A summary of the outcome of the clinical evaluations to validate that the Medonic M32 blood bank application meets the performance claims.
This work aims to evaluate that the Medonic M32 blood bank application meets the performance claims. The Medonic M32 instrument was run with associated reagents and checked with dedicated quality control material. Correlation studies with platelet (PLT) and red blood cell (RBC) concentrates were performed in collaboration with a Swedish University Hospital Blood bank against the reference instrument CA620 CellGuard. The results show good correlation between instruments, indicating the suitability of Medonic M32 for use in blood bank applications.
The Medonic M32 system is an automated hematology analyzer intended for in vitro diagnostic testing of human blood samples, platelet, and erythrocyte concentrates under laboratory conditions. The blood bank application resides in the Medonic M32 system as a special analysis profile. The factory default blood bank profile is named PLT-C (PLT-Concentrate). This profile is pre-installed in the instrument and can be activated by the service technician upon delivery of the instrument.
In the PLT-C profile, several parameters are blocked, and no value is displayed on the screen or printed. In PAS (Print All Settings) the blocked parameters are removed, whereas RBC, PLT, MPV, WBC, PCT, PDW, P-LCC and P-LCR values are displayed and printed. Suggested normal ranges for the active parameters are preset as the default (for a PLT concentrate), but levels may be altered by the user. Two calibration factors are available when the blood bank option is activated, PLT-C and MPV-C.
In this work, the performance of the Medonic M32 blood bank application was compared with the corresponding application in CA620 CellGuard.