Nova POC Creatinine/eGFR Method More Accurate Than Lab Method

In a 670-patient study funded by the International Society of Nephrology, the South Africa Medical Research Council, and the University of Witwatersrand, Johannesburg, South Africa, the Nova POC StatSensor Creatinine/eGFR meter was more accurate than the central laboratory IDMS-traceable Jaffe methodology in estimating GFR when both methods were compared to measured GFR (mGFR).¹

The study is unique and important because of its size, and because it is one of the first studies to compare accuracy of point of care creatinine/eGFR devices to the gold standard iohexol mGFR method in a chronic kidney disease (CKD) screening program. Other studies have only compared POC creatinine/eGFR devices to the laboratory creatinine/eGFR, and not to the true, iohexol measured GFR. This study was performed at University of Witwatersrand in Johannesburg, South Africa, internationally recognized for its research excellence. CKD affects over 10 percent of the population in South Africa and is growing at a disproportional rate. Lack of access to central laboratory services hinders the ability to implement effective CKD screening programs to identify early stages of CKD and prevent progression. The study found StatSensor point-of-care creatinine/eGFR was more accurate than laboratory creatinine/eGFR when compared to mGFR and is practical for use as a CKD screening device in a resource limited setting. 
 
Nova’s StatSensor meter uses a miniaturized, single-use biosensor test strip and tiny capillary blood sample for blood creatinine/eGFR testing. Incorporating patented Multi-Well technology, StatSensor Creatinine enables simple, rapid, and accurate assessment of renal function by fingerstick capillary blood sampling at the point of care.

“This study is very important to government health agencies, kidney or diabetes foundations, health maintenance organizations (HMOs) and other health agencies who want to implement screening programs for CKD” said Rick Rollins, Nova marketing manager. “In addition to superior accuracy, the study noted that StatSensor capillary sampling is preferred by patients and offers the added benefit of eliminating the need for phlebotomy skills.”  

Incorporated in 1976 and based in Waltham, Mass., Nova Biomedical develops and manufactures whole blood, point-of-care and critical care analyzers, as well as instruments for cell culture monitoring in the biotechnology market. Nova uses biosensor technology in products ranging from handheld meters for glucose self- and point-of-care testing to critical care whole blood analyzers designed for stat measurement of over 22 analytes. Nova’s BioProfile line has pioneered comprehensive cell culture testing, providing over 20 critical cell culture tests for broad range of cell culture applications. Nova employs over 1,300 people worldwide and has wholly owned subsidiaries located in Brazil, Benelux, Canada, Great Britain, France, Spain, Italy, Germany, Switzerland, and Japan. 

Nova has manufacturing operations located in the U.S. and Taiwan.

Reference
¹ Currin S et al. Evaluating chronic kidney disease in rural South Africa: comparing estimated glomerular filtration rate using point-of-care creatinine to iohexol measured GFR. Clin Chem Lab Med 2021.