Here is a seemingly simple request from Vicki Lanigan at Niagara Health, Ontario, Canada: “I am looking for a reference for storage of normal pooled plasma (NPP, pooled normal plasma, PNP).”
Vicki, this one drove me back to the books and to the package inserts for distributors Precision BioLogic Inc and George King Bio-Medical, Inc to learn the shelf life for their frozen products. I learned that buffered control platelet-free plasma products that are frozen and prepared for commercial distribution are Class II in vitro diagnostic (IVD) “devices” and their stability data are based on extensive studies whose results are filed at the companies. Conversely, storage of locally prepared platelet-free NPP adheres to the Clinical Laboratory and Standards Institute Guideline H21-A5, which indicates that specimens for analysis demonstrate less than ±10% variation when stored for up to three months at –24°C or for up to 18 months at –70ºC. These values are based upon Woodhams B, Giradot O, Blanco M, Collesse G, Gourmelin Y. Stability of coagulation proteins in frozen plasma. Blood Coag Fibrinolysis 2001;12:229–36. This reference provides stability data for prothrombin time, partial thromboplastin time (PTT), thrombin time, all the coagulation factors, antithrombin, protein C and S, plasminogen, and D-dimer.
Specimens and controls are thawed at 37ºC, mixed well, and tested immediately or stored at 1–6ºC (4ºC per CLSI) for a maximum of two hours before testing.
The management of transfusion service plasma products is slightly different. Fresh frozen plasma (FFP) is donor plasma that is placed in a –70ºC freezer within six hours of collection. The more commonly prepared frozen plasma (FP-24) is donor plasma frozen within 24 hours of collection. According to the AABB Standards for Blood Banks and Transfusion Services, FFP may be stored up to seven years and FP-24 for up to one yearat –70ºC. Anecdotally, most donor services set the expiration date for both at one year. Both FFP and FP-24 are thawed at 30–37ºC in an FDA-cleared device and once thawed, may be stored at 1–6ºC (or transported at 1–10ºC) for up to 24 hours prior to administration, according to AABB.
Thanks to Stephen Duff, Co-CEO, Precision BioLogic, Inc, Dr. Jon Geske, Manager, Emerging Technologies & Markets, Precision BioLogic Inc, Dave McGlasson, Wilford Hall USAF Hospital, and Margaret G. Fritsma for assistance with this post.