Comparison between BRAHMS 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

被引:30
作者
Kutz, Alexander [1 ,2 ]
Hausfater, Pierre [3 ,4 ]
Oppert, Michael [5 ]
Alan, Murat [1 ,2 ]
Grolimund, Eva [1 ,2 ]
Gast, Claire [3 ,4 ]
Alonso, Christine [6 ]
Wissmann, Christoph [6 ]
Kuehn, Christian [5 ]
Bernard, Maguy [4 ,7 ]
Huber, Andreas [8 ]
Mueller, Beat [1 ,2 ]
Schuetz, Philipp [1 ,2 ]
机构
[1] Univ Basel, Kantonsspital Aarau, Univ Dept Med, Tellstr, CH-5001 Aarau, Switzerland
[2] Univ Basel, Fac Med, Tellstr, CH-5001 Aarau, Switzerland
[3] Hop La Pitie Salpetriere, Emergency Dept, Paris, France
[4] Univ Paris 06, Paris, France
[5] Klinikum Ernst von Bergmann, Dept Emergency & Intens Care Med, Potsdam, Germany
[6] BRAHMS GmbH, Clin Diagnost Div, Thermo Fisher Sci, Hennigsdorf, Germany
[7] Hop La Pitie Salpetriere, Dept Biochem, Paris, France
[8] Kantonsspital Aarau, Dept Lab Med, Aarau, Switzerland
基金
瑞士国家科学基金会;
关键词
antibiotic therapy; emergency department; infection; method comparison; point-of-care testing; procalcitonin; RESPIRATORY-TRACT INFECTIONS; ANTIBIOTIC USE; SEVERE SEPSIS; BIOMARKERS; DYSFUNCTION; THERAPY; ASSAY;
D O I
10.1515/cclm-2015-0437
中图分类号
R446 [实验室诊断]; R-33 [实验医学、医学实验];
学科分类号
1001 ;
摘要
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.
引用
收藏
页码:577 / 584
页数:8
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