Kratka analitička validacija Blyscan testa za mjerenje koncentracije glikozaminoglikana u urinu

master's thesis

• Title (english): Analytical validation of the Blyscan test for measuring the concentration of glycosaminoglycans in urine
• Author: Maja Rakić
• Mentor: Ksenija Fumić (mentor)
• Committee member: Ksenija Fumić (predsjednik povjerenstva)
• Committee member: Olga Gornik (član povjerenstva)
• Committee member: Roberta Petlevski (član povjerenstva)
• Granter: University of Zagreb; Faculty of Pharmacy and Biochemistry; Zagreb
• Defense date and country: 2016-06-17, Croatia
• Scientific / art field, discipline and subdiscipline: BIOMEDICINE AND HEALTHCARE; Pharmacy; Medical Biochemistry

Abstract

Mukopolisaharidoze su podgrupa lizosomskih bolesti nakupljanja. Zbog svoje patofiziološke kompleksnosti, kroničnog tijeka, zahvaćanja više organa i kliničke heterogenosti, predstavljaju izazov suvremenoj kliničkoj i laboratorijskoj dijagnostici.
Pravovremeno postavljanje dijagnoze je preduvijet za početak liječenja. Nakon početne kliničke sumnje laboratorijska dijagnostika započinje mjerenjem glikozaminoglikana (GAG) u urinu. Cilj rada je uvođenje Blyscan kompleta reagenasa u rutinski rad laboratorija, čime bi se trebalo standardizirati i ubrzati mjerenje koncentracije GAG-a. Prema zahtjevima kontrole
kvalitete i međunarodne norme ISO 15189, prije uvođenja nove metode u rutinski rad laboratorija potrebno je napraviti kratku validaciju. Validacija je ovjera da su specificirani zahtjevi prikladni za utvrđenu uporabu, a kratka analitička validacija obuhvaća mjerenje preciznosti, istinitosti, linearnosti te ispitivanje referentnih raspona. Dobiveni rezultati zadovoljavaju biološke kriterije i uvjete validacije, te je Blyscan komplet reagenasa pogodan za rutinski rad laboratorija.

Abstract (english)

MPS are a subset of lysosomal storage diseases. Because of its pathophysiological complexity, chronic flow, clinical heterogeneity and envelopment of more organs, they present a challenge to modern medicine and laboratory diagnostics. Early diagnosis is a prerequisite for the start of treatment. After initial clinical suspicion laboratory diagnosis
begins by measuring glycosaminoglycan (GAG) in urine. The aim is to introduce the Blyscan reagents kit in the routine work of the laboratory, which is supposed to standardize and accelerate the measurement of the concentration of GAG's.
According to the requirements of quality control and international standards ISO 15189, before the introduction of the new method it is necessary to validate. The validation is a verification that the specified requirements have been met for the specified use, a short analytical validation includes the measurement of accuracy, precision, linearity test, and
reference range. The results meet the biological criteria and requirements of validation, so the Blyscan reagents kit is introduced into the routine work of the laboratory.

• Keywords: mukopolisaharidoze; glikozaminoglikani; analitička validacija; Blyscan test
• Keywords (english): mucopolysaccharidoses; glycosaminoglycans; analytical validation; Blyscan assay
• Language: croatian
• URN:NBN: urn:nbn:hr:163:129620
• 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: Access restricted to students and staff of home institution
• Created on: 2016-10-27 09:38:16