Effects of reverse osmosis membrane replacement of pure water system on clinical chemistry and immunoassay in clinical laboratory.

Shaocong Liang, Huaxian Wu, Jiayi Zhao, Xuanjie Guo, Yongjie Qiang, Xin Zhao, Meng Lan, Chongquan Zhao, Dongxin Zhang
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Abstract

Introduction: Reverse osmosis (RO) membrane, key component of water-purifying equipment, is often stored in protection fluid containing substances such as glycerol, which may contaminate the water at replacement. This study aims to explore the effects of RO membrane replacement on clinical chemistry and immunoassay, particularly triglyceride (TG), providing reference for managing test interference caused by RO membrane replacement.

Materials and methods: The RO membrane of water-purifying equipment A, which provided water to C16000 biochemistry analyzer (Abbott Laboratories, Abbott Park, USA) and E801 electrochemiluminescence analyzer (Roche, Basel, Switzerland), was replaced. Water resistivity was recorded, and quality control (QC) tests were performed on C16000 and E801. Moreover, TG was measured in 29 of selected serum samples on C16000 at 0.5h and 10.5h after RO membrane replacement and on reference biochemistry analyzer BS2000M (Mindray Biomedical Electronics Co., Shenzhen, China), which was connected to water-purifying equipment B without RO membrane replacement. Finally, blank, calibrator 1 and calibrator 2 of TG reagent were measured on C16000 before and at 0.5h, 2.5h and 10.5h after RO membrane replacement. All statistical analyses of data were done using GraphPad Prism (GraphPad Software Inc., San Diego, USA), and a value of P < 0.05 was considered statistically significant.

Results: After RO membrane replacement, all QC results of clinical chemistry and immune tests passed except TG that showed positive bias of 536% and 371% at two levels, respectively. Moreover, TG results of the same serum samples were significantly higher at 0.5h than 10.5h after RO membrane replacement. Meanwhile, there was worse agreement and correlation of TG results between C16000 and BS2000M at 0.5h than 10.5h after replacement. Furthermore, the absorbance of TG blank, calibrator 1 and calibrator 2 was significantly higher at 0.5h and 2.5h after replacement than before replacement, and the absorbance gradually returned to normal value at 10.5h after replacement.

Conclusions: Replacement of RO membrane could cause significant interference to TG test while have no effects on other laboratory tests performed in the study, which may be due to glycerol contamination. Our data provides important reference for management of test interference caused by RO membrane replacement. Clinical laboratory should observe the effects of RO membrane replacement on laboratory tests through both water quality monitoring and QC detection.

反渗透膜替代纯水系统对临床实验室临床化学和免疫测定的影响。
导言:反渗透(RO)膜是净水设备的关键部件,通常储存在含有甘油等物质的保护液中,更换时可能会污染水。本研究旨在探讨反渗透膜更换对临床化学和免疫测定,特别是甘油三酯(TG)的影响,为管理反渗透膜更换引起的测试干扰提供参考:更换为 C16000 生化分析仪(雅培实验室,雅培公园,美国)和 E801 电化学发光分析仪(罗氏,巴塞尔,瑞士)供水的水纯化设备 A 的反渗透膜。记录了水电阻率,并在 C16000 和 E801 上进行了质量控制(QC)测试。此外,在更换反渗透膜后 0.5 小时和 10.5 小时,在 C16000 上测量了 29 份选定血清样品的 TG,并在参考生化分析仪 BS2000M(明德生物医药电子有限公司,中国深圳)上测量了 TG,该分析仪与水净化设备 B 相连,未更换反渗透膜。最后,在更换 RO 膜前和更换 RO 膜后的 0.5 小时、2.5 小时和 10.5 小时,在 C16000 上测量 TG 试剂的空白、校准品 1 和校准品 2。所有数据的统计分析均使用 GraphPad Prism(GraphPad Software Inc:结果:更换 RO 膜后,除了 TG 在两个水平上分别出现 536% 和 371% 的阳性偏差外,所有临床生化和免疫检验的质控结果均合格。此外,同一血清样本在 RO 膜置换后 0.5 小时的 TG 结果明显高于 10.5 小时。同时,C16000 和 BS2000M 在更换后 0.5 小时的 TG 结果的一致性和相关性比 10.5 小时更差。此外,TG 空白、校准物 1 和校准物 2 在更换后 0.5h 和 2.5h 的吸光度明显高于更换前,更换后 10.5h 吸光度逐渐恢复到正常值:结论:更换反渗透膜会对 TG 检测产生明显干扰,而对其他实验室检测没有影响,这可能是甘油污染所致。我们的数据为处理反渗透膜更换引起的测试干扰提供了重要参考。临床实验室应通过水质监测和质量控制检测来观察反渗透膜更换对实验室测试的影响。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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