Research on Traceability Techniques for Helicobacter pylori 13C Breath Test
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摘要: 针对目前幽门螺杆菌13C呼气检测无法有效溯源的难题,利用DOB标准气体发生系统发生DOB值为0~50‰的标准气体,对13C呼气检测设备进行计量性能评价。实验结果表明,各浓度点的示值误差均不超过±1.5‰,重复性不超过0.3‰。利用标准气体控温加湿装置,模拟人体呼气基体条件(34℃,90%RH),制备34℃加湿标准气体,并在不控温的情况下,制备室温加湿标准气体。对比了34℃加湿以及室温加湿标准气体与室温标准气体(干气)检测13C呼气检测设备的测量结果,结果表明,使用34℃加湿、室温加湿标准气体校准13C呼气试验检测设备时,测试结果与使用干气测量结果无显著差异和趋势性变化。结合理论推导及原理分析,推断标准气体控温加湿后对DOB值无影响。因此,可以直接使用室温干气作为13C呼气检测设备量值溯源所需的标准气体。
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关键词:
- 计量学 /
- 13C尿素呼气试验 /
- 幽门螺杆菌 /
- DOB标准气体发生装置 /
- 人体呼气基体效应
Abstract: Addressing the challenge of ineffective traceability in Helicobacter pylori 13C urea breath test (13C-UBT) in China, this study employed a dynamic continuous generation system to produce reference gases with delta over baseline (DOB) values ranging from 0 to 50‰. The metrological performance of 13C breath test equipment was evaluated using these reference gases. Experimental results demonstrated good agreement between the DOB reference gas values and the measurements of the 13C breath test equipment, with indication errors at each concentration point less than ±1.5‰ and repeatability within 0.3‰. To simulate human breath conditions (34°C, 90% RH), reference gases were humidified using a standard gas humidification device. The study compared the performance of 13C breath test equipment using reference gases under three conditions: simulated human breath (34°C, humidified), room temperature with humidity, and room temperature without humidification (dry gas). Results showed no significant differences or trends among these conditions, supported by theoretical derivations and principle analyses. This demonstrates that altering the temperature and humidity of reference gases does not affect the reported DOB values. Consequently, room temperature dry gas can be used as a reference gas for calibrating 13C-UBT analyzers and similar devices, simplifying the traceability process without compromising accuracy. -
表 1 仪器示值误差测试结果(干气)
Table 1. Indication error test results (dry gas)
仪器 标准值$ {x_s} $‰ 测量平均值$ \overline x $‰ 示值误差$ \Delta x $‰ A 2.00 2.13 0.13 4.00 3.90 −0.10 8.00 8.18 0.18 10.00 10.17 0.17 20.00 19.97 −0.03 40.00 40.20 0.20 B 2.00 2.20 0.20 4.00 3.97 −0.03 8.00 8.30 0.30 10.00 10.33 0.33 20.00 19.80 −0.20 40.00 40.70 0.70 C 2.00 1.77 −0.23 4.00 4.00 0 8.00 8.48 0.48 10.00 10.53 0.53 20.00 21.47 1.47 40.00 41.33 1.33 表 2 仪器重复性测试结果(干气)
Table 2. Measurement repeatability results (dry gas)
仪器 测试结果‰ 重复性‰ 1 2 3 4 5 6 A 8.0 8.2 8.3 8.3 8.1 8.2 0.12 B 8.3 8.2 8.4 8.4 8.2 8.3 0.09 C 8.5 8.4 8.6 8.3 8.7 8.4 0.15 表 3 仪器示值误差测试结果(控温加湿)
Table 3. Indication error test results(temperature and humidity controlled)
条件 室温,加湿90%RH 34℃,加湿90%RH 仪器 标准值$ {x_s} $ 测量平均值$ \overline x $ 示值误差$ \Delta x $ 测量平均值$ \overline x $ 示值误差$ \Delta x $ A 2.00 2.07 0.07 2.22 0.22 4.00 3.87 −0.13 3.86 −0.14 8.00 8.04 0.04 8.23 0.23 10.00 10.10 0.10 10.16 0.16 20.00 20.00 0 19.94 −0.06 40.00 40.33 0.33 40.26 0.26 B 2.00 2.26 0.26 2.35 0.35 4.00 3.87 −0.13 4.08 0.08 8.00 8.42 0.42 8.60 0.60 10.00 10.43 0.43 10.46 0.46 20.00 20.37 0.37 20.20 0.20 40.00 40.17 0.17 40.82 0.82 C 2.00 1.80 −0.20 1.69 −0.31 4.00 4.13 0.13 4.24 0.24 8.00 8.56 0.56 8.48 0.48 10.00 10.47 0.47 10.24 0.24 20.00 21.39 1.39 21.42 1.42 40.00 40.97 0.97 41.43 1.43 表 4 仪器重复性测试结果(控温加湿)
Table 4. Measurement repeatability results(temperature and humidity controlled)
条件 仪器 测试结果‰ 重复性‰ 1 2 3 4 5 6 室温,加湿90%RH A 8.1 8.2 8 7.9 8.1 7.9 0.12 B 8.3 8.5 8.4 8.4 8.5 8.3 0.09 C 8.5 8.7 8.6 8.6 8.7 8.6 0.08 34℃,加湿90%RH A 8.3 8.1 8.2 8.2 8.2 8.3 0.08 B 8.6 8.7 8.6 8.5 8.8 8.6 0.10 C 8.5 8.5 8.5 8.4 8.4 8.7 0.11 表 5 重复性测量结果对比表
Table 5. Comparison of measurement repeatability results
标准值
(‰)重复性(‰) 仪器A 仪器B 仪器C 室温
干气室温
湿气34℃
湿气室温
干气室温
湿气34℃
湿气室温
干气室温
湿气34℃
湿气8.00 0.12 0.09 0.15 0.12 0.09 0.08 0.08 0.10 0.11 -
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