[Evaluation of a non-invasive hemoglobin measurement device for pre-deposited autologous blood donation].

Blood Transfusion Division, Kobe University Hospital, Kobe.
Rinsho byori. The Japanese journal of clinical pathology 12/2006; 54(11):1106-9.
Source: PubMed


A non-invasive hemoglobin measurement instrument (Sysmex Co.Ltd., Kobe, Japan) was used for the evaluation of hemoglobin levels just before blood drawing for repeat autologous blood donation. There was a statistically significant correlation (r = 0.598) between the hemoglobin levels determined with the non-invasive instrument (NINV-Hb) and true Hb levels (T-Hb) evaluated by direct analysis with automatic hematology analyzer, KX-21 (Sysmex). The analysis used 156 data obtained from 66 patients. Ten patients whose differences between NINV-Hb and T-Hb of the first blood donation were more than 2.1 g/dl were excluded from further analysis. Imaging analysis indicated difficulties with the detection of appropriate blood vessel images in one of these patients, but the reasons for other patients were not apparent. There was a closer relationship between NINV-Hb and T-Hb for the 76 measurements for the second or third blood donation obtained from 56 patients (r = 0.704) than for the entire data (r = 0.598). When 12 g/dl was used as the cut off value for NINV-Hb, sensitivity and specificity for the detection of 1l g/dl of T-Hb, which is considered the critical level for drawing autologous blood for donation, were 83.6% and 77.8%, respectively. We conclude, therefore, that NINV-Hb evaluation can be expected to be useful for repeated autologous blood donation of limited patients, however, it is strongly expected to develop a new system having more sensitive and accurately detectable ability.

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    ABSTRACT: Introduction: The Masimo Radical-7 Pulse CO-Oximeter is a medical device recently approved by the US Food and Drug Administration that performs noninvasive oximetry and estimated venous or arterial hemoglobin measurements. A portable, noninvasive device that rapidly measures hemoglobin concentration could be useful in both austere and modern hospital settings. The objective of this study is to determine the degree of variation between the device's estimated hemoglobin measurement and the actual venous hemoglobin concentration in undifferentiated emergency department (ED) patients. Methods: We conducted a prospective, observational, cross-sectional study of adult patients presenting to the ED. The subjects consisted of a convenience sample of adult ED patients who required a complete blood count as part of their care in the ED. A simultaneous probe hemoglobin was obtained and recorded. Results: Bias between probe and laboratory hemoglobin measurements was –0.5 (95% confidence interval, – 0.8 to –0.1) but this was not statistically significant from 0 (t0.05,124 = 0.20, P > 0.5). The limits of agreement were –4.7 and 3.8, beyond the clinically relevant standard of equivalency of ± 1 g/dL. Conclusion: These data suggest that noninvasive hemoglobin determination is not sufficiently accurate for emergency department use.
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