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Clinical Performance of A Semi-Quantitative Assay for SARS-CoV2 IgG and SARS-CoV2 IgM Antibodies.

Authors
  • Jung, Joanna1
  • Garnett, Emily1
  • Jariwala, Purviben2
  • Pham, Hue2
  • Huang, Rongrong3
  • Benzi, Eduardo3
  • Issaq, Niveen3
  • Matzuk, Martin3
  • Singh, Ila1
  • Devaraj, Sridevi4
  • 1 Department of Pathology & Immunology, Baylor College of Medicine, Houston, TX 77030; Section of Clinical Chemistry, Division of Laboratory Medicine, Department of Pathology, Texas Children's Hospital, Houston, TX 77030.
  • 2 Section of Clinical Chemistry, Division of Laboratory Medicine, Department of Pathology, Texas Children's Hospital, Houston, TX 77030.
  • 3 Department of Pathology & Immunology, Baylor College of Medicine, Houston, TX 77030.
  • 4 Department of Pathology & Immunology, Baylor College of Medicine, Houston, TX 77030; Section of Clinical Chemistry, Division of Laboratory Medicine, Department of Pathology, Texas Children's Hospital, Houston, TX 77030. Electronic address: [email protected]
Type
Published Article
Journal
Clinica chimica acta; international journal of clinical chemistry
Publication Date
Sep 18, 2020
Identifiers
DOI: 10.1016/j.cca.2020.09.023
PMID: 32956703
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

While the diagnosis of SARS-CoV-2 infection is primarily based on detection of viral RNA, the detection of SARS-CoV-2 antibodies is useful for assessing past prevalence of the disease, and in corroborating a current infection in challenging cases. Sensitive and specific immunoassays provide the ability to identify exposure to SARS-CoV-2, to determine seroconversion, to confirm eligibility for donation of convalescent plasma as well as play an essential part in epidemiological studies. We report on the validation of the Ansh Laboratories SARS-CoV-2 IgG and SARS-CoV-2 IgM ELISA immunoassays. These assays were evaluated for detection of anti-SARS-CoV-2 IgG and IgM antibodies for clinical use in our hospital as part of an orthogonal testing algorithm recommended by the CDC. Diagnostic specificity and sensitivity of the IgG and IgM ELISA assays were tested using samples confirmed to be negative or positive for COVID-19 by RT-PCR. We also evaluated precision, analytical interference, and cross-reactivity with known cases of infection with other viruses. Additionally, we validated concordance with molecular and other serological testing and evaluated seroconversion in our patient population. The IgG and IgM ELISA assays showed acceptable precision, were robust to analytical interference and did not exhibit cross reactivity with specimens positive for common respiratory viruses. Both assays exhibited 95% agreement with a primary screening serological assay utilized at our institution as well as with a reference laboratory semi-quantitative method. Concordance with RT-PCR was excellent >6 days after symptom onset (100%). The Ansh SARS-CoV-2 ELISA assays have good analytical performance suitable for clinical use. Copyright © 2020 Elsevier B.V. All rights reserved.

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