KidneyIntelX is a quantitative electrochemiluminescence immunoassay using the Meso Sector S 600 instrument for measurement of soluble Tumor Necrosis Factor Receptor 1 (TNFR1), soluble Tumor Necrosis Factor Receptor 2 (TNFR2) and Kidney Injury Molecule-1 (KIM-1) in human plasma combined with clinical data, using an artificial intelligence-derived algorithm to produce a composite risk score. It is indicated for use as an aid to further assess the risk of progressive decline in kidney function within a period of up to 5 years in patients over the age of 21 with type 2 diabetes and existing chronic kidney disease. Patients with chronic kidney disease will have an estimated Glomerular Filtration Rate [eGFR] of 30-59 ml/min/1.73m2 [G3a, G3b]* or eGFR ≥ 60 with albuminuria [UACR] ≥ 30 mg/g [A2, A3]*.
*KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease.
A progressive decline in kidney function occurs when one or more of the following conditions are observed:
- Rapid Kidney Function Decline (RKFD) defined as an eGFR slope of ≥ 5 ml/min/1.73m2/year.
- Sustained decrease in eGFR ≥ 40% confirmed at least 3 months apart.
- Kidney Failure, defined by sustained eGFR < 15 ml/min/1.73m2, initiation of long-term dialysis, or kidney transplantation.
KidneyIntelX is not intended as a screening or stand-alone diagnostic test.