Objectives: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.Methods: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.Results: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.Conclusion: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.