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两台相同血气分析仪结果的三年监测与比较

Three-year monitoring and comparison of results from two identical blood gas analyzers.

作者信息

Huang Yun, Dean Robert, Dubbelman Yvonne, Vincent Anne, Chan Ying-Pui Michael

机构信息

Clinical Laboratories, Kingston Health Sciences Centre, 76 Stuart Street, Kingston, ON, Canada.

Department of Pathology and Molecular Medicine, Queen's University, 76 Stuart Street, Kingston, ON, Canada.

出版信息

Pract Lab Med. 2022 Jun 3;31:e00286. doi: 10.1016/j.plabm.2022.e00286. eCollection 2022 Aug.

Abstract

OBJECTIVES

Measurement comparability between blood gas analyzers within a laboratory is of utmost importance. This study analyzed the data obtained from a three-year period.

DESIGN AND METHODS

For quality monitoring one blood sample was tested on two identical blood gas analyzers at each of three shifts/day for three years. Deming regression analysis was used to determine result correlation and statistical identity between the two analyzers for H, CO, O, sodium, potassium, chloride, ionized calcium, glucose, and lactate. Failures in the two-analyzer comparison were determined by the performance limits from the Institute of Quality Management in Healthcare (IQMH) and from the manufacturer respectively.

RESULTS

Correlation coefficients were greater than 0.96 (0.9622-0.9975) for all tested analytes. The measurements of every analyte on both analyzers were statistically identical. In the two-analyzer comparison failure numbers/1000 tests for O and glucose varied with the performance limits (IQMH: 0.6 and 49.2; the manufacturer: 19.3 and 4.4, respectively). In addition, persistent glucose failures (>5/week) between the two analyzers occurred occasionally.

CONCLUSIONS

Results of all tested analytes between the two blood gas analyzers were interchangeable. Recurring glucose discrepancies might be a result of different lots of cartridges used on each analyzer, which were not identified during the initial installation.

摘要

目的

实验室内部血气分析仪之间的测量可比性至关重要。本研究分析了三年期间获得的数据。

设计与方法

为进行质量监测,每天三个班次,连续三年在两台相同的血气分析仪上对一份血样进行检测。采用戴明回归分析来确定两台分析仪在氢离子、二氧化碳、氧、钠、钾、氯、离子钙、葡萄糖和乳酸方面的结果相关性及统计一致性。两台分析仪比较中的失败情况分别根据医疗质量管理协会(IQMH)和制造商的性能限值来确定。

结果

所有检测分析物的相关系数均大于0.96(0.9622 - 0.9975)。两台分析仪上每种分析物的测量结果在统计学上是一致的。在两台分析仪比较中,氧和葡萄糖每1000次检测的失败次数随性能限值而变化(IQMH:分别为0.6和49.2;制造商:分别为19.3和4.4)。此外,两台分析仪之间偶尔会出现持续性葡萄糖检测失败(>每周5次)。

结论

两台血气分析仪之间所有检测分析物的结果具有互换性。反复出现的葡萄糖差异可能是由于每台分析仪使用的不同批次的试剂盒所致,这在初始安装时未被识别。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b540/9185016/50bacc1c431f/gr1.jpg

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