Clinical publications and validation evidence

Clinical Validationfor uACR and haemoglobin testing

A consolidated view of Neodocs publications, validation studies, and regulatory support across kidney health and haemoglobin screening workflows.

Regulatory readiness

Both uACR and HB are represented here with CDSCO support notes or certification references.

Institutional support

The evidence set includes ICMR-supported references for both uACR and haemoglobin workflows.

uACR

Published and listed uACR evidence

Clinical publications, pilot studies, and hospital-based validation work supporting early CKD screening in India.

Institutional support

The uACR kit is also supported by ICMR and ICMR Center of Excellence programs.

Regulatory note

The uACR kit is listed here as CDSCO approved.

Study 1PublishedInternational Journal of Scientific Research

Decoding Clinical Biomarkers from Neodocs Test Card POCT strips Accuracy viz-a-viz compared with routine urine microscopy

Authors

Neodocs team; Dr Ateeb Sheikh

Brief

This evaluation compared Neodocs 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.

Study 2PublishedWorld Congress of Nephrology / ScienceDirect

WCN25-2230 A new urine dipstick for the digital age, community screening of CKD need of the hour: Pilot study

Authors

Neodocs team; Dr Rohit Srivastava; Dr Vijay Kher; Dr Ajay Kher

Brief

The study showed that the Neodocs strip paired with the app can accurately classify the vast majority of screened patients into A1 versus A2/A3 categories, enabling earlier referral for evaluation and management.

Study 3Study listedReal-world cross-sectional study

Early detection of CKD using uACR screening in high-risk Indian Adults: A cross-sectional, real-world study using the Neodocs Kit

Authors

Neodocs team; Mudit Sabharwal; Seema Bagri; Soumik Goswami; Apurv Parekh; Debmalya Saniyal; Bharat Saboo; Subodh Banzal; Abhyudaya Verma; BS Shah; Satyam Chakraborty; Sayantan Chakraborty; Chandreshkumar Sudani; Pratyush Kumar

Brief

This study evaluated CKD prevalence in high-risk individuals using the Neodocs uACR kit, with emphasis on diabetes and hypertension. The findings describe a high CKD burden, especially in patients living with both conditions together.

Public study link not provided yet.
Study 4PublishedSA-PO1202 / Journal of the American Society of Nephrology

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

Authors

Neodocs team; Mudit Sabharwal

Brief

In 94 hospital patients, this study evaluated the Neodocs point-of-care card for microalbuminuria detection using uACR against a reference analyzer. The device showed 91.23% sensitivity, 94.7% specificity, and good agreement with the reference method.

Study 5PublishedScienceDirect

Point-of-Care Testing and Integrated Digital Health Technology for CKD Screening in High-Risk Populations of India

Authors

Rama Krishna Chinta; Venkateswar Shri; Bogdan Milojkovic; Dennis Begos; Shyamala Kemisetti; Naresh Kumar Chintagunti; Boris Bikbov; FOCUS-CKD Project

Brief

This pilot study assessed point-of-care testing and digital health for CKD screening in high-risk urban and rural populations in Andhra Pradesh. Screening of 2,060 participants found high CKD prevalence with very low awareness, supporting scale-up of POCT-based screening.

Study 6PublishedIndian 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: A Comprehensive Approach to Glycemic Control

Authors

Ateeb Shaikh; Sameer Baluni; Nikunj Malpani; Pratik Lodha; Anurag Meena

Brief

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 compared with standard care and supported earlier kidney risk detection.

Evidence summary

Why this matters

Across community, hospital, and diabetes care settings, the listed studies position Neodocs uACR screening as a practical tool for earlier CKD risk detection and triage.

Focus areas

CKD screening, microalbuminuria detection, diabetes-linked kidney risk, hypertension-linked kidney risk, and point-of-care workflow adoption.

Product context

Neodocs combines urine strip chemistry with app-assisted interpretation to make uACR screening faster and more accessible beyond conventional lab settings.

Haemoglobin

Published haemoglobin validation studies

Validation data and supporting publications for the Neodocs haemoglobin point-of-care testing workflow.

Institutional support

HB is also supported by ICMR.

Regulatory note

HB also has a CDSCO certificate.

Study 1PublishedValidation study

DJL Validation

Authors

Not listed in provided note

Brief

Validation material provided for the Neodocs haemoglobin workflow.

Study 2PublishedIIT Bombay study

IIT Bombay Hb study

Authors

Not listed in provided note

Brief

Study material provided for Neodocs haemoglobin testing validation.

Study 3PublishedInternational Journal of Scientific Research

Performance Evaluation and validation of Neodocs Hb Testing Point of care device with standard laboratory analyzer

Authors

Neodocs Team; Shubham Munde

Brief

A validation study evaluated a point-of-care haemoglobin testing device designed to support anemia screening under India’s Anemia Mukt Bharat program. The device showed high precision, reproducibility (SD ≤0.57), and strong agreement with a standard laboratory hematology analyzer, accurately detecting moderate-to-severe anemia.

Evidence summary

Why this matters

The listed haemoglobin evidence supports Neodocs Hb testing as a rapid and reliable point-of-care option for anemia screening programs and field use.

Focus areas

Anemia screening, point-of-care haemoglobin testing, reproducibility, laboratory agreement, and large-scale public health deployment.

Product context

The Neodocs Hb workflow is positioned for quick screening in clinical and community settings where fast decision support and portable testing matter.