Use of expired panel cell reagents TRM312.50

[macarton]

If we don't have the antisera, we order the antigen neg units from our blood supplier. If we have time we also order little e antigen negative units from them. We screen for e only in an emergency. You figure up the Tech time and antisera costs screen 40+ units or more. A lot of times they will send us historical antigen neg units and we will confirm when they come in.

[estiner]

I do order antigen-negative units from my supplier - what I am asking is how do you QC the selected cells that you do not have antisera for when you are trying to ID an antibody???

[webersl]

I do order antigen-negative units from my supplier - what I am asking is how do you QC the selected cells that you do not have antisera for when you are trying to ID an antibody???

You can't.

1. We have never received a CAP defficiency on this.
   
2. Our policy defines "cells with the particular antigen combination needed to complete an antibody identification" as 'rare', if not found among our in-stock in-dated panels.
   
3. Our QC on out-dated panel cells:
   
   1. 
      
   2. When intending to use, or using, a selected cell to rule out, we run a positive control for the antigen(s) whose antibodies we are ruling out.
      
   3. When intending to use, or using, a selected cell to rule in, we run a negative control for the antigen(s) whose antibodies we are ruling in.
      
   4. If you intended to use a cell in one way (ex ruling out), but ended up using it another way (ex ruling in), then you end up having to run both.
      
      
   5. We did a validation (5 different lots each of Immucor 3% and Ortho 0.8%) to show that the antigens (for which we had antisera - the usual commons) remained present with a similar reaction strength 90 days post-expiration [on cells that passed visual QC]. Ortho passed for all antigens tested; Immucor passed for most. I called CAP to see if they would accept this in liu of running controls on expired Ortho panel cells. They said absolutely not. They also said we must run BOTH a pos and neg control on any out-dated panel cell we select, regardless of its intended use or final use.
      
      

[kirkaw]

Is QC'ing outdated reagent red cells for ruling out required by AABB as well as CAP?

[Dr. Pepper]

Is QC'ing outdated reagent red cells for ruling out required by AABB as well as CAP?

I did not see anything in Standards but the Tech Manual says outdated screening cells should not be used (that shouldn't be a problem), then "Most serologists use in-date reagent cells for initial ab ID panels and, if necessary, use expired reagent RBC to exclude or confirm specificities. Each lab should establish a policy for using expired reagent RBC and validate any procedures associated with this practice." This is footnoted to Standards for Immunohematology Reference Labs, which I don't have a copy of. So, I would say yes to your question. And, as has been pointed out before in this forum, QC/QA/QI does not have to be performed just to satisfy an inspector, but also to reflect what you feel should be done as sound laboratory practice in putting the highest quality product out the door.

Edited May 10, 2012 by Dr. Pepper

[MWCrsy]

You can't.

1. We have never received a CAP defficiency on this.
   
2. Our policy defines "cells with the particular antigen combination needed to complete an antibody identification" as 'rare', if not found among our in-stock in-dated panels.
   
3. Our QC on out-dated panel cells:
   
   1. 
      
   2. When intending to use, or using, a selected cell to rule out, we run a positive control for the antigen(s) whose antibodies we are ruling out.
      
   3. When intending to use, or using, a selected cell to rule in, we run a negative control for the antigen(s) whose antibodies we are ruling in.
      
   4. If you intended to use a cell in one way (ex ruling out), but ended up using it another way (ex ruling in), then you end up having to run both.
      
      
   5. We did a validation (5 different lots each of Immucor 3% and Ortho 0.8%) to show that the antigens (for which we had antisera - the usual commons) remained present with a similar reaction strength 90 days post-expiration [on cells that passed visual QC]. Ortho passed for all antigens tested; Immucor passed for most. I called CAP to see if they would accept this in liu of running controls on expired Ortho panel cells. They said absolutely not. They also said we must run BOTH a pos and neg control on any out-dated panel cell we select, regardless of its intended use or final use.
      
      
      
      Generally we do antigen testing in tube. Is it necessary to dilute the antisera to use it to QC the panel cell in gel?
      Thanks.

[webersl]

Generally we do antigen testing in tube. Is it necessary to dilute the antisera to use it to QC the panel cell in gel?

Thanks.

We use both tube and gel. Before using commercial antisera (that is designed for tube) on a cell that is designed for gel (0.8%) in conjunction with patient results, we concentrate the 0.8% cell to 3%, and then run it in tube against the commercial antisera.

Before making a practice of using gel technique with antisera-not-designed-for-use-in-gel when it would have impact on patient results, you would want do a full validation, unless your antisera mfg says it's OK to use it in gel. Ours don't. Having said that, I found that using them straight worked just fine for all but one. I also titrated the commercial antisera to see how much I could dilute it before testing (to save $$). Some could be diluted as high as 1:10, but others could not be diluted at all. Unfortunately, the most expensive one (anti-Fya) could not be diluted at all.