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 -