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Comparison of two commercial and one in-house real-time PCR assays for the diagnosis of bacterial gastroenteritis
INTRODUCTION: The aim of the study was a comparative evaluation of in-house real-time PCR and commercial real-time PCR (Fast Track Diagnostics (FTD), ampliCube/Mikrogen) targeting enteropathogenic bacteria from stool in preparation of Regulation (EU) 2017/746 on in vitro diagnostic medical devices....
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Akadémiai Kiadó
2020
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7753976/ https://www.ncbi.nlm.nih.gov/pubmed/33279885 http://dx.doi.org/10.1556/1886.2020.00030 |
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author | TANIDA, KONSTANTIN HAHN, ANDREAS FRICKMANN, HAGEN |
author_facet | TANIDA, KONSTANTIN HAHN, ANDREAS FRICKMANN, HAGEN |
author_sort | TANIDA, KONSTANTIN |
collection | PubMed |
description | INTRODUCTION: The aim of the study was a comparative evaluation of in-house real-time PCR and commercial real-time PCR (Fast Track Diagnostics (FTD), ampliCube/Mikrogen) targeting enteropathogenic bacteria from stool in preparation of Regulation (EU) 2017/746 on in vitro diagnostic medical devices. METHODS: Both 241 stool samples from patients and 100 samples from German laboratory control schemes (“Ringversuche”) were used to comparatively assess in-house real-time PCR, the FTD bacterial gastroenteritis kit, and the ampliCube gastrointestinal bacterial panels 1&2 either with the in-house PCRs as gold standard and as a test comparison without gold standard applying latent class analysis. Sensitivity, specificity, intra- and inter-assay variation and Cohen’s kappa were assessed. RESULTS: In comparison with the gold standard, sensitivity was 75–100% for strongly positive samples, 20–100% for weakly positive samples, and specificity ranged from 96 to 100%. Latent class analysis suggested that sensitivity ranges from 81.2 to 100% and specificity from 58.5 to 100%. Cohen’s kappa varied between moderate and nearly perfect agreement, intra- and inter-assay variation was 1–3 to 1–4 Ct values. CONCLUSION: Acceptable agreement and performance characteristics suggested replaceability of the in-house PCR assays by the commercial approaches. |
format | Online Article Text |
id | pubmed-7753976 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Akadémiai Kiadó |
record_format | MEDLINE/PubMed |
spelling | pubmed-77539762021-01-06 Comparison of two commercial and one in-house real-time PCR assays for the diagnosis of bacterial gastroenteritis TANIDA, KONSTANTIN HAHN, ANDREAS FRICKMANN, HAGEN Eur J Microbiol Immunol (Bp) Original Research Paper INTRODUCTION: The aim of the study was a comparative evaluation of in-house real-time PCR and commercial real-time PCR (Fast Track Diagnostics (FTD), ampliCube/Mikrogen) targeting enteropathogenic bacteria from stool in preparation of Regulation (EU) 2017/746 on in vitro diagnostic medical devices. METHODS: Both 241 stool samples from patients and 100 samples from German laboratory control schemes (“Ringversuche”) were used to comparatively assess in-house real-time PCR, the FTD bacterial gastroenteritis kit, and the ampliCube gastrointestinal bacterial panels 1&2 either with the in-house PCRs as gold standard and as a test comparison without gold standard applying latent class analysis. Sensitivity, specificity, intra- and inter-assay variation and Cohen’s kappa were assessed. RESULTS: In comparison with the gold standard, sensitivity was 75–100% for strongly positive samples, 20–100% for weakly positive samples, and specificity ranged from 96 to 100%. Latent class analysis suggested that sensitivity ranges from 81.2 to 100% and specificity from 58.5 to 100%. Cohen’s kappa varied between moderate and nearly perfect agreement, intra- and inter-assay variation was 1–3 to 1–4 Ct values. CONCLUSION: Acceptable agreement and performance characteristics suggested replaceability of the in-house PCR assays by the commercial approaches. Akadémiai Kiadó 2020-12-05 /pmc/articles/PMC7753976/ /pubmed/33279885 http://dx.doi.org/10.1556/1886.2020.00030 Text en © 2020, The Author(s) https://creativecommons.org/licenses/by-nc/4.0/ Open Access. This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (https://creativecommons.org/licenses/by-nc/4.0/), which permits unrestricted use, distribution, and reproduction in any medium for non-commercial purposes, provided the original author and source are credited, a link to the CC License is provided, and changes - if any – are indicated. |
spellingShingle | Original Research Paper TANIDA, KONSTANTIN HAHN, ANDREAS FRICKMANN, HAGEN Comparison of two commercial and one in-house real-time PCR assays for the diagnosis of bacterial gastroenteritis |
title | Comparison of two commercial and one in-house real-time PCR assays for the diagnosis of bacterial gastroenteritis |
title_full | Comparison of two commercial and one in-house real-time PCR assays for the diagnosis of bacterial gastroenteritis |
title_fullStr | Comparison of two commercial and one in-house real-time PCR assays for the diagnosis of bacterial gastroenteritis |
title_full_unstemmed | Comparison of two commercial and one in-house real-time PCR assays for the diagnosis of bacterial gastroenteritis |
title_short | Comparison of two commercial and one in-house real-time PCR assays for the diagnosis of bacterial gastroenteritis |
title_sort | comparison of two commercial and one in-house real-time pcr assays for the diagnosis of bacterial gastroenteritis |
topic | Original Research Paper |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7753976/ https://www.ncbi.nlm.nih.gov/pubmed/33279885 http://dx.doi.org/10.1556/1886.2020.00030 |
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