Undiagnosed Rare Diseases Interdepartmental Unit, Istituto Superiore di Sanità, National Center Rare Diseases, 00161 Rome, Italy.
Unità di Bioetica, Istituto Superiore di Sanità, 00161 Roma, Italia.
Int J Environ Res Public Health. 2020 May 4;17(9):3196. doi: 10.3390/ijerph17093196.
(1) Background: Diagnostic testing for cystic fibrosis (CF) is based on a sweat chloride test (SCT) considering the appropriate signs and symptoms of the disease and results of a gene mutation analysis. In 2014, the Istituto Superiore di Sanità (ISS) established a pilot Italian external quality assessment program for CF SCT (Italian EQA-SCT), which is now a third party service carried out by the ISS. (2) Methods: The ongoing scheme is prospective, enrollment is voluntary, and the payment of a fee is required. Results are shared through a dedicated web-facility. Assessment covers the analysis, interpretation, and reporting of results. (3) Results: Thirteen, fifteen, sixteen, and fifteen different laboratories, respectively, participated from 2015 to 2016 and from 2018 to 2019 in the Italian EQA-SCT scheme. Eleven different laboratories participated each year in all four rounds of the Italian EQA-SCT. (4) Conclusions: The overall results obtained from the laboratories participating constantly clearly show that their qualitative and quantitative performance improved significantly. This is due to the opportunity-after receiving the EQA results-to constantly review their performance and address any inconsistencies. We firmly believe that participation in the EQA program will improve the quality of participating laboratories and that EQA participation should become mandatory as a fundamental requirement for laboratory accreditation.
(1) 背景：囊性纤维化（CF）的诊断测试基于汗液氯测试（SCT），考虑到疾病的适当体征和症状以及基因突变分析的结果。2014 年，意大利高等卫生研究院（ISS）建立了 CF SCT（意大利 EQA-SCT）的试点意大利外部质量评估计划，该计划现在由 ISS 作为第三方服务进行。(2) 方法：现行计划是前瞻性的，注册是自愿的，需要支付费用。结果通过专用网络设施共享。评估涵盖分析、解释和报告结果。(3) 结果：分别有 13、15、16 和 15 个不同的实验室参加了 2015 年至 2016 年和 2018 年至 2019 年的意大利 EQA-SCT 计划。11 个不同的实验室每年都参加了意大利 EQA-SCT 的四轮。(4) 结论：参加实验室的整体结果清楚地表明，他们的定性和定量性能显著提高。这是因为在收到 EQA 结果后，他们有机会不断审查自己的表现并解决任何不一致之处。我们坚信，参加 EQA 计划将提高参与实验室的质量，并且 EQA 参与应成为实验室认证的强制性基本要求。
