• Gabriel N Maine, Kriselle Maris Lao, Subhashree Mallika Krishnan, Olabisi Afolayan-Oloye, Seyedalireza Fatemi, Sandeep Kumar, Lindsay VanHorn, Ashley Hurand, Elizabeth Sykes, and Qian Sun.
• Department of Pathology and Laboratory Medicine, Beaumont Health, Royal Oak, MI, USA; Department of Pathology and Laboratory Medicine, Oakland University William Beaumont School of Medicine, Auburn Hills, MI, USA. Electronic address: Gabriel.Maine@beaumont.edu.
• J. Clin. Virol. 2020 Dec 1; 133: 104663.

BackgroundAntibody testing has recently emerged as an option to assist with determining exposure to SARS-CoV-2, the causative agent of COVID-19. Elucidation of the kinetics and duration of the humoral response is important for clinical management and interpreting results from serological surveys.ObjectivesHere we evaluated the clinical performance of Abbott SARS-CoV-2 IgM and IgG assays, as well as the longitudinal dynamics of the antibody response in symptomatic COVID-19 patients.Study Design And ResultsThe diagnostic specificity was 100 % for IgM and 99.67 % for IgG using 300 pre-COVID-19 serum specimens. Using 1349 sequential serum samples collected up to 168 days post symptom onset from 427 PCR-confirmed individuals, clinical test sensitivity of the SARS-CoV-2 IgM assay was 24.6 % at ≤7 days, 75.3 % at 8-14 days, 95.0 % at 15-21 days, and 96.0 % at 4-5 weeks (peak test sensitivity). The median duration of time for IgM seroconversion was 10 days. IgM levels declined steadily 4-5 weeks after symptom onset, and the positive rate dropped to 30.8 % at >3 months. The diagnostic sensitivity for the SARS-CoV-2 IgG assay post symptom onset was 23.2 % at ≤7 days, 69.5 % at 8-14 days, 93.6 % at 15-21 days, and 99.6 % at 4-5 weeks (peak test sensitivity). The median duration of time for IgG seroconversion was 11.5 days. During the convalescent phase of the infection, a decline in the IgG level was observed in patients who were followed for >100 days. Despite that decline, 92.3 % of the patient cohort remained IgG positive 3-6 months following symptom onset.ConclusionsThis study demonstrates the Abbott IgM assay against SARS-CoV-2 is detected slightly earlier compared to IgG, with both tests exhibiting excellent overall sensitivity and specificity. In symptomatic patients who test negative by PCR for a SARS-CoV-2 infection, assessing IgM and IgG antibodies can aid in supporting a diagnosis of COVID-19.Copyright © 2020 Elsevier B.V. All rights reserved.

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