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Kidney Week

Abstract: SA-PO1202

Clinical Evaluation of Neodocs Dipstick for Rapid Nephropathy Screening in Hospital Settings

Session Information

Category: CKD (Non-Dialysis)

  • 2302 CKD (Non-Dialysis): Clinical, Outcomes, and Trials

Authors

  • Malpani, Nikunj, Neodocs Healthcare Pvt. Ltd., Mumbai, Maharashtra, India
  • Sabharwal, Mudit, Director & Consultant Diabetologist, Dharma Diabetes & Metabolic Clinics, Delhi & Gurugram, Delhi, India
  • Meena, Anurag, Neodocs Healthcare Pvt. Ltd., Mumbai, Maharashtra, India
  • Lodha, Pratik, Neodocs Healthcare Pvt. Ltd., Mumbai, Maharashtra, India
  • Munde, Shubham, Neodocs Healthcare Pvt. Ltd., Mumbai, Maharashtra, India
Background

Microalbuminuria, a condition characterized by urinary albumin excretion between 30-300 mg/day, is a crucial early sign of nephropathy and kidney damage. The urinary albumin-to-creatinine ratio (uACR) is the preferred method for measuring this condition, but it remains underdiagnosed due to lack of access to reliable testing. Conventional methods require trained staff and controlled environments, making them less accesible for remote areas. To overcome this, a new point-of-care device, Neodocs (ND) test card, has been developed to provide quick, and decentralized testing in resource-constrained environments, particularly in emergency and nephrology units.

Methods

As part of a study, 94 patients were tested in a hospital setting to assess the performance of ND device against the reference analyzer. The primary analysis focused on uACR performance metrics, with other urinary parameters serving as secondary outcomes. The ND device uses a mobile app to analyse urine reagent strip images, allowing operators to capture and quantify albumin and creatinine levels. The app then also records the subsequently calculated uACR levels. The results were saved digitally and reviewed in the cloud.

Results

The ND device showed excellent diagnostic accuracy for uACR with 91.23% sensitivity and 94.74% specificity compared to the reference analyzer. Other urinary parameters also showed strong accuracy (Table 1). The Pearson coefficient of 0.582 indicates a good level of agreement between the two methods. The Bland-Altman plot analysis revealed that over 95% of device readings fell within the limits of agreement with the reference system (bias -79.7 mg/g).

Conclusion

This study confirms that ND test cards are a reliable alternative for reference analyzer. The high sensitivity and specificity results can assure its application for reliable and early identification in scenarios requiring rapid nephropathy assessment in hospitals. Furthermore, estimating utility for a more accurate assessment will be made possible by studies involving larger cohorts.

Digital Object Identifier (DOI)