半自动方法与全自动分析仪方法生化参数检测性能的比较。

Comparison of test performance of biochemical parameters in semiautomatic method and fully automatic analyzer method.

作者信息

Kumari Suchitra, Bahinipati Jyotirmayee, Pradhan Tapaswini, Sahoo Durgesh P

机构信息

Department of Biochemistry, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, Odisha, India.

Department of Biochemistry, Kalinga Institute of Medical Sciences (KIMS), Bhubaneswar, Odisha, India.

出版信息

J Family Med Prim Care. 2020 Aug 25;9(8):3994-4000. doi: 10.4103/jfmpc.jfmpc_94_20. eCollection 2020 Aug.

DOI:10.4103/jfmpc.jfmpc_94_20

PMID:33110800

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7586617/

Abstract

BACKGROUND

The primary health-care center (PHC) and community health center (CHC) are not well equipped with laboratory services. Semiauto analyzer-based reporting could be an effective modality, provided that the performance standard is comparable to that of the fully automatic analyzer. So, the objective of this study was to analyze the test results of biochemical parameters in semiauto and fully automatic analyzer and to compare the quality performance.

MATERIALS AND METHODS

One hundred forty-nine patients undergoing routine biochemical investigations in the department laboratory were enrolled in this study. Two millimeter of venous blood was collected from all the participants and processed for urea, cholesterol, triglyceride (TG), serum glutamate-oxaloacetate transaminase (SGOT) (aspartate aminotransferase), and serum glutamate-pyruvate transaminase (SGPT) (alanine aminotransferase) by using standard kits (ERBA) in semiauto analyzer (Transasia Erba Chem5X by Calbiotech Inc. USA, semiautomated clinical chemistry analyzer) and the fully automatic analyzer (Cobas Integra 400 Roche, Germany) method.

RESULTS

There was high variability in the distribution of urea, TG, SGOT, and SGPT values in both measurement methods, whereas cholesterol data followed a normal distribution (skewness: 1.522, 1.037; kurtosis: 2.373, 0.693 in semiauto and automated methods, respectively). A significant positive correlation between both the methods of assessment was observed in urea, cholesterol, TGs, SGOT, and SGPT. The mean difference for urea was -9.85 ± 23.997 (LOA: 37.189, -56.88), whereas it was highest for TG -24.34 ± 38.513 (LOA: 51.144, -99.829), suggesting that both methods can measure urea with less difference in absolute values, whereas for TG the measurement values are highly variable.

CONCLUSION

The test performance of biochemical parameters such as urea, total cholesterol, TGs, SGOT, and SGPT taken by semiauto analyzer and fully automatic analyzer method of assessment were highly related and comparable.

摘要

背景

基层医疗中心（PHC）和社区卫生中心（CHC）的实验室服务设备配备不足。基于半自动分析仪的报告可能是一种有效的方式，前提是其性能标准与全自动分析仪相当。因此，本研究的目的是分析半自动分析仪和全自动分析仪检测生化参数的结果，并比较其质量性能。

材料与方法

本研究纳入了149名在科室实验室接受常规生化检查的患者。从所有参与者采集2毫升静脉血，使用标准试剂盒（ERBA）在半自动分析仪（美国Calbiotech公司的Transasia Erba Chem5X，半自动临床化学分析仪）和全自动分析仪（德国罗氏Cobas Integra 400）中检测尿素、胆固醇、甘油三酯（TG）、血清谷氨酸草酰乙酸转氨酶（SGOT）（天冬氨酸转氨酶）和血清谷氨酸丙酮酸转氨酶（SGPT）（丙氨酸转氨酶）。

结果

两种测量方法中尿素、TG、SGOT和SGPT值的分布差异很大，而胆固醇数据呈正态分布（半自动和自动方法的偏度分别为1.522、1.037；峰度分别为2.373、0.693）。在尿素、胆固醇、TG、SGOT和SGPT的两种评估方法之间观察到显著的正相关。尿素的平均差异为-9.85±23.997（一致性界限：37.189，-56.88），而TG的平均差异最高，为-24.34±38.513（一致性界限：51.144，-99.829），这表明两种方法测量尿素的绝对值差异较小，而对于TG，测量值变化很大。