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BloodBanker80

Validation/Correlation help needed!

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If you use a diluted 3% panel for routine gel testing and want to validate it's performance/stability for 1 week...How many days or specimens would be required? 

If you are changing manufacturers for reagents - are correlations needed?  Like for Anti-A/AntiB we could do 20 days of the new brand along with QC.  What about a new brand C3 or antigen typing sera such as Anti-K?

Any input is greatly appreciated!

Edited by BloodBanker80
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Good 1st question and I don't know.  

For the second, if the reagent is licensed and approved for what you want to use it for I would do QC with current and new reagent and quickie comparison .- say a weak, mid strength and strong reaction on a couple of samples.  The goal would be that the new reagent compares with the current and reaction strengths do not differ by more than 1 (or whatever you decide). 

Edited by R1R2

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If you use a diluted 3% panel for routine gel testing and want to validate it's performance/stability for 1 week...How many days or specimens would be required? 

Please check manufacturer package insert. I know Ortho insert is 24 hrs. If you are extending days against package insert, you should validate with all kind of specimens and include worst cases. And definetly, you should run every day and in parallel with reagent prepared per package insert.

Eg. you can run X number of specimens (Pos and Neg) with freshly diluted cells (up to 24 hrs expiration) and diluted cells you are trying to validate. Make sure to document reaction strength and any missed reaction. I would try to make sure there is no variability in procedure. (tech to tech variation).

Edited by Eagle Eye

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