We have been doing a lot of bioanalysis of serum samples, for that there is no clarity about the expiry of blank biological matrix (basically serum) stored frozen. Is there any reference till how many days these matrix can be used?
It depends on the compounds you are analyzing and what is storage temperature (-20 or -80).
@Orwa Barakat, I m talking about the blank matrix, not about any analyte. Storage temperature is -80
Dear Soumyaranjan Mohapatra
Actually there are no guidelines that would explain this problem. From my point of view plasma stability should be confirmed in relation to its potential impact on the validation parameters of the specific analytical method.
The determinant of the baseline for the matrix is in fact the long-term stability of the analyte. We must assume that in the storage conditions of samples to be analyzed (eg PK studies), both plasma and analyte will be stable from the moment of taking the first sample until the last analysis of the last sample.
So if this period is 1 month, it means that the sample of blanc plasma that can be a reference point for us to determine its shelf life is 1 month. Its first assumption.
Now if we can say what plasma sample could be a reference we can check possible impact of ... for example 24 months stored blanc plasma. For example you can make 3 calibrations curves spiking 1 month blanc plasma (fresh-representing baseline) and make comparison with predefined acceptance criteria which should be proposed by you in validation (there is no guidelines probably) with 3 curves spiking 24 month blanc plasma stored with the same temperature. Then you can really prove that in case your specific internal standard analyte or metabolites etc etc 24 months blanc plasma can be considered as representative for your specific method.
Some company's suggest shelf life of Fresh Frozen Plasma (FFP) a priori as:
-18°C is 1 year (http://bca.coop/products-services/blood-products/plasma/)
-30°C is 2 year's (https://www.gla.ac.uk/media/media_184672_en.pdf)
-65°C is 7 year's (http://pathology.ucla.edu/workfiles/Education/Transfusion%20Medicine/2-4-Plasma-Products.pdf)
Some nice papers and technical notes around this problem are available:
https://www.sigmaaldrich.com/content/dam/sigma-aldrich/docs/SAFC/Bulletin/1/storing-and-thawing-serum.pdf
https://www.atlanta-biologicals.com/wp-content/uploads/2017/04/Technical-Bulletin-Storing-Thawing-and-Freezing-Serum.pdf
http://www.serumsourceintl.com/animal-fetal-bovine-serum-handling-msds-storage-shelf-life-expiration-thawing-freezing.html
http://www.austincc.edu/mlt/bb/bblect2componentsSp08.pdf
Article Sample Management: Recommendation for Best Practices and Har...
Article Effects of Storage Temperature and Time on Clinical Biochemi...
Article Blood stability testing: European Bioanalysis Forum view on ...
One guidance by WHO mention -65°C = 7 year's shelf life for FFP.
https://www.who.int/bloodsafety/Manual_on_Management,Maintenance_and_Use_of_Blood_Cold_Chain_Equipment.pdf
Hope it helps,
Best regards
Tomasz
good question. Stability of blank plasma , best way to look at is values of glucose and lactic acid heamatology and serum biochemistry values. normally -80 should be good for storage atleast for 3 months. but you can determine the above parameters every month and make your own stability data.
regards
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