Presepsin: what is important for correct interpretation

Česká verzia

Authors: Antonín Jabor ^1,2; Zdenek Kubíček ¹; Magda Labanczová ¹; Janka Franeková ^1,2
Authors place of work: Oddělení klinické biochemie, pracoviště laboratorních metod IKEM, Praha ¹; 3. LF UK, Praha ²
Published in the journal: Vnitř Lék 2019; 65(7-8): 490-496
Category: Original Contributions

Summary

Introduction: Presepsin (soluble CD14 subtype) is a new biomarker of infection and sepsis. Correct interpretation is based on the knowledge of analytical reliability, biological variation, decision limits, and diagnostic effectivity. Aim: The aim of the study was to verify analytical precision of presepsin measurements, to assess biological variation in healthy subjects, to verify reference and decision limits, to assess diagnostic effectivity, and to compare data with commonly used septic biomarkers – procalcitonin (PCT), CRP and interleukin 6 (IL6).

Material and methods: Analytical precision (repeatability and intermediate precision) was estimated by repeated measurements of commercial control materials. Biological variation was evaluated in a group of 20 healthy volunteers in a 7-week experiment. Reference ranges were extracted from the literature and compared with data from healthy subjects.

Results: Precisions of presepsin measurements were 2.0–4.0 % (“within-run”) and 6.1–9.5 % (“between-run”). Intraindividual biological variation of presepsin was 22.3 %, interindividual variation 20.8 %. Index of individuality was 1.07, reference change value (RCV – critical difference) was 72 %. Upper reference limit was around 180 ng/l.

Conclusion: Analytical quality of presepsin measurement is suitable for clinical use. Biological variation parameters enable the use of reference limits, upper reference limit of presepsin is around 180 ng/l. None of the tested biomarkers has universal cut-off value, multiple biomarkers are needed and repeated measurements are advisable.

Keywords:

analytical reliability – CRP – decision limits – interindividual biological variation – interleukin 6 – intraindividual biological variation – presepsin – procalcitonin – reference limits

Zdroje

Singer M, Deutschman CS, Seymour CW et al. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA 2016; 315(8): 801–810. Dostupné z DOI: <http://dx.doi.org/10.1001/jama.2016.0287>.
Simpson SQ. New sepsis criteria: a change we should not make. Chest 2016; 149(5): 1117–1118. Dostupné z DOI: <http://dx.doi.org/10.1016/j.chest.2016.02.653>.
Jabor A, Kubíček Z, Fraňková S et al. Enhanced liver fibrosis (ELF) score: Reference ranges, biological variation in healthy subjects, and analytical considerations. Clin Chim Acta 2018; 483: 291–295. Dostupné z DOI: <http://dx.doi.org/10.1016/j.cca.2018.05.027>.
Jabor A, Kubíček Z, Komrsková J et al. Within-subject biological variation of pairs of heavy/light immunoglobulin IgM chains (HLC IgM κ and λ) is low and requires monitoring: A comparison with HLC IgA, HLC IgG, and free light immunoglobulin chains (FLC) in healthy subjects. Clin Chim Acta 2018; 486: 311–312. Dostupné z DOI: <http://dx.doi.org/10.1016/j.cca.2018.08.023>.
Braga F, Panteghini M. Generation of data on within-subject biological variation in laboratory medicine: An update. Crit Rev Clin Lab Sci 2016; 53(5): 313–325. Dostupné z DOI: <http://dx.doi.org/10.3109/10408363.2016.1150252>.
Franeková J, Sečník P, jr., Lavríková P et al. Serial measurement of presepsin, procalcitonin, and C-reactive protein in the early postoperative period and the response to antithymocyte globulin administration after heart transplantation. Clin Transplant 2017; 31(1): e12870. Dostupné z DOI: https://doi.org/10.1111/ctr.12870
Westgard biobase. Desirable Specifications for Total Error, Imprecision, and Bias, derived from intra- and inter-individual biologic variation. Dostupné z WWW: <https://www.westgard.com/biodatabase1.htm>. (Přečteno 28.12.2018).
Barassi A, Pallotti F, Melzi d’Eril G. Biological variation of procalcitonin in healthy individuals. Clin Chem 2004; 50(10): 1878. Dostupné z DOI: <http://dx.doi.org/10.1373/clinchem.2004.037275>.
Shozushima T, Takahashi G, Matsumoto N et al. Usefulness of presepsin (sCD14-ST) measurements as a marker for the diagnosis and severity of sepsis that satisfied diagnostic criteria for systemic inflammatory response syndrome. J Infect Chemother 2011; 17(6): 764–769. Dostupné z DOI: <http://dx.doi.org/10.1007/s10156–011–0254-x>.
Giavarina D, Carta M. Determination of reference interval for presepsin, an early marker for sepsis. Biochem Med (Zagreb) 2015; 25(1): 64–68. Dostupné z DOI: <http://dx.doi.org/10.11613/BM.2015.007>.
Biyik I, Caglar FNT, Isiksacan N et al. Serum presepsin levels are not elevated in patients with controlled hypertension. Int J Hypertens 2018: 8954718. Dostupné z DOI: <http://dx.doi.org/10.1155/2018/8954718>.
Chenevier-Gobeaux C, Trabattoni E, Roelens M et al. Presepsin (sCD14-ST) in emergency department: the need for adapted threshold values? Clin Chim Acta 2014; 427: 34–36. Dostupné z DOI: <http://dx.doi.org/10.1016/j.cca.2013.09.019>.
Spanuth E, Ebelt H, Ivandic B et al. Diagnostic and prognostic value of presepsin (soluble CD14 subtype) in emergency. 21st International Congress of Clinical Chemistry and Laboratory Medicine, IFCC-WorldLab – EuroMedLab, Berlin, 2011. Poster 0333. Dostupné z WWW: <http://medi-lab.hu/doc/Poster_sCD14-ST.pdf>.
Vodnik T, Kaljevic G, Tadic T et al. Presepsin (sCD14-ST) in preoperative diagnosis of abdominal sepsis. Clin Chem Lab Med 2013; 51(10): 2053–2062. Dostupné z DOI: <http://dx.doi.org/10.1515/cclm-2013–0061>.
Tate JR, Yen T, Jones GR. Transference and validation of reference intervals. Clin Chem 2015; 61(8): 1012–1015. Dostupné z DOI: <http://dx.doi.org/10.1373/clinchem.2015.243055>.
Clinical and Laboratory Standard Institute (CLSI). Defining, establishing, and verifying reference intervals in the clinical laboratory: Approved guidelines. 3rd ed. CLSI: Wayne (USA) 2008. Dostupné z WWW: <https://clsi.org/media/1421/ep28a3c_sample.pdf>.
Godnic M, Stubljar D, Skvarc M et al. Diagnostic and prognostic value of sCD14-ST–presepsin for patients admitted to hospital intensive care unit (ICU). Wien Klin Wochenschr 2015; 127(13–14): 521–527. Dostupné z DOI: <http://dx.doi.org/10.1007/s00508–015–0719–5>.
Ulla M, Pizzolato E, Lucchiari M et al. Diagnostic and prognostic value of presepsin in the management of sepsis in the emergency department: a multicenter prospective study. Crit Care 2013; 17(4): R168. Dostupné z DOI: <http://dx.doi.org/10.1186/cc12847>.
Ishikura H, Nishida T, Murai A et al. New diagnostic strategy for sepsis-induced disseminated intravascular coagulation: a prospective single-center observational study. Crit Care 2014; 18(1): R19. Dostupné z DOI: <http://dx.doi.org/10.1186/cc13700>.
Behnes M, Bertsch T, Lepiorz D et al. Diagnostic and prognostic utility of soluble CD 14 subtype (presepsin) for severe sepsis and septic shock during the first week of intensive care treatment. Crit Care 2014; 18(5): 507. Dostupné z DOI: <http://dx.doi.org/10.1186/s13054–014–0507-z>.
Romualdo LG, Torrella PE, González MV et al. Diagnostic accuracy of presepsin (soluble CD14 subtype) for prediction of bacteremia in patients with systemic inflammatory response syndrome in the Emergency Department. Clin Biochem 2014; 47(7–8): 505–508. Dostupné z DOI: <http://dx.doi.org/10.1016/j.clinbiochem.2014.02.011>.
Kweon OJ, Choi JH, Park SK et al. Usefulness of presepsin (sCD14 subtype) measurements as a new marker for the diagnosis and prediction of disease severity of sepsis in the Korean population. J Crit Care 2014; 29(6): 965–970. Dostupné z DOI: <http://dx.doi.org/10.1016/j.jcrc.2014.06.014>.
Zheng Z, Jiang L, Ye L et al. The accuracy of presepsin for the diagnosis of sepsis from SIRS: a systematic review and meta-analysis. Ann Intensive Care 2015; 5(1): 48. Dostupné z DOI: <http://dx.doi.org/10.1186/s13613–015–0089–1>.
Beňovská M, Bučková D, Petříková D et al. Presepsin jako diagnostický a prognostický nástroj při posuzování sepse. Klin Biochem Metab 2015; 23(3): 89–94. Dostupné z WWW: <http://www.cskb.cz/res/file/KBM-pdf/2015/2015–3/KBM-3–2015–89-Benovska.pdf>.
Káňová M, Dobiáš R, Liszková K et al. Presepsin v diagnostice sepse. Vnitř Lék 2019; 65(7–8): 497–505.
Kettner J, Holek M, Franekova J et al. Procalcitonin Dynamics after Long-Term Ventricular Assist Device Implantation. Heart Lung Circ 2017; 26(6): 599–603. Dostupné z DOI: <http://dx.doi.org/10.1016/j.hlc.2016.09.014>.