Serum 17 Alpha-Hydroxyprogesterone Analysis- Performance Evaluation of Maglumi^® X-8 Chemiluminescence Immunoassay

Congenital Adrenal Hyperplasia (CAH) is primarily caused by 21-hydroxylase deficiency, leading to abnormal adrenal hormone production. Accurate measurement of 17-hydroxyprogesterone (17-OHP) is critical for diagnosing and managing CAH. Traditionally, 17-OHP levels are assessed using ELISA, but methods like chemiluminescent immunoassays (CLIA) offer potential improvements in accuracy and efficiency. We evaluated the Maglumi^® X-8 CLIA system for measuring 17-OHP levels and compared its performance with the established ELISA method. The study included serum samples from 39 patients, analyzed for accuracy, precision, linearity, and reportable range. The correlation between CLIA and ELISA results was assessed using regression analysis and Bland-Altman plots. The Maglumi^® X-8 CLIA demonstrated acceptable precision, with low coefficients of variation (CVs) at both low and high 17-OHP concentrations. The assay showed strong correlation with the ELISA method (slope: 0.961, intercept: 1.712) and consistent accuracy across a broad reportable range (0.10 to 320 ng/mL). The CLIA system also proved to be faster and more automated, reducing the potential for human error and facilitates faster results for clinical decision making. The Maglumi^® X-8 CLIA is a highly precise, accurate, and efficient method for measuring 17-OHP levels, making it a suitable alternative to ELISA in clinical laboratories. Its integration into routine workflows offers faster results and improved reliability.