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The Study and Clinical Application on High-throughput, Low-cost Testing System

Author: WangKunYing
Tutor: DingJinFang；YangLing
School: Lanzhou University
Course: Clinical Laboratory Science
Keywords: Of ZS-2SWK HRP / biochemical function analyzer NCCLS document Performance Evaluation ALT Reference range Relevant factors
CLC: R446.1
Type: Master's thesis
Year: 2007
Downloads: 44
Quote: 0
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Abstract


Objective: To establish a set of low-cost, efficient inspection system for rural health screening; elevated serum alanine aminotransferase (ALT) and its clinical application of research to explore and establish Xishuangbanna serum ALT reference range . Methods: application NCCLS (American Clinical Laboratory Standards Committee) EP-5 (clinical chemistry equipment operation precision evaluation), the EP-6 (quantitative analysis method of linear evaluation), EP-7 (clinical chemistry experiment interference), EP- 9 (with patient specimens methodological comparison and bias estimation) inspection system ZS-2SWK HRP / biochemical function analyzer, pipettes, reagents and system precision and accuracy to do a comprehensive evaluation. Application SPSS11.5 statistical software to analyze the data obtained, the 95% reference range of serum ALT unilateral establish; elevated serum ALT study by X ~ 2 test and two classification Logistic regression analysis. Stable results: ① ZS-2SWK HRP / biochemical function analyzer light source, a small difference between the channel difference and hole good precision, wide linear range, accurate and reliable; pipette dd mode and d mode; reagent (chosen according to the proportion of the system serum reagent) sufficiently wide linear range, more stable reaction plateau, good stability and strong anti-jamming; system detects various projects approved within imprecision and total imprecision were less than 5%, the average recovery in less than 100 ± 5%, compared with OLYMPUSAU5400 automatic biochemical analyzer test results, the correlation coefficient (r) were greater than 0.975 deviation less than 1/2CLIA '88 (American Society of Clinical Laboratory Amendment Act) allows the error. ② analysis through of Xishuangbanna examination qualifier test results, preliminary establishment of the laboratory, the healthy crowd serum ALT reference range. Studies have shown that serum ALT activity in males was significantly higher than women (t = 9.57, P <0.001). ALT upper limit of the reference values: male 42U / L, and the female for the 37U / L. Different age groups: male, 20-59-year-old group and ≥ 60 age group no significant difference in serum ALT activity. ALT upper reference value: 20 years of age to 34U / L over the age of 20 to 44U / L; women, serum ALT activity was significantly increased with increasing age, ALT upper reference value: 31U / L ,20-59, 20 years of age years old to 38U / L, 40U / L over the age of 60. ③ serum ALT elevations related factors: overweight or obesity, fatty liver, increased hemoglobin (HGB), elevated triglycerides (TG), elevated blood glucose (GLU), hepatitis B surface antigen (HBsAg)-positive and related (P <0.001), serum ALT elevations and are independent risk factors (OR> 1) serum ALT elevations. Conclusion: The test system is simple, accurate, high-throughput, low-cost, fully meet the demand of the majority of rural disease census; through the study of the of Xishuangbanna examination test results, found the reference value of the healthy population serum ALT: Male < 42U / L; in women <37U / L, and in this study, elevated serum ALT largely with the metabolic syndrome and fatty liver is closely related to, therefore, people should pay enough attention to unscientific lifestyle.

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CLC: > Medicine, health > Clinical > Diagnostics > Laboratory diagnosis > Biochemical testing, clinical testing
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