This two-center study was designed to verify comparability of procalcitonin (PCT) values among 10 different commercial immunoassays.
A total number of 176 routine lithium-heparin plasma samples were divided in identical aliquots and simultaneously analyzed with 10 different PCT immunoassays, including Kryptor BRAHMS PCT sensitive, Abbott Architect BRAHMS PCT, Beckman Coulter Access PCT (on Access and DXI), BioMérieux Vidas BRAHMS PCT, Diasorin Liaison BRAHMS PCT, Fujirebio Lumipulse G BRAHMS PCT, Roche BRAHMS PCT (on Cobas E801), Diazyme PCT (on Roche Cobas C702) and SNIBE Maglumi PCT.
Highly significant correlation was always found across multiple comparisons, with correlation coefficients comprised between 0.918 and 0.997 (all p < 0.001). Bland and Altman plots analysis revealed highly variable bias among immunoassays, ranging between ±0.2% and ±38.6%. Diazyme PCT on Roche Cobas C702 and SNIBE Maglumi PCT displayed the larger overestimation, whilst PCT values were underestimated by Cobas BRAHAMS PCT. The agreement was always >80% (all p < 0.001), but varied largely across multiple comparisons, ranging between 90%–99% at 0.1 μg/L, 81%–99% at 0.25 μg/L, 83%–100% at 0.5 μg/L, 94%–100% at 2.0 μg/L and 90%–99% at 10 μg/L, respectively. The larger disagreement was observed comparing Diazyme PCT and Maglumi PCT with the other methods.
Although we found acceptable correlation among 10 commercial PCT immunoassays, the limited agreement at clinical decision thresholds remains a major issue, especially at lower end of PCT concentration, thus potentially contributing to jeopardize the clinical value of this biomarker.
Meisner M. Procalcitonin – biochemistry and clinical diagnosis, 1st ed. Bremen: UNI-MED, 2010.
Meisner M. Update on procalcitonin measurements. Ann Lab Med 2014;34:263–73.
Lippi G, Meschi T, Cervellin G. Inflammatory biomarkers for the diagnosis, monitoring and follow-up of community-acquired pneumonia: clinical evidence and perspectives. Eur J Intern Med 2011;22:460–5.
Lippi G, Montagnana M, Balboni F, Bellone A, Casagranda I, Cavazza M, et al. Academy of Emergency Medicine and Care-Society of Clinical Biochemistry and Clinical Molecular Biology consensus recommendations for clinical use of sepsis biomarkers in the emergency department. Emerg Care J 2017;13:6877.
Bartoletti M, Antonelli M, Bruno Blasi FA, Casagranda I, Chieregato A, Fumagalli R, et al. Procalcitonin-guided antibiotic therapy: an expert consensus. Clin Chem Lab Med 2018;56:1223–9.
Hey J, Thompson-Leduc P, Kirson NY, Zimmer L, Wilkins D, Rice B, et al. Procalcitonin guidance in patients with lower respiratory tract infections: a systematic review and meta-analysis. Clin Chem Lab Med 2018;56:1200–9.
Schuetz P, Beishuizen A, Broyles M, Ferrer R, Gavazzi G, Gluck EH, et al. Procalcitonin (PCT)-guided antibiotic stewardship: an international experts consensus on optimized clinical use. Clin Chem Lab Med 2019;57:1308–18.
Cortegiani A, Misseri G, Ippolito M, Bassetti M, Giarratano A, Martin-Loeches I, et al. Procalcitonin levels in candidemia versus bacteremia: a systematic review. Crit Care 2019;23:190.
Lippi G, Cervellin G. Can presepsin be used for screening invasive fungal infections? Ann Transl Med 2019;7:87.
Cervellin G, Schuetz P, Lippi G. Towards a holistic approach for diagnosing sepsis in the emergency department. Adv Clin Chem 2019 [Epub ahead of print].
Lippi G. Sepsis biomarkers: past, present and future. Clin Chem Lab Med 2019;57:1281–3.
Dipalo M, Guido L, Micca G, Pittalis S, Locatelli M, Motta A, et al. Multicenter comparison of automated procalcitonin immunoassays. Pract Lab Med 2015;2:22–8.
Kutz A, Hausfater P, Oppert M, Alan M, Grolimund E, Gast C, et al. 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. Clin Chem Lab Med 2016;54:577–84.
Ceriotti F, Marino I, Motta A, Carobene A. Analytical evaluation of the performances of Diazyme and BRAHMS procalcitonin applied to Roche Cobas in comparison with BRAHMS PCT-sensitive Kryptor. Clin Chem Lab Med 2017;56:162–9.
Soh A, Binder L, Clough M, Hernandez MH, Lefèvre G, Mostert K, et al. Comparison of the novel ARCHITECT procalcitonin assay with established procalcitonin assay systems. Pract Lab Med 2018;12:e00110.
Eidizadeh A, Asif AR, von Ahsen N, Binder L, Schnelle M. Differences in procalcitonin measurements between three BRAHMS-partnered immunoassays (Liaison, Elecsys and Architect). Clin Chem Lab Med 2018;57:e207–10.
Chambliss AB, Hayden J, Colby JM. Evaluation of procalcitonin immunoassay concordance near clinical decision points. Clin Chem Lab Med 2019;57:1414–21.
Samsudin I, Vasikaran SD. Clinical utility and measurement of procalcitonin. Clin Biochem Rev 2017;38:59–68.
Lippi G, Panteghini M, Bernardini S, Bonfanti L, Carraro P, Casagranda I, et al. Laboratory testing in the emergency department: an Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC) and Academy of Emergency Medicine and Care (AcEMC) consensus report. Clin Chem Lab Med 2018;56:1655–9.
Schuetz P, Mueller B. Procalcitonin-guided antibiotic stewardship from newborns to centennials. Lancet 2017;390:826–9.
Branche A, Neeser O, Mueller B, Schuetz P. Procalcitonin to guide antibiotic decision making. Curr Opin Infect Dis 2019;32:130–5.
Neeser O, Branche A, Mueller B, Schuetz P. How to: implement procalcitonin testing in my practice. Clin Microbiol Infect 2019 Jan 4. [Epub ahead of print].
Farooq A, Colón-Franco JM. Procalcitonin and its limitations: why a biomarker’s best isn’t good enough. Appl Lab Med 2019;3:716–9.
Schuetz P, Bretscher C, Bernasconi L, Mueller B. Overview of procalcitonin assays and procalcitonin-guided protocols for the management of patients with infections and sepsis. Expert Rev Mol Diagn 2017;17:593–601.
Lippi G, Cervellin G. Procalcitonin for diagnosing and monitoring bacterial infections: for or against? Clin Chem Lab Med 2018;56:1193–5.
Wojtalewicz N, Schellenberg I, Hunfeld KP. Evaluation of INSTAND e.V.’s external quality assessment for C-reactive protein and procalcitonin. PLoS One 2019;14:e0221426.
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