Enhancing the concordance of two commercial dengue IgG ELISAs by exchange of the calibrator sample.


Journal

Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology
ISSN: 1873-5967
Titre abrégé: J Clin Virol
Pays: Netherlands
ID NLM: 9815671

Informations de publication

Date de publication:
09 2019
Historique:
received: 12 02 2019
revised: 01 07 2019
accepted: 04 07 2019
pubmed: 14 7 2019
medline: 17 6 2020
entrez: 14 7 2019
Statut: ppublish

Résumé

Dengue IgG testing is being recommended before dengue vaccination. Presently, the diagnostic method of choice is the dengue IgG ELISA. Determine the test performance and concordance of two commercial dengue IgG ELISA kits. A diagnostic study to examine the sensitivity, specificity, accuracy and concordance of the Panbio Dengue Indirect IgG ELISA kit and the NovaLisa Dengue IgG ELISA kit. Sera (483) were from dengue-endemic regions in Sudan. Test performance characteristics were determined when tests were performed as indicated in the test kits and when the Panbio calibrator sample was used for both tests. The sensitivity of the Panbio and the NovaLisa ELISA was 91.1% and 99.0% and the specificity was 79.4% and 50.9%. The Panbio test was slightly more accurate (87.5% compared with 84.0%). Quantitative measurement readings of the tests correlated. The calibrator samples gave different cutoff values. Replacing the NovaLisa cutoff sample with the Panbio calibrator sample raised the accuracy of the NovaLisa assay to 88% and increased the concordance of the tests from 82.8 to 93%. The study shows that the two dengue IgG ELISAs differed clearly in sensitivity and specificity and gave discordant results for 17.2% of the sera. For the most part the discrepancy depended on the calibrator sample. The findings indicate that an optimized dengue IgG calibrator standard can enhance accuracy and concordance of commercial dengue ELISAs. An optimized standard calibrator would make dengue IgG seroprevalence testing more reliable.

Sections du résumé

BACKGROUND
Dengue IgG testing is being recommended before dengue vaccination. Presently, the diagnostic method of choice is the dengue IgG ELISA.
OBJECTIVE
Determine the test performance and concordance of two commercial dengue IgG ELISA kits.
STUDY DESIGN
A diagnostic study to examine the sensitivity, specificity, accuracy and concordance of the Panbio Dengue Indirect IgG ELISA kit and the NovaLisa Dengue IgG ELISA kit. Sera (483) were from dengue-endemic regions in Sudan. Test performance characteristics were determined when tests were performed as indicated in the test kits and when the Panbio calibrator sample was used for both tests.
RESULTS
The sensitivity of the Panbio and the NovaLisa ELISA was 91.1% and 99.0% and the specificity was 79.4% and 50.9%. The Panbio test was slightly more accurate (87.5% compared with 84.0%). Quantitative measurement readings of the tests correlated. The calibrator samples gave different cutoff values. Replacing the NovaLisa cutoff sample with the Panbio calibrator sample raised the accuracy of the NovaLisa assay to 88% and increased the concordance of the tests from 82.8 to 93%.
CONCLUSIONS
The study shows that the two dengue IgG ELISAs differed clearly in sensitivity and specificity and gave discordant results for 17.2% of the sera. For the most part the discrepancy depended on the calibrator sample. The findings indicate that an optimized dengue IgG calibrator standard can enhance accuracy and concordance of commercial dengue ELISAs. An optimized standard calibrator would make dengue IgG seroprevalence testing more reliable.

Identifiants

pubmed: 31301516
pii: S1386-6532(19)30150-7
doi: 10.1016/j.jcv.2019.07.004
pii:
doi:

Substances chimiques

Antibodies, Viral 0
Immunoglobulin G 0

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1-5

Informations de copyright

Copyright © 2019 Elsevier B.V. All rights reserved.

Auteurs

Tom Schüttoff (T)

Institute for Virology, University Clinics and Medical Faculty, University of Leipzig, 04103 Leipzig, Germany.

Awadalkareem Adam (A)

Institute for Virology, University Clinics and Medical Faculty, University of Leipzig, 04103 Leipzig, Germany.

Sven Reiche (S)

Institute for Virology, University Clinics and Medical Faculty, University of Leipzig, 04103 Leipzig, Germany.

Christian Jassoy (C)

Institute for Virology, University Clinics and Medical Faculty, University of Leipzig, 04103 Leipzig, Germany. Electronic address: Christian.jassoy@medizin.uni-leipzig.de.

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Classifications MeSH