Evaluation of the Truvian Easy Check COVID-19 IgM/IgG Lateral Flow Device for Rapid Anti-SARS-CoV-2 Antibody Detection.
COVID-19
Coronavirus
Diagnostics
IgG
IgM
Lateral flow
Point-of-care
SARS-CoV-2 antibodies
Surveillance
Journal
American journal of clinical pathology
ISSN: 1943-7722
Titre abrégé: Am J Clin Pathol
Pays: England
ID NLM: 0370470
Informations de publication
Date de publication:
04 02 2021
04 02 2021
Historique:
pubmed:
3
11
2020
medline:
3
3
2021
entrez:
2
11
2020
Statut:
ppublish
Résumé
To evaluate the analytical and clinical performance of the Truvian Easy Check coronavirus disease 2019 (COVID-19) IgM/IgG anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody test.Serologic assays have become increasingly available for surveillance through the Food and Drug Administration emergency use authorization in the ongoing COVID-19 global pandemic. However, widespread application of serologic assays has been curbed by reports of faulty or inaccurate tests. Therefore, rapid COVID-19 antibody tests need to be thoroughly validated prior to their implementation. The Easy Check device was analytically evaluated and its performance was compared with the Roche Elecsys anti-SARS-CoV-2 antibody assay. The test was further characterized for cross-reactivity using sera obtained from patients infected by other viruses. Clinical performance was analyzed with polymerase chain reaction-confirmed samples and a 2015 prepandemic reference sample set. The Easy Check device showed excellent analytical performance and compares well with the Roche Elecsys antibody assay, with an overall concordance of 98.6%. Clinical performance showed a sensitivity of 96.6%, a specificity of 98.2%, and an overall accuracy of 98.1%. The Easy Check device is a simple, reliable, and rapid test for detection of SARS-CoV-2 seropositivity, and its performance compares favorably against the automated Roche Elecsys antibody assay.
Identifiants
pubmed: 33135049
pii: 5948895
doi: 10.1093/ajcp/aqaa221
pmc: PMC7665287
doi:
Substances chimiques
Antibodies, Viral
0
Immunoglobulin G
0
Immunoglobulin M
0
Types de publication
Evaluation Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
286-295Informations de copyright
© American Society for Clinical Pathology, 2020. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.
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