Comparison of Six Automated Immunoassays With Isotope-Diluted Liquid Chromatography–Tandem Mass Spectrometry for Total Thyroxine Measurement
2
조회
0
다운로드
0
인용
0
참고문헌
키워드
초록
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.
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.
참고문헌 (25)
- Goemann IM, "Role of thyroid hormones in the neoplastic process : an overview", Endocr Relat Cancer, 24, pp.R367~R385 (2017)
- Williams GR, "Thyroid diseases and bone health", J Endocrinol Invest, 41, pp.99~109 (2018)
- Shui-Boon Soh, "Laboratory Testing in Thyroid Conditions – Pitfalls and Clinical Utility", Annals of Laboratory Medicine, 39(1), pp.3~14 (2019), 대한진단검사의학회[DOI]
- Baloch Z, "Laboratory medicine practice guidelines. Laboratory support for the diagnosis and monitoring of thyroid disease", Thyroid, 13, pp.3~126 (2003)
- Mendel CM, "The free hormone hypothesis : a physiologically based mathematical model", Endocr Rev, 10, pp.232~274 (1989)
- Thienpont LM, "Report of the IFCC Working Group for Standardization of Thyroid Function Tests; Part 2 : Free thyroxine and free triiodothyronine", Clin Chem, 56, pp.912~920 (2010)
- Després N, "Antibody interference in thyroid assays : a potential for clinical misinformation", Clin Chem, 44, pp.440~454 (1998)
- Thienpont LM, "Report of the IFCC Working Group for Standardization of Thyroid Function Tests; Part 3 : Total thyroxine and total triiodothyronine", Clin Chem, 56, pp.921~929 (2010)
- Steele BW, "Analytic bias of thyroid function tests : analysis of a College of American Pathologists fresh frozen serum pool by 3900 clinical laboratories", Arch Pathol Lab Med, 129, pp.310~317 (2005)
- Jonklaas J, "Total and free thyroxine and triiodothyronine : measurement discrepancies, particularly in inpatients", Clin Biochem, 47, pp.1272~1278 (2014)
- Tai SS, "Candidate reference method for total thyroxine in human serum : use of isotope-dilution liquid chromatography-mass spectrometry with electrospray ionization", Clin Chem, 48, pp.637~642 (2002)
- "Database of higher order reference materials, measurement methods/procedures and services" (2017)[URL]
- Serdar MA, "Comparison of relationships between FT4 and log TSH in Access DXI 800 Unicel, Modular E170 and ADVIA Centaur XP Analyzer", Clin Chem Lab Med, 50, pp.1849~1852 (2012)
- Jonklaas J, "Correlations of free thyroid hormones measured by tandem mass spectrometry and immunoassay with thyroid-stimulating hormone across 4 patient populations", Clin Chem, 55, pp.1380~1388 (2009)
- CLSI, "User demonstration of performance for precision and trueness; Approved Guideline, NCCLS document EP15-A (ISBN 1-56238-451-1)", NCCLS, ~ (2001)
- Perich C, "Biological variation database : structure and criteria used for generation and update", Clin Chem Lab Med, 53, pp.299~305 (2015)
- "Desirable specifications for total error, imprecision, and bias, derived from intra- and inter-individual biologic variation" (2014)[URL]
- Petersen PH, "Combination of analytical quality specifications based on biological within-and between-subject variation", Ann Clin Biochem, 39, pp.543~550 (2002)
- Bilić-Zulle L, "Comparison of methods: Passing and Bablok regression", Biochem Med(Zagreb), 21, pp.49~52 (2011)
- Giavarina D, "Understanding Bland Altman analysis", Biochem Med(Zagreb), 25, pp.141~151 (2015)
- Burtis CA, "Tietz textbook of clinical chemistry and molecular diagnostics", pp.1931~1933 (2012), Elsevier
- "Medicare, Medicaid and CLIA programs; Regulations Implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA)–HCFA. Final rule with comment period", Fed Regist, 57, pp.7002~7186 (1992)
- Nelson JC, "Underestimates and overestimates of total thyroxine concentrations caused by unwanted thyroxine-binding protein effects", Thyroid, 15, pp.12~15 (2005)
- Stockigt JR, "Medications that distort in vitro tests of thyroid function, with particular reference to estimates of serum free thyroxine", Best Pract Res Clin Endocrinol Metab, 23, pp.753~767 (2009)
- Bowen RA, "Blood collection tube-related alterations in analyte concentrations in quality control material and serum specimens", Clin Biochem, 47, pp.150~157 (2014)