Serial research of traceability and harmonization of thyroid-stimulating hormone detection approved by IFCC
10.3969/j.issn.1673-4130.2016.06.013
- VernacularTitle:IFCC 促甲状腺激素国际溯源和检测一致性系列研究（二）
- Author:
Xiang YU
;
Wenfei CHEN
;
Xiaoliu YU
;
Ming JIANG
;
Ke LI
;
Zhiguang YU
- Publication Type:Journal Article
- Keywords:
thyroid-stimulating hormone;
chemiluminescent immunoassay;
international federation of clinical chemistry-committee of standardization of thyroid functional tests;
all procedure trimed mean
- From:
International Journal of Laboratory Medicine
2016;37(6):751-753
- CountryChina
- Language:Chinese
-
Abstract:
Objective To implement the harmonization of thyroid-stimulating hormone(TSH) of Mindray assay system by par-ticipating in harmonization research program of International Federation of Clinical Chemistry (IFCC)-Standardization of Thyroid Function Tests(C-STFT ) .Methods A total of three combinations of TSH reagents and calibrators were used to measure 20 serum samples of healthy human .Within-run precision and batch-to-batch variation were assessed .The concept of harmonization was dem-onstrated by comparing our test results with All Procedure Trimmed Mean (APTM ) provided by IFCC and recalibrating with Mater Calibrators .Results The within-run precision was 1 .96% ,batch-to-batch variation was 0 .47% - 1 .15% ,depending on the level of TSH analyte .There existed a positive bias compared to APTM values .After recalibration with Mater Calibrators and Passing &Bablok regression ,the slope of method comparison was 1 .0 ,and correlation coefficient was more than 0 .975 .Conclusion By using a panel of real human specimen and recalibration based on APTM ,the test results of Mindray assay system could be harmonized with mainstream manufacturers globally .
