评估一种新型的用于检测穿尿布儿童尿路感染的体外诊断设备。

Evaluation of a novel in-vitro diagnostic device for the detection of urinary tract infections in diaper wearing children.

机构信息

Cabinet Médical, Le Mont-sur-Lausanne, Switzerland.

出版信息

Swiss Med Wkly. 2012 Apr 5;142:w13560. doi: 10.4414/smw.2012.13560. eCollection 2012.

DOI:10.4414/smw.2012.13560

PMID:22481595

Abstract

QUESTIONS

Is the novel in-vitro diagnostic device U-Test(®) reliable and secure for urine collection in diaper-wearing children and simultaneous evaluation of the urine collected for the presence of leucocytes and nitrite?

METHODS

The qualitative and functional performance of U-Test(®) was evaluated in a multicentre prospective clinical trial. The diagnostic performance of the novel in-vitro diagnostic device was determined in reference to the established procedure involving urine sampling by urine-bag, clean-catch, catheterisation and suprapubic aspiration followed by dipstick analysis and urine culture, and in an in-vitro study.

RESULTS

U-Test(®) proved to be comfortable and secure for the child and well accepted by the persons responsible for the participating children. No undesired side-effects were seen and in 75.8% (95% CI ± 10.5%; n = 66) of the tests used, enough urine was collected within the permitted time for immediate and successful urine analysis by the integrated test card. Diagnostic performance was found to be comparable to the established procedure using dipstick analysis (leucocytes: κ-coefficient 0.86; nitrite: κ-coefficient 0.74; n = 150). Sensitivity of the U-Test(®) for leucocyte detection was found to be 96.7% and specificity 100.0%. For nitrite detection sensitivity of 90.0% and specificity of 98.3% were found.

CONCLUSIONS

The evaluation shows that U-Test(®) is a safe and reliable device of high functionality and diagnostic performance for the detection of leucocytes and nitrite directly and without time delay in a child's diaper. This statement is based on a comprehensive comparison of the novel device with accepted diagnostic test systems and procedures based on the same dry chemistry technology. Due to its simplicity of use, U-Test(®) can be considered an alternative to the cumbersome procedures of urine collection by the bag-method or clean-catch followed by dipstick analysis for the presence of leucocytes and nitrite.

摘要

问题

U-Test（®）新型体外诊断设备在收集纸尿裤中尿液以及同时评估收集尿液中的白细胞和亚硝酸盐方面是否可靠和安全？

方法

在一项多中心前瞻性临床试验中，评估了 U-Test（®）的定性和功能性能。新型体外诊断设备的诊断性能是通过与既定程序进行比较确定的，该程序涉及使用尿袋、清洁接取、导尿和耻骨上抽吸收集尿液，然后进行尿液试纸分析和尿液培养，并进行体外研究。

结果

U-Test（®）被证明对儿童舒适且安全，并且得到了参与儿童负责人的认可。没有观察到不良副作用，并且在 75.8%（95%置信区间±10.5%；n=66）的测试中，在允许的时间内收集到足够的尿液，可立即使用集成测试卡成功进行尿液分析。诊断性能与使用尿液试纸分析的既定程序相当（白细胞：κ 系数 0.86；亚硝酸盐：κ 系数 0.74；n=150）。U-Test（®）检测白细胞的敏感性为 96.7%，特异性为 100.0%。对于亚硝酸盐检测，敏感性为 90.0%，特异性为 98.3%。

结论

评估表明，U-Test（®）是一种安全可靠的设备，具有高功能和诊断性能，可直接在儿童尿布中无时间延迟地检测白细胞和亚硝酸盐。这一说法是基于对新型设备与基于相同干化学技术的公认诊断测试系统和程序的全面比较得出的。由于其使用简便，U-Test（®）可作为繁琐的袋法或清洁接取后进行白细胞和亚硝酸盐尿液试纸分析的替代方法。