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Quality_Lady

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

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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.

 

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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

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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.

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Out of curiousity, which manufacturer are you trying to validate?

Another hospital in my town validated ortho cells in the grifols gel. We played with it, but they always had a small trail of cells in the negative reactions. Nothing I was comfortable using.

I've considered validating the quotient cells in the grifols gel. I've been told they work well together.

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MOBB -

We are looking at Immucor and / or Quotient.  I have heard through the grapevine that Ortho cells do not work well - the make-up of the diluent interferes.

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On ‎1‎/‎20‎/‎2018 at 6:40 PM, Carrie Easley said:

We validated Quotient  panel cells for use in Grifols DG gel.  It’s nice to get more rule-out’s/in’s while still using the same method.

Carrie - would you consider sharing your plan - or at least a high level summary of your rationale for the number and distribution of samples / cells tested?

Thanks!

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We use Immucor cells in Grifols gel cards and they work fine.  (we use them for additional rule outs when necessary, not the first line of the ABID.)

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9 hours ago, Quality_Lady said:

Carrie - would you consider sharing your plan - or at least a high level summary of your rationale for the number and distribution of samples / cells tested?

Thanks!

I'd like a copy too if you don't mind :)

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4 hours ago, MaryPDX said:

We use Immucor cells in Grifols gel cards and they work fine.  (we use them for additional rule outs when necessary, not the first line of the ABID.)

Can you share your validation plan? 

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We include a step in our method corelation (twice a year) where we run Ortho gel panel (0.8%), Tube panel (immucor 3%) and Immucor gel panel(dilute immucor to 0.8%). Our method was correlated almost 20 years ago!

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On ‎1‎/‎26‎/‎2018 at 6:59 PM, MOBB said:

Can you share your validation plan? 

  We've been doing it for over 15 years (from the time we had Ortho's gel cards).  Whatever validation was recorded, it's from eons ago and I wasn't involved with that one.

I would imagine it was similar to the validation done with the DAT method in gel cards (from my other post in that section)

Edited by MaryPDX

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On ‎1‎/‎28‎/‎2018 at 9:27 AM, Eagle Eye said:

We include a step in our method corelation (twice a year) where we run Ortho gel panel (0.8%), Tube panel (immucor 3%) and Immucor gel panel(dilute immucor to 0.8%). Our method was correlated almost 20 years ago!

Great idea!

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On 1/28/2018 at 9:27 AM, Eagle Eye said:

We include a step in our method corelation (twice a year) where we run Ortho gel panel (0.8%), Tube panel (immucor 3%) and Immucor gel panel(dilute immucor to 0.8%). Our method was correlated almost 20 years ago!

How many antibodies do you include in your method to method?

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For method correlation: only two sample. one positive and negative. Usually postive has one of two antibodies.

Initial validation was done many years ago but if i have to do it now, i will do total 20 specimens and at least five or more positive with different antibodies (Anti-E, anti-K, ANti-D due to RHogam, warm auto and atleast one example of cold antibody)

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For those of you who dilute 3-5% reagent RBC solution to a 0.8% solution what dilution process do you follow? what volumes of 3-5% suspension or packed RBCs and diluent do you use? The Ortho/MTS instructions for use gives the example of 10µL of packed RBCs in 1.0mL of diluent but leaves it open to other processes and preparing 1.0mL of cell suspension per reagent RBC tested seems excessive.

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19 hours ago, Lucky Jack said:

For those of you who dilute 3-5% reagent RBC solution to a 0.8% solution what dilution process do you follow? what volumes of 3-5% suspension or packed RBCs and diluent do you use? The Ortho/MTS instructions for use gives the example of 10µL of packed RBCs in 1.0mL of diluent but leaves it open to other processes and preparing 1.0mL of cell suspension per reagent RBC tested seems excessive.

I think most would agree that using up 10uL of reagent RBCs is not excessive.  That is less than 1/2 drop.  You would have trouble measuring out anything less.

Scott

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