Verification of UriSed 3 PRO automated urine microscope in regional laboratory environment

Timo Kouri; Katariina Alagrund; Maaret Lehtonen; Niina Tohmola; Tero Pihlajamaa; Vesa-Petteri Kouri; Sirpa Friman; Tanja Holma; Vesa Kirjavainen; Anu Pätäri-Sampo; Anna Lempiäinen

doi:10.1016/j.cca.2021.01.005

Verification of UriSed 3 PRO automated urine microscope in regional laboratory environment

Clin Chim Acta. 2021 Apr:515:96-103. doi: 10.1016/j.cca.2021.01.005. Epub 2021 Jan 16.

Affiliations

¹ Department of Clinical Chemistry, HUSLAB, Helsinki University Hospital, HUS Diagnostic Center, FIN-00029 HUS, Helsinki, Finland; Department of Clinical Chemistry, University of Helsinki, Finland. Electronic address: timo.kouri@helsinki.fi.
² Department of Clinical Chemistry, HUSLAB, Helsinki University Hospital, HUS Diagnostic Center, FIN-00029 HUS, Helsinki, Finland.
³ Department of Clinical Microbiology, HUSLAB, Helsinki University Hospital, HUS Diagnostic Center, FIN-00029 HUS, Helsinki, Finland.

PMID: 33460593
DOI: 10.1016/j.cca.2021.01.005

Abstract

Background and aims: Ten UriSed 3 PRO automated microscopes (77 Elektronika, Hungary) were verified for nine HUSLAB laboratories with 160 000 annual urine samples.

Materials and methods: Particle counting of the primary UriSed 3 PRO instrument (77 Elektronika, Hungary) was verified against reference visual microscopy with 463 urine specimens, and against urine culture on chromogenic agar plates with parallel 396 specimens. Nine secondary instruments were compared pairwise with the primary instrument.

Results: Relative imprecisions compared to Poisson distribution, R(CV), were estimated to be 1.0 for white blood cell (WBC) and 1.5 for red blood cell (RBC) counts, respectively. Spearman's correlations against visual microscopy were r_S = 0.94 for WBC, r_S = 0.87 for RBC, and r_S = 0.82 for squamous epithelial cell (SEC) counts. Agreement with visual microscopy (Cohen's weighted kappa) was 0.94 for WBC, 0.89 for RBC, 0.88 for SEC, 0.59 for combined casts, and 0.49 for non-squamous epithelial cells (NEC). Bacteria were detected with a sensitivity of 90% and specificity of 39 against culture at 10⁷ CFB/L (10⁴ CFU/mL). Created flagging limits allowed automated reporting for 70-75% of patient results.

Conclusions: UriSed 3 PRO instruments were adopted into routine use after acceptance of the verification.

Keywords: Automation; Particle counting; Poisson distribution; UriSed 3 PRO; Urinalysis; Urine sediment.

MeSH terms

Humans
Hungary
Laboratories*
Microscopy*
Reproducibility of Results
Urinalysis
Urine