Developing a novel device based on a new technology for non-invasive measurement of blood biomarkers irrespective of skin color

Background: Human hemoglobin is a tetrameric metalloporphyrin. The heme part contains iron radicle and porphyrin. The globin part consists of two pairs of amino-acid chains. The absorption spectrum of hemoglobin spans from 250 nm to as high as 2,500 nm, with high coefficients reported in blue and green color zone. The visible absorption spectrum of deoxyhemoglobin has one, while the visible absorption spectrum of oxyhemoglobin shows two peaks. Objective: (1) To study absorption spectrometry of hemoglobin in 420 to 600 nm range; (2) to conduct preclinical experiments to validate a new device and technology based on green color absorption by hemoglobin; (3) to use this new technology and device for phase 1 study in healthy human volunteers for confirmation Design, material and methods: (1) Checking absorption spectrometry of hemoglobin in venous blood. We measured absorption spectrometry of 25 mother-baby pairs as an observational study. Readings were plotted from 400 nm to 560 nm. These included peaks, flat lines and deeps. Graph tracings of all samples – cord blood and maternal blood – showed similar patterns. (2) Preclinical experiments were set up (a) to correlate the reflection of green light by hemoglobin and concentration of hemoglobin, (b) to correlate concentration of O2 and reflection of green light related to oxyhemoglobin, (c) to correlate concentration of melanin in upper and the hemoglobin in lower layer of tissue phantom and to check the sensitivity of new device with green light for measuring Hb in presence of high levels of melanin, and lastly (d) to check if the new device can measure changes in oxy-hemoglobin and deoxy-hemoglobin, again in presence of high levels of melanin with normal as well as with low levels of hemoglobin. The experiments using bilayer tissue phantom were conducted with horse blood in lower cup as dermal tissue phantom and synthetic melanin in upper layer as epidermal tissue phantom. (3) Phase 1 observational studies following a protocol approved by the institutional review board (IRB) were done in two cohorts. Readings were taken using our device and a commercially available pulse oximeter. In the comparison arm we had Point of Care (POC) Hb test (HemoCu or iSTAT blood test). We had 127 data points of POC Hb test and 170 data points for our device and pulse oximeters. This device uses two wavelengths from the visible spectrum of light and uses reflected light. Light of specific wavelengths is shone on the skin of the individual, and the reflected light is collected as ‘optical signal’. This optical signal – after conversion to electrical signal – is processed and finally analysed with a digital display on the screen. Melanin is accounted using Von Luschan’s chromatic scale (VLS) and a specially designed algorithm. Results: In this set of various preclinical experiments using different concentrations of hemoglobin and melanin, we indeed demonstrated good sensitivity of our device. It could pick up signals from hemoglobin despite high levels of melanin. Our device is a non-invasive device to measure hemoglobin like a pulse oximeter. Results of our device and pulse oximeter were compared with those by POC Hb test like HemoCu and iSTAT. Our device showed better trending linearity and concordance than a pulse oximeter. Since the absorption spectrum of hemoglobin is the same is new-borns and adults, we could develop one device for all age groups and for people of all colors. Furthermore, the light is shone on the wrist of the individual and is then measured. So, in future this device has the potential of being incorporated in a wearable or smart watch technology.