Pighi Laura, Negrini Davide, Henry Brandon M, Salvagno Gian Luca, Lippi Giuseppe
Section of Clinical Biochemistry and School of Medicine, University of Verona, Verona, Italy.
Clinical Laboratory, Division of Nephrology and Hypertension, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Adv Lab Med. 2023 Oct 20;4(4):431-434. doi: 10.1515/almed-2023-0114. eCollection 2023 Dec.
The purpose of this proof-of-concept study was to investigate whether a commercially available urine dipstick may provide potentially useful information for screening plasma glucose and bilirubin in human plasma samples.
Glucose and bilirubin were assayed in 60 anonymized lithium-heparin residual plasma samples using the Roche COBAS 8000 or after pipetting 10 µL of plasma onto the pads of a commercial urine dipstick. Semiquantitative urine test results obtained with the dipstick were directly compared to paired test results obtained with COBAS.
Median plasma glucose values between COBAS and dipstick were slightly different (5.8 vs. 5.6 mmol/L; p=0.040), while no significant difference was found in bilirubin values between COBAS and dipstick (11.2 vs. 8.6 μmol/L; p=0.090). The Spearman's correlation between COBAS and dipstick was 0.83 (95% CI, 0.73-0.90; p<0.001) for plasma glucose and 0.78 (95% CI, 0.66-0.87; p<0.001) for plasma bilirubin, respectively. Cumulative agreement between COBAS and dipstick was high for both glucose (88%; kappa statistic statistics, 0.75; 95% CI, 0.58-0.92; p<0.001) and bilirubin (88%; kappa statistics, 0.76; 95% CI, 0.60-0.92; p<0.001).
The results of this proof-of-concept study indicate that the commercial urine test strip used in our study provides acceptable performance for screening plasma glucose and bilirubin levels compared with reference laboratory assays.
本概念验证研究的目的是调查一种市售尿液试纸是否可为筛查人血浆样本中的血糖和胆红素提供潜在有用信息。
使用罗氏 cobas 8000 或在将 10 μL 血浆移液到市售尿液试纸的试垫上之后，对 60 份匿名锂肝素残留血浆样本中的葡萄糖和胆红素进行检测。将试纸获得的半定量尿液检测结果直接与 cobas 获得的配对检测结果进行比较。
cobas 和试纸之间的血浆葡萄糖中位数略有不同（5.8 对 5.6 mmol/L；p = 0.040），而 cobas 和试纸之间的胆红素值未发现显著差异（11.2 对 8.6 μmol/L；p = 0.090）。血浆葡萄糖的 cobas 和试纸之间的斯皮尔曼相关性分别为 0.83（95% CI，0.73 - 0.90；p < 0.001）和血浆胆红素为 0.78（95% CI，0.66 - 0.87；p < 0.001）。cobas 和试纸之间葡萄糖（88%；kappa 统计量，0.75；95% CI，0.58 - 0.92；p < 0.001）和胆红素（88%；kappa 统计量，0.76；95% CI，0.60 - 0.92；p < 0.001）的累积一致性都很高。
本概念验证研究的结果表明，与参考实验室检测相比，我们研究中使用的市售尿液试纸条在筛查血浆葡萄糖和胆红素水平方面具有可接受的性能。
