^(13)碳-呼气试验质控方法的建立及初步应用  

Establishment of Method for Quality Control of ^(13)C-urea Breath Test and the Preliminary Application

作　　者：谢昌辉[1] 李秀江[1] 刘日信 冼碧霞[1] 朱琳[1] 

机构地区：[1]南方医科大学附属深圳宝安医院,518101

出　　处：《医学研究杂志》2015年第12期157-160,共4页Journal of Medical Research

摘　　要：目的建立^(13)碳-呼气试验(^(13)C-UBT)的质控方法并进行初步应用。方法每月1次使用空白样本对^(13)C红外光谱仪进行重复性测试(每通道6次),测定结果记为超基准值(DOB);每季度一次使用标准品(DOB=3.0)对光谱仪进行重复性测试(每通道3次);日常工作中,当^(13)C-UBT测试结果可疑时,首先检查仪器的工作条件是否达标,再使用空白样本对光谱仪的每一通道进行单次测试;以空白或标准品测定值-标准值≥1.5和(或)≤-1.5作为光谱仪测试状态异常的判断标准。结果空白样本重复性测试时,如单个通道≥2次异常[即DOB值≥1.5和(或)≤-1.5],该通道应封闭停用;6通道中,>2通道异常,应停机维修。标准品重复性测试时,如单个通道2次异常[即DOB值≥4.5和(或)≤1.5],通道应封闭停用;6通道中,>2通道异常,应停机调试。日常空白测试,≤1通道异常,结果可信;≥3通道异常,整机的测试结果应当舍弃,应停机维修。如2通道异常,可关机半小时后再启动光谱仪,再次对每一通道进行空白单次测试。如≤1通道异常,继续进行^(13)C-UBT,仅原2通道异常则封闭停用。结论建议将空白样本和标准品的重复性测试作为^(13)C-UBT的常规质控方法,以确保^(13)C-UBT结果的准确、可信。Objective To establish the method for quality control of ^13C-urea breath test（^13C-UBT） and conduct the preliminary application. Methods A repeatable test of ^13C infrared spectrometer（6 times per channel） was carried out with a blank sample once a month. The determination results may be recorded as delta over baseline（DOB）. A repeatable test of spectrometer（3 times per channel） was used with a standard sample（DOB value=3.0） once a quarter. The working conditions of instrument were first checked to see whether they were up to scratch when the ^13C-UBT results were suspect in daily work, and then a single test of spectrometer（per channel） was used with the blank samples. The difference of the blank or standard measured value and standard is more than 1.5 and/or -1.5 as the criterion for judging whether to determine the abnormal test status of spectrometer. Results Such as greater than or equal to 2 times abnormalities（DOB value ≥ 1.5 and/or ≤ -1.5） were found for a single channel, the channel should be closed out when the repeatable test was carried out with a blank sample. The spectrometer should be repaired if more than 2 channels were abnormal among 6 channels. Such as greater than or equal to 2 times abnormalities（DOB value ≥ 4.5 and/or ≤ 1.5）, the channel should be closed out when the repeatable test is used with a standard sample. The spectrometer should be adjust if more than 2 channels are abnormal among 6 channels. The result was credible if less than 1 channel is abnormalities when the single daily test was used with a blank sample. The spectrometer should be repaired and the test results of the machine should be abandoned if greater than or equal to 3 channels were abnormal among 6 channels. You can start spectrometer again after shutting down half an hour if 2 channels are abnormalities. Then a single blank test was used again. ^13C-UBT should be continued if less than 1 channel was abnormalities when the single daily test again. Such as only the original 2 chan

关 键 词：^13碳-呼气试验 重复性测试 质量控制 超基准值 红外光谱仪 

分 类 号：R57[医药卫生—消化系统]