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

Autor: Coyle PV; Hamad Medical Corporation, Doha, Qatar.; Biomedical Research Center, Qatar University, Doha, Qatar.; Wellcome-Wolfson Institute for Experimental Medicine, Queens University, Belfast, United Kingdom., El Kahlout RA; Hamad Medical Corporation, Doha, Qatar., Dargham SR; Infectious Disease Epidemiology Group, Weill Cornell Medicine-Qatar, Cornell University, Qatar Foundation - Education City, Doha, Qatar.; World Health Organization Collaborating Centre for Disease Epidemiology Analytics on HIV/AIDS, Sexually Transmitted Infections, and Viral Hepatitis, Weill Cornell Medicine-Qatar, Cornell University, Qatar Foundation - Education City, Doha, Qatar., Chemaitelly H; Infectious Disease Epidemiology Group, Weill Cornell Medicine-Qatar, Cornell University, Qatar Foundation - Education City, Doha, Qatar.; World Health Organization Collaborating Centre for Disease Epidemiology Analytics on HIV/AIDS, Sexually Transmitted Infections, and Viral Hepatitis, Weill Cornell Medicine-Qatar, Cornell University, Qatar Foundation - Education City, Doha, Qatar., Kacem MABH; Hamad Medical Corporation, Doha, Qatar., Al-Mawlawi NHA; Hamad Medical Corporation, Doha, Qatar., Gilliani I; Hamad Medical Corporation, Doha, Qatar., Younes N; Hamad Medical Corporation, Doha, Qatar., Al Kanaani Z; Hamad Medical Corporation, Doha, Qatar., Al Khal A; Hamad Medical Corporation, Doha, Qatar., Al Kuwari E; Hamad Medical Corporation, Doha, Qatar., Jeremijenko A; Hamad Medical Corporation, Doha, Qatar., Kaleeckal AH; Hamad Medical Corporation, Doha, Qatar., Latif AN; Hamad Medical Corporation, Doha, Qatar., Shaik RM; Hamad Medical Corporation, Doha, Qatar., Rahim HFA; College of Health Sciences, QU Health, Qatar University, Doha, Qatar., Nasrallah GK; Biomedical Research Center, Qatar University, Doha, Qatar.; Department of Biomedical Science, College of Health Sciences, Member of QU Health, Qatar University, Doha, Qatar., Yassine HM; Biomedical Research Center, Qatar University, Doha, Qatar.; Department of Biomedical Science, College of Health Sciences, Member of QU Health, Qatar University, Doha, Qatar., Al Kuwari MG; Primary Health Care Corporation, Doha, Qatar., Al Romaihi HE; Ministry of Public Health, Doha, Qatar., Tang P; Department of Pathology, Sidra Medicine, Doha, Qatar., Bertollini R; Ministry of Public Health, Doha, Qatar., Al-Thani MH; Ministry of Public Health, Doha, Qatar., Abu-Raddad LJ; Infectious Disease Epidemiology Group, Weill Cornell Medicine-Qatar, Cornell University, Qatar Foundation - Education City, Doha, Qatar.; World Health Organization Collaborating Centre for Disease Epidemiology Analytics on HIV/AIDS, Sexually Transmitted Infections, and Viral Hepatitis, Weill Cornell Medicine-Qatar, Cornell University, Qatar Foundation - Education City, Doha, Qatar.; Department of Population Health Sciences, Weill Cornell Medicine, Cornell University, New York, New York, United States of America.
Jazyk: angličtina
Zdroj: PloS one [PLoS One] 2022 Jan 31; Vol. 17 (1), pp. e0262897. Date of Electronic Publication: 2022 Jan 31 (Print Publication: 2022).
DOI: 10.1371/journal.pone.0262897
Abstrakt: 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.
Competing Interests: The authors have declared that no competing interests exist.
Databáze: MEDLINE
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