Biological variation in 32 clinical laboratory routine tests
10.3760/cma.j.issn.1009-9158.2012.10.014
- VernacularTitle:常规生化检验项目生物学变异的研究
- Author:
Zhengjun CHEN
;
Chen ZHANG
;
Binbin SONG
;
Jiong WU
;
Beili WANG
;
Chunyan ZHANG
;
Wei GUO
;
Baishen PAN
- Publication Type:Journal Article
- Keywords:
Clinical chemistry tests;
Diagnostic tests,routine;
Quality control
- From:
Chinese Journal of Laboratory Medicine
2012;35(10):926-931
- CountryChina
- Language:Chinese
-
Abstract:
Objective To set quality goals of conventional biochemical tests through the research of biological variation of the 32 routine items in Chinese population to provide the basis for Chinese clinical and laboratory standards.Methods According to the experimental designs and computing methods from foreign counterparts,the results of biological variation,individual indexes and quality goals were calculated through the serum detection of 22 subjects from clinical laboratory of Zhongshan Hospital in Shanghai (male 12,female 10,ages varying from 20 to 40 years old,median age 30) in short-term (five blood draws within one day at 8:00,10:00,12:00,14:00 and 16:00) and long-term (one blood draw at 8:00 in 6 weeks consecutively) and serum controls (mixed from healthy people).Results (1) Based on the results of shortterm and long-term biological variation in 32 routine itens,the individual indexes and quality goals were obtained.(2)The influence of diet on the biological variation of part of the test items could be observed,especially free fatty acid (the mean value of post-meal was less than pre-meal about 30％),and then followed by high-sensitivity C-reactive protein (the mean value of post-meal was lower than pre-meal about 20％) and triglyceride (the mean value of post-meal was higher than pre-meal about 10％).(3)There were some differences between the quality goals we accessed and the the indicators from Europe and CLIA.Conclusions (1)The results of apolipoprotein E and free fatty acid in this study made up for the inadequate of the European biology database.(2) Only a small part of the 32 routine items were affected by dietary factors.(3) Most quality goals obtained from this study generally consisted with Europe biology quality goals,but a few items existed different.(4)It's more practical and effective to use the results of biological variatiou than CLIA standards for setting up quality goals.
