Diagnostic Validation and Feasibility of a Non-invasive Haemoglobin Screening Device (EzeCheck) for 'Anaemia Mukt Bharat' in India.

Abstract

Anaemia remains a major public health issue in India despite several efforts. It is crucial to introduce technology-based innovations for the mass screening and early diagnosis of anaemia. Traditional anaemia screening requires drawing blood and laboratory analysis and can be logistically expensive in resource-constrained settings. A non-invasive haemoglobin test for mass screening in such settings is vital which can quickly and efficiently screen large populations. This study validated the haemoglobin estimation between the invasive haematology analyzer and the non-invasive EzeCheck (EzeRx Health Tech Pvt. Ltd.,Bhubaneswar, Odisha, India) in the community setting. We conducted a cross-sectional study among 416 urban slum members in Bhubaneswar, India. We used inter-rater reliability (kappa statistic) of haemoglobin estimation between the haematology analyzer and EzeCheck devices. The finding showed a moderate agreement between both devices (kappa=0.4221). Between both devices, 91.59% of the results were with +/-1.5 difference; 43.51%, no difference; 33.65%, less than one difference; and 14.42%, +/-1 to +/-1.5 difference of haemoglobin estimation. There was no significant difference in overall anaemia status estimates between the devices. Mass screening in schools and communities with non-invasive haemoglobin tests can help identify anaemic people for early diagnosis and bring patients for timely treatment, which can be used in remote areas to support 'Anaemia Mukt Bharat'.