Standardizacija kvalitativne analize mokraće u Republici Hrvatskoj

master's thesis

• Title (english): Standardization of qualitative urinalysis in Croatia
• Author: Valentina Špoljarić
• Mentor: Ana-Maria Šimundić (mentor)
• Committee member: Ana-Maria Šimundić (predsjednik povjerenstva)
• Committee member: Nada Vrkić (član povjerenstva)
• Committee member: Sandra Šupraha Goreta (član povjerenstva)
• Granter: University of Zagreb; Faculty of Pharmacy and Biochemistry; (Department of medical biochemistry and haematology); Zagreb
• Defense date and country: 2018-05-02, Croatia
• Scientific / art field, discipline and subdiscipline: BIOMEDICINE AND HEALTHCARE; Pharmacy; Medical Biochemistry

Abstract

U laboratorijima u Republici Hrvatskoj koriste se različite vrste test traka za kemijsku analizu mokraće od različitih proizvođača. Prema harmonizaciji laboratorijskih nalaza za kvalitativnu analizu mokraće ne postoje definirane kategorije za pojedini koncentracijski raspon, stoga laboratoriji proizvoljno dodjeljuju kategorije. Cilj ovog istraživanja bio je ispitati stanje kemijske analize mokraće test trakama u Republici Hrvatskoj te postoji li mogućnost izdavanja različitih rezultata kemijske analize iz istog uzorka u različitim laboratorijima. Poslana je anketa o kemijskoj analizi test trakama svim medicinsko-biokemijskim laboratorijima u RH. Ispitane su reproducibilnost, usporedivost te točnost za 12 najčešćih test traka na 75 uzoraka mokraće. Prema deklaraciji prilaženoj uz pakiranje test traka, napravljena je usporedba koncentracijskih raspona za sve parametre i pridruženih kategorija (0/1+/2+/3+) definiranih prema proizvođačima. Prema anketama, laboratoriji u Republici Hrvatskoj ne pridržavaju se harmonizacije prilikom izdavanja nalaza kemijske analize mokraće. Prisutno je preklapanje između kategorija koje laboratoriji sami definiraju i neusklađenost među proizvođačima test traka koji istim koncentracijskim rasponima dodjeljuju različite kategorije. Reproducibilnost test traka zadovoljavajuća je za sve parametre osim za pH. Najbolje slaganje rezultata između test traka je za proteine i nitrite, dok je najlošije slaganje rezultata za bilirubin, specifičnu težinu i pH. Niti jedne test trake nemaju zadovoljavajuću osjetljivost i specifičnost za proteine (AU400). U usporedbi sa analizatorima Cobas i Architect, niti jedne test trake nemaju zadovoljavajuću osjetljivost za proteine, a 7 test traka ima zadovoljavajuću specifičnost. Zadovoljavajuću osjetljivost za glukozu ima 10 test traka, dok zadovoljavajuću specifičnost imaju 4 test trake. Na temelju svega navedenog, zaključujemo da su rezultati kemijske analize mokraće u laboratorijima diljem Republike Hrvatske neusporedivi. Testiranjem istog uzorka mokraće u različitim laboratorijima postoji mogućnost izdavanja različitih nalaza kemijske analize.

Abstract (english)

Laboratories in Croatia use different brands of urine dipsticks from different manufacturers for urinalysis. There is no defined categories for each range of concentration according to laboratory test result harmonization for urinalysis, so each laboratory has to define it by themselves. The aim of this study was to examine urinalysis in Croatia and if there is a possibility to issue different urinalysis result in different laboratories because of the reasons above. The qualitative urinalysis poll was sent to all laboratories in Croatia. The reproducibility, comparability and accuracy of 12 the most used brands of dipsticks were examined on 75 urine samples. According to declaration provided with every package of dipsticks, concentration ranges for each test spot and categories (0/1+/2+/3+) that manufacturer suggested, were compared between manufacturers. According to the conducted pool, laboratories in Croatia do not follow harmonization while reporting the urinalysis results and there is overlap between categories defined by different laboratories. There is an inconsistency between dipstick manufacturers who categorize the same concentration ranges in different categories. Reproducibility of dipsticks was acceptable for all parameters except for pH. The best agreement of results between dipsticks was for proteins and nitrites, while the worst agreement was for bilirubin, specific gravity and pH. None of the dipsticks had acceptable sensitivity and specificity for proteins (AU400). When compared with analyzers Cobas and Architect, none of dipsticks had acceptable sensitivity for proteins and seven dipsticks had acceptable specificity for proteins. For glucose, 10 dipsticks had acceptable sensitivity, while acceptable specificity had just four dipsticks. To conclude, results of qualitative urinalysis in laboratories all around Croatia are not comparable. There is a possibility that testing the same urine sample in different laboratories in Croatia will result with different test result.

• Keywords: analiza urina; test trake; standardizacija
• Keywords (english): urinalysis; dipstick; standardization
• Language: croatian
• URN:NBN: urn:nbn:hr:163:591893
• 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: 2018-12-12 12:44:33