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Evaluation of HemoQR device against Gold Standard method for faster Anemia screening

Evaluation (accuracy, sensitivity, reliability and concordance) of HemoQR device against Gold Standard method (Automated Hematology Analyzers) for Anemia Screening/Hemoglobin determination - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/10/074607
Enrollment
500
Registered
2024-10-01
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Control Intervention1: Automated Hematology Analyzers, Gold Standard Biochemical Analysis: Gold standard method for detection of the biomarker (hemoglobin). Control Intervention2: NIL: NIL

Sponsors

SmartQR Technologies PVT LTD
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Outpatients of age group above 6 months attending the hematology laboratory for routine investigations, after taking prior written informed consent.

Exclusion criteria

Exclusion criteria: Pregnant women, infants below the age of 6 months. Seriously ill patients known to suffer from bleeding diathesis

Design outcomes

Primary

MeasureTime frame
Evaluate the diagnostic accuracy, sensitivity, reliability and concordance of HemoQR against Gold Standard method (Automated Hematology Analyzers) for Anemia Screening/Hemoglobin determination within a time frame of 7 days .The determination of feasibility and patient experience of the device by conducting a repeatability study to determine the consistency and precision of HemoQR results over multiple tests, ensuring its reliability for routine diagnostic and screening use.Timepoint: The study can be completed within 7 days from the point of sample collection to result interpretation.—

Secondary

MeasureTime frame
Assess the analytical accuracy, sensitivity, reliability & concordance value of HemoQR against the gold standard methods of estimation of hemoglobin for anemic & non-anemic patients Conduct a comprehensive usability study, particularly targeting layman users, to assess the ease of use, user-friendliness, & effectiveness of the HemoQR system in real-world settings. To implement a robust patient tracking system, utilizing the capabilities of the HemoQR mobile application, to monitor & manage patient data, ensuring seamless follow-up & continuity of care.Timepoint: All the studies can be completed within a time frame of 1 week—

Countries

India

Contacts

Public ContactSohom Banerjee

IIT Kharagpur

suman@mech.iitkgp.ac.in9837402939

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026