Case Study for Two Noninvasive Devices Measuring Hemoglobin
Objective: This test report focuses on the evaluation of two noninvasive CFDA approved devices, TensorTip MTX (Cnoga Medical Ltd., Caesarea, Israel) and Radical-7 Pulse CO-Oximeter (Masimo Corporation, Irvine, CA), as part of the exploration of selecting a noninvasive device to be used in the Blood Bank in the Chinese People’s Liberation Army General Hospital, Beijing, China. The aim of the evaluation was to verify the accuracy of hemoglobin measurements of each device independently vs the hospital clinical laboratory reference.
Methods: The TensorTip MTX and Radical-7 noninvasive measurements were compared separately to the hospital’s clinical hematology analyzer measurements, taken by venipuncture. The test cases for each comparison included at least 26 patients over the age of 18 from the Blood Bank.
Results: The study showed that there was no significant difference between the non-invasive TensorTip MTX and the invasive clinical laboratory reference (P<0.05, paired, two-tailed t-test) in contrast to the noninvasive Radical-7 which provided statistically different results compared to the same hospital reference.
Conclusion: The performance of the TensorTip MTX noninvasive device was found as sufficiently equivalent to the hospital’s clinical laboratory reference. From a clinical point of view, the TensorTip MTX is an extremely useful device with far reaching implications for patients. It provides for the first time commercially available, fast and reliable measurements of hemoglobin in a totally noninvasive manner.
Feng Yannan, Wang Deqing and Yu Yang