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Licensed Unlicensed Requires Authentication Published by De Gruyter September 30, 2015

Comparison between B·R·A·H·M·S PCT direct, a new sensitive point-of-care testing device for rapid quantification of procalcitonin in emergency department patients and established reference methods – a prospective multinational trial

Alexander Kutz, Pierre Hausfater, Michael Oppert, Murat Alan, Eva Grolimund, Claire Gast, Christine Alonso, Christoph Wissmann, Christian Kuehn, Maguy Bernard, Andreas Huber, Beat Mueller and Philipp Schuetz

Abstract

Background: Procalcitonin (PCT) is increasingly being used for the diagnostic and prognostic work up of patients with suspected infections in the emergency department (ED). Recently, B·R·A·H·M·S PCT direct, the first high sensitive point-of-care test (POCT), has been developed for fast PCT measurement on capillary or venous blood samples.

Methods: This is a prospective, international comparison study conducted in three European EDs. Consecutive patients with suspicion of bacterial infection were included. Duplicate determination of PCT was performed in capillary (fingertip) and venous whole blood (EDTA), and compared to the reference method. The diagnostic accuracy was evaluated by correlation and concordance analyses.

Results: Three hundred and three patients were included over a 6-month period (60.4% male, median age 65.2 years). The correlation between capillary or venous whole blood and the reference method was excellent: r2=0.96 and 0.97, sensitivity 88.1% and 93.0%, specificity 96.5% and 96.8%, concordance 93% and 95%, respectively at a 0.25 μg/L threshold. No significant bias was observed (–0.04 and –0.02 for capillary and venous whole blood) although there were 6.8% and 5.1% outliers, respectively. B·R·A·H·M·S PCT direct had a shorter time to result as compared to the reference method (25 vs. 144 min, difference 119 min, 95% CI 110–134 min, p<0.0001).

Conclusions: This study found a high diagnostic accuracy and a faster time to result of B·R·A·H·M·S PCT direct in the ED setting, allowing shortening time to therapy and a more wide-spread use of PCT.


Corresponding author: Prof. Dr. med. Philipp Schuetz, MD, MPH, University Department of Medicine, Kantonsspital Aarau and Medical Faculty of the University of Basel, Tellstrasse, 5001 Aarau, Switzerland, Phone: +41 (0)62 838 4141, Fax: +41 (0)62 838 4100, E-mail:

Acknowledgments

We are grateful to all local physicians, the nursing staff and the patients and their relatives who participated in this study. We especially thank the central laboratory staff (Martha Kaeslin, Renate Hunziker, Ursina Minder).

Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

Research funding: AK, PH and MO have received financial support from Thermo Fisher Scientific Biomarkers to attend meetings and fulfill speaking engagements. PS and BM has received financial support from Thermo Fisher Scientific Biomarkers and bioMérieux to attend meetings and fulfill speaking engagements and has received research grants from both companies. PS is supported in part by the Swiss National Science Foundation (SNSF Professorship, PP00P3_150531/1), the Swiss Academy for Medical Sciences (Schweizerische Akademie der Medizinischen Wissenschaften [SAMW]), and the Research Council of the Kantonsspital Aarau (1410.000.044).

Employment or leadership: None declared.

Honorarium: None declared.

Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

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Received: 2015-5-8
Accepted: 2015-8-26
Published Online: 2015-9-30
Published in Print: 2016-4-1

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