Cirilli Natalia, Floridia Giovanna, Amato Annalisa, Padoan Rita, Censi Federica, Ferrari Gianluca, Raia Valeria, Castaldo Giuseppe, Capoluongo Ettore, Taruscio Domenica, Salvatore Marco
Cystic Fibrosis Centre, Department of Gastroenterology and Transplantation, Marche University Hospital, Ancona, Italy.
Unità di Bioetica, Istituto Superiore di Sanità, 00161, Rome, Italy.
Pract Lab Med. 2024 May 21;40:e00403. doi: 10.1016/j.plabm.2024.e00403. eCollection 2024 May.
The advent of CFTR modulators highlighted that the sweat test (ST) for CF can be used also as an outcome measure for the basic defect of CFTR. Despite the technological advances, ST still remains operator-dependent and its execution should be strongly paired with guidelines. In 2022, due to the advent of CFTR modulators, the Italian CF Society introduced a specific ST report. The aim of the present paper is to discuss the impact of this new report in the 2022-23 round of the Italian External Quality Assessment program for ST (I-EQA-SCT).
The scheme of the I-EQA-SCT is prospective, enrolment is voluntary, the payment of a fee is required and results are shared through a web-facility. Assessment covers analysis, interpretation, and reporting of results. In the 2022-23 round, 2 out of the 3 mock clinical information referred to patients who started modulators.
Fourteen laboratories completed the 2022-23 I-EQA-SCT round. Three of them failed in the interpretation of results from these two mock cases and/or used a wrong report not consistent with the more recent Italian Sweat Test Recommendations.
The overall results obtained from the laboratories involved in the I-EQA-SCT program clearly showed that the laboratories' qualitative and quantitative performance improved significantly. Results emerged from this round highlighted an issue in the report form used for monitoring patients on CFTR modulator therapy thus stressing the importance of these programs in improving both the performance of lab services and ameliorating the sweat test recommendations.
CFTR调节剂的出现凸显出，用于囊性纤维化（CF）诊断的汗液试验（ST）也可作为CFTR基本缺陷的一项结果指标。尽管技术有所进步，但ST仍依赖操作人员，其实施应严格遵循指南。2022年，由于CFTR调节剂的出现，意大利CF协会推出了一份特定的ST报告。本文旨在探讨这份新报告对2022 - 2023年意大利ST外部质量评估计划（I - EQA - SCT）的影响。
I - EQA - SCT计划是前瞻性的，自愿报名参加，需缴纳费用，结果通过网络设施共享。评估涵盖结果分析、解读和报告。在2022 - 2023年这一轮中，3份模拟临床信息中有2份涉及开始使用调节剂的患者。
14家实验室完成了2022 - 2023年I - EQA - SCT轮次。其中3家在解读这两个模拟病例的结果时出现失误，和/或使用了与最新意大利汗液试验建议不符的错误报告。
参与I - EQA - SCT计划的实验室获得的总体结果清楚表明，实验室的定性和定量表现有显著改善。本轮结果凸显了用于监测接受CFTR调节剂治疗患者的报告表格存在的一个问题，从而强调了这些计划对于提高实验室服务表现和完善汗液试验建议的重要性。
