B-073 Performance evaluation of the new MAGLUMI Angiotensin-1 Assay for the Measurement of Plasma Rein Activity

Background Plasma renin activity (PRA) is a critical biomarker in the evaluation of the renin-angiotensin-aldosterone system (RAAS), which was involved in the regulation of blood pressure and blood volume. Given its central role in the pathophysiology of hypertension, accurate assessment of PRA is essential for both clinical diagnosis and therapeutic decision-making. Two-site sandwich chemiluminescent enzyme immunoassay was developed to measure Angiotensin-1. The objective of this study was to evaluate the analytical and clinical performance of the new MAGLUMI Angiotensin-1 Assay for the measurement of plasma renin activity. Methods To evaluate the analytical performance of the new MAGLUMI Angiotensin-1 Assay, precision and analytical sensitivity were thoroughly assessed. The clinical accuracy of the new assay was validated by comparing results from 100 clinical specimens analyzed using the MAGLUMI Angiotensin-1 Assay and liquid chromatography-tandem mass spectrometry (LC-MS/MS). Additionally, to verify the reference intervals for both standing and supine positions, plasma samples were collected from 40 healthy adults with normal blood pressure. Results The limits of detection (LoD), the limits of blank (LoB) and the limits of quantitation (LoQ) of Angiotensin-1were 0.07ng/mL, 0.03 ng/mL, and 0.1ng/mL. The intra-assay imprecision results was =5% and the inter-assay imprecision result was =10%. The Angiotensin-1 determined by the new MAGLUMI assay was significantly correlated with that measured by LC-MS/MS (y=-0.0810+1.098x, r=0.9910, P<0.0001). All 40 healthy samples passed the verification for the reference intervals in standing and supine positions. Conclusion To conclude, the new MAGLUMI Angiotensin-1 assay demonstrates excellent analytical and clinical performance with well-defined LoD, LoB, and LoQ, as well as great comparability with LC-MS/MS. This assay is a reliable and accurate tool for measuring plasma renin activity (PRA) and can be effectively used in evaluating the RAAS in clinical settings.