Tags

Type your tag names separated by a space and hit enter

Longitudinal Monitoring of SARS-CoV-2 IgM and IgG Seropositivity to Detect COVID-19.
J Appl Lab Med. 2020 09 01; 5(5):908-920.JA

Abstract

BACKGROUND

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.

METHODS

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.

RESULT

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 (IQR: 2.75-9 days) and 4 days (IQR: 2.75-6.75 days), respectively.

CONCLUSIONS

Our data demonstrate that the Diazyme IgM/IgG assays are suited for the purpose of detecting SARS-CoV-2 IgG and IgM in patients with suspected SARS-CoV-2 infections. For the first time, we report longitudinal data showing the evolution of seroconversion for both IgG and IgM in a cohort of acutely ill patients in the United States. We also demonstrate a low false positive rate in patients who were presumed to be disease free.

Authors+Show Affiliations

Department of Pathology UC, San Diego Health, San Diego, CA.Department of Pathology UC, San Diego Health, San Diego, CA.Department of Pathology UC, San Diego Health, San Diego, CA.Department of Pathology UC, San Diego Health, San Diego, CA.Department of Pathology UC, San Diego Health, San Diego, CA.Department of Pathology UC, San Diego Health, San Diego, CA.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32428207

Citation

Suhandynata, Raymond T., et al. "Longitudinal Monitoring of SARS-CoV-2 IgM and IgG Seropositivity to Detect COVID-19." The Journal of Applied Laboratory Medicine, vol. 5, no. 5, 2020, pp. 908-920.
Suhandynata RT, Hoffman MA, Kelner MJ, et al. Longitudinal Monitoring of SARS-CoV-2 IgM and IgG Seropositivity to Detect COVID-19. J Appl Lab Med. 2020;5(5):908-920.
Suhandynata, R. T., Hoffman, M. A., Kelner, M. J., McLawhon, R. W., Reed, S. L., & Fitzgerald, R. L. (2020). Longitudinal Monitoring of SARS-CoV-2 IgM and IgG Seropositivity to Detect COVID-19. The Journal of Applied Laboratory Medicine, 5(5), 908-920. https://doi.org/10.1093/jalm/jfaa079
Suhandynata RT, et al. Longitudinal Monitoring of SARS-CoV-2 IgM and IgG Seropositivity to Detect COVID-19. J Appl Lab Med. 2020 09 1;5(5):908-920. PubMed PMID: 32428207.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Longitudinal Monitoring of SARS-CoV-2 IgM and IgG Seropositivity to Detect COVID-19. AU - Suhandynata,Raymond T, AU - Hoffman,Melissa A, AU - Kelner,Michael J, AU - McLawhon,Ronald W, AU - Reed,Sharon L, AU - Fitzgerald,Robert L, PY - 2020/04/21/received PY - 2020/05/11/accepted PY - 2020/5/20/pubmed PY - 2020/9/24/medline PY - 2020/5/20/entrez KW - COVID-19 KW - SARS-CoV-2 KW - antibody KW - diagnosis KW - serology SP - 908 EP - 920 JF - The journal of applied laboratory medicine JO - J Appl Lab Med VL - 5 IS - 5 N2 - BACKGROUND: 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. METHODS: 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. RESULT: 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 (IQR: 2.75-9 days) and 4 days (IQR: 2.75-6.75 days), respectively. CONCLUSIONS: Our data demonstrate that the Diazyme IgM/IgG assays are suited for the purpose of detecting SARS-CoV-2 IgG and IgM in patients with suspected SARS-CoV-2 infections. For the first time, we report longitudinal data showing the evolution of seroconversion for both IgG and IgM in a cohort of acutely ill patients in the United States. We also demonstrate a low false positive rate in patients who were presumed to be disease free. SN - 2576-9456 UR - https://www.unboundmedicine.com/medline/citation/32428207/Longitudinal_Monitoring_of_SARS_CoV_2_IgM_and_IgG_Seropositivity_to_Detect_COVID_19_ L2 - http://jalm.aaccjnls.org/cgi/pmidlookup?view=long&pmid=32428207 DB - PRIME DP - Unbound Medicine ER -