Celebrating 50 years of Combur-Test® strip technology from Roche
Routine analysis of urine is becoming fully automated
More than 10 percent of the world’s population suffers from kidney damage. The kidneys are the most important excretion organ in the human body. Unfortunately, the causes of many kidney diseases are still unknown. However, diabetes, high blood pressure and a family history of kidney failure are well-known risk factors of kidney disease.
Usually the damage happens over a number of years and there may be very few, if any, symptoms. People in the early stages of kidney disease usually do not feel sick, however by the time of present symptoms, it may be too late.
Studies show that the progression to kidney failure can be delayed or even prevented by controlling blood sugar levels, blood pressure and protein in the urine.1 The urine strip test is a key diagnostic tool, which yields quick and reliable information on pathological changes in the urine. Its diagnostic significance lies primarily in first-line diagnosis, screening during routine or preventive examinations, and treatment monitoring.
In the case of kidney disease, screening serves as a basis for further examination of the urine. Treatment monitoring allows healthcare professionals to check on the results of the prescribed therapy, and to introduce any changes as necessary. Under a doctor’s instruction, patients can benefit directly from using urine strip tests. This is particularly important for diabetics, for whom self-monitoring and preventive checks of their metabolic status are vital tools.
Efficient testing of the urine since 1964
Roche has continuously improved strip technology for clinical and general medical use. A portfolio of analyzers with differing degrees of automation and throughput capabilities combine Roche Combur-Test strip technology with our expertise in laboratory automation, thereby enhancing efficiency and safety. Roche offers customized urinalysis solutions for physician office laboratories, hospital point-of-care and central laboratory settings.
The Combur-Test strip technology permits efficient analysis of 10 key parameters with a consistent reading time of 60 seconds. The strip consists of a special paper with reagent pads and an underlying absorbent layer, both of which are covered with a thin skin of porous nylon mesh. The nylon mesh protects the reagent pads from contamination, fixes the reagent pads reliably to the carrier foil, and ensures uniform color development. In the event of pathological findings, a color change in one or more of the pads occurs. Their color intensity enables the result to be rapidly evaluated by visual inspection.
Building on 50 years of experience in Combur-Test strip technology since 1964, Roche has now brought a fully automated solution to healthcare professionals in laboratories which enables them to handle increasing testing volumes more effectively while keeping costs under control.
Introducing full automation of routine analysis
Continuing improvement, integration and automation development, Roche launched a new system - the cobas® 6500 urine analyzer series in June 2014. This new system is suited for diagnostic laboratories processing 100-1000 urine samples a day, and features two modular analyzer units instead of manual workflows. The cobas 6500 combines fully automated urine testing and urine microscopy, designed to ensure high-quality results and increased laboratory productivity. Likewise, it reduces manual intervention and contamination risk.
Using Combur-Test strip technology, the cobas 6500 consolidates urine test results for 23 key parameters while using real images to examine urine particles. For flexible use, the analyzer units can be operated separately or together as a single platform which forms a fully equipped urine work area.
With up to 240 tests per hour and the combination of proven technology and new innovative features, the cobas u 601 module provides precise and secure test strip results for the risk of urinary tract disease such as kidney disease, urinary tract infection, and diabetes using the same Combur-Test strip technology found in all Roche urinalysis systems. A simple cassette concept and easy-to-use operator screen for testing and imaging provide additional value by streamlining procedures in fast-paced working environments.
In replacing the manual steps involved in urine microscopy in a laboratory, the cobas u 701 microscopy module allows fully automated quantification and classification of urine microscopy by real images. The unit significantly speeds up and standardizes the microscopy process, with as many as 116 samples per hour, while eliminating variability of test results.
Urine analysis currently still entails quite a number of manual steps. With the cobas 6500, however, healthcare professionals in the laboratory can now perform automated urine testing, processing more than thousand urine samples per day, which is significantly more than they can do manually.
Did you know?
More than 20 percent of all urine specimens contain vitamin C concentrations that may induce a risk of interference in testing. Vitamin C is added to many foods and beverages on account of its preservative properties; for example, it is added to flour, bread, cakes and pastries, to sausages, cereal flakes, fruit and vegetable juices. The risk of false-negative results increases particularly sharply in the flu season, when many people take vitamin supplements. The Combur-Test strip product line contains iodate, a measure designed to prevent interference in testing by oxidation of vitamin C which significantly reduces the risk of false-negative results.
1) Snyder, S. and Pendergraph, B. (2005): Detection and Evaluation of Chronic Kidney Disease, in American Family Physician, Volume 72, Number 9, 1723–1732