Chronic kidney disease diagnostics and surveillance

The global burden of CKD

Chronic kidney disease diminishes patients’ quality of life, especially at a later stage when CKD progresses into end-stage renal failure and renal replacement therapies (RRT) become necessary. High healthcare expenditures and socio-economic disadvantages are additional consequences.

• 5.4 million people will require RRT (renal replacement therapy) by 2030.
• 36 million disability-adjusted life-years (DALYs) are accumulated among CKD patients.
• Estimated annual costs are 45000€ per stage five CKD patient.

This healthcare burden will further increase; by 2040, CKD is expected to become the fifth most common cause of death.

Since the development of CKD can be reverted or its progression slowed down if detected at an early stage, a regular screening of risk patients for the disease’s onset can help ease the burden and fight CKD.

Can a test strip support the fight against the burden of CKD?

The Sysmex Meditape 11A test strips are classic dye-binding-based dry chemistry sticks that detect and quantify various urinary parameters, including albumin and creatinine, to accurately measure the albumin to creatinine ratio (ACR) by accounting for the physiological variation of urinary albumin levels.

In combination with a reflectance measurement using the CMOS technology of the UC-3500, the Meditape 11A test strip allows the sensitive and accurate detection of albuminuria at physiological levels. With a limit of detection as low as 5.5 mg/L and a reportable range of 10 mg/L, the Meditape 11A test strip in combination with the UC-3500 reaches measurement ranges that compare to traditional immunonephelometric assays, allowing the quantification of albuminuria at an early stage.

Considering the comparatively low costs for test strip-based techniques, economic considerations might no longer prevent a broad screening approach for CKD among risk group patients.

At the University Hospital San Juan (Alicante, Spain), Dr María Salínas, Head of Clinical Analytical Services, and her team investigated the potential of the automated test strip analysis on the UC-3500 to replace quantitative tests. Here, a new workflow was concluded, with test strip analysis as the default screening for albuminuria. Upon exceeding defined cut-off values (≥ 10 mg/L albumin and ≥ 4.42 mmol/L creatinine), samples are flagged for a suspected increased albumin:creatinine ratio (ACR) and are subjected to quantitative assessment [6].

Meanwhile, the laboratory was able to reduce the need for quantitative assessments of albuminuria by up to 80%, resulting in remarkable cost savings. These savings are directly converted into additional capacities for screening risk group individuals for the disease’s onset. This allows a wider-ranging early detection of CKD, supporting efforts to reduce the healthcare burden it represents (Fig. 5).

However, the laboratory at the University Hospital San Juan has capitalised on these advantages beyond the immediate scope of CKD, using the cost savings to screen for other occult diseases, such as diabetes. The early detection of these diseases allows early treatment to revert or at least slow down disease progression, with a positive impact on public health and social costs [Publication in preparation].

Here, screening is performed using defined algorithms that consider patient history, public health data and clinical practice guidelines, lifting laboratory diagnostics to the next level – not only by highlighting the importance of laboratory diagnostics but also by strengthening the role of the clinical laboratory as a hub for decision-making [9].