尿试纸筛选血糖和胆红素在低资源设置:概念验证研究

IF 1.1 Q4 MEDICAL LABORATORY TECHNOLOGY
Laura Pighi, Davide Negrini, Brandon M. Henry, Gian Luca Salvagno, Giuseppe Lippi
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引用次数: 0

摘要

摘要目的:本概念验证性研究的目的是调查市售尿试纸是否可以为筛选人血浆样本中的血糖和胆红素提供潜在的有用信息。方法使用罗氏COBAS 8000或将10µL血浆移液到市售尿量尺垫上后,对60份匿名锂-肝素残留血浆样品进行葡萄糖和胆红素检测。用试纸获得的半定量尿液测试结果直接与COBAS获得的配对测试结果进行比较。结果COBAS和测温仪的中位血糖值略有差异(5.8 vs. 5.6 mmol/L;p=0.040),而COBAS和试纸之间的胆红素值无显著差异(11.2 vs. 8.6 μmol/L;p = 0.090)。COBAS与测油尺的Spearman相关系数为0.83 (95% CI, 0.73-0.90;p < 0.001)和0.78 (95% CI, 0.66-0.87;p < 0.001),分别为血浆胆红素。COBAS和试纸对葡萄糖的累积一致性都很高(88%;Kappa统计量统计值为0.75;95% ci, 0.58-0.92;P<0.001)和胆红素(88%;Kappa统计量为0.76;95% ci, 0.60-0.92;术中,0.001)。结论:这项概念验证性研究的结果表明,与参考实验室检测相比,我们研究中使用的商业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。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Urine dipstick for screening plasma glucose and bilirubin in low resource settings: a proof-of-concept study
Abstract Objectives 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. Methods 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. Results 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). Conclusions 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.
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