摘要
目的为保证KRAS基因突变检测质量，加强所使用试剂和方法的性能验证，本研究对2014年中国KRAS基因突变检测室间质量评价的总体情况及存在问题进行了分析和讨论。方法2014年两次室间质评样本盘均包含5支样本。要求各参评实验室收到样本后在规定的时间内检测样本并将检测结果上传至向中心数据库。依据回报结果计算各实验室和各检测试剂的成绩，汇总和分析每份样本的总体符合率、假阴性率和假阳性率。结果2014年两次室问质评分别收到58份和57份有效回报结果。检测结果完全正确实验室分别为79．31％（46／58）和94．73％（54／57）。阳性样本总体符合率为93．53％（217／232）和96．49％（165／171），阴性样本总体符合率为100％（58／58）和98．25％（112／114）。样本检测假阴性率分别为1．29％（3／232）和0％，假阳性率分别为4．14％（12／290）和3．15％（9／285）。结论各实验室在KRAS基因突变检测总体符合率上有显著提高，但假阳性和假阴性结果是影响KRAS基因突变检测的主要问题。各实验室需要标准化基因突变检测流程，严格执行扩增产物污染防治措施；各试剂厂家需要通过改良试剂探针设计，优化结果判读标准，最终提高KRAS基因突变检测质量。
Objective To evaluate the performance of KRAS gene mutation detection in 2014 external quality assessment （EQA） program and discuss the problems in clinical laboratories. Methods The sample panel of 2014 EQA program contained 5 artificial formalin-fixed, paraffin-embedded （FFPE） samples. The participating laboratories were asked to report their results before the deadline. The scores of EQA and the rate of overall coincidence, false positive and false negative were calculated. Results The EQA program for KRAS testing was set twice a year. In 2014, 58 and 57 valid lab results were submitted respectively. About 79. 31% （46/58）and 94. 73 % （54/57） of the laboratories were correct for all samples. The coincidence rate of positive samples were 93.53% （217/232） and 96.49% （165/171）. The coincidence rate for negative ones were 100% （58/58） and 98.25% （112/114 ）. The false-negative ratio was 1.29% （ 3/232 ） and 0%. The false-positive ratio was 4. 14% （ 12/290 ） and 3.15% （ 9/285 ）. Conclusions The results of 2014 EQA for KRAS gene mutation testing suggested that the performance of laboratories had been improved significantly, however, the false-negative and false-positive results had always been the major problems affecting the accuracy of KRAS mutations testing. Laboratories needed to standardize the testing process and manufacturers should optimize the reagents and the Way of interpretation, to guarantee the performance of KRAS gene mutation detection.
出处
《中华检验医学杂志》
CAS
CSCD
北大核心
2015年第10期661-665,共5页
Chinese Journal of Laboratory Medicine
