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.
References
1. Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, et al. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med 2001;345:1368–77.10.1056/NEJMoa010307Search in Google Scholar
2. Warren HS. Strategies for the treatment of sepsis. N Engl J Med 1997;336:952–3.10.1056/NEJM199703273361311Search in Google Scholar
3. Parrillo JE, Parker MM, Natanson C, Suffredini AF, Danner RL, Cunnion RE, et al. Septic shock in humans. Advances in the understanding of pathogenesis, cardiovascular dysfunction, and therapy. Ann Intern Med 1990;113:227–42.10.7326/0003-4819-113-3-227Search in Google Scholar
4. Kumar A, Roberts D, Wood KE, Light B, Parrillo JE, Sharma S, et al. Duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock. Crit Care Med 2006;34:1589–96.10.1097/01.CCM.0000217961.75225.E9Search in Google Scholar
5. Ronney KD, Schilling UM. Point-of-care testing in the overcrowded emergency department – can it make a difference? Crit Care 2014;18:692.10.1186/s13054-014-0692-9Search in Google Scholar
6. Schuetz P, Wolbers M, Christ-Crain M, Thomann R, Falconnier C, Widmer I, et al. Prohormones for prediction of adverse medical outcome in community-acquired pneumonia and lower respiratory tract infections. Crit Care 2010;14:R106.10.1186/cc9055Search in Google Scholar
7. Schuetz P, Maurer P, Punjabi V, Desai A, Amin DN, Gluck E. Procalcitonin decrease over 72 hours in US critical care units predicts fatal outcome in sepsis patients. Crit Care 2013;17:R115.10.1186/cc12787Search in Google Scholar
8. Schuetz P, Christ-Crain M, Muller B. Biomarkers to improve diagnostic and prognostic accuracy in systemic infections. Curr Opin Crit Care 2007;13:578–85.10.1097/MCC.0b013e3282c9ac2aSearch in Google Scholar
9. Wacker C, Prkno A, Brunkhorst FM, Schlattmann P. Procalcitonin as a diagnostic marker for sepsis: a systematic review and meta-analysis. Lancet Infect Dis 2013;13:426–35.10.1016/S1473-3099(12)70323-7Search in Google Scholar
10. Dusemund F, Bucher B, Meyer S, Thomann R, Kuhn F, Bassetti S, et al. Influence of procalcitonin on decision to start antibiotic treatment in patients with a lower respiratory tract infection: insight from the observational multicentric ProREAL surveillance. Eur J Clin Microbiol Infect Dis 2013;32:51–60.10.1007/s10096-012-1713-8Search in Google Scholar PubMed
11. Schuetz P, Briel M, Christ-Crain M, Stolz D, Bouadma L, Wolff M, et al. Procalcitonin to guide initiation and duration of antibiotic treatment in acute respiratory infections: an individual patient data meta-analysis. Clin Infect Dis 2012;55:651–62.10.1093/cid/cis464Search in Google Scholar PubMed PubMed Central
12. Schuetz P, Christ-Crain M, Thomann R, Falconnier C, Wolbers M, Widmer I, et al. Effect of procalcitonin-based guidelines vs standard guidelines on antibiotic use in lower respiratory tract infections: the ProHOSP randomized controlled trial. J Am Med Assoc 2009;302:1059–66.10.1001/jama.2009.1297Search in Google Scholar PubMed
13. Briel M, Schuetz P, Mueller B, Young J, Schild U, Nusbaumer C, et al. Procalcitonin-guided antibiotic use vs a standard approach for acute respiratory tract infections in primary care. Arch Intern Med 2008;168:2000–7; discussion 7–8.10.1001/archinte.168.18.2000Search in Google Scholar PubMed
14. Burkhardt O, Ewig S, Haagen U, Giersdorf S, Hartmann O, Wegscheider K, et al. Procalcitonin guidance and reduction of antibiotic use in acute respiratory tract infection. Eur Respir J 2010;36:601–7.10.1183/09031936.00163309Search in Google Scholar PubMed
15. de Wolf HK, Gunnewiek JK, Berk Y, van den Ouweland J, de Metz M. Comparison of a new procalcitonin assay from roche with the established method on the brahms kryptor. Clin Chem 2009;55:1043–4.10.1373/clinchem.2008.117655Search in Google Scholar PubMed
16. Hubl W, Krassler J, Zingler C, Pertschy A, Hentschel J, Gerhards-Reich C, et al. Evaluation of a fully automated procalcitonin chemiluminescence immunoassay. Clin Lab 2003;49:319–27.Search in Google Scholar
17. Sanders RJ, Schoorl M, Dekker E, Snijders D, Boersma WG, Ten Boekel E. Evaluation of a new procalcitonin assay for the Siemens ADVIA Centaur with the established method on the B.R.A.H.M.S Kryptor. Clin Lab 2011;57:415–20.Search in Google Scholar
18. Schuetz P, Christ-Crain M, Huber AR, Muller B. Long-term stability of procalcitonin in frozen samples and comparison of Kryptor and VIDAS automated immunoassays. Clin Biochem 2010;43:341–4.10.1016/j.clinbiochem.2009.08.029Search in Google Scholar PubMed
19. Rascher D, Geerlof A, Kremmer E, Kramer P, Michael S, Hartmann A, et al. Total internal reflection (TIRF)-based quantification of procalcitonin for sepsis diagnosis – a point-of-care testing application. Biosens Bioelectron 2014;59:251–8.10.1016/j.bios.2014.03.052Search in Google Scholar PubMed
20. Schuetz P, Chiappa V, Briel M, Greenwald JL. Procalcitonin algorithms for antibiotic therapy decisions: a systematic review of randomized controlled trials and recommendations for clinical algorithms. Arch Intern Med 2011;171:1322–31.10.1001/archinternmed.2011.318Search in Google Scholar PubMed
21. Schuetz P, Christ-Crain M, Muller B. Procalcitonin and other biomarkers to improve assessment and antibiotic stewardship in infections – hope for hype? Swiss Med Wkly 2009;139:318–26.Search in Google Scholar
22. Goyal M, Pines JM, Drumheller BC, Gaieski DF. Point-of-care testing at triage decreases time to lactate level in septic patients. J Emerg Med 2010;38:578–81.10.1016/j.jemermed.2007.11.099Search in Google Scholar PubMed
23. Nguyen HB, Loomba M, Yang JJ, Jacobsen G, Shah K, Otero RM, et al. Early lactate clearance is associated with biomarkers of inflammation, coagulation, apoptosis, organ dysfunction and mortality in severe sepsis and septic shock. J Inflamm 2010;7:610.1186/1476-9255-7-6Search in Google Scholar PubMed PubMed Central
24. Pecoraro V, Germagnoli L, Banfi G. Point-of-care testing: where is the evidence? a systematic survey. Clin Chem Lab Med 2014;52:313–24.10.1515/cclm-2013-0386Search in Google Scholar PubMed
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