Ann Lab Med.  2019 Jul;39(4):381-387. 10.3343/alm.2019.39.4.381.

Comparison of Six Automated Immunoassays With Isotope-Diluted Liquid Chromatography-Tandem Mass Spectrometry for Total Thyroxine Measurement

Affiliations
  • 1Department of Clinical Laboratory, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China. lingqiubj@163.com
  • 2National Center for Clinical Laboratories, Beijing Hospital, National Center for Gerontology, Beijing Engineering Research Center of Laboratory Medicine, Beijing, China.
  • 3Department of Clinical Laboratory, The Affiliated Hospital of Qingdao University, Qingdao, China.

Abstract

BACKGROUND
Accurate serum total thyroxine (TT4) measurement is important for thyroid disorder diagnosis and management. We compared the performance of six automated immunoassays with that of isotope-diluted liquid chromatography-tandem mass spectrometry (ID-LC-MS/MS) as the reference method. We also evaluated the correlation of thyroid stimulating hormone (TSH) with TT4 measured by ID-LC-MS/MS and immunoassays.
METHODS
Serum was collected from 156 patients between October 2015 and January 2016. TT4 was measured by immunoassays from Abbott (Architect), Siemens (ADVIA Centaur XP), Roche (E601), Beckman-Coulter (Dxi800), Autobio (Autolumo A2000), and Mindray (CL-1000i), and by ID-LC-MS/MS. Results were analyzed using Passing-Bablok regression and Bland-Altman plots. Minimum requirements based on biological variation were as follows: a mean bias of ≤4.5% and total imprecision (CV) of ≤3.7%.
RESULTS
All immunoassays showed a correlation >0.945 with ID-LC-MS/MS; however, the slope of the Passing-Bablok regression line varied from 0.886 (Mindray) to 1.23 (Siemens) and the intercept from −12.8 (Siemens) to 4.61 (Mindray). Only Autobio, Beckman-Coulter, and Roche included the value of one in the 95% confidence interval for slope. The mean bias ranged from −10.8% (Abbott) to 9.0% (Siemens), with the lowest value noted for Roche (3.5%) and the highest for Abbott (−10.8%). Only Abbott and Roche showed within-run and total CV ≤3.7%.
CONCLUSIONS
Though all immunoassays correlated strongly with ID-LC-MS/MS, most did not meet the minimum clinical requirement. Laboratories and immunoassay manufacturers must be aware of these limitations.

Keyword

Immunoassay; Isotope-diluted liquid chromatography tandem mass spectrometry; Thyroxine; Evaluation; Performance

MeSH Terms

Bias (Epidemiology)
Diagnosis
Humans
Immunoassay*
Mass Spectrometry*
Methods
Thyroid Gland
Thyrotropin
Thyroxine*
Thyrotropin
Thyroxine

Figure

  • Fig. 1 Passing-Bablok regression analyses between immunoassays (A, Abbott; B, Autobio; C, Beckman-Coulter; D, Mindray; E, Roche; F, Siemens) and ID-LC-MS/MS. Solid black line: Passing-Bablok regression line, dashed brownish red lines: 95% CI for the regression line, dotted blue line: identity line (x=y).Abbreviations: TT4, total thyroxine; ID-LC-MS/MS, isotope-diluted liquid chromatography-tandem mass spectrometry; CI, confidence interval.

  • Fig. 2 Bland-Altman plots for assessing agreement between immunoassays (A, Abbott; B, Autobio; C, Beckman-Coulter; D, Mindray; E, Roche; F, Siemens) and ID-LC-MS/MS. Solid black line: mean difference, dashed brownish red dotted line: allowable limits (from −4.5% to 4.5%), dashed blue line: limits of agreement (from −1.96 SD to +1.96 SD).Abbreviations: see Fig. 1.


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