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Development and Validation of an Ultrasensitive Procalcitonin Sandwich Immunoassay

Procalcitonin (PCT) is well established as a highly specific biomarker for the detection of bacterial infections and sepsis. However, the currently available diagnostic tests are not able to detect very low or very early increases of PCT or even baseline levels in healthy individuals or patients wit...

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Autores principales: Carcamo Yañez, Viviana A., Göpfert, Jens C., Otto, Markus, Tumani, Hayrettin, Peter, Andreas, Joos, Thomas O.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5748597/
https://www.ncbi.nlm.nih.gov/pubmed/29479055
http://dx.doi.org/10.3390/ht6040018
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author Carcamo Yañez, Viviana A.
Göpfert, Jens C.
Otto, Markus
Tumani, Hayrettin
Peter, Andreas
Joos, Thomas O.
author_facet Carcamo Yañez, Viviana A.
Göpfert, Jens C.
Otto, Markus
Tumani, Hayrettin
Peter, Andreas
Joos, Thomas O.
author_sort Carcamo Yañez, Viviana A.
collection PubMed
description Procalcitonin (PCT) is well established as a highly specific biomarker for the detection of bacterial infections and sepsis. However, the currently available diagnostic tests are not able to detect very low or very early increases of PCT or even baseline levels in healthy individuals or patients with non-bacterial infections. In order to be able to detect these very low concentrations of PCT, a sandwich immunoassay was developed using high sensitivity Single Molecule Array technology (Simoa). The assay was thoroughly validated and applied to analyze human cerebrospinal fluid (CSF) and serum samples from patients with bacterial or viral meningitis as well as CSF, serum, and K2 EDTA plasma from healthy control subjects. A 50-fold increase in sensitivity compared to the current gold standard assays was achieved, which was sensitive enough for the detection of baseline PCT levels. Both serum and CSF showed significantly elevated PCT levels in patients with bacterial meningitis compared to patients with viral meningitis and the healthy control group. Procalcitonin concentration levels for patients with viral meningitis and the control group could be measured, but were not significantly different. The determination of PCT in the low pg·mL(−1) range could help to improve the monitoring of bacterial infectious diseases, as PCT level changes could be detected earlier.
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spelling pubmed-57485972018-01-07 Development and Validation of an Ultrasensitive Procalcitonin Sandwich Immunoassay Carcamo Yañez, Viviana A. Göpfert, Jens C. Otto, Markus Tumani, Hayrettin Peter, Andreas Joos, Thomas O. High Throughput Article Procalcitonin (PCT) is well established as a highly specific biomarker for the detection of bacterial infections and sepsis. However, the currently available diagnostic tests are not able to detect very low or very early increases of PCT or even baseline levels in healthy individuals or patients with non-bacterial infections. In order to be able to detect these very low concentrations of PCT, a sandwich immunoassay was developed using high sensitivity Single Molecule Array technology (Simoa). The assay was thoroughly validated and applied to analyze human cerebrospinal fluid (CSF) and serum samples from patients with bacterial or viral meningitis as well as CSF, serum, and K2 EDTA plasma from healthy control subjects. A 50-fold increase in sensitivity compared to the current gold standard assays was achieved, which was sensitive enough for the detection of baseline PCT levels. Both serum and CSF showed significantly elevated PCT levels in patients with bacterial meningitis compared to patients with viral meningitis and the healthy control group. Procalcitonin concentration levels for patients with viral meningitis and the control group could be measured, but were not significantly different. The determination of PCT in the low pg·mL(−1) range could help to improve the monitoring of bacterial infectious diseases, as PCT level changes could be detected earlier. MDPI 2017-11-16 /pmc/articles/PMC5748597/ /pubmed/29479055 http://dx.doi.org/10.3390/ht6040018 Text en © 2017 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Carcamo Yañez, Viviana A.
Göpfert, Jens C.
Otto, Markus
Tumani, Hayrettin
Peter, Andreas
Joos, Thomas O.
Development and Validation of an Ultrasensitive Procalcitonin Sandwich Immunoassay
title Development and Validation of an Ultrasensitive Procalcitonin Sandwich Immunoassay
title_full Development and Validation of an Ultrasensitive Procalcitonin Sandwich Immunoassay
title_fullStr Development and Validation of an Ultrasensitive Procalcitonin Sandwich Immunoassay
title_full_unstemmed Development and Validation of an Ultrasensitive Procalcitonin Sandwich Immunoassay
title_short Development and Validation of an Ultrasensitive Procalcitonin Sandwich Immunoassay
title_sort development and validation of an ultrasensitive procalcitonin sandwich immunoassay
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5748597/
https://www.ncbi.nlm.nih.gov/pubmed/29479055
http://dx.doi.org/10.3390/ht6040018
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