Objective: To evaluate the diagnostic accuracy of the FDA cleared Minuteful Kidney Test (MKT), a home based semi quantitative urine albumin to creatinine ratio (uACR) test, compared to the Beckman Coulter AU 480 analyzer, a standard laboratory quantitative method, for detecting albuminuria in individuals with or at risk for chronic kidney disease (CKD). Methods: Urine samples were obtained from individuals with risk factors for kidney damage. Each sample was analyzed for uACR using both the MKT and the laboratory standard method. Albuminuria was classified according to KDIGO guidelines: A1 (Normal to mildly increased, uACR is equal to or less than 30 mg/g), A2 (Moderately increased, uACR 30 to 300 mg/g), and A3 (Severely increased, uACR is equal to or greater than 300 mg/g). Sensitivity, specificity, PPV, and NPV of MKT were calculated against the laboratory standard. Results: Out of 615 collected urine samples, 555 met inclusion criteria. Albuminuria, defined as a uACR greater than 30 mg/g, was detected in 24.9% of samples when analyzed using laboratory methods (95% CI, 21.3 to 28.5%). The MKT demonstrated a sensitivity of 96.4%, specificity of 84.2%, NPV of 98.6%, and PPV of 66.8%. The test accurately categorized 85.6% of samples into the KDIGO albuminuria categories A1, A2, and A3, accurately identifying 100% of laboratory-confirmed A3 samples as abnormal. Conclusions: The Minuteful Kidney Test shows high sensitivity, exceeding the guideline required threshold (>85%, P<0.001), and robust specificity for detecting albuminuria in high risk populations. This device offers potential to improve CKD screening and management and facilitate early intervention in primary care and community settings, where accurate rule out capabilities are essential.

The authors have declared no competing interest.

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The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The study protocol was approved by the Sterling IRB (Study Number: 11415) with expedited review. Informed consent was waived for this retrospective study involving de-identified urine samples and medical records, which posed minimal risk to participants. No identifying information was accessible to the authors during or after data collection. The approval document was sent via email to the medRxiv team.

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I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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All data supporting the findings of this study are included within the manuscript and/or the Supporting Information files. Raw data from the study, encompassing both methods (the index device, Minuteful Kidney Test, and the comparator device, Beckman Coulter chemistry analyzer), are available upon request.