Verifikacija automatskih analizatora Roller 20 PN i iSED za mjerenje brzine sedimentacije eritrocita

master's thesis

• Title (english): Verification of automated analyzers Roller 20 PN and iSED for measuring erythrocyte sedimentation rate
• Author: Helena Čičak
• Mentor: Ana-Maria Šimundić (mentor)
• Committee member: Ana-Maria Šimundić (predsjednik povjerenstva)
• Committee member: Marija Grdić Rajković (član povjerenstva)
• Committee member: Petra Turčić (član povjerenstva)
• Granter: University of Zagreb; Faculty of Pharmacy and Biochemistry; (Department of medical biochemistry and haematology); Zagreb
• Defense date and country: 2018-07-13, Croatia
• Scientific / art field, discipline and subdiscipline: BIOMEDICINE AND HEALTHCARE; Pharmacy; Medical Biochemistry

Abstract

Westergrenova metoda podložna je brojnim vanjskim čimbenicima koji utječu na dobivene brzine sedimentacije eritrocita dok su automatski analizatori zatvoreni sustavi gdje je utjecaj vanjskih čimbenika značajno smanjen pri određivanju brzine sedimentacije eritrocita. Odnedavno dostupni na tržištu, automatski analizatori za mjerenje sedimentacije eritrocita koriste krv uzetu na EDTA antikoagulans. Time se smanjuje vrijeme pretrage, volumen potrebne krvi za analizu što je povoljno za bolesnika te se smanjuju troškovi. Prije uvođenja automatskog analizatora za mjerenje sedimentacije eritrocita u rutinski rad, potrebno je ispitati analitičke značajke analizatora koje je deklarirao proizvođač. Cilj ovog istraživanja bio je verifikacija automatskog analizatora Roller 20 PN (Alifax, Polverara, Italija) i automatskog analizatora iSED (AlcorScientific, Smithfield, SAD) za automatsko mjerenje sedimentacije eritrocita. Verifikacija oba automatska analizatora je uključila ispitivanje preciznosti iz dana u dan te ispitivanje preciznosti u seriji i usporedbu s Westergrenovom metodom. Ispitivanje preciznosti iz dana u dan je provedena na kontrolnim uzorcima u tri razine za automatski analizator Roller 20 PN te u dvije razine za iSED. Ispitivanje preciznosti u seriji je provedena na kontrolnim uzorcima i uzorcima krvi bolesnika. Uzorci koji su korišteni u ovom istraživanju su ostatni uzorci krvi bolesnika iz Kliničke bolnice Sveti Duh. Za usporedbu su analizirani isti uzorci na automatskim analizatorima i Westergrenovom metodom. Dobiveni rezultati verifikacije pokazali su kako oba automatska analizatora za ispitivanje preciznosti ne zadovoljavaju u potpunosti kriterije koje je deklarirao proizvođač. Passing-Bablok regresijom utvrđeno je kako automatski analizator Roller 20 PN nije usporediv u cijelom području brzine sedimentacije eritrocita s Westergrenovom metodom dok automatski analizator iSED nije usporediv u području nižih brzina sedimentacije eritrocita ali je usporediv u području viših brzina sedimentacije eritrocita. Oba automatska analizatora u području brzina sedimentacije eritrocita < 20 mm/h mjere niže brzine sedimentacija eritrocita, a u području brzina sedimentacija eritrocita ≥ 20 mm/h mjere veće brzine sedimentacije eritrocita.

Abstract (english)

Westergren method suffers from numerous external factors that affect the obtained erythrocyte sedimentation rates while auto analyzers are closed systems where the influence of external factors is significantly reduced when determining the erythrocyte sedimentation rate. Recently available in the market, auto analyzers for erythrocyte sedimentation rate measurements use EDTA blood. This reduces the turn-around-time, the volume of blood needed for analysis, which is beneficial to the patient, and reduces the cost. Before introducing the automatic analyzer to measure erythrocyte sedimentation rate in routine, it is necessary to examine the analytical performance of the analyzer declared by the manufacturer. The aim of this study was to verify automatic analyzer Roller 20 PN (Alifax, Polverara, Italy) and automatic analyzer iSED (Alcor Scientific, Smithfield, USA) for automatic measurement of erythrocyte sedimentation rate. Verification of both automatic analyzers included day-to-day precision and series precision testing and comparison with the Westergren method. Day-to-day precision testing was performed on three level control samples for Roller 20 PN automatic analyzer and two levels for iSED. The intra-run precision was determined with control samples and patient blood samples. Samples used in this study are the leftover blood samples from patients in the Clinical Hospital of Sveti Duh. Agreement was analyzed by running samples simultaneously on automatic analyzers Roller 20 PN and iSED and the Westergren method. The results of the verification showed that precision for both automatic analyzers do not fully meet the criteria stated by the manufacturer. Passing-Bablok regression showed that automatic roller 20 PN analyzer was not comparable across the entire measurement range of erythrocyte sedimentation rate with the Westergren method while the iSED auto-analyzer was not comparable in the lower measurement range but was comparable in the higher range of erythrocyte sedimentation measurement. Both auto analyzers in the range of < 20 mm/h measure lower erythrocyte sedimentation rate, and in the range ≥ 20 mm/h measure higher rates of erythrocyte sedimentation rate.

• Keywords: sedimentacija eritrocita; Westergrenova metoda; automatski analizatori; Roller 20 PN; iSED
• Keywords (english): erythrocyte sedimentation rate; Westergren method; automated analyzers; Roller 20 PN; iSED
• Language: croatian
• URN:NBN: urn:nbn:hr:163:426972
• 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: 2018-12-18 09:59:34