Standardizing Detection of Kidney Disease

A new laboratory standardization program was developed to implement a recommendation by the U.S. National Institutes of Health (NIH, Bethesda, MD, USA) aimed at detecting kidney disease in earlier stages, when treatment can slow the progression of the disease.

The NIH recommendation is that laboratories report an estimated glomerular filtration rate (eGFR) with every adult serum creatinine test. The eGFR is calculated with the modification of diet in renal disease (MDRD) prediction equation that uses the patient's serume creatinine value, age, gender, and ethnicity.

Accurate eGFR requires accurate creatinine, but studies show that creatinine measurements are not standardized. They vary significantly between laboratories and different analytic instruments. Nonstandardized testing may result in mis-classification of patients and missed opportunities for prevention and intervention. The DigitalPT program provides an immediate solution for calibration bias while manufacturers work towards recalibrating their platforms.

The efficacy of the program was validated in an extensive pilot study with a large healthcare organization comprising 107 laboratories and 7,800 doctors. The program quickly and efficiently standardized creatinine measurements and the reporting of eGFR throughout the entire organization. By using corrected creatinine results in the eGFR calculation, recalibration of instruments was not required.

"The DigitalPT standardization program enables labs and managed care organizations to more effectively detect early kidney disease,” stated Bill Donohue, president of AccuTest (Dayton, NJ, USA), which is providing the program to U.S. laboratories. HealthMetrx (Vancouver, Canada) is providing the program to Canadian and international laboratories.


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