Verifikacija potpuno automatiziranog sustava za analizu mokraće

master's thesis

• Title (english): Verification fully automated urinalysis system
• Author: Tajana Tunjić
• Mentor: Dunja Rogić (mentor)
• Committee member: Dunja Rogić
• Committee member: Sandra Šupraha Goreta
• Granter: University of Zagreb; Faculty of Pharmacy and Biochemistry; Zagreb
• Defense date and country: 2015-09-15, Croatia
• Scientific / art field, discipline and subdiscipline: BIOMEDICINE AND HEALTHCARE; Pharmacy; Medical Biochemistry

Abstract

Analiza mokraće od velike je važnosti za otkrivanje bolesti bubrega i mokraćnog trakta. Standardizacija postupaka za prikupljanje, transport, pripremu uzorka i analizu ključan su segment učinkovite strategije za analizu mokraće. U skladu s dobrom laboratorijskom praksom, prije uvođenja takvog potpuno automatiziranog uređaja, neophodno je provesti verifikaciju, odnosno provjeriti specifikacije proizvođača, koji je obavio opširnu validaciju. Svrha verifikacije jest provjeriti da li je analizator pogodan za rad u laboratorijskim uvjetima u kojima će se koristiti. U ovome istraživanju, ispitane su pozitivna i negativna kontrola, koje su se analizirale tijekom pet dana u triplikatu kako bi se odredila međupreciznost, ponovljivost i postotak slaganja. Dobiveni su zadovoljavajuću rezultati za sve analite uz manja odstupanja na Cobas u601 u kontroli 65821 za glukozu. Osim toga, obrađeno je 400 uzoraka mokraće, koji su uspoređeni s analizatorom koji je u rutinskoj primjeni te mikroskopskim pregledom sedimenta mokraće kao referentnom metodom. Rezultati ukazuju na odstupanja u podudarnosti rezultata za eritrocite kod kemijske analize mokraće, a kod mikroskoske analize mokraćnog sedimenta rezultati ukazuju na odstupanja podudarnosti rezultata za bakterije. Uočena odstupanja pripisuju se metodološkim razlikama različitih analizatora pri ispitivanju istog analita. Verifikacija uređaja za automatiziranu analizu mokraće Cobas® 6500 provedena u ovom radu pokazala je zadovoljavajuće rezultate i uređaj je prihvatljiv za rutinski rad u laboratoriju.

Abstract (english)

Urinalysis has a large importance for the detection of kidney and urinary tract disease. This is why it is important for the report indicate of pathological condition to be accurate, precise and issued on time. Standardization of procedures for the collection, transport, sample preparation and analysis are a key segment of effective strategies for the urinalysis. In accordance with good laboratory practice, prior to the introduction of such a fully automated device, it is necessary to carry out verification, or check the manufacturer's specifications, who performed extensive validation. The purpose of verification is to check whether the analyzer is suitable for work in the laboratory in which it is going to be used. In this study, positive and negative controls were examined, which were taken and analyzed for five days in triplicate to determine interprecision, repeatability and the percentage of agreement. Satisfactory results were obtained for all analytes with minor deviations to the cobas u601 control 65821 for glucose. In addition, 400 urine samples were processed, which were compared with the analyzer, which is the routine application, and microscopic examination of urine sediment as a reference method. The results show deviations within the results regarding erythrocytes in the chemical analysis of urine, as well as deviations in composition results for bacteria as a test parameter in the microscopic analysis of the urinary sediment. The observed differences are attributed to methodological differences between the different analyzers when testing the same analyte. Verification fully automated urinalysis system Cobas® 6500 conducted in this thesis has shown satisfactory results and analyzer is acceptable for routine work in the lab.

• Keywords: mokraća; analiza mokraće; potpuna automatizacija; test trake; sedimenti mokraće
• Keywords (english): urynalysis; fully automatisation; test strip; urine sediments
• Language: croatian
• URN:NBN: urn:nbn:hr:163:407424
• 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: 2016-01-22 16:47:04