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Kidney Week

Abstract: TH-PO1180

Evaluation of an At-Home Creatinine Assay for CKD Management: Pilot Method Comparison Study and Clinical Implications

Session Information

Category: CKD (Non-Dialysis)

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

Authors

  • Gopalakrishnan, Vissaagan, Jana Care, Boston, Massachusetts, United States
  • Anilkumar, Amrutha, Jana Care, Boston, Massachusetts, United States
  • Chavan, Supriya, Jana Care, Boston, Massachusetts, United States
  • Rangaswamy, Bharath B, Jana Care, Boston, Massachusetts, United States
  • Williams, Richard E, Jana Care, Boston, Massachusetts, United States
  • Hoang, Anh N, Jana Care, Boston, Massachusetts, United States
  • Januzzi, James, Jana Care, Boston, Massachusetts, United States
Background

Chronic kidney disease (CKD) management relies on regular serum creatinine monitoring, traditionally requiring phlebotomy and central laboratory analysis. There is a large unmet need for reliable at-home tools to measure creatinine, empowering patients, increasing testing compliance, and enabling timely interventions. A smartphone-enabled, low-cost reader system for analyte-specific strips is being developed for patient use in chronic disease management. The initial application is a fingerstick creatinine assay for self-administered at-home use (Fig 1).

Methods

The candidate creatinine assay was evaluated in a pilot study involving study participants across a range of CKD stages. The primary endpoint was a comparison of the fingerstick assay's performance to a central laboratory reference method (Vitros XT 7600 Integrated System, QuidelOrtho). Additional studies included a linearity study across a range of creatinine concentrations, and an interference study involving creatine and ascorbic acid.

Results

Among 50 study participants (mean age 49.7 + 15.5 years) with a range of CKD severity (mean creatinine 5.74 mg/dL), the assay demonstrated strong agreement with the Vitros XT 7600, achieving correlation coefficients (R) of 0.98 (Fig 2A). Additionally, the linearity study confirmed a direct relationship (R= 0.99) across the tested creatinine concentrations, validating accuracy across the spectrum of CKD severity (Fig 2B). The interference study showed no interference of creatine and ascorbic acid at 6 times physiological concentrations (300μM).

Conclusion

The development of a reliable at-home creatinine assay represents a significant advancement towards the scalable monitoring of CKD progression and early detection of kidney function decline, addressing a critical gap in management practices. By enabling regular monitoring, this assay has the potential to promote equitable health access and improve disease management.

A: Creatinine Result Comparison
B: Linearity Study

Funding

  • Commercial Support – Jana Care, Inc.