Comparative Analysis of the Results Between the Improved Candidate Reference Method and the Conventional De-tection System

Meng Xiangzhao; Li Min; Sun Jiangman

doi:10.3969/j.issn.1004-5775.2024.22.017

Abstract：Objective:To evaluate the comparability of serum total bilirubin(Tbil)results between the two detection systems according to the requirements of CLSI EP9-A3,and to evaluate the bias and consistency of the results between the two detection systems.Methods:40 serum samples were collected from patients in Beijing Aerospace General Hospital,and the reference system of the modified total bilirubin candidate method was used by the Institute of Clinical Chemistry in Hanover,Germany,the conventional detection system used in the laboratory is used as the system to be evaluated.Firstly,the correctness experiments were carried out on the two systems,and then the detection results of the two groups of systems are analyzed statistically,the deviation at the level of medical decision was calculated,and 1/2TEa(7.5% )was used as the acceptable standard to evaluate the results.Results:The accuracy test results of the system to be evaluated and the reference system showed that the test results of the two systems were within the effective range of the standards.Linear fitting was performed using Passing-Baklok regression with a regression equation of Y=0.973X-1.397(r=0.998).The relative deviation was-7.02%,-3.58% and-3.16% respectively when the medical determinate level of serum total bilirubin 34.20,171.00 and 342.00 were substituted into the regression equation,it was less than 1/2TEa(7.5% )of National Health Commission's Clinical Laboratory Center,and met the requirement.Conclusion:There is a negative deviation between the routine detection system used in the laboratory and the improved candidate reference method for total bilirubin at the Institute of Clinical Chemistry in Hanover,Germany.The deviation at the level of medical determination is acceptable to meet the clinical needs.The improved TBIL candidate reference method is effective in the evaluation of the results of routine detection system.