摘要
目的遗传代谢病筛查目前国际及国内普遍使用串联质谱技术检测,对实验室拥有的Waters TQD串联质谱仪经工程师2015年度8月份维护保养后仪器性能进行验证,以符合实验室检测要求。方法按照行业要求使用PEG400进行MS1、MS2质量数校正,后经维拉帕米峰面积重现性、室内质控、内标离子响应强度重复性、准确度等进行验证。结果质量数校正MS1及MS2 STATIC(静态)、SCANNING(动态扫描)、SCAN Speed Compensation(FAST)(扫描速度补偿)20个校正质量数,从45.03~696.44无一离子丢失,小于厂家声明丢失个数小于2个、理论值与校正后采集到的绝对质量数相差均小于0.03Da小于厂家声明0.2Da,均方根(RMS)在0.00848~0.0195小于厂家声明0.05;维拉帕米峰面积相对标准偏差RSD为2.03%小于厂家声明5%;氨基酸及酰基肉碱室内质控高低值均在靶值±2SD范围之内,结果均不违反质控规则;氨基酸内标离子响应强度变异系数CV%在7.26%~10.2%均小于保养前20天内标离子响应强度的变异系数8.38%~11.82%、酰基肉碱内标离子响应强度变异系数CV%在5.01%~10.39%均小于保养前20天内标离子响应强度的变异系数5.38%~10.45%;卫生部PT材料201521~201525氨基酸中瓜氨酸(Cit)、亮氨酸(Leu)、甲硫氨酸(Met)、苯丙氨酸(phe)、缬氨酸(Val)得分100,酪氨酸(Tyr)得分80,异戊酰肉碱(C5)、辛酰肉碱(C8)、棕榈酰肉碱(C16)、十八碳酰肉碱(C18)得分100,游离肉碱(C0),丙酰肉碱(C3)、月桂酰肉碱(C12)得分80,整体结果为合格满意。结论 Waters TQD串联质谱仪经年度维护保养后仪器的质量数校正、维拉帕米峰面积重现性、室内质控、内标离子响应强度重复性、准确度等均达到了厂家声明及相关行业检测的性能,满足实验室在遗传代谢病检测要求。
Objective：Nowadays,the screening of Genetic Metabolic Disease is commonly done by Tandem Mass Spectrometer（MS/MS）home and abroad. The engineer maintained and verified the Waters TQD Tandem Mass Spectrometer owned by our laboratory on August 2015 to meet the requirement of laboratory testing. Methods：Following the requirement from the industry,we made the use of PEG400 to perform the Mass Calibration of MS1 and MS2,then using the Verapamil Peak Area Reproducibility,Internal Quality Control,Ion Internal Standard Response Repeatability and Precision to perform the verification. Results：The Mass Calibration contains MS1,MS2 STATIC,SCANING,and SCAN Speed Compensation. The total number of Mass Calibration is 20,and there is no one ion losing from 45.03 to 696.44,lower than the ion losing number of 2 declared by the manufacturer. The different value between the theoretical value and the absolute mass value collected after the calibration is less than 0.03 Da,lower than the value of 0.2 Da declared by the manufacturer. The Root Mean Square（RMS）is between 0.00848~0.0195,lower than the value of 0.05 declared by the manufacturer. The Relative Standard Deviation（RSD）of Verapamil Peak Area is 2.03%,lower than the value of 5% declared by the manufacturer. The Hi-Low value of amino acids and acylcarnitines Internal Quality Control is all in the range of the target value±2 SD. All the results do not against the rule of quality control. The Coefficient Variation（CV）of amino acids Ion Internal Standard Response is 7.26~10.2%,all lower than the CV 8.38~11.82% within 20 days before the maintenance. The Coefficient Variation（CV）of acylcarnitines Ion Internal Standard Response is 5.01~10.39%,all lower than the CV 5.38~10.45% within 20 days before the maintenance. Within the protein materials of Taiwan Health Department 201521~201525,the points of amino acids Citrulline,Leucine,Methionine,Phenylalanine and Valine are 100. The point of amino acid Tyrosine is 80. The points of C5,C8,C16 and C18 are 100,and the
作者
卢东裕
常海涛
计娓娓
贾玉红
孙佳惠
张道杰
LU Dong-yu, CHANG Hai-tao, Jl Wei-wei, JIA Yu-hong, SUN Jia-hui, ZHANG Dao-jie(Department of Biochemical Genetics, Beijing Shengyuan Huiren Medical Laboratory Institute, Beijing101101, Chin)
出处
《中国优生与遗传杂志》
2018年第3期9-12,31,共5页
Chinese Journal of Birth Health & Heredity
关键词
串联质谱
遗传代谢病
性能验证
Tandem Mass Spectrometer
Inherited metabolic disorders
Performance verification
