Laboratory Products
Fast Frozen – Ready-to-Use Plasma Products Improve Quality and Process Flow
Mar 26 2014
Compared to traditional lyophilised plasma controls, the Precision BioLogic range of cryocheck Factor Deficient Plasmas provide significant quality and productivity improvements for the haemostasis laboratory. Exclusively available in the UK from Alpha Laboratories, these frozen, platelet-poor plasmas are immunodepleted and assayed at less than 1% for the specific factor, by functional and antigenic methods. The plasma is buffered and frozen, resulting in an excellent quality product that is consistent vial to vial.
Being ready-to-use, quality is further ensured as no reconstitution is required. In contrast, lyophilised material needs to be dissolved in a specific quantity of deionised water. Any inaccuracies in pipetting or calibration of pipettes can lead to errors, affecting the concentration of the reconstituted plasma. Consequently, this can lead to variation within batch and potentially affect assay performance over time. The frozen cryocheck range of Factor Deficient Plasmas provides consistent product every time, a fundamental requirement for good quality control.
Using frozen plasmas also brings valuable process improvements and time savings. Prior to use, they just need to be removed from their -40 to -80°C storage and thawed in a water bath at 37°C for 4-5 minutes, depending on the vial size. Lyophilised plasmas require much more time and operator handling. Stored at 2 to 8°C they must be brought up to room temperature before use. Typically, instructions for use suggest 15-20 minutes. A further 15-20 minutes are required for the lyophilised material to become completely dissolved and ready for use. Thus, the total time before testing can begin is at best 30 minutes and in the worst case, 40 minutes.
Finally, frozen plasma has a long shelf life, typically 3 years from the date of manufacture, versus a shelf life of 2 years for lyophilised plasma. The benefit of having longer shelf life means that standardising the test method with lot changes of reagents is reduced, thus lowering the set-up cost and reducing interruptions to work flow.
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