Dubot Patricia, Liang Jing, Dubs Jacobé, Missiak Yohann, Sarazin Cédric, Couderc François, Caussé Elizabeth
Laboratoire de Biochimie, Institut Fédératif de Biologie, Hôpital Purpan, 330, av de Grande Bretagne TSA 40031, 31059 Toulouse Cedex 9, France.
WynSep SAS, Prologue 1, 815 La Pyrénéenne, 31670 Labège, France.
Pract Lab Med. 2018 Dec 7;13:e00114. doi: 10.1016/j.plabm.2018.e00114. eCollection 2019 Jan.
Cystic fibrosis (CF) is the less rare and severe genetic disease among the European population. Biochemical diagnosis of CF is based on the demonstration of increased chloride concentration in sweat samples, obtained during the sweat test (ST). WynSep developed a capillary electrophoresis with contactless conductivity detection (CE-C4D) able to measure sweat chloride with a low sample volume. We evaluated the clinical feasibility of this device in a cohort of patients suspected of CF, in comparison with the common coulometric method (ChloroChek chloridometer).
We determined sweat chloride concentration of 65 samples from patients referred to our institution to undergo a sweat test. Each sample was submitted to coulometric method first, then WynSep-CE, with or without internal standard (IS) subject to sufficient volume sample.
A total of 53 samples were analysed by both coulometric and WynSep-CE (using IS) methods. The method validation showed comparable analytical performances for both methods; no false positive or false negative was recorded. The two methods showed a high correlation (r = 0.993, p < 0.001) and a close agreement was demonstrated by two different statistical tests (Bland-Altman and Passing-Bablok).
WynSep-CE is an accurate, fast, easy-to-use and an appropriate method for CF diagnosis.
囊性纤维化（CF）是欧洲人群中相对常见且严重的遗传性疾病。CF的生化诊断基于在汗液试验（ST）中获得的汗液样本中氯化物浓度升高的证明。WynSep开发了一种具有非接触式电导检测的毛细管电泳（CE-C4D），能够以低样本量测量汗液氯化物。我们将该设备与常用的电量分析法（ChloroChek氯化物测定仪）进行比较，评估了其在疑似CF患者队列中的临床可行性。
我们测定了65例转诊至我院进行汗液试验的患者样本的汗液氯化物浓度。每个样本首先采用电量分析法，然后采用WynSep-CE法，样本量充足时使用或不使用内标（IS）。
共对53个样本采用电量分析法和WynSep-CE法（使用IS）进行了分析。方法验证表明两种方法具有可比的分析性能；未记录到假阳性或假阴性。两种方法显示出高度相关性（r = 0.993，p < 0.001），并且通过两种不同的统计检验（Bland-Altman和Passing-Bablok）证明了密切一致性。
WynSep-CE是一种准确、快速、易于使用且适用于CF诊断的方法。
