中国全科医学2025，Vol.28Issue(35)：4494-4500,7.DOI:10.12114/j.issn.1007-9572.2025.0008
标准弥散模拟器在肺弥散功能检查仪器质量评估中的应用研究
Application of a Standard Diffusion Simulator in Quality Evaluation of DLCO Instruments
摘要
Abstract
Background The accuracy of diffusing capacity of the lung for carbon monoxide(DLCO)instruments directly influences clinical decision-making in pulmonary diseases.However,long-term use of these instruments may lead to performance drift and measurement errors.At present,daily calibration using 3-L syringes and biological controls is commonly applied in clinical practice,but their sensitivity is insufficient to detect potential errors.Therefore,there is an urgent need to explore more precise and objective methods for quality evaluation of these instruments.Objective To evaluate the accuracy of DLCO instruments using a standard diffusion simulator that mimics human single-breath maneuvers,to identify and correct the sources of measurement errors,to observe the stability of calibration over time,and to assess the application value of this method in combination with biological control tests.Methods From March to July 2021,four DLCO instruments were tested in the pulmonary function laboratory of the National Clinical Research Center for Respiratory Diseases.A standard diffusion simulator(Hans Rudolph series 5560,USA)was employed with three carbon monoxide concentrations(0.08%,0.10%,0.13%)and three inhalation volumes(1.5 L,3 L,4.5 L)in different combinations to simulate single-breath DLCO tests.An absolute error of<2 mL·min-1·mmHg-1 between the measured and target DLCO values was defined as the acceptable range.The accuracy of four DLCO instruments(two brands,two models each)was evaluated as baseline,and the sources of measurement errors were analyzed.Each instrument was then corrected according to its error sources,and changes in accuracy before and after calibration as well as within three months were compared.Biological control testing was also performed to observe inter-instrument differences.Results At baseline,50%(2/4)of the instruments had a mean absolute DLCO error greater than 2 mL·min-1·mmHg-1.The error sources varied,including damaged components,incorrect calibration methods,and syringe leakage.After targeted corrections,all instruments achieved a mean absolute DLCO error within 2 mL·min-1·mmHg-1(P<0.001),and this accuracy was maintained for three months.Post-calibration,the differences among instruments in biological control testing were significantly reduced,particularly in the range and coefficient of variation(CV)of DLCO measurements,which showed statistically significant improvements(P<0.05).Conclusion DLCO instruments that have been in long-term clinical use show considerable variability in accuracy,with large measurement differences across instruments.Quality evaluation using a standard diffusion simulator is effective and feasible,enabling objective assessment of instrument accuracy and compensating for the limitations of routine calibration.Regular use of simulators is recommended for instrument quality evaluation and quality control.关键词
肺弥散功能/肺弥散功能仪/准确性/弥散模拟器/肺一氧化碳弥散量Key words
Pulmonary diffusing capacity/Pulmonary diffusion function instrument/Accuracy/Simulator/Diffusion capacity of the lung for carbon monoxide分类
医药卫生引用本文复制引用
吴仲平,黄锐波,林暌清,虞欣欣,钟丽萍,陈树冰,郑劲平,高怡..标准弥散模拟器在肺弥散功能检查仪器质量评估中的应用研究[J].中国全科医学,2025,28(35):4494-4500,7.基金项目
癌症、心脑血管、呼吸和代谢性疾病防治研究国家科技重大专项(2023ZD0506300) （2023ZD0506300）
