Result of 2014 external quality assessment for KRAS mutation testing
10.3760/cma.j.issn.1009-9158.2015.10.004
- VernacularTitle:2014年中国 KRAS 基因突变检测室间质量评价
- Author:
Yanxi HAN
;
Rui ZHANG
;
Jinming LI
- Publication Type:Journal Article
- Keywords:
Colorectal neoplasms;
Proto-oncogene proteins;
ras Proteins;
Mutation;
Individualized medicine
- From:
Chinese Journal of Laboratory Medicine
2015;(10):661-665
- CountryChina
- Language:Chinese
-
Abstract:
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 .
