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comment_94780

Hi,

I would like to get rid if ortho reagents antisera and red cells to replace with immucor reagents.. how many samples are needed and how many aborh,dat,etc to validate this immucor reagents.

Please share your procedure. Thanks

Edited by Bren
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  • Ensis01
    Ensis01

    Question to those wiser than I. Is the primary reason for these required validation comparisons to ensure we in the lab know how to follow the package inserts and so use the reagents correctly? I ask

  • Like @Bet'naSBB said, there's really no easy answer. My first response is ALWAYS, check with the manufacturer to see if they have documents or guidance. Then, read the package inserts, they may have i

comment_94793

Not sure that there is a specific number. We just validated some Grifols antisera and ran 20 comparisons.

comment_94794

Like @Bet'naSBB said, there's really no easy answer.

My first response is ALWAYS, check with the manufacturer to see if they have documents or guidance.

Then, read the package inserts, they may have info.

Then, barring anything definitive from above, you and your medical director need to review your patient population and determine how many of each type of patient you want to test. Do you have a lot of antibody patients? Do you treat cancer patients?

comment_94853

Question to those wiser than I. Is the primary reason for these required validation comparisons to ensure we in the lab know how to follow the package inserts and so use the reagents correctly? I ask because I can't imagine any lab will be able to test the reagents to the level the manufacturer can with respect to numbers and variants (see package insert).

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