临床化学分析仪ERBA XL-640与ERBA XL-1000葡萄糖测定的比较

Sheetal Paresh Patel, Kalpesh Nakrani, Vilas U. Chavan, Nikunj R. Patel, Roshani Prajapati
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引用次数: 0

摘要

随着技术的进步,市场上和实验室里有许多原理或技术种类繁多的仪器,可以在规定的时间内进行样品处理。为了实现实验室的质量目标,所有用于检测的生化分析仪的结果都必须符合要求。方法/仪器比较的文件证据可用于将来的质量改进。目的:评价和比较ERBA XL-640与ERBA XL-1000在临床生化实验室中葡萄糖检测结果的等效性和一致性。材料和方法:根据结果协调和综述文章方法比较的EP09-3A协议,通过比较2021年6月至2021年10月在苏拉特市医学教育与研究所临床生物化学实验室的两个自动化系统ERBA XL-640和ERBA XL-1000中获得的葡萄糖测量结果,进行了一项比较研究。根据1988年临床实验室改进修订(CLIA’88)的总允许误差对结果值进行比较。结果采用目视和定量分析方法进行分析。回归分析、Bland-Altman图、方法评价图(归一化MEDx图)。结果:批内及批间样品共48份,并进行了差异定量分析。与总允许误差相比,40mg /dL、120mg /dL和180mg /dL在医疗决策水平上是可以接受的。结论:本研究认为ERBA XL-640和ERBA XL-1000在终点法{葡萄糖氧化酶-过氧化物酶(GOD-POD)法}葡萄糖检查中的比较是可以接受的,并且可以在主要临床决策水平上互换使用而无需重复。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Comparison of Clinical Chemistry Analysers ERBA XL-640 vs ERBA XL-1000 for Glucose Estimation
Introduction: With advance in technology, many instruments with wide variety of principle or technologies are available in market and in laboratory to conduct sample processing in time bound period. To fulfill the laboratory quality goal, it is essential that result matching be obtained in all used biochemical analysers for examinations. Documented evidence of method/instrument comparison can be used in future for quality improvement purposes. Aim: To assess and compare equivalence and harmonisation in glucose results produce by ERBA XL-640 vs ERBA XL-1000 in clinical biochemistry laboratory. Materials and Methods: A comparative study was carried out by results comparison of glucose measurements obtained in two automated systems ERBA XL-640 and ERBA XL-1000 in Clinical Biochemistry laboratory at Surat Municipal Institute of Medical Education and Research between June 2021 to October 2021, based on protocol EP09-3A of result harmonisation and review article-method comparison. The results value were compared according to the total allowable error in Clinical Laboratory Improvement Amendments of 1988 (CLIA’88). Results were analysed by visual and quantitative analysis method Regression analysis and Bland-Altman plot, Method evaluation chart (Normalised MEDx chart). Results: Total of 48 samples were run within the batches and between the batches and quantitative analysis of difference was done. It is acceptable at medical decision level 40 mg/dL, 120 mg/dL and 180 mg/dL with comparison to total allowable error. Conclusion: The present study concluded that the comparison of ERBA XL-640 and ERBA XL-1000 for glucose examination by end point method {Glucose Oxidase-Peroxidase (GOD-POD) method} is acceptable and can be used interchangeably without repeat at major clinical decision levels.
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