[Histonet] Expired antibodies...for immunos..

Mon May 1 11:55:49 CDT 2006

Here is some info on this from a vendor standpoint. 

A vendor supplies antibodies and guarantees a certain lifetime. That
lifetime is limited by the expiration date. The vendor has to do stability
tests to support the expiry date (required by FDA and CE (European Union)).
Various tests are used for stability testing - Some may use accelerated
tests ( such as a certain time in an oven at a certain temp is considered
one year or two years), or may do real time tests - leave it in the fridge
for two years. In any case it is mainly to satisfy the regulatory agencies
that the reagent is indeed stable for a given period of time. 

The time period is up to the vendor. The main concern is liability over
time. Since a vendor guarantees a reagent for a given time it means if they
are wrong about the stability they have to replace the reagent. If the
vendor gave something too far out they may end up replacing a lot of
reagent.  So it is in the vendors interest to be conservative on these
expiry dates. That means the antibody most likely will be good well after
the expiry date. So the expiry date is a limit on the liability of the
vendor, not an absolute drop-dead date. But it is certainly not arbitrary
either. Vendors aren't going to offer unlimited time to get your money back
if it does not work. Also vendors would rather offer one set of expiry dates
than customizing it for every antibody. Most vendors are too small to
support complicated stability testing for every antibody they offer. 

I'm not sure why CAP and CLIA and CLMA have insisted on absolute recognition
of the expiry dates.  But my personal opinion is that it is probably because
they don't want to be liable for accrediting labs using self-labeled
extended expiry dates - a definite lawyer magnent if things go wrong. While
I have done this very thing for years, and have seen many labs do it,
essentially they don't trust the labs to do the job well.

What do do about it? Most vendors probably won't want to extend their
liability for the reagents. The alternative is to order lower quantities. If
the vendor does not supply in small quantities, ask them to do so.  If
enough people ask, they will get the message. Vendors want people to be
happy with the product, but aren't necessarily going to offer something no
one asks for.

Tim Morken
Lab Vision/Neomarkers

Re: [Histonet] Expired antibodies...for immunos..
From: Rene J Buesa  

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Hi all:
  I want to jump into this thread that has already been a subject of
discussion on November of last year.

  1- I had never this expriration problem because our IHC volume was large,
but is is something a great concern to small laboratories, some of which
have opted not to do IHC and send it to a reference lab.

  2- The experiration date is set by the manufacturer, but no manufacturer
says which studies are behing their dating system.

  3- CAP has now stablished a rigid rule about not allowing "expired" Abs to
be used BUT the same CAP in thei Laboratory Improvement Programs published
in 1998 the following:
  Tubbs et al. (1998): "Extension of Useful Reagent Shelf Life Beyond
Manufacturer's Recommendations" Arch Pathol Lab Med. 122: 1051-52 and
concluded: "The data suggest review of the Health Care Financing
Administration's ruling on extending the useful reagent shelf life beyond
manufacturers recommendations. Similar studies using more inherently
quantitative methodology are suggested" (sic.)

  4- The next year Balaton et al. published a paper under the title of:
  "Satisfactory performance of primary antibodies beyond manufacturers'
recommended expiration dates" Applied Immunohistochemistry & Molecular
Morphology 7(3):221-25
  They tested 65 antibodies that had expired 6 to 134 months previously
(average of 33 months) and concluded that"....These results indicate that
primary antibodies have a shelf life significantly longer than the one
specified by the manufacturers...."(sic.).

  5- It is worth noting that both papers stress the fact that those
expiration dates are manufacturers' recommendations, they are not written on
stone. The one now doing the writing on stone is CAP after sponsoring a
contradictory study.

  So, when you decide to flame Joe Nocito, please leave a space for me.
Joe's suggestion seems to be very reasonable.
  Another thing, please use cajun sauce for my roasting.
  Best wishes
  René J.

Dana Settembre  wrote:
  Hello Kat,

JCAHO does not allow anything expired to be used for patients
Antibodies cannot be used either, if they are expired.

Dana Settembre
University Hospital-UMDNJ
Newark, NJ

>>> 04/27/06 3:23 PM >>>
How does JCAHO handle expired antibodies if you have them...and are
using 
them...
Is it ok ....or not??
Kat
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Tim Morken
Product Development
Lab Vision - Neomarkers

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