Introduction: The Clinical Importance of Early Renal Function Monitoring：

Chronic kidney disease (CKD) has become a global public health challenge. According to statistics from the World Health Organization, approximately 850 million people worldwide suffer from various kidney diseases, and the global prevalence of chronic kidney disease is approximately 9.1%. What is more serious is that early chronic kidney disease often has no obvious symptoms, causing a large number of patients to miss the best time for intervention. Against this background, microalbuminuria, as a sensitive indicator of early kidney damage, has become increasingly valuable. Traditional renal function testing methods such as serum creatinine and estimated glomerular filtration rate (eGFR) will only show abnormalities when renal function is lost by more than 50%, while urine albumin testing can provide early warning signals when renal function is lost by 10-15%.

Clinical value and current status of ALB urine test

Albumin (ALB) is the most abundant protein in the urine of healthy people, with a normal excretion rate of less than 30mg/24h. When the urinary albumin excretion rate is within the range of 30-300mg/24h, it is defined as microalbuminuria, and this stage is the golden window period for intervention to reverse kidney damage. Currently, the commonly used ALB detection methods in clinical practice include radioimmunoassay, enzyme-linked immunosorbent assay (ELISA), immunoturbidimetry, etc., but these methods generally have problems such as complex operation, long time consumption, or the need for special equipment. Especially for primary medical institutions and home monitoring scenarios, existing technologies are difficult to meet the needs of simplicity, speed, and accuracy, resulting in a large number of patients with early kidney damage not being discovered in time.

Innovative Breakthroughs in Precision ALB Urine Test Reagent

In response to the limitations of the existing testing technology, our company has developed the Precision ALB Urine Test Reagent to realize a number of technological breakthroughs. The reagent adopts advanced immunochromatographic technology with high affinity and high specificity anti-human albumin monoclonal antibody to ensure the accuracy and reliability of the test. The technical innovation is mainly reflected in three aspects:

• Significantly improved sensitivity: the lower limit of detection reaches 2mg/L, and is able to accurately recognize the urinary threshold of microalbumin of 30mg/24h, which is much better than the sensitivity of traditional test strips.
• Enhanced anti-interference ability: Through the unique buffer system design, it can effectively overcome the interference of urine pH fluctuations, ionic strength changes and other factors on the test results, ensuring the stability of the test under different physiological conditions.
• Innovative quantitative detection: the supporting special reader can realize semi-quantitative to quantitative detection, the detection range covers 0-200mg/L, to meet different clinical needs from screening to monitoring.

Product Performance and Advantages

Clinically validated in several tertiary hospitals, this reagent demonstrates excellent performance indicators. Compared with the gold standard 24-hour urine albumin quantification, the correlation coefficient reaches more than 0.98; intra- and inter-batch coefficients of variation are less than 5%, much lower than the industry standard; the detection time is only 15 minutes, which greatly improves the clinical work efficiency. The advantages of the product are summarized below:

• Simplicity of operation: no need for complex pre-treatment, urine samples can be directly on the sample, three-step operation to complete the test, non-professionals can master after a short training.
• Intuitive results: the use of clear color development system, the naked eye can be read initially, matching color cards can be semi-quantitative analysis, to meet the needs of different application scenarios.
• Economical and efficient: the cost of a single test is significantly lower than that of laboratory tests, which is suitable for large-scale screening and long-term monitoring, and has outstanding health economic value.

• Early warning value: kidney damage can be detected 3-5 years earlier than traditional renal function indicators, winning valuable time for clinical intervention.

Clinical application scenarios and guideline recommendations

Precision ALB Urine Test has a wide range of application scenarios. In the field of diabetes mellitus, the American Diabetes Association (ADA) guidelines clearly recommend that all patients with type 1 diabetes mellitus ≥ 5 years and all patients with type 2 diabetes mellitus should undergo urine albumin testing annually. In hypertension management, the ESC/ESH hypertension guidelines list microalbuminuria as an important marker of target organ damage. In addition, the reagent is suitable for multiple scenarios such as cardiovascular disease risk assessment, renal function screening in the elderly, and renal monitoring during pregnancy.

Of particular interest is that this product perfectly fits the needs of hierarchical diagnosis and treatment. It can be used as an efficient screening tool for kidney disease in primary medical institutions such as community hospitals and township health centers; in the nephrology and endocrinology departments of general hospitals, it can be used as an important tool for disease management and efficacy monitoring; in medical checkup centers, it can be incorporated into health checkup packages to expand the detection rate of early kidney injury; and it is even expected to enter the family health monitoring market after further validation in the future.

Conclusion

We Baysen Medical is  always focus on diagnostic technique  to improve the quality of life . We have developed  5 technology platforms-  Latex , colloidal gold , Fluorescence Immunochromatographic Assay , Molecular,Chemiluminescence Immunoassay.We have ALB FIA Test for  Monitoring early-stage kidney injury