肺炎支原体SAT检测的室内质量控制与室间质量评价

Internal Quality Control and External Quality Assessment of SAT Test for Mycoplasma Pneumoniae

目的:采用RNA实时荧光恒温扩增检测技术(simultaneous amplification and testing,SAT)检测肺炎支原体,对张家口健垣医学检验实验室进行室内质量控制和室间质量评价,以发现实验室的不足并进行调整,提高实验室的检验质量。方法:取肺炎支原体(mycoplasma pneumoniae,MP)质控品进行10倍稀释后作为阳性对照,并在阳性对照的基础上进行10倍、100倍和1000倍的稀释,其中100倍和1000倍稀释重复进行四次,与阴性对照和阳性对照在相同条件下,采用新型检验技术SAT进行检验,观察曲线,检测灵敏度和精密度。并将天津儿童医院儿研所分子实验室提供MP的多例样本,进行RNA盲测,最后比较两间实验室的检测结果,对实验室进行精确评价。结果:质控品的10倍、100倍和1000倍稀释的质控品的检测均为阳性,CT值均小于30循环数;观察100倍稀释质控品的四个重复管的曲线、1000倍稀释质控品的四个重复管的曲线,均为“S”形曲线。MP样本RNA盲测的结果中第一个为阳性,其余为阴性,与天津儿童医院儿研所分子实验室提供的结果一致。结论:内部质量控制检测表明实验室具有良好的灵敏度和精密度,室间质量评价检测表明实验室具有极高的准确度,均符合相关准则对实验室的要求,使得检验结果更具有意义。

Objective:The method of testing Mycoplasma pneumoniae by SAT was used to carry out Internal Quality Control and External Quality Assessment in Zhangjiakou Jianyuan Medical Laboratory,so as to find out the deficiencies of the laboratory and make adjustments to improve the laboratory quality.Methods:Mycoplasma pneumoniae(MP)quality control products were diluted 10 times as positive control,and then diluted 10 times,100 times and 1000 times on the basis of the positive control,in which the dilution of 100 times and 1000 times was repeated for four times.Simultaneous Amplification and Testing(SAT)of RNA was used to observe the curve,sensitivity and precision of detection under the same conditions as negative control and positive control.In addition,multiple MP samples provided by the Molecular Laboratory of the Pediatric Research Institute of Tianjin Children’s Hospital were carried out blind RNA testing.Finally,the test results of the two laboratories were compared to make an accurate evaluation of the laboratory.Results:The quality control products with 10 times,100 times and 1000 times dilution were all positive,and the CT values were all less than 30 cycles.Observe the curves of four repeat tubes of 100 times diluted quality control products and the curves of four repeat tubes of 1000 times diluted quality control products,all of which are“S”shaped curves.The results of MP sample RNA blind test were positive for the first one and negative for the rest,which were consistent with the results provided by the Molecular Laboratory of Pediatric Research Institute of Tianjin Children’s Hospital.Conclusion:IQC test shows that the laboratory has good sensitivity and precision,and EQA test shows that the laboratory has very high accuracy,which all meet the requirements of relevant standards for the laboratory,making the test results more meaningful.