According to statistics, nearly 10 percent of the world's population suffer from kidney disease. Early chronic kidney disease (CKD) is a silent killer and a person may lose about 90 percent of kidney function before any symptoms are noticed. In an effort to combat this growing health crisis, Siemens Healthcare Diagnostics and the US-based National Kidney Foundation (NKF) have devised a simple urine test to help improve diagnosis of CKD and identify the disease early on. The NKF recommends that healthcare professionals screen for kidney disease with this simple urine ACR test during the annual physical examination of high-risk individuals.

Q. Please elaborate on the ACR test developed for early detection of CKD in patients?

A. Elevated levels of albumin in urine provide an early warning sign that the kidneys are not functioning properly. Screening for increased urinary albumin excretion can be performed by measuring the albumin-to-creatinine ratio (ACR) in a random spot collection. Ratios utilizing creatinine account for the variability of urine concentrations, ensuring the accuracy of untimed specimen collections.

The analysis of a spot sample for the ACR is strongly recommended by most authorities. The other two alternatives (24-hour collection and timed specimen) are rarely necessary. (Source: Standard of Medical Care in Diabetes, America Diabetes Association Position Statement, Diabetes Care, Volume 27, Supplement 1, January 2004).

Q. What is the potential of the renal diagnostic market across India?
A. CKD is a condition affecting almost 200 million people around the world today. (Source: World Health Organization [who.org]). Of these, about 20-30 percent will develop a kidney disease, which is the most common complication of diabetes (Source: International Diabetes Federation). Early CKD often has no sign or symptoms. A person can lose up to 90 percent of their kidney function before experiencing any signs. (Source: National Kidney Foundation, kidney.org/kidneydisease/global-facts-about-kidney-disease).

CKD is increasing in India at an alarming rate. The major risk groups are people with diabetes, hypertension, age group of 60 years and above and people with family history of kidney disease. In majority of the cases, it has been seen that the disease has been diagnosed when the kidney damage has progressed to a critical stage. Early diagnosis of kidney diseases thus becomes critical to avoid potential damage to the kidneys.

The rising incidences of kidney diseases in India are leading to a huge potential for the diagnostic market.

Q. Please explain the importance of early diagnosis and screening tests in the detection of kidney ailments?

A.Over 1 billion people are at risk of kidney disease globally! Statistics quoted from the organizers of World Kidney Day indicate that this equates to 1 in 10 people for kidney disease. The major risk groups are diabetics, hypertensives, people with family history of kidney disease and people over the age of 60 years. Obesity also plays a very large part in the risk. Early diagnosis is paramount to detecting the disease early. This improves quality of life and can delay people from moving to transplantation or dialysis. Urine testing using the ACR test at the Point of Care is the fastest, most effective way to screen the 1 billion at risk.

Q. How is Siemens healthcare aiming to increase awareness of these tests?

A. Our strategic alliance with the NKF has been a large factor in the awareness of risk factors and how a very simple urine test (ACR) can be used to detect kidney disease in the 1 billion at risk individuals. We also advertise electronically around the world on these topics and on our website and through social media.

Q. How is Siemens planning to market their ACR test?

A. Siemens offers ACR testing at the POC with our Microalbustix urine strip (visual read), the CLINITEK Microalbumin-2 urine strip (used on our CLINITEK Status analyzer) and is offered on our central lab instrument, the CLNITEK Novus analyzer. Our strategic alliance with the NKF has been a large factor in the marketing of these products worldwide.

Q. Any other thoughts that you can give on the subject?

A. Siemens CLINITEK Microalbumin 2 Reagent Strips detect albumin and creatinine levels in urine, providing an albumin-to-creatinine ratio and allowing treatment to begin sooner.
• Detect kidney disease at the earliest stages-albumin sensitivity as low as 10 mg/L
• Ratios utilizing creatinine account for the variability of albumin results due to urine concentration
• Provide results in one minute
• Reduce transcription errors and wait time-when used in combination with CLINITEK Status family of analyzers, results can be electronically managed or printed
The CLINITEK Microalbumin 2 Reagent Strips provide semi-quantitative results with a hard-copy report on the CLINITEK Status family of analyzers, making them ideal for point-of-care testing. Patient samples can be tested immediately during a physician, clinic or hospital visit, rather than sending them out and waiting for results. The strips are also convenient for testing random urine samples, eliminating the need to collect a timed sample.