Our Anti-Leb antisera was expired and thrown away.  Our normal supplier is on back order for 3 months. 

I want to switch suppliers anyhow.   How can I bring in a new anti-sera without doing correlations ?

Usually reagent antisera has FDA potency requirements.  I just run qc to make certain they react like they are supposed to.  (Plus I run a lot of mine in gel so I verify that they work in that medium also).

We have never done correlations between manufacturers. It's a qualitative test and we perform QC every time we use it, never had any issues with inspectors.

Is there a certain standard you are looking at?

We've never done correlations either.

The only time I have ever done correlations between antisera was when the manufactuer switched from AHG to RT. I had a few select people compare a few samples with the poly and then the mono and write results on a nice little form. Did training and got everyone's signatures. But really this was more of a process change. I do have something to show an inspector which is always a good thing!

The CAP standards state that reagents must be correlated. I somewhat freaked out about this so I called CAP to get the scoop. The lady at CAP said BB reagents were different and correlations were not required. BB reagents must meet FDA potency requirements and we do QC on each day of use. I think Chem and Heme must correlate because QC is not done every day or their results are more of a range. With BB you are either positive or negative, not alot of gray area. She said some reagents were very expensive and it would waste reagents to do correlations. She did say that we must correlate "kits" which would include FMH and Elu-kit and any other kits we use in BB. Bummer, but better than having to do all the rare and not so rare reagents.

I really wish CAP would be a bit more clear on the standards. If BB is exempt I wish that would be stated in the fine print. I want to do what I should for patient safety but I surely do not want to do more than is necessary. It is a waste of tech time and reagents. That is all for my rant!

oh good!  I think my boss just assumed I would have to!  But I figured I'd start with you guys to see what the deal is.

 

You will probably need to "qualify" the vendor is some fashion, but I don't believe you have to do any serological comparisons providing you are going to use the material according to the manufacturer's directions.