Innovative technology to eliminate the racial bias in non-invasive, point-of-care (POC) haemoglobin and pulse oximetry measurements

Abstract

There is a significant unmet clinical need for a reliable point-of-care (POC) estimation of the blood haemoglobin (Hb) method. Current available methods, notably pulse oximetry, have certain limitations related to design and methodology of devices. These have low sensitivity for detecting serial change in the Hb values, especially at the lower range and are inaccurate in people with darker skin. Objective This study aimed at developing a novel, non-invasive technology for the measurement of Hb and oxygen saturation. Design This was an observational study. Recruitment This was approved by the Institutional Review Board at the University of Texas at Arlington and 16 healthy adult volunteers (age 20–40 years) were recruited in this study. The investigational device (Shani) probe (United States Patent 11191460B1) consists of light emitting diodes with wavelengths ranging 520–580 nm, and a photosensor component. The probe is gently placed on the back of the subject’s wrist and reflected light is measured as an electrical signal, with digital recordings. Skin tone (or skin colour) was assessed by Von Luschan Chromatic Scale (VLS). Using a specific algorithm accounting for melanin (as determined from VLS Scale) and employing a software, the results can be displayed on screen as Hb values and ratio of tissue oxygen saturation. Results The results of the investigational non-invasive (Shani) device were comparable with the invasive, point of care (POC) method (iSTAT, Abbott Inc.).