我国当前肾素测定试剂的现状与改进建议

The current status and improvement recommendations for renin assay reagents in China

  • 摘要: 肾素是诊断原发性醛固酮增多症等继发性高血压疾病的关键指标,肾素相关的实验室检测项目包括血浆肾素活性(PRA)测定和直接肾素浓度(PRC)测定,两者在方法学及临床意义上差异显著,易导致临床应用混淆。本文重点介绍当前两类肾素测定试剂在检验方法原理、影响因素及实际应用中的差异,并对其注册现状进行梳理,同时探讨了相关注册审评问题并提出了改进建议。

     

    Abstract: Renin is a critical biomarker for diagnosing secondary hypertension such as primary aldosteronism. Renin-related laboratory tests include the measurement of plasma renin activity (PRA) and direct plasma renin concentration (PRC). These two tests differ significantly in both methodology and clinical implications, which can easily lead to confusion in clinical practice. This article elaborates on the differences between the two types of renin assay kits in terms of detection principles, influencing factors, and practical applications, reviews their current registration status, discusses issues related to regulatory evaluation, and proposes improvement suggestions.

     

/

返回文章
返回