Kvantitativna analiza fekalnog kalprotektina novom kemiluminiscentnom metodom na analizatoru Bio-Flash (Inova Diagnostics)

master's thesis

• Title (english): Quantitative analysis of faecal calprotectin using a new chemiluminescent method for the Bio-Flash analyzer (Inova Diagnostics)
• Author: Anamarija Beljan
• Mentor: Donatella Verbanac (mentor)
• Mentor: Andrea Tešija Kuna (mentor)
• Committee member: Donatella Verbanac (predsjednik povjerenstva)
• Committee member: Andrea Tešija Kuna (član povjerenstva)
• Committee member: Lidija Bach-Rojecky (član povjerenstva)
• Granter: University of Zagreb; Faculty of Pharmacy and Biochemistry; (Department of medical biochemistry and haematology); Zagreb
• Defense date and country: 2022-09-05, Croatia
• Scientific / art field, discipline and subdiscipline: BIOMEDICINE AND HEALTHCARE; Pharmacy; Medical Biochemistry

Abstract

Fekalni kalprotektin prepoznat je kao specifičan i vrlo osjetljiv biomarker upale crijevne sluznice koji omogućuje razlikovanje upalnih bolesti crijeva od sindroma iritabilnog crijeva. Dijagnostički testovi pojedinih proizvođača temeljeni su na različitim imunokemijskim metodama te još uvijek ne postoji standardiziran postupak ekstrakcije uzorka, pohrane i analize što dovodi do velike varijacije u dobivenim rezultatima i otežava njihovu međusobnu usporedbu.
U ovome radu opisano je provođenje postupka verifikacije kvantitativne kemiluminiscentne metode QUANTA Flash® Calprotectin (INOVA Diagnostics, San Diego, CA, USA) za određivanje koncentracije fekalnog kalprotektina u uzorku stolice na analizatoru Bio-Flash (Biokit S.A.©, Španjolska) i usporedbe s postojećim dijagnostičkim testom u rutinskoj primjeni Bühlmann fCAL® turbo (Bühlmann, Schönenbuch, Switzerland) na analizatoru Abbott Architect c8000 (Abbott S.r.l., Roma, Italy) u KBC-u Sestre Milosrdnice. Mjerenja su vršena na 59 ostatnih uzoraka stolica pacijenata kod kojih je zatraženo određivanje fekalnog kalprotektina. Nepreciznost ispitivane metode zadovoljila je zadane kriterije što ju čini prihvatljivom za kliničku primjenu. Unatoč statistički značajnom odstupanju vrijednosti dobivenih ispitivanom i postojećom metodom, podudaranje u kategorizaciji rezultata u dvije interpretativne kategorije pokazalo se snažnim. Zaključeno je da se ispitivana metoda može koristiti u rutinskom radu, ali je preporučljivo za istog pacijenta koncentraciju fekalnog kalprotektina uvijek mjeriti istim testom kako bi rezultati bili međusobno usporedivi jer rezultati dobiveni različitim imunokemijskim metodama nisu međusobno usporedivi i zamjenjivi.

Abstract (english)

Fecal calprotectin was recognized as a specific and sensitive biomarker of intestinal inflammation, making it easier to differentiate inflammatory bowel diseases from irritable bowel syndrome. Numerous existing assays based on different immunochemical methods, along with the lack of standardization of sample extraction, storage, and analysis, have led to significant variation in assays results and exacerbated assay comparability.
This thesis describes the verification process of quantitative chemiluminescent method QUANTA Flash® Calprotectin assay (INOVA Diagnostics, San Diego, CA, USA) on analyzer Bio-Flash (Biokit S.A.ã, Spain) and comparison to Bühlmann fCAL® turbo assay (Bühlmann, Schönenbuch, Switzerland) on Abbott Architect c8000 (Abbott S.r.l., Roma, Italy) analyzer which is routinely used within the Department of Clinical Chemistry, University Hospital Centre ''Sestre Milosrdnice'', Zagreb. Samples used for measurement were obtained from remainders of 59 stool samples of patients for whom the clinicians requested the analysis of fecal calprotectin. Assay imprecision met the set criteria, which makes it acceptable for clinical use. Despite statistically significant bias of obtained values, the classification of results of both methods into two categories (positive and negative) proved that the agreement between the two methods is reliable. In conclusion, QUANTA Flash® Calprotectin assay can be used routinely. For follow-up of the same patient, it is advisable always to use the same diagnostic test since the results obtained by different methods are not comparable or interchangeable.

• Keywords: fekalni kalprotektin; verifikacija metode; usporedba metoda; QUANTA Flash Calprotectin; upalne bolesti crijeva
• Keywords (english): faecal calprotectin; method verification; method comparison; QUANTA Flash Calprotectin; inflammatory bowel disease
• Language: croatian
• URN:NBN: urn:nbn:hr:163:840166
• Study programme: Title: Medical biochemistry; Study programme type: university; Study level: integrated undergraduate and graduate; Academic / professional title: magistar/magistra medicinske biokemije (magistar/magistra medicinske biokemije)
• Type of resource: Text
• File origin: Born digital
• Access conditions: Open access
• Created on: 2022-09-13 12:22:57