Using Expired Anti-Sera

[jhaig]

Is it acceptable to use expired anti-sera as long as the QC gives acceptable results? Any regs to support/disprove this?

[David Saikin]

Yes . . . the only indated antisera you must use are for ABO and Rh(o)D testing.

[Bill]

In New York State, the Clinical Laboratory Standards of Practice (Jan 2008 pg. 46) states, "Laboratories may use reagents beyond the expiration date only if the manufacturer has provided written authorization to do so. The laboratory may not conduct its own validation studies to extend the shelf life of reagents." Every time a New York State Lab Inspector comes into a lab, he/she looks at outdates of most reagent, but specifically they look at the blood bank reagents.

[David Saikin]

That's unfortunate, esp with the exhorbitant increase in price for the rare antisera. Even the FDA allows the use of rares that are outdated as long as the QC is valid.

[Lcsmrz]

I look at "rare" antisera as those you can't readily obtain.

While my outdated Anti-S and Anti-Fya won't be replaced, I would not use something like expired Anti-E, Anti-C or Anti-K, except for training students and new employees. I obtain antigen-negative units from the blood center, rather than use expired antisera that passed my QC to select units for transfusion.

I gave up years ago attempting to think of a proper QC scheme for testing the sensitivity, specificity and potency of expired antisera. One heterozygous postiive cell (Sorry, Dr Judd, if you're still lurking) and one negative cell doesn't do it for me, when dealing with an expired antisera.

And I rarely do anything for the sole purpose of saving money ...

[OPUS104]

We currently use our expired antisera only as a screening tool. We only record our positive results in the donors permenant record and we note "old" to know we used outdated. Negative results must be confirmed with in-date. We also do this with diluted antisera when mass screening, with applicable QC and so on and so forth. ALL reported results are with in-date except the instances of like Bga where we have used non-lic. antisera, and these are labeled as such per AABB guidelines.