Vernooij-van Langen Annette, Dompeling Edward, Yntema Jan-Bart, Arets Bert, Tiddens Harm, Loeber Gerard, Dankert-Roelse Jeannette
Department of Paediatrics, St Jansdal Hospital, PO box 138, 3840 AC, Harderwijk, The Netherlands,
Eur J Pediatr. 2015 Aug;174(8):1025-34. doi: 10.1007/s00431-015-2501-0. Epub 2015 Feb 13.
After a positive newborn screening test for cystic fibrosis (CF), a sweat test is performed to confirm the diagnosis. The success rate of the generally acknowledged methods (Macroduct/Gibson and Cooke) in newborns varies between 73 and 99%. The Nanoduct sweat test system is easier to perform and less sweat is needed. The main aim of this study was to measure the success rate of the Nanoduct compared to current approved sweat test methods in a newborn population. After informed consent of the parents, newborns with a positive screening test for CF were included. The Macroduct or Gibson and Cooke and Nanoduct were performed in all infants, during the same appointment. The chloride concentration was determined by standard coulorimetry; conductivity was measured directly and converted to a NaCl molarity. One hundred eight newborns were included: 17 with CF, 7 with cystic fibrosis transmembrane regulator (CFTR)-related metabolic syndrome (CRMS), and 84 healthy children. The success rate of the Nanoduct was 93% and for the Macroduct/Gibson and Cooke 79% (McNemar, p = 0.002). The Nanoduct detected the same CF patients as the Macroduct/Gibson and Cooke; one CF patient had an equivocal result for both tests, and no patients were missed. The area under the receiver operating characteristic curve for detection of CF with the Nanoduct was 0.999, with ideal cutoff levels of 91 and 66 mmol/l, comparable to former studies.
The success rate of the Nanoduct to collect sufficient sweat in infants was higher compared to the Macroduct and Gibson and Cooke.
新生儿囊性纤维化（CF）筛查试验呈阳性后，需进行汗液试验以确诊。公认方法（Macroduct/吉布森法和库克法）在新生儿中的成功率在73%至99%之间。Nanoduct汗液检测系统操作更简便，所需汗液量更少。本研究的主要目的是在新生儿群体中，与当前批准的汗液检测方法相比，测定Nanoduct的成功率。在获得家长知情同意后，纳入CF筛查试验呈阳性的新生儿。所有婴儿在同一次就诊时均进行Macroduct或吉布森法和库克法以及Nanoduct检测。通过标准比色法测定氯化物浓度；直接测量电导率并换算为氯化钠摩尔浓度。共纳入108名新生儿：17名患有CF，7名患有囊性纤维化跨膜传导调节因子（CFTR）相关代谢综合征（CRMS），84名健康儿童。Nanoduct的成功率为93%，Macroduct/吉布森法和库克法为79%（麦克尼马尔检验，p = 0.002）。Nanoduct检测出的CF患者与Macroduct/吉布森法和库克法相同；1名CF患者两种检测结果均不明确，且无患者漏诊。使用Nanoduct检测CF的受试者操作特征曲线下面积为0.999，理想临界值为91和66 mmol/l，与先前研究相当。
与Macroduct以及吉布森法和库克法相比，Nanoduct在婴儿中收集足够汗液的成功率更高。
