High clinical performance and quantitative assessment of antibody kinetics using a dual recognition assay for the detection of SARS-CoV-2 IgM and IgG antibodies |
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| Affiliation: | 1. Department of Laboratory Medicine, Cliniques Universitaires St-Luc and Université catholique de Louvain, Brussels, Belgium;2. Department of Laboratory Medicine, Clinique St-Luc Bouge, Namur, Belgium;3. Department of Pharmacy, Namur Research Institute for LIfes Sciences, University of Namur, Belgium;4. Department of Laboratory Medicine, Iris Hospitals South, Brussels, Belgium;5. Faculty of Medicine, Université libre de Bruxelles, Brussels, Belgium;6. Department of Laboratory Medicine, Saint Nikolaus Hospital, Eupen, Belgium;7. Qualiblood sa, Namur, Belgium;1. Department of Pathology, University of Utah School of Medicine, Salt Lake City, UT, United States;2. ARUP Institute for Clinical and Experimental Pathology, Salt Lake City, UT, United States;1. Department of Pathology and Laboratory Medicine, Weill Cornell Medicine, New York, NY, USA;2. New York-Presbyterian Hospital, Weill Cornell Medicine, New York, NY, USA;3. Department of Emergency Medicine, Weill Cornell Medicine, New York, NY, USA;4. Department of Pathology, The Ohio State University Wexner Medical Center, Columbus, OH, USA;5. Departments of Laboratory Medicine and Pathology, Hennepin Healthcare/Hennepin County Medical Center and University of Minnesota, Minneapolis, MN, USA;1. Department of Medical Biochemistry, Cerrahpasa Faculty of Medicine, Istanbul University-Cerrahpasa, Istanbul, Turkey;2. Department of Cardiology, Cerrahpasa Faculty of Medicine, Istanbul University-Cerrahpasa, Istanbul, Turkey;3. Department of Physiology, Cerrahpasa Faculty of Medicine, Istanbul University-Cerrahpasa, Istanbul, Turkey;4. Department of Public Health, Cerrahpasa Faculty of Medicine, Istanbul University-Cerrahpasa, Istanbul, Turkey;1. Hazrat Aliasghar Children’s Hospital, Iran University of Medical Sciences, Tehran, Iran;2. Metabolic Disorders Research Center, Endocrinology and Metabolism Molecular-Cellular Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran;3. Department of Biochemistry, School of Medicine, Iran University of Medical Sciences, Tehran, Iran;4. Department of Medical Genetics and Molecular Biology, Faculty of Medicine, Iran University of Medical Sciences, Tehran, Iran;5. Computer Engineering Department, Sharif University of Technology, Tehran, Iran;6. PardisGene Company, Tehran, Iran;7. Department of Medical Genetics, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran |
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| Abstract: | ObjectivesSeveral serological SARS-CoV-2 immunoassays have been developed recently but require external validation before widespread use. This study aims at assessing the analytical and clinical performance of the iFlash® anti-SARS-CoV-2 chemiluminescence assay for the detection of both IgM and IgG antibodies. The kinetics of the antibody response was also evaluated.Design & MethodsThe precision, carry-over, linearity, limit of blank, detection and quantification were assessed. Sensitivity analysis was performed by using 178 sera collected from 154 RT-PCR confirmed COVID-19 patients. The specificity analysis was performed from 75 selected non-SARS-CoV-2 sera with a potential cross-reaction to the SARS-CoV-2 immunoassay.ResultsThis iFlash® SARS-CoV-2 assay showed excellent analytical performance. After 2 weeks since symptom onset, the sensitivities for IgM and IgG were 62.2% (95% CI: 52.3–71.2%) and 92.9%% (95% CI: 85.7–96.7%), respectively by using the cut-off provided by the manufacturer. After cut-off optimization (i.e. >2.81 for IgM and >4.86 for IgG), the sensitivity for IgM and IgG were 81.6 (95% CI: 72.7–88.1%) and 95.9% (95% CI: 89.4–98.7%), respectively. Optimized cut-off for IgG improved the sensitivity to reach 100% (95%CI: 87.6–100) from 28 days since symptom onset.ConclusionsThis study shows that the iFlash® SARS-CoV-2 assay from YHLO biotechnology, has satisfactory analytical performance. Nevertheless, the sensitivity of the IgM is limited for a proper clinical use compared to IgG. The determination of anti-SARS-CoV-2 IgG antibodies from 28 days since symptom onset was associated with high sensitivity, especially using optimized cut-offs (i.e. 100%). |
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| Keywords: | COVID-19 SARS-CoV-2 Serology Kinetics Symptom onset |
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