Post marketing study of hemodynamic and hematological noninvasive readings in a blood bank

This validation test was conducted in the Fujisan Blood Bank, Fortaleza, Brazil and evaluated the noninvasive TensorTip MTX (MTX, Cnoga Medical Ltd.) readings of hemoglobin, hematocrit, red blood cells, blood pressure, and heart rate compared to reference lab device readings. Generally, these parameters are measured from venous or capillary blood samples run on a laboratory analyzer or handheld invasive testing devices. Needle sticks are inconvenient to blood donors with relatively high exposure risks. To our vision, noninvasive determination would be of benefit to blood contributors and medical professional teams; it would be fast and painless.

A total of 334 subjects were included in the Fujisan blood bank validation (65% male, 35% female). Hemoglobin, hematocrit, and red blood cells, as well as blood pressure and heart rate, were measured noninvasively using the MTX device and were compared to venous blood samples run on two laboratory hematology analyzers (Horiba ABX Micros60 and Siemens blood count analyzer), to digital sphygmomanometer (OMRON BP786) and to manual auscultation. The noninvasive measurement with the appropriate virtual arm cuff setting was performed simultaneously with the blood sample extraction of the reference devices measurement.

There was no statistically significant difference (p > 0.05, paired, two-tailed t-test) between the average daily hemoglobin, hematocrit, and red blood cells measurements provided by the MTX device and the laboratory hematology analyzer. In addition, there was no significant difference between the daily blood pressure and heart rate results provided by the MTX device and the digital and manual sphygmomanometers. The error calculated between the MTX and the reference device was found to be sufficiently accurate according to the relevant standards.

The MTX accuracy of noninvasive hemoglobin, hematocrit, red blood cells, blood pressure, and heart rate measurements satisfies the industrial standards; therefore, the device enables more accurate, efficient, and effective patient care.