Indication for Use
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.
Important Risk Information
KidneyIntelX should not be used in patients who are taking ENBREL. ENBREL interferes with the ability to reliably measure sTNFR2 in patient specimens and is contraindicated for patients when ordering KidneyIntelX testing.