Harmonization of lipid results and influence on clinical diagnosis

Abstract

Objective To improve the harmonization of lipid results and reduce the impact on clinical practice by using the unified calibration approach. Methods Sera from 400 inpatients in Zhongshan Hospital of Fudan University (March 13 2012 to March 19; age: 37-68; 238 male; 162 female) were collected.Serum TC,TG,HDL-c,LDL-c,Apo A-Ⅰand Apo B levels were measured by 5 different methods including Roche,Wako,Nittobo,DiaSys and Seikisui.Roche manufacturers were used as the reference method,and fresh samples were chosen as calibration serum to calibrate the five methods.The values of the calibration sera were similar to those of Roche calibrators.After being calibrated by calibration serum,we retested all samples and compared the results before and after calibration.Variation coefficient was used to describe the difference among the results of same sample that measured by each method before and after calibration.According to the concentrations of TG or LDL-c,we classified the samples into 4 or 5 groups and compared the results of each group,including different systems as well as before and after calibration.When TC values≥6.22 mmol/L or LDL-c values≥4.14 mmol/L was taken as the assessment criterion,we compared the influence of results from different systems on clinical treatment by calculating numbers of patients who need clinical treatment. Results The data showed that the harmonization was not well in different detection systems (CV 4.50%-10.46%),however,CV values could be reduced (2.82%-6.71%) after being calibrated by the calibration serum.There were significant difference among the groups (CV:LDL-c groups 4.03%-12.14%;TG groups 4.02%-18.42%),the CV values had no correlation with the LDL-c levels,while they raised with the increase of TG levels.In addition to the group that TG values>5.65 mmol/l,the CV values in other groups could be improved by calibration serum (CV:LDL-c groups 2.35%-6.91%;TG groups 2.08%-8.91%).Furthermore,the harmonization of the lipid and lipoprotein results would influence the clinical treatment. Conclusions The lipid and lipoprotein results of different detection systems were still significantly different.This may have an impact on clinical diagnosis and treatment.Using the same calibration serum to calibrate all systems could reduce the difference of results significantly and improve the harmonization of lipid as well as lipoprotein detection.TG high value had an impact on lipid and lipoprotein detection and could not be eliminated by calibration.(Chin J Lab Med,2013,36:832-835) Key words: Lipids; Blood chemical analysis; Reproducibility of results