Evidence-Based

Clinical Validation for CKD Screening

A consolidated view of HelloKidney publications, validation studies, and regulatory approvals across point-of-care kidney health screening.

Published Evidence

Published uACR & CKD Studies

Clinical publications, pilot studies, and validation work supporting HelloKidney's point-of-care CKD screening platform.

Study 1 Published Indian Journal of Diabetes & Technology

Decoding Type 2 Diabetes Through Point-of-Care Testing, Cloud-Based Monitoring, and Generative Augmented Retrieval Model-Driven Virtual Diabetes Education

Authors
Ateeb Shaikh; Sameer Baluni; Nikunj Malpani; Pratik Lodha; Anurag Meena
Summary
In a randomized controlled trial, an AI-driven metabolic coaching intervention combined with point-of-care monitoring — including POCT uACR screening — significantly improved glycemic control and supported earlier kidney risk detection compared with standard care.
Read the full study
Study 2 Published International Journal of Scientific Research

Decoding Clinical Biomarkers from POCT Strips — Accuracy Compared with Routine Urine Microscopy

Authors
Dr Ateeb Sheikh et al.
Summary
This evaluation compared point-of-care test cards with the Acon Mission U120 urine analyzer across 14 urine biomarkers. The study reported strong performance for rapid detection of important health indicators, with notable accuracy and reliability.
Read the full study
Evidence Summary

Why This Matters

Across community, hospital, and diabetes care settings, the evidence positions HelloKidney UACR screening as a practical, validated tool for earlier CKD risk detection and triage.

Focus Areas

CKD screening · Microalbuminuria detection · Diabetes-linked kidney risk · Hypertension-linked kidney risk · Point-of-care workflow adoption · Rural and urban population screening.

Product Context

HelloKidney combines urine strip chemistry with smartphone-assisted AI interpretation to make UACR screening faster and more accessible — beyond conventional lab settings, at the point of care.

Clinical Performance

99% Specificity · 96% Sensitivity · Results in 60 seconds · Clinically validated against laboratory reference methods · CDSCO-approved test strips.

Real-World Impact

2,060+ participants screened in India pilot · 9 in 10 patients previously unaware of CKD · Successfully deployed in both urban and rural settings across Andhra Pradesh.

Want to learn more?

Request access to clinical data, partnership details, or a product demonstration.

Contact Us