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

This study aims to clinically validate the performance of the HELO HB point of care digital hemoglobinometer by comparing hemoglobin measurements obtained from the device with those obtained from an automated hematology analyzer among patients undergoing routine complete blood count testing at Shrimad Rajchandra Hospital and Research Centre Dharampur. The study will be a hospital based cross sectional comparative analytical  study including approximately 500 participants across different age groups and hemoglobin ranges. From the same venous blood sample hemoglobin estimation will be performed using both the HELO HB device and the laboratory analyzer without collecting any additional blood exclusively for research purposes. The study will evaluate accuracy correlation agreement sensitivity and specificity of the device and assess its usability for routine clinical use and mass screening programs. The findings are expected to provide evidence regarding the reliability and clinical applicability of the HELO HB device for rapid hemoglobin estimation in hospital and community healthcare settings.