J 2018

Evaluation of FUS-2000 urine analyzer: analytical properties and particle recognition

BEŇOVSKÁ, Miroslava, Ondřej WIEWIORKA a Jana PINKAVOVA

Základní údaje

Originální název

Evaluation of FUS-2000 urine analyzer: analytical properties and particle recognition

Autoři

BEŇOVSKÁ, Miroslava (203 Česká republika, garant, domácí), Ondřej WIEWIORKA (203 Česká republika, domácí) a Jana PINKAVOVA (203 Česká republika)

Vydání

SCANDINAVIAN JOURNAL OF CLINICAL & LABORATORY INVESTIGATION, ABINGDON, INFORMA HEALTHCARE, 2018, 0036-5513

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30100 3.1 Basic medicine

Stát vydavatele

Velká Británie a Severní Irsko

Utajení

není předmětem státního či obchodního tajemství

Impakt faktor

Impact factor: 1.380

Kód RIV

RIV/00216224:14110/18:00103986

Organizační jednotka

Lékařská fakulta

DOI

UT WoS

000424952600023

Klíčová slova anglicky

Laboratory routines and automation; urinalysis; analytical performance; laboratory statistics; microscopy; medical biochemistry

Štítky

Příznaky

Mezinárodní význam, Recenzováno
Změněno: 9. 2. 2019 22:55, Soňa Böhmová

Anotace

V originále

This study evaluates the performance of microscopic part of a hybrid analyzer FUS-2000 (Dirui Industrial Co., Changchun, China), its analytical properties and particle recognition. The evaluation of trueness, repeatability, detection limit, carry-over, linearity range and analytical stability was performed according to Dirui protocol guidelines designed by Dirui Company to guarantee the quality of the instrument. Trueness for low, medium and high-value concentrations was calculated with bias of 15.5, 4.7 and -6.6%, respectively. Detection limit of 5 Ery/l was confirmed. Coefficient of variation of 11.0, 5.2 and 3.8% was measured for within-run repeatability of low, medium and high concentration. Between-run repeatability for daily quality control had coefficient of variation of 3.0%. Carry-over did not exceed 0.05%. Linearity was confirmed for range of 0-16,000 particles/l (R-2=0.9997). The analytical stability had coefficient of variation of 4.3%. Out of 1258 analyzed urine samples, 362 positive were subjected to light microscopy urine sediment analysis and compared to the analyzer results. Cohen's kappa coefficients were calculated to express the concordance. Squared kappa coefficient was 0.927 (red blood cells), 0.888 (white blood cells), 0.908 (squamous epithelia), 0.634 (transitional epithelia), 0.628 (hyaline casts), 0.843 (granular casts) and 0.623 (bacteria). Single kappa coefficients were 0.885 (yeasts) and 0.756 (crystals), respectively. Aforementioned results show good analytical performance of the analyzer and tight agreement with light microscopy of urine sediment.