Performance of the non-invasive point-of-care device, EzeCheck, for haemoglobin assessment in adults and children in community and institutional care settings.

ABSTRACT

Anaemia is a major public health problem, especially in resource constrained settings. Dependency on assessment of blood hemoglobin (Hgb) concentration impedes anemia detection, risk stratification and intervention. Thus, valid, frugal and scalable technologies are needed. EzeCheck is a noninvasive portable device developed in India for predicting hemoglobin levels in human beings aged 4 years and above using a finger-tip biosensor. In this assessment, we aimed to (i) evaluate EzeCheck's performance with an automated whole blood hemato-analyzer (Sysmex XN 1000) as the gold standard, and (ii) estimate EzeCheck's agreement with Sahli's method and HemoCue (Hb-301) in real-world primary and higher care facilities. Paired assessments were done at five sites across India i.e., Bhubaneshwar, Shimla, Solan and Mashobra and Ulhasnagar. Participants across all age groups (4 years and above) were assessed. We used a range of statistical tests to evaluate the performance of EzeCheck. It was found that EzeCheck performed well across age and gender categories with convincing validity, concordance, precision and accuracy, and acceptable bias. While comparing EzeCheck with Hemato-analyzer, no statistically significant systematic bias was found. However, EzeCheck showed significant systematic bias when compared to Sahli's method and HemoCue. We concluded that EzeCheck could detect anemia (as per WHO Hgb cut-offs) in 'real-world settings' and 'across age and gender categories', with high sensitivity, specificity and accuracy, and can serve as a replacement to traditional methods of hemoglobin assessment. Further, for countries with higher prevalence of anemia where universal screening may be mandated, the positive predictive value of EzeCheck will be higher. The likelihood ratios also indicated that the device had moderate-to-good utility. EzeCheck is suitable for embedment into program and out-patient health care settings in resource constrained contexts as a spot-check hemoglobinometer.