Journal
CLINICAL CHEMISTRY AND LABORATORY MEDICINE
Volume 54, Issue 4, Pages 577-584Publisher
WALTER DE GRUYTER GMBH
DOI: 10.1515/cclm-2015-0437
Keywords
antibiotic therapy; emergency department; infection; method comparison; point-of-care testing; procalcitonin
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Funding
- Thermo Fisher Scientific Biomarkers
- bioMerieux
- Swiss National Science Foundation (SNSF) [PP00P3_150531/1]
- Swiss Academy for Medical Sciences (Schweizerische Akademie der Medizinischen Wissenschaften [SAMW])
- Research Council of the Kantonsspital Aarau [1410.000.044]
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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: r(2) = 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 mu g/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.
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