Abstract
In vitro hemolysis testing is an essential method for assessing the hemolytic potential of blood pumps, but has poor reproducibility. Further investigations are needed to determine the sources and extent of variability and to find a practical way to reduce the variation. A small volume blood circulating loop driven by a Centrimag pump was established to provide relatively higher hemolysis readouts within a short run time and to be able to sequentially perform multiple repeated hemolysis tests in a working day. The repeatability with this system was demonstrated as the %RSD at 4.3% for the NIH or MIH from three repeated tests using the same blood. The bovine blood from different randomly selected donors was tested and gave more than a two-fold difference in NIH results (0.077 vs. 0.032 g/100 L) under the same testing conditions and same pump. This wide variation in hemolysis using bovine blood from different donors happened repeatedly. More importantly, it was observed that the difference in hemolysis test results using the blood drawn from the same donor on multiple days was narrow although the native hematocrits varied. The %RSD of NIH values obtained on five different days were 6.8%, 8.4%, 11.5%, and 7.8% for donor-specific blood from donors 1 to 4, respectively. The study results indicate that the mechanical stress-induced hemolysis behavior is donor-dependent. It has been also demonstrated that the reproducibility of in vitro hemolysis testing can be improved when the blood drawn from same donor is used.
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