Article Sidebar

PDF (Tiếng Việt)
Published: 2025-09-30
Abstract Views: 0
Views PDF (Tiếng Việt): 0
DOI: https://doi.org/10.52852/tcncyh.v194i9.3825
Issue
Vol. 194 No. 9 (2025)
Section
Các bài báo
How to Cite
Hiền, N. T., Anh, T. T. N., Dung, T. T. P., Tùng, C. V., Sương, N. T. B., & Thắng, T. N. (2025). 4. Comparability of serum Estradiol between two automated analyzers: Cobas pro and atellica solutio. Journal of Medical Research, 194(9), 30-36. https://doi.org/10.52852/tcncyh.v194i9.3825

4. Comparability of serum Estradiol between two automated analyzers: Cobas pro and atellica solutio

Nguyen Thi Hien, Tran Thi Ngoc Anh, Trinh Thi Phuong Dung, Cao Viet Tung, Nguyen Thi Bang Suong, Tran Ngoc Thang

Main Article Content

Abstract

This study aimed to evaluate the comparability of serum estradiol quantification results between two automated analyzers-Cobas Pro and Atellica Solution-at the Vietnam National Children's Hospital. The study included 186 pediatric serum samples and 125 serum samples from females, with estradiol concentrations covering the measurement range specified by the manufacturers. The analysis was conducted following CLSI EP09-A3 guidelines, using statistical methods such as Spearman correlation, Passing-Bablok regression, and Bland-Altman analysis. The results show a strong correlation between the two systems (r = 0.899 in children and r = 0.968 in females; p < 0.0001). However, Atellica Solution reported higher estradiol values than Cobas Pro, with mean differences of 24.65 pmol/L in children and 142.18 pmol/L in females. Therefore, despite the high correlation, the two systems cannot be used interchangeably without appropriate adjustments. The study recommends establishing individual reference ranges or applying a conversion factor to ensure accuracy in clinical interpretation.

Article Details

Keywords

Method comparison, serum estradiol, children, women

References

1. Ankarberg-Lindgren C, Norjavaara E. A purification step prior to commercial sensitive immunoassay is necessary to achieve clinical usefulness when quantifying serum 17beta-estradiol in prepubertal children. Eur J Endocrinol. 2008; 158(1): 117-124. doi:10.1530/EJE-07-0403.
2. Rosner W, Hankinson SE, Sluss PM, Vesper HW, Wierman ME. Challenges to the measurement of estradiol: an endocrine society position statement. J Clin Endocrinol Metab. 2013; 98(4): 1376-1387. doi:10.1210/jc.2012-3780.
3. Chakravarthy SN, Ramanathan S, S S, Nallathambi T, S M. EP15A3 Based Precision and Trueness Verification of VITROS HbA1C Immunoassay. Indian J Clin Biochem. 2019; 34(1): 89-94. doi:10.1007/s12291-017-0712-z.
4. Budd JR, Durham AP, Gwise TE, et al. Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline. Clinical Laboratory Standards Institute; 2013.
5. Kaplowitz P, Bloch C, Endocrinology S on, et al. Evaluation and referral of children with signs of early puberty. Pediatrics. 2016; 137(1): e20153732.
6. Adeli K, Higgins V, Trajcevski K, White-Al Habeeb N. The Canadian laboratory initiative on pediatric reference intervals: A CALIPER white paper. Crit Rev Clin Lab Sci. 2017; 54(6): 358-413. doi:10.1080/10408363.2017.1379945.