Tan Hwee Tong, Liu Qinde, Teo Tang Lin
Chemical Metrology Division, Applied Sciences Group, Health Sciences Authority, Singapore, Singapore.
Ann Lab Med. 2025 Jul 1;45(4):367-380. doi: 10.3343/alm.2024.0583. Epub 2025 Jun 18.
Chronic kidney disease (CKD) is a major non-communicable disease and a leading cause of mortality worldwide. With the increasing prevalence of risk factors such as diabetes mellitus, obesity, and hypertension in the 21st century, CKD currently affects over 10% of the global population. The clinical and economic burden of this widespread disease is projected to continue to rise worldwide. Early detection, treatment, and monitoring of this progressive condition through accurate clinical laboratory testing of CKD biomarkers are paramount to mitigate this growing healthcare challenge. The development of reference materials (RMs) and reference measurement procedures (RMPs) for these clinical analytes is pivotal to ensuring accurate measurements using diagnostics. In this review, we emphasize the importance of establishing RMs and RMPs to standardize the measurements of key clinical markers for CKD, i.e., urine and serum creatinine, urine albumin, serum cystatin C, and urea. Standardizing CKD biomarker measurements based on RMs and RMPs can help support global efforts to reduce CKD-related morbidity and healthcare costs by ensuring reliable diagnostic practices.
慢性肾脏病（CKD）是一种主要的非传染性疾病，也是全球范围内主要的死亡原因。随着21世纪糖尿病、肥胖症和高血压等风险因素的患病率不断上升，CKD目前影响着全球超过10%的人口。预计这种广泛疾病的临床和经济负担在全球范围内将继续上升。通过对CKD生物标志物进行准确的临床实验室检测来早期发现、治疗和监测这种进行性疾病，对于缓解这一日益严峻的医疗挑战至关重要。开发这些临床分析物的参考物质（RMs）和参考测量程序（RMPs）对于确保使用诊断方法进行准确测量至关重要。在本综述中，我们强调建立RMs和RMPs以标准化CKD关键临床标志物（即尿和血清肌酐、尿白蛋白、血清胱抑素C和尿素）测量的重要性。基于RMs和RMPs标准化CKD生物标志物测量有助于通过确保可靠的诊断实践来支持全球减少CKD相关发病率和医疗成本的努力。
