Jump to content
Sign in to follow this  
Quality_Lady

Validation of Other Manufacturer's Reagent Red Cells for Use in Manual Grifols Gel

Recommended Posts

Has anyone validated the use of other manufacturer's (Ortho, Immucor, Bio-Rad, Quotient) reagent red cells in the Grifols gel system.  I realize that they need to be washed, and resuspended to 0.8% in Grifols diluent.  What I am looking for is general information on the actual validation performed -

  • how many cells
  • what antigen groups
  • distribution between positive and negative cells
  • use of patient samples for testing

Also - what is probably more of an issue.  Have you been inspected by FDA (or CAP, AABB) and has your plan been accepted?

Thanks in advance for your help.

 

Share this post


Link to post
Share on other sites


Regardless of how many tests you carry out to validate, please remember one thing.  If you have problems with results in the future, neither manufacturer will take responsibility unless their IFUs specifically state that you are allowed to cross over like this

Share this post


Link to post
Share on other sites
4 hours ago, galvania said:

Regardless of how many tests you carry out to validate, please remember one thing.  If you have problems with results in the future, neither manufacturer will take responsibility unless their IFUs specifically state that you are allowed to cross over like this

A very good point, Anna. The same applies to anything done "off-label", regardless of how much validation has been done.

Share this post


Link to post
Share on other sites

Create an account or sign in to comment

You need to be a member in order to leave a comment

Create an account

Sign up for a new account in our community. It's easy!

Register a new account

Sign in

Already have an account? Sign in here.

Sign In Now
Sign in to follow this  

  • Advertisement

×