Celebrating 50 years of Combur-Test^® strip technology from Roche

Urinalysis was the first laboratory test performed in medicine and has been used for several thousand years.¹ Urinalysis can reveal serious damage that is asymptomatic in early stages yet treatable when identified in time, enabling earlier and potentially more convenient treatment of patients than testing blood samples.²

Today Roche offers a broad portfolio of urinalysis solutions for different customer needs. Drawing on our 50 years of experi­ence in urinalysis, starting with the launch of the first Combur-Test^® strip, we have continuously improved strip technology for clinical and general practice. In response to customer needs for increased efficiency and safety, we have developed a range of analyzers with differing degrees of automation and throughput capabilities.

Urine remains a key indicator of many diseases such as urinary tract infection and kidney disease. 

Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) stated in their Urinalysis Guideline that "Urinalysis is a simple, rapid, and basic part of clinical laboratory testing. Its usefulness is proven in diagnosis of disease (diseases of the kidney, urinary tract, and liver, as well as metabolic disorders such as diabetes), in monitoring the effectiveness of treatment of chronic problems, and in screening for asymptomatic conditions." ³

The Roche Diagnostics urinalysis portfolio offers a solution for every lab workflow and has evolved over time to address changing laboratory needs. The portfolio ranges from:

• Different test strips designed for smaller labs and for manual use with convenient reading by color comparison: Micral-Test^® & Combur-Test^® strips
  
• A portfolio of semi-automated systems for Point of Care and mid volume laboratory testing needs: Urisys 1100^® and cobas u 411 urine analyzer
  
• Integrated and digitalized high volume urine chemical testing and sediment analysis with full automation: cobas u 601 urine analyzer, cobas u 701 microscopy analyzer and cobas^® 6500 urine analyzer series
  

Efficient testing of the urine since 1964

Roche has a history of continuous innovation in strip and measurement technology, manual testing, and automated systems from low to high throughput. The latest innovation, digital analysis on cobas^® 6500 urine analyzer series is a recent example of Roche’s commitment to Roche’s customers. 

A portfolio of analyzers with differing degrees of automation and throughput capabilities combining Roche Combur-Test^® strip technology and new digitalization technologies with our expertise in laboratory automation, enhances efficiency and safety. The Roche Diagnostics urinalysis portfolio offers a solution for every lab work flow and has evolved over time to address changing laboratory needs.

Did you know?

More than 20 percent of all urine specimens contain vitamin C concentrations that may induce a risk of interference in testing.⁴ 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.⁵

Reference

1. Rai, A.J., 2010. The Urinary Proteome - Methods and Protocols. Humana Press, c/o Springer Science+Business Media, New York. p.1.
   
2. Suthar, K. S. & Vanikar, A. V., 2017. Urinary Screening for Early Detection of Kidney Diseases. The Indian Journal of Pediatrics, pp. DOI 10.1007/s12098-017-2494-y.
3. CLSI, 2009. Urinalysis; Approved Guideline-Third Edition (GP16-A3). 3rd ed. Wayne(Pennsylvania): Clinical and Laboratory Standards Institute.
   
4. Brigden ML, Edgell D, McPherson M, et al. High incidence of significant urinary ascorbic acid concentrations in a west coast population--implications for routine urinalysis. Clin Chem 1991;38(3):426-31
   
5. Nagel D, Seiler D, Hohenberger EF, et al. Investigations of ascorbic acid interference in urine test strips. Clin Lab 2006;52(3-4):149-53