Research Department, Cell Biology and Biotherapy Unit, INT Fondazione G.Pascale, Via M. Semmola, Naples, Italy.
J Thorac Oncol. 2013 Jun;8(6):773-8. doi: 10.1097/JTO.0b013e31828c2b08.
The Italian Association of Medical Oncology (AIOM) and the Italian Society of Pathology and Cytology organized an external quality assessment (EQA) scheme for EGFR mutation testing in non-small-cell lung cancer.
Ten specimens, including three small biopsies with known epidermal growth factor receptor (EGFR) mutation status, were validated in three referral laboratories and provided to 47 participating centers. The participants were requested to perform mutational analysis, using their usual method, and to submit results within a 4-week time frame. According to a predefined scoring system, two points were assigned to correct genotype and zero points to false-negative or false-positive results. The threshold to pass the EQA was set at higher than 18 of 20 points. Two rounds were preplanned.
All participating centers submitted the results within the time frame. Polymerase chain reaction (PCR)/sequencing was the main methodology used (n = 37 laboratories), although a few centers did use pyrosequencing (n = 8) or real-time PCR (n = 2). A significant number of analytical errors were observed (n = 20), with a high frequency of false-positive results (n = 16). The lower scores were obtained for the small biopsies. Fourteen of 47 centers (30%) that did not pass the first round, having a score less than or equal to 18 points, used PCR/sequencing, whereas 10 of 10 laboratories, using pyrosequencing or real-time PCR, passed the first round. Eight laboratories passed the second round. Overall, 41of 47 centers (87%) passed the EQA.
The results of the EQA for EGFR testing in non-small-cell lung cancer suggest that good quality EGFR mutational analysis is performed in Italian laboratories, although differences between testing methods were observed, especially for small biopsies.
意大利肿瘤医学协会（AIOM）和意大利病理与细胞学学会联合组织了一项非小细胞肺癌表皮生长因子受体（EGFR）突变检测的外部质量评估（EQA）计划。
在三个参考实验室中验证了包括三个已知 EGFR 突变状态的小活检在内的十个标本，并分发给 47 个参与中心。参与者被要求使用其惯用方法进行突变分析，并在 4 周的时间内提交结果。根据预先设定的评分系统，正确的基因型得 2 分，假阴性或假阳性结果得 0 分。通过 EQA 的阈值设定为 20 分以上。计划了两轮。
所有参与中心都在规定的时间内提交了结果。聚合酶链反应（PCR）/测序是主要使用的方法（n = 37 个实验室），尽管少数中心使用焦磷酸测序（n = 8）或实时 PCR（n = 2）。观察到大量分析错误（n = 20），假阳性结果的频率很高（n = 16）。小活检的得分较低。在第一轮中，有 14 个得分低于或等于 18 分（n = 47）的中心未通过，使用的是 PCR/测序，而 10 个使用焦磷酸测序或实时 PCR 的实验室均通过了第一轮。有 8 个实验室通过了第二轮。总的来说，47 个中心中有 41 个（87%）通过了 EQA。
非小细胞肺癌 EGFR 检测的 EQA 结果表明，意大利实验室进行了良好质量的 EGFR 突变分析，尽管观察到了检测方法之间的差异，尤其是对于小活检。
