Kouri Timo, Alagrund Katariina, Lehtonen Maaret, Tohmola Niina, Pihlajamaa Tero, Kouri Vesa-Petteri, Friman Sirpa, Holma Tanja, Kirjavainen Vesa, Pätäri-Sampo Anu, Lempiäinen Anna
Department of Clinical Chemistry, HUSLAB, Helsinki University Hospital, HUS Diagnostic Center, FIN-00029 HUS, Helsinki, Finland; Department of Clinical Chemistry, University of Helsinki, Finland.
Department of Clinical Chemistry, HUSLAB, Helsinki University Hospital, HUS Diagnostic Center, FIN-00029 HUS, Helsinki, Finland.
Clin Chim Acta. 2021 Apr;515:96-103. doi: 10.1016/j.cca.2021.01.005. Epub 2021 Jan 16.
Ten UriSed 3 PRO automated microscopes (77 Elektronika, Hungary) were verified for nine HUSLAB laboratories with 160 000 annual urine samples.
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.
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 = 0.94 for WBC, r = 0.87 for RBC, and r = 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 10 CFB/L (10 CFU/mL). Created flagging limits allowed automated reporting for 70-75% of patient results.
UriSed 3 PRO instruments were adopted into routine use after acceptance of the verification.
对10台UriSed 3 PRO自动显微镜（匈牙利77 Elektronika公司）进行了验证，这些显微镜供9个HUSLAB实验室使用，这些实验室每年处理160000份尿液样本。
使用463份尿液标本，将UriSed 3 PRO主要仪器（匈牙利77 Elektronika公司）的颗粒计数与参考目视显微镜检查结果进行对比，并使用396份平行标本与显色琼脂平板上的尿液培养结果进行对比。将9台辅助仪器与主要仪器进行两两比较。
与泊松分布相比，白细胞（WBC）计数的相对不精密度R（CV）估计为1.0，红细胞（RBC）计数为1.5。与目视显微镜检查的Spearman相关性，白细胞为r = 0.94，红细胞为r = 0.87，鳞状上皮细胞（SEC）计数为r = 0.82。与目视显微镜检查的一致性（Cohen加权kappa值），白细胞为0.94，红细胞为0.89，SEC为0.88，混合管型为0.59，非鳞状上皮细胞（NEC）为0.49。检测细菌的灵敏度为90%，与10CFB/L（10CFU/mL）培养结果相比特异性为39。设定的标记限值允许对70 - 75%的患者结果进行自动报告。
验证通过后，UriSed 3 PRO仪器被投入常规使用。
