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Performing QC for Leukoreduced Products
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3/16/2017 at 10:21:52 PM GMT
Posts: 9
Performing QC for Leukoreduced Products

What is your procedure for performing QC for LR products, including how to calculate residual WBC and recovery rate?  Can you share detailed procedures including on how to collect samples for quadruple and double LR blood bags?



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3/20/2017 at 11:55:36 PM GMT
Posts: 9
Reply to Performing QC for LR Products

Our CBBS ENetwork Forum Moderator with donor center expertise responds:

 

We are not able to share our procedure currently as we are waiting for our Biologics License Application approval. In general, we follow the recommendations in the FDA guidance document, specifically the pre-LR on Whole Blood released by FDA on September 2012, but we also refer to the Platelet Guidance in 2007. Here are links to the FDA guidance documents:

 

http://tinyurl.com/mmyryzk

 

http://tinyurl.com/kaepfgb

 

The blood bag package inserts also would have some recommendations. We use both Flow Cytometer and Adams in detecting residual WBC though some centers are still using the Nageotte chambers.

 

Product QC methods or requirements can also be reviewed using the old purple Quality Control manual published by AABB which may need some updating  but most information are still applicable today. We copied two formulas from manual and pasted below:

 

Each filter type will need a separate data set, and FDA recommends using the binomial or hypergeometric sampling contained in the 2012 Pre-LR guidance document.



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Last edited Tuesday, March 28, 2017
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