Performance of a Point of Care Test for Detecting IgM and IgG Antibodies Against SARS-CoV-2 and Seroprevalence in Blood Donors and Health Care Workers in Panama

Centro de Biología Celular y Molecular de las Enfermedades, City of Knowledge, Instituto de Investigaciones Científicas y Servicios de Alta Tecnología (INDICASAT-AIP), Panama City, Panama. Institute of Biophysics, Chinese Academy of Sciences, Beijing, China. Beijing Zhongke Jianlan Biotechnology Co. Ltd., Beijing, China. Zhongke Jianlan International Medical Research Institute, Melbourne, VIC, Australia. Escuela de Psicología, Universidad Santa María La Antigua, Panama City, Panama. Facultad de Medicina, Universidad de Panamá, Panama City, Panama. Centro de Neurociencia, Instituto de Investigaciones Científicas y Servicios de Alta Tecnología, AIP (INDICASAT AIP), Panama City, Panama. Department of Research in Virology and Biotechnology, Gorgas Memorial Institute of Health Studies, Panama City, Panama. Department of Research in Surveillance and Biologic Risk 3, Gorgas Memorial Institute of Health Studies, Panama City, Panama. Beijing Kewei Clinical Diagnostic Reagent Inc., Beijing, China. Centro de Vacunación e Investigación, Centro de Vacunación e Investigación Panama Clinic, Panama City, Panama. Medical Research Center, Pacifica Salud, Hospital Punta Pacifica, Panama City, Panama. Departamento de Microbiología Humana/Inmunología, Facultad de Medicina, Universidad de Panamá, Panama City, Panama. Servicio de Neurología. Complejo Hospitalario Dr. AAM, Universidad Nacional de Panamá, Panama City, Panama. Complejo Hospitalario Metropolitano Dr. Arnulfo Arias Madrid, Caja de Seguro Social, Panama City, Panama. Servicio de Hematología. Complejo Hospitalario Metropolitano Dr. Arnulfo Arias Madrid, Caja de Seguro Social, Panama City, Panama. Compleo Hospitalario Manuel Amador Guerrero, Caja de Seguro Social, Colón, Panama. Servicio de Hematología, Banco de Sangre. Complejo Hospitalario Metropolitano Dr. Arnulfo Arias Madrid, Caja de Seguro Social, Panama City, Panama. Dirección Nacional de Laboratorios Clínicos, Ministerio de Salud, Panama City, Panama. GlaxoSmithKline Vaccines, City of Knowledge, Panama City, Panama.

Frontiers in Medicine. 2021;8:616106
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Abstract
Novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the etiologic agent of the ongoing coronavirus disease 2019 (COVID-19) pandemic, which has reached 28 million cases worldwide in 1 year. The serological detection of antibodies against the virus will play a pivotal role in complementing molecular tests to improve diagnostic accuracy, contact tracing, vaccine efficacy testing, and seroprevalence surveillance. Here, we aimed first to evaluate a lateral flow assay's ability to identify specific IgM and IgG antibodies against SARS-CoV-2 and second, to report the seroprevalence estimates of these antibodies among health care workers and healthy volunteer blood donors in Panama. We recruited study participants between April 30th and July 7th, 2020. For the test validation and performance evaluation, we analyzed serum samples from participants with clinical symptoms and confirmed positive RT-PCR for SARS-CoV-2, and a set of pre-pandemic serum samples. We used two by two table analysis to determine the test positive and negative percentage agreement as well as the Kappa agreement value with a 95% confidence interval. Then, we used the lateral flow assay to determine seroprevalence among serum samples from COVID-19 patients, potentially exposed health care workers, and healthy volunteer donors. Our results show this assay reached a positive percent agreement of 97.2% (95% CI 84.2-100.0%) for detecting both IgM and IgG. The assay showed a Kappa of 0.898 (95%CI 0.811-0.985) and 0.918 (95% CI 0.839-0.997) for IgM and IgG, respectively. The evaluation of serum samples from hospitalized COVID-19 patients indicates a correlation between test sensitivity and the number of days since symptom onset; the highest positive percent agreement [87% (95% CI 67.0-96.3%)] was observed at ≥15 days post-symptom onset (PSO). We found an overall antibody seroprevalence of 11.6% (95% CI 8.5-15.8%) among both health care workers and healthy blood donors. Our findings suggest this lateral flow assay could contribute significantly to implementing seroprevalence testing in locations with active community transmission of SARS-CoV-2.
Study details
Language : eng
Credits : Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine