Evaluation (accuracy, sensitivity, reliability and concordance) of HemoQR device against Gold Standard method (Automated Hematology Analyzers) for Anemia Screening/Hemoglobin determination

Anemia which is one of world’s most prevalent nutritional disorder which affects 1/3rd of the global population. Hemoglobin monitoring is the most common biomarker for detecting anemia. About 50% population in India gets affected by anemia and have low Hemoglobin level. The impact of this can be fatal and increase mortality in children in the age bracket of 6- 59 months and also responsible for 20% maternal deaths. These data have been obtained from National Family Health Survey-5(NFHS-5) (2019-2021). Apart from anemia, hemoglobin levels can help in diagnosing other critical health problems like liver, kidney diseases, blood and other type of cancers, heart, and lungs conditions.

The novelty of HemoQR as compared to the Gold Standard method is that it provides a quick, economical, easy to use and premium hassle-free method for individuals to monitor their hemoglobin levels without usage of hemoglobinometer or any other commonly used biochemical and automated techniques thus reducing the cost dramatically and also making it cost effective and easy to use even for non-technical personnel thus helping to achieve mass screening in the remotest areas as well.

Our objectives are to validate the accuracy, sensitivity, reliability and concordance of our technology from the existing gold standard tests and also analyze the usability of the technology as a POC (point of care) solution and evaluate its efficiency and finally we will analyze the repeatability, consistency and precision of the results obtained from our technology in rural hospital/public health centre/medical college using fresh blood samples from 200 patients with equal male to female ratio.

Our methodology will revolve around participation selection, inclusion and exclusion criteria, duration of the study, procedure, data collection and analysis.

The expected outcome will be to determine hemoglobin level in the range of 3-18 gm/dl in the blood within a time period of less than 60 seconds. The system will also have autocalibration and minimal sample volume of not more than 30 μL will be used. Anemia which is one of world’s most prevalent nutritional disorder which affects 1/3rd of the global population. Hemoglobin monitoring is the most common biomarker for detecting anemia. About 50% population in India gets affected by anemia and have low Hemoglobin level. The hemoglobin analysis is done using numerous methods which involves laboratory, analysers and POC like hemoglobinometers. Some of the popular methods are, cyanmethemoglobin method, automated hematology analyzers, hemoglobin electrophoresis, HemoCue method, colorimetric method, gas chromatography, spectrophotometric methods, hemoglobin color scale (HCS), reflectance photometry, portable hemoglobinometers, capillary blood sampling. HemoQR is a sensor technology which represents a significant advancement in Hemoglobin measurement in real time. The most important points of our HemoQR technology which makes its different from others are it will provide real time monitoring, high accuracy and precision and convenience and accessibility to wide range of the user. The working principle is based on digital image colorimetry using a mobile application only and thus removing the device dependency. The detection range of hemoglobin will be 3-18 gm/dl and the sample volume used will be 30 μL. This patented technology provides an easy to use, economical technique that utilizes smart phone-based reader to measure hemoglobin levels in the bloodstream. This makes it a perfect POC for the modern time which can auto calibrate and the data generated can be stored for a long time in the mobile app and on the server to monitor the change of hemoglobin with time without a paper print out. Its precision and reliability make it a promising tool in overall health management especially in detecting anemia and other critical health diseases. This technology will not only help in providing a quality of life but also it will help in decreasing infant and female mortality rates. The novelty of this technology is that it provides a quick, economical, easy to use and premium hassle-free method for individuals to monitor their hemoglobin levels