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International Journal of Clinical and Experimental Medicine Research

ISSN Print: 2575-7989 Downloads: 161415 Total View: 2139084
Frequency: quarterly ISSN Online: 2575-7970 CODEN: IJCEMH
Email: ijcemr@hillpublisher.com
Article http://dx.doi.org/10.26855/ijcemr.2023.10.003

Method Comparison Evaluation of Two Difference Assays for the Measurement of TT3 and TT4

Yongwei Chen1,#, Jing Wang1, Xiaolong Yang2,#,*, Fangyu Hu2, Fang Lin2

1Department of Clinical Laboratory, JiangYuan Hospital Affiliated to Jiangsu Institute of Nuclear Medicine, Wuxi, Jiangsu, China.

2Sysmex Wuxi Co. Ltd., Wuxi, Jiangsu, China. 

#These authors contributed equally to this work.

*Corresponding author: Xiaolong Yang

Published: November 8,2023

Abstract

Introduction: Different systems for serum total triiodothyronine (TT3) and total thyroxine (TT4) measuring are performed in clinical laboratories with evaluated consistency. Method comparison and bias estimation are important components of this study. The operation and analytical methods are conducted according to the Clinical and Laboratory Standard Institute (CLSI) new guideline EP09-A3. Methods: The two measurands were analyzed and evaluated on the Roche Cobas e602 and Sysmex HISCL 5000 analyzers. Analytical performance and method comparisons were performed according to EP09-A3. Outliers were computed by statistical methods and classified regression techniques were performed to evaluate and interpret biases. Results: No outliers were detected in this study. Linearity assessment demonstrated a coefficient of correlation as greater than 0.95 for the analytes. The comparison study and 95%CI computed by different regression methods showed acceptable biases except for the weighted Deming regression for TT4 measurement. Conclusion: The study demonstrated excellent analytical performance and acceptable biases for the two systems measuring TT3 and TT4. The new EP09 guide is suitable for the evaluation of methods comparison.

References

[1] Khadem N, Ayatollahi H, Roodsari FV. Comparison of serum levels of tri-iodothyronine (T3), thyroxin (T4), and thyroid-stimulating hormone (TSH) in preeclampsia and normal pregnancy. Iranian Journal of Reproductive Medicine, 2012; 10(1):47-52.

[2] Kazerouni F, Amirrasouli H. Performance characteristics of three automated immunoassays for thyroid hormones. Caspian J Intern Med., 2012; 3(2):400-404.

[3] Bowerbank SL, Carlin MG, Dean JR. A direct comparison of liquid chromatography-mass spectrometry with clinical routine testing immunoassay methods for the detection and quantification of thyroid hormones in blood serum. Analytical and Bioanalytical Chemistry, 2019; 411:2839-2853.

[4] Zhang JJ, Arbault S, Sojic N, et al. Electrochemiluminescence imaging for bioanalysis. Annu. Rev. Anal. Chem., 2019; 12:17.1–17.21.

[5] CLSI. Measurement procedure comparison and bias estimation using patient samples; approved guideline — third edition. CLSI document EP09-A3. Clinical and Laboratory Standards Institute; 2013.

[6] CLSI. Method comparison and bias estimation using patient samples; approved guidelines —second edition. CLSI document EP09-A2. Clinical and Laboratory Standard Institute; 2003.

[7] Tian H, Cheng F, Zhang JB, et al. Comparability analysis of CLSI EP9-A3 on headspace gas chromatography and dry chemical colorimetry for determination of blood alcohol content. Journal of Medical Information, 2021; 34:19.

[8] Lin L, Dai YH, Liu DD, et al. Comparison and bias estimation of three methods in determination of glycated hemoglobin A1c. National Medical Journal of China, 2016; 96:8.

[9] Zheng XE, Li J, Xia WL, et al. Methodological assessment and bias estimation of two procalcitonin analysis systems according to EP9-A2. China Medical Device Information, 2018; 13:3.

[10] Hu HX, Zhang XM, Wen DM, et al. Comparable study on determination of glycosylated hemoglobin (HbA1c) with different methods. Chinese Journal of Clinical Laboratory Science, 2016; 34:2.

[11] Kitchen S, Geisen U, Kappelmayer J, et al. Evaluating the analytical performance of four new coagulation assays for the measurement of fibrinogen, D-dimer and thrombin time. Int J Lab Hem., 2018; 40:637-644.

[12] Shi XF, Lin Y, Zhang XZ, et al. The application of new guidelines CLSI EP9-A3 in the blood coagulation analyzer comparison. Laboratory Medicine and Clinic., 2017; 14:13.

[13] Kraus BL, Kraus FB. Similar but not consistent: Revisiting the pitfalls of measuring IgG subclasses with different assays. J Clin Lab Anal., 2017; 31: e22146.

[14] Broek I, Romijin F, Smit N, et al. Quantifying protein measurands by peptide measurements: where do errors arise? Journal of Proteome Research, 2014.

[15] Su HJ, Zhou CY, Yang WH. Application of CLSI EP-A3 in comparison of two blood cell analyzer detection systems. Chinese Journal of New Clinical Medicine, 2019; 12:7.

[16] Lee B, Park HD. Performance evaluation of the i-Smart 300E cartridge for point-of-care electrolyte measurement in serum and plasma. J Clin Lab Anal., 2022; 36: e24295.

[17] Westgard S, Petrides V, Schneider S, et al. Assessing precision, bias and sigma-metrics of 53 measurements of the alinity ci systems. Clinical Biochemistry, 2017; 09:005.

[18] Ihara H, Kiuchi S, Ishige T, et al. Surveillance evaluation of the standardization of assay values for serum total 25-hydroxyvitamin D concentration in Japan. Annals of Clinical Biochemistry, 2018; 55(6):647-656.

How to cite this paper

Method Comparison Evaluation of Two Difference Assays for the Measurement of TT3 and TT4

How to cite this paper: Yongwei Chen, Jing Wang, Xiaolong Yang, Fangyu Hu, Fang Lin. (2023) Method Comparison Evaluation of Two Difference Assays for the Measurement of TT3 and TT4. International Journal of Clinical and Experimental Medicine Research7(4), 531-537.

DOI: https://dx.doi.org/10.26855/ijcemr.2023.10.003