Practical Considerations for Implementation of SARS-CoV-2 Serological Testing in the Clinical Laboratory: Experience at an Academic Medical Center.

SARS-CoV-2 antibodies immunoglobulin G immunoglobulin M serology utilization

Journal

Academic pathology
ISSN: 2374-2895
Titre abrégé: Acad Pathol
Pays: United States
ID NLM: 101698648

Informations de publication

Date de publication:
Historique:
received: 16 01 2021
revised: 16 01 2021
accepted: 06 02 2021
entrez: 23 4 2021
pubmed: 24 4 2021
medline: 24 4 2021
Statut: epublish

Résumé

Molecular techniques, especially reverse transcriptase polymerase chain reaction (RT-PCR), have been the gold standard for the diagnosis of acute severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection. Serological tests for SARS-CoV-2 have been widely used for serosurveys, epidemiology, and identification of potential convalescent plasma donors. However, the clinical role of serologic testing is still limited and evolving. In this report, we describe the experience of selecting, validating, and implementing SARS-CoV-2 serologic testing for clinical purposes at an academic medical center in a rural state. Successful implementation involved close collaboration between pathology, infectious diseases, and outpatient clinics. The most common clinician concerns were appropriateness/utility of testing, patient charges/insurance coverage, and assay specificity. In analyzing test utilization, serologic testing in the first month after go-live was almost entirely outpatient and appeared to be strongly driven by patient interest (including health care workers and others in high-risk occupations for exposure to SARS-CoV-2), with little evidence that the results impacted clinical decision-making. Test volumes for serology declined steadily through October 31, 2020, with inpatient ordering assuming a steadily higher percentage of the total. In a 5-month period, SARS-CoV-2 serology test volumes amounted to only 1.3% of that of reverse transcriptase polymerase chain reaction. Unlike reverse transcriptase polymerase chain reaction, supply chain challenges and reagent availability were not major issues for serology testing. We also discuss the most recent challenge of requirements for SARS-CoV-2 testing in international travel protocols. Overall, our experience at an academic medical center shows that SARS-CoV-2 serology testing assumed a limited clinical role.

Identifiants

pubmed: 33889715
doi: 10.1177/23742895211002802
pii: S2374-2895(21)00006-3
pmc: PMC8040556
doi:

Types de publication

Journal Article

Langues

eng

Pagination

23742895211002802

Informations de copyright

© The Author(s) 2021.

Déclaration de conflit d'intérêts

Declaration of Conflicting Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

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Auteurs

Robert M Humble (RM)

Department of Pathology, University of Iowa Hospitals and Clinics, Iowa City, IA, USA.

Anna E Merrill (AE)

Department of Pathology, University of Iowa Hospitals and Clinics, Iowa City, IA, USA.

Bradley A Ford (BA)

Department of Pathology, University of Iowa Hospitals and Clinics, Iowa City, IA, USA.

Daniel J Diekema (DJ)

Department of Pathology, University of Iowa Hospitals and Clinics, Iowa City, IA, USA.
Division of Infectious Diseases, Department of Internal Medicine, University of Iowa Hospitals and Clinics, Iowa City, IA, USA.

Matthew D Krasowski (MD)

Department of Pathology, University of Iowa Hospitals and Clinics, Iowa City, IA, USA.

Classifications MeSH