幽门螺杆菌<sup>13</sup>C呼气检测溯源技术研究

郝静坤; 刘沂玲; 胡树国; 马兴; 谢聪慧; 尹冬梅; 王德发

doi:10.12338/j.issn.2096-9015.2024.0144

幽门螺杆菌¹³C呼气检测溯源技术研究

doi: 10.12338/j.issn.2096-9015.2024.0144

1.
中国计量科学研究院，北京 100029
2.
福建省计量科学研究院，福州 350001

基金项目: 中国计量科学研究院基本科研探索性创新项目(AKYCX2208)。

详细信息

作者简介:
郝静坤（1983-），中国计量科学研究院高级工程师，研究方向：气体计量，邮箱：haojk@nim.ac.cn

通讯作者:
王德发（1977-），中国计量科学研究院副研究员，研究方向：气体计量，邮箱：wangdf@nim.ac.cn

中图分类号: TB99
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出版历程
- 收稿日期: 2024-04-25
- 录用日期: 2024-05-09
- 修回日期: 2024-05-23
- 网络出版日期: 2024-08-02

Research on Traceability Techniques for Helicobacter pylori ¹³C Breath Test

1.
National Institute of Metrology, Beijing 100029, China
2.
Fujian Metrology Institute, Fuzhou 350001, China

摘要

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。
- 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.
- metrology /
- ¹³C-urea breath test /
- Helicobacter pylori /
- DOB reference gas generation device /
- human breath matrix effect

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图 1 ¹³C尿素呼气试验原理图

Figure 1. Schematic of ¹³C-UBT

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图 2 DOB标准气体发生装置实物图

Figure 2. DOB standard gas generation device

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图 3 标准气体控温加湿装置实物图

Figure 3. Standard gas temperature and humidity control device

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图 4 DOB标准气体（干气）发生系统示意图

Figure 4. Schematic diagram of DOB reference gas generation system (dry gas)

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图 5 控温加湿DOB标准气体发生系统示意图

Figure 5. Schematic diagram of temperature-controlled and humidified DOB reference gas generation system

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图 6 示值误差测量结果对比图

Figure 6. Comparison of indication error measurement results

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图 7 CO₂红外吸收光谱与H₂O红外吸收光谱对比图

Figure 7. Comparison of CO₂ and H₂O infrared absorption spectra

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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

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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‰
仪器	1	2	3	4	5	6	重复性‰
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

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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

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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‰
条件	仪器	1	2	3	4	5	6	重复性‰
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

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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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