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Testing the accuracy of the Helo-HB Digital Hemoglobinometer compared to gold standard laboratory methods at Shrimad Rajchandra Hospital

Clinical Validation of HELO HB Point-of-Care Digital Hemoglobinometer Compared with Automated Hematology Analyzer (Sysmex/Erba) at Shrimad Rajchandra Hospital and Research Centre, Dharampur - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/104847
Enrollment
500
Registered
2026-02-26
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Health Condition 1: Z000- Encounter for general adult medical examination

Interventions

Intervention1: Helo HB: Hemoglobin estimation using HELO HB point of care digital hemoglobinometer will be performed from the same venous blood sample at the time of routine CBC testing as per manufac

Sponsors

Adarsa Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of any age and gender undergoing CBC testing 2. Patients (or legal guardians) providing written informed consent

Exclusion criteria

Exclusion criteria: 1. Refusal to provide consent 2. Hemolyzed or clotted blood samples 3. Any condition precluding safe sample collection

Design outcomes

Primary

MeasureTime frame
Accuracy (bias) of hemoglobin values obtained using HELTimepoint: For completion of 500 tests for comparision, we would need about 3-6 months duration—

Secondary

MeasureTime frame
Correlation, agreement (Bland Altman), sensitivity, specificity, performance across Hb ranges & age groups, & operator usability - all assessed at the time of sample testing.Timepoint: For completion of 500 tests for comparison, we would need about 3-6 months duration—

Countries

India

Contacts

Public ContactDr Gaurij Hood

Shrimad Rajchandra Hospital and Research Centre

clinicalresearch@hospital.srmd.org9673879921

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026