Back story: Our small hospital has never done antigen testing. To save money I was going to start implimenting antigen testing for patients with (C,E&K - these are our normal antibodies that we see most often, and also antisera that can be tested at IS without IgG).

 

My questions are:

1. Antisera is very expensive, I know at previous hospitals that I've been a part of we were able to use antisera past expiration date as long as QC checked. How long can expiration dates be extended?

2. We only do gel testing so naturally we have only gel screening and panel cells. I know there is a way to turn tube cells into gel cells is there also a way to turn gel cells into tube cells to use for antisera QC?

 

Thanks guys!

Why don't you just validate the antisera for use with gel.  You can use the buffered gel tubes and only 25uL of antisera (or 50 if you want to).  You just have to validate that the antisera work in gel (they do) and have a good procedure.   

 

If you want to turn gel cells into 3% cell suspensions you will need at least 5 drops washed to a dry button and resuspended in saline (or whatever you use).  Ortho says 4 drops but I find the button too small and do not do this at all.

 

You can extend the life of the antisera to your comfort level as long as the qc works (theoretically).  CAP and the FDA say you can do this so you can

This is perfect! Thanks so much, I'm dorking out a little with excitement!

I agree with David regarding the antisera, but I would like to emphasize having a procedure, specificaly stating what antisera you will save, what conditions you wouldn't use it (like discoloration) and things like that. CAP will like that.

Are you in the States or in Europe?  If you are in Europe, none of the above applies

Are you in the States or in Europe?  If you are in Europe, none of the above applies

 

None of the above applies because you can't use expired reagents at all?

 

I agree with David regarding the antisera, but I would like to emphasize having a procedure, specificaly stating what antisera you will save, what conditions you wouldn't use it (like discoloration) and things like that. CAP will like that.

 

I agree with Liz, make sure you develop a policy regarding the extension of the expiration date. Are you CAP accredited?

Another comment:  I don't think most inspectors would consider it acceptable to use antisera beyond its expiration date just to save money.  My experience is that they consider this practice as acceptable only if the antisera is considered to be "rare" or unavailable.

 

Donna

Edited April 11, 201411 yr by L106

_{If you are Joint Commission acrredited in the states - they don't seem to like it either.  My last inspection was with them and, even with a procedure defining "expired - which and what and how long", the inspector just didn't think it was worthwhile.  Tell that to some lab trying to find Little-s or Cw or.....}

Another comment:  I don't think most inspectors would consider it acceptable to use antisera beyond its expiration date just to save money.  My experience is that they consider this practice as acceptable only if the antisera is considered to be "rare" or unavailable.

 

Donna

I agree with Donna.  

TRM.31250 Reagent Expiration Dates Phase II

All reagents are used within their indicated expiration date.

NOTE: Rare reagents may be used beyond their expiration date if appropriate positive and negative

controls are run each day of use and react as expected. This exception is permitted by the FDA.

This does NOT apply to reagents that are readily available. The laboratory should establish criteria

defining which reagents are considered “rare.”

 

Write a procedure identifying what your criteria is for rare/unavailable, how you ensure QC is appropriate/acceptable, have your medical director approve it and you should be good to hook.