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

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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 languageEnglish
Article numbere0262897
JournalPLoS ONE
Issue number1
Publication statusPublished - 31 Jan 2022


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


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