Gylcine Soja standardization

[bloodbankem]

Hello,

We recently switched from Immucor's ficin-10 panel to Biorad's papain-treated panel.  We'd like to continue using glycine max as our means of evaluating enzyme treatment of our autologous cells and/or any selected cells.  Since no one manufactures lectin panels anymore, we're looking at purchasing it from Sigma and preparing our own stock solution.  Does anyone have, and willing to share, their process for preparing and standardizing its use? Any other advice/comments on evaluating enzyme treatment?

Thank you!

[David Saikin]

If you are making your own test system will this be considered a Lab Developed Test?  Might want to run it by CAP, FDA, CMMS.

I use anti-M to QC my enzyme pretreatment.

[bloodbankem]

Thank you for the reply.

The actual treatment of the cells is according to package insert.  I'm not sure I'd classify preparing a reagent as a lab developed test (but I don't have any experience with what's classified as such).  As far as QC goes, the insert just says "run a positive and negative control".  Glycine max has been a quick means of QC with the ficin panel and would serve as the positive control, then just run 6% albumin as the negative control.  I felt we should run an RH and FY system antibody, but that turned into a discussion of human source (availability) vs commercial (cost).

Do you use commercial anti-M?  And are you testing just pre-treatment (positive control) and post-treatment (negative control)?

[David Saikin]

Commercial anti-M (I have it because I use Ortho's gel and find more than a few Ms).  I test the cell treated and untreated.  I use papain.

Also, a few years ago the FDA was considering having BBs file for lab developed tests if you used any enhancement media, even though you were following the pkg inserts.  If you used more than saline and serum you could file for a lab developed test with no surcharge ($250,000) up until a designated date.  After that date you would have to pay. I have not heard that they were pursuing this any longer.  That surcharge is what vendors have to pay initially to have their product evaluated for FDA approval (or so I understand).

Edited August 18, 2020 by David Saikin
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[AMcCord]

21 hours ago, David Saikin said:

Also, a few years ago the FDA was considering having BBs file for lab developed tests if you used any enhancement media, even though you were following the pkg inserts.  If you used more than saline and serum you could file for a lab developed test with no surcharge ($250,000) up until a designated date.  After that date you would have to pay. I have not heard that they were pursuing this any longer.  That surcharge is what vendors have to pay initially to have their product evaluated for FDA approval (or so I understand).

I would hope that someone has convinced them that this is a crazy thought.

[David Saikin]

they must have as this was about 3-4 yrs ago.

[AMcCord]

22 hours ago, David Saikin said:

they must have as this was about 3-4 yrs ago.

Although they are notoriously slow in making decisions sometimes. How long did they ponder on the platelet testing scenario that will become law next year?