Evaluation of a Point-of-Care Diagnostic HemoQR: A Hemoglobin Detection Kit in a Cohort of 500 Patient Samples in Comparison with Gold Standard

Background: A chronic and large level global health concern, anemia disproportionately affects those living in low-resource environments. The performance of a new point-of-care (POC) hemoglobin (Hb) detection system is examined in this study using 500 patients. Rapid Hb readings was performed by this POC device, which amalgamates the smartphone technology with a biodegradable paper-strip approach.  Methods: We have compared two devices Device A (HemoQR) and Device B [Hematology Analyzer- Fully Automated-3 Parts (ERBA H 360)] in multiple primary healthcare center’s (PHCs) in a district in Maharashtra, India using 500 samples from patients of different age groups using fingertip pricked blood for the test to monitor Hb.  Results: As the result of this study qualifies the criteria of Anemia Mukt Bharat (AMB) program initiated by the Government of India which requires a sensitivity and specificity of more than 80% for invasive digital hemoglobinometer for the determination of Hb levels in blood. In context to our device A was able to obtain sensitivity, specificity and accuracy of around 90.19%, 97.60% and 96.15% respectively in this study using 500 live samples.  Conclusion: The study concludes that HemoQR can be an efficient, economical and smart POC Hb detection test system using a mobile based application for analyzing Hb levels in all kind of medical setup and it can also help in collecting and analyzing the data for monitoring purposes.