3. Evaluation of serum 17-hydroxyprogesterone measurement on Maglumi 800 chemiluminescence immunoassay analyzer
Main Article Content
Abstract
The aim of this study was to evaluate the analytical performance characteristics for serum 17-hydroxyprogesterone chemiluminescence immunoassay measurement on Maglumi 800. The linear range was validated according to the CLSI EP6 guideline. Precision was evaluated according to CLSI EP5 guidelines. Accuracy was evaluated according to CLSI guidelines EP7 and EP9. The method was linear up to 59.1 nmol/L. The short - term imprecision was observed with a range of 2.8 to 6.3%, lower than optimal biological variation and long - term imprecision was in range of 3.4 to 9.2%, lower than desirable biological variation. The recovery of QC and real patient samples were in the range of 90 - 110%. Passing - Bablok analysis of the data showed good agreement between the serum 17-OHP measurement on Maglumi 800 and external quality assessment results, the regression equation was: y = 1.026x - 0.107 (slope 95%CI: 0.952 to 1.110, intercept 95%CI: -0.933 to 1.257) (n = 15, r = 0.993). The serum 17-OHP chemiluminescence immunoassay on Maglumi 800 was proven to be reliable and can be applied for routine analysis.
Article Details
Keywords
17-hydroxyprogesterone, method verification, precision, trueness, linearity range
References
2. Nguyễn Hà Hương Ly., Nguyễn Văn Phong., Nguyễn Thị Việt Hà., Trần Văn Tuấn. Nghiên cứu chẩn đoán di truyền trước làm tổ bệnh tăng sản thượng thận bẩm sinh thể thiếu enzyme 21-hydroxylase. Tạp Chí Nghiên cứu Y học. 2023; 163(2), 9-17.
3. Tahirovic H., Toromanovic A., Grubic M. và cộng sự. Untreated congenital adrenal hyperplasia due to 21-hydroxylase deficiency. Eur J Pediatr. 2009; 168(7), 847–849.
4. John W Honour. 17-Hydroxyprogesterone in children, adolescents and adults. Annals of Clinical Biochemistry. 2014; Vol. 51(4) 424-440.
5. CLSI. Evaluation of the linearity of quantitative measurement procedures: A statistical approach; approved guideline. CLSI document EP06-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2003.
6. CLSI. Evaluation of precision performance of quantitative measurement methods; approved guideline-second edition. CLSI document EP05-A2. Wayne, PA: Clinical and Laboratory Standards Institute; 2004.
7. Speiser, Phyllis W., et al. Congenital adrenal hyperplasia due to steroid 21-hydroxylase deficiency: an Endocrine Society clinical practice guideline. The Journal of Clinical Endocrinology & Metabolism, 2010; 95. 9: 4133-4160.
8. Nguyen, An TT; Brown, Justin J.; Warne, Garry L. Growth in congenital adrenal hyperplasia. The Indian Journal of Pediatrics, 2006; 73: 89-93.9. CLSI. Interference testing in clinical chemistry; approved guideline-second edition. CLSI document EP07-A2. Wayne, PA: Clinical and Laboratory Standards Institute; 2005.
10. CLSI. Measurement procedure comparison and bias estimation using patient samples; approved guideline-third edition. CLSI document EP09-A3. Wayne, PA: Clinical and Laboratory Standards Institute; 2013.
11. The EFLM Biological Variation database. Available from: https://biologicalvariation.eu/search?query=17-a-hydroxyprogesterone.
12. V. Tripathi, Seema Nara, Shail K. Chaube, Kiran Rangari, Ashish Saroha, Kiran P. Kariya, H. Singh, and Tulsidas G. Shrivastav. Development of Rapid and Sensitive One-Step Direct Enzyme Linked Immunosorbent Assay for 17-a-OH Progesterone in Serum. Journal of Immunoassay & Immunochemistry. 2008; 29: 117-127.
13. Snibe diagnostic package insert. 17-hydroxyprogesterone (130298004M). Available from: https://uploads-ssl.webflow.com/614120d27c709e9576862512/6345dcdaea70ccf5010e61a1_17-OH%20PROGESTERONA.pdf
14. Ivana Lapić, Saša Kralik Oguić, and Dunja Rogić. Preliminary evaluation of eight less frequent endocrine assays designed for MAGLUMI 800 chemiluminescence immunoanalyzer. Scandinavian Journal of Clinical and Laboratory Investigation. 2021; 81(4): 332-338.
15. Turpeinen U, Itkonen O, Ahola L, et al. Determination of 17alpha-hydroxyprogesterone in serum by liquid chromatography-tandem mass spectrometry and immunoassay. Scand J Clin Lab Invest. 2005; 65: 3–12.
16. Michele L. Ettera, Jeff Eichhorsta, Denis C. Lehotay. Clinical determination of 17-hydroxyprogesterone in serum by LC–MS/MS: Comparison to Coat-A-CountTM RIA method. J. Chromatogr. B. 2006; 840(1): 69-74.