Jump to content

Concentration or Dilution of Manufacturer's Antibody Screening Cells


JLF

Recommended Posts

Do you concentrate or dilute manufactured antibody screening cells for testing? If so, do you perform QC on the concentrated or diluted cells? Do you consider this an LDT since you are altering the manufacturer's product?

Link to comment
Share on other sites

I would agree with those who already pointed out that if you modify a reagent of any kind (unless it is part of the prep according to the manufacturer) you would have to, at the least, document QC as you are indeed on your way to using a LDT. 

 

But anyway, why are you diluting screening cells?

Scott

Link to comment
Share on other sites

The only time I have seen reagent cells diluted is when they are being used for an antibody titer, and here QC is run. The other manipulation to reagent cells that I have witnessed, but not practiced, is the replacement of the manufacturer's reagent cell solvent with blood bank saline, when trying to get rid of week non-specific reactions. I do not know if QC is run in this case. I do have to ask a dumb question though; what does LDT stand for? Keeping track of the meaning of lettered abbreviations is difficult especially when they are not used regularly enough.

Thank you in advance for any reply,

Ronald 

Link to comment
Share on other sites

I assumed that by LDT, Lab Developed Test is intended -- but I may be mistaken (speaking from experience!).  LDTs have their own series of regulatory hoops to jump through in order to be used for patient testing.

Scott

Link to comment
Share on other sites

I think you will all find that the manufacturers do indeed have something to say on the topic.  Most IFUs (box inserts /package inserts) will have a disclaimer about products not being used in the way they were intended.  So diluting cells from 5% to 1% would definitely come under 'off-label' use unless the manufacturer specifically says you can do this and specifies what you should use as a diluent

Link to comment
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
  • Recently Browsing   0 members

    • No registered users viewing this page.
  • Advertisement

×
×
  • Create New...

Important Information

We have placed cookies on your device to help make this website better. You can adjust your cookie settings, otherwise we'll assume you're okay to continue.