Open AccessAssessing the performance of a serological point-of-care test in measuring detectable antibodies against SARS-CoV-2
Author(s) -
Peter Coyle,
Reham Awni El Kahlout,
Soha R. Dargham,
Hiam Chemaitelly,
Mohamed Ali Ben Hadj Kacem,
Naema Al-Mawlawi,
Imtiaz Gilliani,
Nagy Younes,
Zaina Al Kanaani,
Abdullatif Al Khal,
Einas AlKuwari,
Andrew Jeremijenko,
Anvar Hassan Kaleeckal,
Ali Nizar Latif,
Riyazuddin Mohammad Shaik,
Hanan F. Abdul Rahim,
Gheyath K. Nasrallah,
Hadi M. Yassine,
Mohamed Ghaith AlKuwari,
Hamad Eid Al Romaihi,
Patrick Tang,
Roberto Bertollini,
Mohamed H. AlThani,
Laith J Abu-Raddad
Publication year - 2022
Publication title -
plos one
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.99
H-Index - 332
ISSN - 1932-6203
DOI - 10.1371/journal.pone.0262897
Subject(s) - concordance , serology , seroprevalence , medicine , kappa , logistic regression , antibody , titer , point of care testing , antibody titer , covid-19 , cohen's kappa , immunoassay , immunology , virology , disease , infectious disease (medical specialty) , linguistics , philosophy , machine learning , computer science
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.