| 13碳-呼气试验质控方法的建立及初步应用 |
| 投稿时间：2015-04-15 修订日期：2015-05-19 点此下载全文 |
| 引用本文：谢昌辉,李秀江,刘日信,冼碧霞,朱琳.13碳-呼气试验质控方法的建立及初步应用[J].医学研究杂志,2015,44(12):157-160 |
| DOI：
10.11969/j.issn.1673-548X.2015.12.044 |
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| 中文摘要:目的建立13碳-呼气试验(13C-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13C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13C-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13C-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13C-UBT的常规质控方法,以确保13C-UBT结果的准确、可信。 |
| 中文关键词:13碳-呼气试验 重复性测试 质量控制 超基准值 红外光谱仪 |
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| Establishment of Method for Quality Control of 13C-urea Breath Test and the Preliminary Application. |
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| Abstract: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 channels were abnormal, they were closed out. Conclusion The repeatable test of of blank samples and standard were recommended as a routine quality control method of 13C-UBT to ensure that the results of 13C-UBT were accurate and credible. |
| keywords:13Carbon-urea breath test Repeatable test Quality control Delta over baseline Infrared spectrometer |
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