soha R. Dargham, Hiam Chemaitelly, Mohamed Ali Ben Hadj Kacem, Naema Hassan Abdulla Al-Mawlawi, Imtiaz Gilliani, Nourah Younes, Zaina Al Kanaani, Abdullatif Al Khal, Einas Al Kuwari, Andrew Jeremijenko, Anvar Hassan Kaleeckal, Ali Nizar Latif, Riyazuddin Mohammad Shaik, Hanan F. Abdul Rahim, Gheyath K. Nasrallah, Hadi M. Yassine, Mohamed G. Al Kuwari, Hamad Eid Al RomaihiPatrick Tang, Roberto Bertollini, Mohamed H. Al-Thani, Laith J. Abu-Raddad^*, Muhammed Elhadi (Editor)

^*Corresponding author for this work

School of Medicine, Dentistry and Biomedical Sciences

Research output: Contribution to journal › Article › peer-review

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Abstract

This study investigated the performance of a rapid point-of-care antibody test, the BioMedomics COVID-19 IgM/IgG Rapid Test, in comparison with a high-quality, validated, laboratory-based platform, the Roche Elecsys Anti-SARS-CoV-2 assay. Serological testing was conducted on 709 individuals. Concordance metrics were estimated. Logistic regression was used to assess associations with seropositivity. SARS-CoV-2 seroprevalence was 63.5% (450/709; 95% CI 59.8%-67.0%) using the BioMedomics assay and 71.9% (510/709; 95% CI 68.5%-75.2%) using the Elecsys assay. There were 60 discordant results between the two assays, all of which were seropositive in the Elecsys assay, but seronegative in the BioMedomics assay. Overall, positive, and negative percent agreements between the two assays were 91.5% (95% CI 89.2%-93.5%), 88.2% (95% CI 85.1%-90.9%), and 100% (95% CI 98.2%-100%), respectively, with a Cohen’s kappa of 0.81 (95% CI 0.78–0.84). Excluding specimens with lower (Elecsys) antibody titers, the agreement improved with overall, positive, and negative percent concordance of 94.4% (95% CI 92.3%-96.1%), 91.8% (95% CI 88.8%-94.3%), and 100% (95% CI 98.2%-100%), respectively, and a Cohen’s kappa of 0.88 (95% CI 0.85–0.90). Logistic regression confirmed better agreement with higher antibody titers. The BioMedomics COVID-19 IgM/IgG Rapid Test demonstrated good performance in measuring detectable antibodies against SARS-CoV-2, supporting the utility of such rapid point-of-care serological testing to guide the public health responses and vaccine prioritization.

Original language	English
Article number	e0262897
Journal	PLoS ONE
Volume	17
Issue number	1
DOIs	https://doi.org/10.1371/journal.pone.0262897
Publication status	Published - 31 Jan 2022

Keywords

Research Article
Medicine and health sciences
Biology and life sciences
Research and analysis methods
People and places

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1371/journal.pone.0262897Licence: CC BY

Assessing the performance of a serological point-of-care test in measuring detectable antibodies against SARS-CoV-2
Copyright 2022 the authors. This is an open access article published under a Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium, provided the author and source are cited.
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Coyle, P. V., El Kahlout, R. A., Dargham, S. R., Chemaitelly, H., Kacem, M. A. B. H., Al-Mawlawi, N. H. A., Gilliani, I., Younes, N., Al Kanaani, Z., Al Khal, A., Al Kuwari, E., Jeremijenko, A., Kaleeckal, A. H., Latif, A. N., Shaik, R. M., Rahim, H. F. A., Nasrallah, G. K., Yassine, H. M., Al Kuwari, M. G., ... Elhadi, M. (Ed.) (2022). Assessing the performance of a serological point-of-care test in measuring detectable antibodies against SARS-CoV-2. PLoS ONE, 17(1), [e0262897]. https://doi.org/10.1371/journal.pone.0262897

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title = "Assessing the performance of a serological point-of-care test in measuring detectable antibodies against SARS-CoV-2",

abstract = "This study investigated the performance of a rapid point-of-care antibody test, the BioMedomics COVID-19 IgM/IgG Rapid Test, in comparison with a high-quality, validated, laboratory-based platform, the Roche Elecsys Anti-SARS-CoV-2 assay. Serological testing was conducted on 709 individuals. Concordance metrics were estimated. Logistic regression was used to assess associations with seropositivity. SARS-CoV-2 seroprevalence was 63.5% (450/709; 95% CI 59.8%-67.0%) using the BioMedomics assay and 71.9% (510/709; 95% CI 68.5%-75.2%) using the Elecsys assay. There were 60 discordant results between the two assays, all of which were seropositive in the Elecsys assay, but seronegative in the BioMedomics assay. Overall, positive, and negative percent agreements between the two assays were 91.5% (95% CI 89.2%-93.5%), 88.2% (95% CI 85.1%-90.9%), and 100% (95% CI 98.2%-100%), respectively, with a Cohen{\textquoteright}s kappa of 0.81 (95% CI 0.78–0.84). Excluding specimens with lower (Elecsys) antibody titers, the agreement improved with overall, positive, and negative percent concordance of 94.4% (95% CI 92.3%-96.1%), 91.8% (95% CI 88.8%-94.3%), and 100% (95% CI 98.2%-100%), respectively, and a Cohen{\textquoteright}s kappa of 0.88 (95% CI 0.85–0.90). Logistic regression confirmed better agreement with higher antibody titers. The BioMedomics COVID-19 IgM/IgG Rapid Test demonstrated good performance in measuring detectable antibodies against SARS-CoV-2, supporting the utility of such rapid point-of-care serological testing to guide the public health responses and vaccine prioritization.",

keywords = "Research Article, Medicine and health sciences, Biology and life sciences, Research and analysis methods, People and places",

author = "Coyle, {Peter V.} and {El Kahlout}, {Reham Awni} and Dargham, {Soha R.} and Hiam Chemaitelly and Kacem, {Mohamed Ali Ben Hadj} and Al-Mawlawi, {Naema Hassan Abdulla} and Imtiaz Gilliani and Nourah Younes and {Al Kanaani}, Zaina and {Al Khal}, Abdullatif and {Al Kuwari}, Einas and Andrew Jeremijenko and Kaleeckal, {Anvar Hassan} and Latif, {Ali Nizar} and Shaik, {Riyazuddin Mohammad} and Rahim, {Hanan F. Abdul} and Nasrallah, {Gheyath K.} and Yassine, {Hadi M.} and {Al Kuwari}, {Mohamed G.} and {Al Romaihi}, {Hamad Eid} and Patrick Tang and Roberto Bertollini and Al-Thani, {Mohamed H.} and Abu-Raddad, {Laith J.} and Muhammed Elhadi",

year = "2022",

month = jan,

day = "31",

doi = "10.1371/journal.pone.0262897",

language = "English",

volume = "17",

journal = "PLoS One",

issn = "1932-6203",

publisher = "Public Library of Science (PLOS)",

number = "1",

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Coyle, PV, El Kahlout, RA, Dargham, SR, Chemaitelly, H, Kacem, MABH, Al-Mawlawi, NHA, Gilliani, I, Younes, N, Al Kanaani, Z, Al Khal, A, Al Kuwari, E, Jeremijenko, A, Kaleeckal, AH, Latif, AN, Shaik, RM, Rahim, HFA, Nasrallah, GK, Yassine, HM, Al Kuwari, MG, Al Romaihi, HE, Tang, P, Bertollini, R, Al-Thani, MH, Abu-Raddad, LJ & Elhadi, M (ed.) 2022, 'Assessing the performance of a serological point-of-care test in measuring detectable antibodies against SARS-CoV-2', PLoS ONE, vol. 17, no. 1, e0262897. https://doi.org/10.1371/journal.pone.0262897

TY - JOUR

T1 - Assessing the performance of a serological point-of-care test in measuring detectable antibodies against SARS-CoV-2

AU - Coyle, Peter V.

AU - El Kahlout, Reham Awni

AU - Dargham, Soha R.

AU - Chemaitelly, Hiam

AU - Kacem, Mohamed Ali Ben Hadj

AU - Al-Mawlawi, Naema Hassan Abdulla

AU - Gilliani, Imtiaz

AU - Younes, Nourah

AU - Al Kanaani, Zaina

AU - Al Khal, Abdullatif

AU - Al Kuwari, Einas

AU - Jeremijenko, Andrew

AU - Kaleeckal, Anvar Hassan

AU - Latif, Ali Nizar

AU - Shaik, Riyazuddin Mohammad

AU - Rahim, Hanan F. Abdul

AU - Nasrallah, Gheyath K.

AU - Yassine, Hadi M.

AU - Al Kuwari, Mohamed G.

AU - Al Romaihi, Hamad Eid

AU - Tang, Patrick

AU - Bertollini, Roberto

AU - Al-Thani, Mohamed H.

AU - Abu-Raddad, Laith J.

A2 - Elhadi, Muhammed

PY - 2022/1/31

Y1 - 2022/1/31

N2 - This study investigated the performance of a rapid point-of-care antibody test, the BioMedomics COVID-19 IgM/IgG Rapid Test, in comparison with a high-quality, validated, laboratory-based platform, the Roche Elecsys Anti-SARS-CoV-2 assay. Serological testing was conducted on 709 individuals. Concordance metrics were estimated. Logistic regression was used to assess associations with seropositivity. SARS-CoV-2 seroprevalence was 63.5% (450/709; 95% CI 59.8%-67.0%) using the BioMedomics assay and 71.9% (510/709; 95% CI 68.5%-75.2%) using the Elecsys assay. There were 60 discordant results between the two assays, all of which were seropositive in the Elecsys assay, but seronegative in the BioMedomics assay. Overall, positive, and negative percent agreements between the two assays were 91.5% (95% CI 89.2%-93.5%), 88.2% (95% CI 85.1%-90.9%), and 100% (95% CI 98.2%-100%), respectively, with a Cohen’s kappa of 0.81 (95% CI 0.78–0.84). Excluding specimens with lower (Elecsys) antibody titers, the agreement improved with overall, positive, and negative percent concordance of 94.4% (95% CI 92.3%-96.1%), 91.8% (95% CI 88.8%-94.3%), and 100% (95% CI 98.2%-100%), respectively, and a Cohen’s kappa of 0.88 (95% CI 0.85–0.90). Logistic regression confirmed better agreement with higher antibody titers. The BioMedomics COVID-19 IgM/IgG Rapid Test demonstrated good performance in measuring detectable antibodies against SARS-CoV-2, supporting the utility of such rapid point-of-care serological testing to guide the public health responses and vaccine prioritization.

AB - This study investigated the performance of a rapid point-of-care antibody test, the BioMedomics COVID-19 IgM/IgG Rapid Test, in comparison with a high-quality, validated, laboratory-based platform, the Roche Elecsys Anti-SARS-CoV-2 assay. Serological testing was conducted on 709 individuals. Concordance metrics were estimated. Logistic regression was used to assess associations with seropositivity. SARS-CoV-2 seroprevalence was 63.5% (450/709; 95% CI 59.8%-67.0%) using the BioMedomics assay and 71.9% (510/709; 95% CI 68.5%-75.2%) using the Elecsys assay. There were 60 discordant results between the two assays, all of which were seropositive in the Elecsys assay, but seronegative in the BioMedomics assay. Overall, positive, and negative percent agreements between the two assays were 91.5% (95% CI 89.2%-93.5%), 88.2% (95% CI 85.1%-90.9%), and 100% (95% CI 98.2%-100%), respectively, with a Cohen’s kappa of 0.81 (95% CI 0.78–0.84). Excluding specimens with lower (Elecsys) antibody titers, the agreement improved with overall, positive, and negative percent concordance of 94.4% (95% CI 92.3%-96.1%), 91.8% (95% CI 88.8%-94.3%), and 100% (95% CI 98.2%-100%), respectively, and a Cohen’s kappa of 0.88 (95% CI 0.85–0.90). Logistic regression confirmed better agreement with higher antibody titers. The BioMedomics COVID-19 IgM/IgG Rapid Test demonstrated good performance in measuring detectable antibodies against SARS-CoV-2, supporting the utility of such rapid point-of-care serological testing to guide the public health responses and vaccine prioritization.

KW - Research Article

KW - Medicine and health sciences

KW - Biology and life sciences

KW - Research and analysis methods

KW - People and places

U2 - 10.1371/journal.pone.0262897

DO - 10.1371/journal.pone.0262897

M3 - Article

VL - 17

JO - PLoS One

JF - PLoS One

SN - 1932-6203

IS - 1

M1 - e0262897

ER -

Assessing the performance of a serological point-of-care test in measuring detectable antibodies against SARS-CoV-2

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Keywords

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