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KidneyIntelX.dkd is for in-vitro diagnostic use for the determination of a KidneyIntelX.dkd Level using an algorithm to combine clinical variables (blood urea nitrogen (BUN), hemoglobin A 1c (HbAlc) and urine albumin creatinine ratio (uACR)) and the quantitative measurements of tumor necrosis factor receptor-1 (TNFR-1), tumor necrosis factor receptor-2 (TNFR-2) and kidney injury molecule-1 (KIM-1) in human plasma employing a Meso Sector S 600 electrochemiluminescence immunoassay. It is indicated for use as an aid in assessment of the risk of progressive decline in kidney function (sustained decrease in eGFR greater than or equal to 40% lasting more than 3 months) within a period of up to 5 years following KidneyIntelX.dkd Level measurement in adult patients with type 2 diabetes and existing chronic kidney disease (defined for the purposes of this device as patients with an estimated glomerular filtration rate of 30-59 ml/min/1.73m2 or eGFR ≥ 60 ml/min/1.73m2 with albuminuria (uACR ≥ 30 mg/g)). KidneyIntelX.dkd is not intended for screening or as a stand-alone diagnostic test.

KidneyIntelX.dkd provides the KidneyIntelX.dkd level, generated by the KidneyIntelX.dkd algorithm. The algorithm includes inputs from clinical data collected on the patient as well as component analytes measured directly by KidneyIntelX.dkd. The three component analytes measured by KidneyIntelX.dkd directly are quantitated via a multiplex electrochemiluminescence technology for the in vitro quantitative determination the concentration of three circulating biomarkers in human EDTA plasma: - i) soluble Tumor Necrosis Factor Receptor 1 (TNFR-1), - ii) soluble Tumor Necrosis Factor Receptor 2 (TNFR-2), - iii) and Kidney Injury Molecule (KIM)-1. The three measured components of the KidneyIntelX.dkd level are measured using the MESO SECTOR® S 600 instrument, by trained laboratory personnel using the assay components that includes the KidneyIntelX 96-well plate, the detection antibody, calibrator, and controls along with the Meso Scale Diagnostics diluents, blocker, wash buffer and read buffer. A sandwich immunoassay is used to measure KIM-1, TNFR-1, and TNFR-2. The plate wells are precoated with goat polyclonal antibodies to KIM-1, and mouse monoclonal antibodies specific to TNFR-1 and TNFR-2. After treating the wells with a blocking solution, the specimens and controls are incubated in the wells then washed. The analytes are quantified via electrochemiluminescence, with secondary detection antibodies (goat polyclonal antibodies to KIM-1, and mouse monoclonal antibodies specific to TNFR-1 and TNFR-2) covalently linked to electrochemiluminescent labels. The MESO SECTOR® S 600A instrument measures the light emitted via charged-coupled device (CCD) camera. A software with an artificial intelligence derived algorithm provides a risk assessment score by combining the biomarker results from the assay (TNFR-1, TNFR-2, and KIM-1) and a set of clinical data, which are provided by a patient's physician via a test requisition form (urine albumin creatinine ratio [uACR], hemoglobin A1c [HbA1c], and Blood Urea Nitrogen [BUN]). The algorithm generates a risk level (Low, Moderate, or High) for progressive decline in kidney function, defined as sustained decrease (<40% of baseline value) in eGFR. The KidneyIntelX.dkd algorithm was modeled using machine learning (Random Forest) to identify and analyze risk factors for kidney disease progression. The software is installed and maintained in the KidneyIntelX Portal, a cloud-based system. The biomarker results and clinical data set are manually inputted into the KidneyIntelX Portal determining the KidneyIntelX.dkd level. A KidneyIntelX.dkd Test Report containing the KidneyIntelX.dkd level is provided to the ordering physician. The KidneyIntelX.dkd level is to be used in conjunction with clinical information as an aid in assessing progressive decline in kidney function in T2D patients with DKD.