Vision Antigen Typing & Meditech

[Darren]

We just went live with doing weak D on the Vision with Ortho Sera. I also got the anti-K set up as well, but haven't rolled that out to everyone.

On the Provue we ran some antigen typing using the IS XM and IgG XM to cross the antisera to the unit cells. I have figured out how this can be done on the Vision as well. The question is, as long as I do a validation, can I proceed with using it? I would be using another company's antisera barcoded to run on the machine. Ortho has made a big deal about their new Ortho Sera being specifically for gel, but I know people have been using antisera in gel forever. I'm just wondering if there's any prohibition against this aside from Ortho preferring that you buy their stuff.

As for the meditech portion of this, those of you with interfaced analyzers know that at least in version 6 of meditech (and probably expanse) antigen typing doesn't interface and neither does crossmatching. Just thought it might be a good time of year to remind meditech that they need to add that functionality to the interface. Let's all spam them with it!

[David Saikin]

That's up to you and your Medical Director.  One thing to consider - that would be a lab developed test.  I thought I read a few years ago that the FDA was going to look at those (LDTs) - I think there was going to be a $250,000.00 fee (the initial fee for them to evaluate proposed new tests/drugs).  Also, when the Orthos and Immucors validate their antisera I believe they run considerably more than the "20" samples (including variants), so, while you may validate your process I don't believe your validation is as extensive, esp since you will be using reagent "off label".   I'd be more concerned with the LDT.  I'd check w the FDA to see their take on your proposal.  

FYI - I've used gel off label for years w antigen typing (and a few other assorted tests).

[AB123]

Maybe I'm reading your question wrong but why do you need to use XM profile? we do antigen typing for all antigens on our vision and the Vision has profiles setup for all the sera it offers. Ortho also has the option for other manufacturers sera and these can be setup in the UDP (User defined protocols). You have to titre the sera to ensure it has a tire of less that 1:1024 as this is what Ortho claim is the limit of their analyser for carry over. 

[Malcolm Needs ☆]

4 hours ago, srichar3 said:

You have to titre the sera to ensure it has a tire of less that 1:1024 as this is what Ortho claim is the limit of their analyser for carry over. 

1:1024 is NOT a titre; it is a dilution.