The Trial of a New Non-Invasive Method of Estimation of Haemoglobin Levels in Apheresis Donors at the Welsh Blood Service
University of Wales Institute Cardiff
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Background Prior to donation, every whole blood donor must be screened for their haemoglobin levels. This screening procedure is set in place to ensure the safety of the donor and to prevent any blood collection from a potentially anaemic donor. For this reason it is crucial that the method used for haemoglobin screening is accurate. The current method for the screening of haemoglobin in whole blood donors is the capillary finger prick copper sulphate test. Although cheap and easy to use, this screening method does not provide an acceptable degree of accuracy thus the purpose of this study is to investigate a new non-invasive method which could result in less unnecessary blood donation deferrals. Method A healthy population of 125 apheresis donors participated in this study. These donors were already planning to make a donation in the apheresis clinic and were not specifically selected for this study. A total of 104 males and 21 females participated in the trial. This study required the participants to have two methods of Hb screening prior to their platelet donation. The screening methods performed were the routine invasive method using the ABX Pentre 80 Haematology Analyser in the quality assurance laboratory of the WBS, this being the control for the study, and the new non-invasive NBM-200 method. These methods were then compared using statistical analysis. Results The Hb reference values for the non-invasive NBM-200 method ranged from 10.9 to 16.4 g/dl with an average of 15.052 g/dl. Hb reference values for the invasive venous samples ranged from 10.8 to 17.3 g/dl with a mean of 14.611g/dl. As a test to discriminate between a pass value of 13.5 for males and 12.5 for females, the NBM-200 does better when calculating the positive predictive values than the venous method, with a pass rate of 96.67%. The mean difference (bias) between the NBM-200 readings and the venous sample was 0.4408mg/dl. The standard deviation between the two methods was 1.0707mg/dl. The paired samples t-test show that there is a significant difference in the two methods of Hb screening (P<0.0001). Both the paired t-test and the Wilcoxon test for the two methods give P values of <0.0001. Conclusion The results obtained from this study have shown that there was a P value of P<0.0001. This value proves that there is a significant difference in the two methods. Therefore the OrSense NBM-200 does not give the same results as the analyser in the control venous sample, indicating that this method of Hb screening is inaccurate.
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