Longitudinal Monitoring of SARS-CoV-2 IgM and IgG Seropositivity to Detect COVID-19.

The Journal of Applied Laboratory Medicine
R. T. SuhandynataRobert Fitzgerald

Abstract

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is a novel beta-coronavirus that has recently emerged as the cause of the 2019 coronavirus pandemic (COVID-19). Polymerase chain reaction (PCR) based tests are optimal and recommended for the diagnosis of an acute SARS-CoV-2 infection. Serology tests for viral antibodies provide an important tool to diagnose previous exposure to the virus. Here we evaluate the analytical performance parameters of the Diazyme SARS-CoV-2 IgM/IgG serology assays and describe the kinetics of IgM and IgG seroconversion observed in patients with PCR-confirmed COVID-19 who were admitted to our hospital. We validated the performance of the Diazyme assay in 235 presumed SARS-CoV-2 negative subjects to determine specificity. Subsequently, we evaluated the SARS-CoV-2 IgM and IgG seroconversion of 54 PCR-confirmed COVID-19 patients and determined sensitivity of the assay at three different timeframes. Sensitivity and specificity for detecting seropositivity at ≥15 days following a positive SARS-CoV-2 PCR result, was 100.0% and 98.7% when assaying for the panel of IgM and IgG. The median time to seropositivity observed for a reactive IgM and IgG result from the date of a positive PCR was 5 days (...Continue Reading

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Citations

Jul 16, 2020·Journal of Medical Virology·Marie Tré-HardyLaurent Blairon
Jul 28, 2020·The Journal of Applied Laboratory Medicine·Anna E MerrillMatthew D Krasowski
Aug 5, 2020·The Journal of Applied Laboratory Medicine·Thessicar Antoine-ReidJonathan E Schmitz
Jul 28, 2020·International Journal of Molecular Sciences·Alessandra FierabracciPaolo Rossi
Sep 11, 2020·International Journal of Environmental Research and Public Health·Meiling QiCindy Jones
Jun 26, 2020·American Journal of Clinical Pathology·Andrea P EspejoCarolyn Cray
Sep 26, 2020·The Analyst·Surasak KasetsirikulNam-Trung Nguyen
Jul 28, 2020·The Journal of Applied Laboratory Medicine·C S LauT C Aw
Aug 9, 2020·The Journal of Applied Laboratory Medicine·Raymond T SuhandynataRobert L Fitzgerald
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Nov 11, 2020·Biochemical Society Transactions·Jiayue-Clara Jiang, Yan Zhang
Sep 26, 2020·The Journal of Applied Laboratory Medicine·Jacqueline A HubbardRobert D Nerenz
Oct 22, 2020·Clinical Chemistry·Raymond T SuhandynataRobert L Fitzgerald
Jan 22, 2021·Clinical Biochemistry·Victoria HigginsVathany Kulasingam
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Jun 26, 2021·The Journal of Applied Laboratory Medicine·Raymond T SuhandynataRobert L Fitzgerald

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