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
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Alexander Kutz
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.
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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©2016 by De Gruyter
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- Frontmatter
- Editorial
- Macroprolactin: searching for a needle in a haystack?
- Review
- Laboratory medicine in the new healthcare environment
- Opinion Paper
- Developing GRADE outcome-based recommendations about diagnostic tests: a key role in laboratory medicine policies
- EFLM Survey
- Accreditation process in European countries – an EFLM survey
- Genetics and Molecular Diagnostics
- HB Puerta del Sol [HBA1:c.148A>C], HB Valdecilla [HBA2:c.3G>T], HB Gran Vía [HBA2:c.98T>G], HB Macarena [HBA2:c.358C>T] and HB El Retiro [HBA2:c.364_366dupGTG]: description of five new hemoglobinopathies
- General Clinical Chemistry and Laboratory Medicine
- A candidate reference method using ICP-MS for sweat chloride quantification
- Quantification of hemoglobin A1c by off-line HPLC separation and liquid chromatography-tandem mass spectrometry: a modification of the IFCC reference measurement procedure
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- Evaluation of a hand-held blood gas analyzer for rapid determination of blood gases, electrolytes and metabolites in intensive care setting
- Use of a faecal immunochemical test for haemoglobin can aid in the investigation of patients with lower abdominal symptoms
- A possible cause of the variable detectability of macroprolactin by different immunoassay systems
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- Analytical and clinical performance of the new Fujirebio 25-OH vitamin D assay, a comparison with liquid chromatography-tandem mass spectrometry (LC-MS/MS) and three other automated assays
- Development and validation of a 2nd tier test for identification of purine nucleoside phosphorylase deficiency patients during expanded newborn screening by liquid chromatography-tandem mass spectrometry
- A cross-sectional study of biomarkers of exposure and effect in smokers and moist snuff consumers
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- Development of reference intervals for serum alkaline phosphatase among adults in Southern China traced to the new IFCC reference measurement procedure
- Birth season predicts the values of red blood cell distribution width (RDW) in adulthood
- Cardiovascular Diseases
- Cardiovascular risk stratification in hemodialysis patients in the era of highly sensitive troponins: should we choose between hs-troponin I and hs-troponin T?
- A standardised FACS assay based on native, receptor transfected cells for the clinical diagnosis and monitoring of β1-adrenergic receptor autoantibodies in human heart disease
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- The diagnostic value of serum fucosylated fetuin A in hepatitis B virus-related liver diseases
- Letters to the Editor
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