Tim,

The person we have to convince is not CAP but our internal QA/QC person; SHE
will not allow us this leniency unless it is specifically spelled out in the
CAP regulations.

Linda A. Sebree, HT(ASCP)
University of Wisconsin Hospital & Clinics
IHC/ISH Laboratory
A4/204-2472
600 Highland Ave.
Madison, WI 53792-2472
(608)265-6596
FAX: (608)262-7174


-----Original Message-----
From: Morken, Tim [mailto:tim9@cdc.gov]
Sent: Friday, February 01, 2002 9:55 AM
To: histonet@pathology.swmed.edu
Subject: RE: Use of outdated antibodies


Linda wrote;
<>

More to the point, is there anything in the CAP checklist that prohibits the
extension of shelf life? As far as I know, no there isn't.

This is one of those areas where CAP has done us a favor and left things
ambiguous. Since they don't explicitly disallow the practice of extending
antibody shelf life, and actually give references on how to do so, they are
practically encouraging us to extend the shelf life of antibodies. This was
discussed several years ago on Histonet and one factor that was brought up
then that not everyone realizes is that the shelf life given by manufactures
is a guess, not a proven fact. The shelf life is more related to the length
of time the manufacturer is willing to guarantee the viability of the
antibody rather than the actual shelf life (especially if frozen for years).
The CAP seems to recognize this and allows us some leeway in using
antibodies past their stated shelf life. Don't push too hard on things like
this or you may be sorry!

Tim Morken
CDC, Atlanta


-----Original Message-----
From: Sebree Linda A. [mailto:la.sebree@hosp.wisc.edu]
Sent: Friday, February 01, 2002 9:09 AM
To: 'Lee & Peggy Wenk'; Smith, Sherry A. (Histology);
histonet@pathology.swmed.edu
Subject: RE: Use of outdated antibodies


To those of you saying that one can use outdated antibodies per CAP, can
anyone site a CAP reference/regulation stating unequivocally that this is
allowed as long as the quality is assured by the use of controls.  Our
internal QA/QC person checked into this extensively back in 2000 and the
most she could come up with is that CAP would not site a lab for this
practice but CAP did not at that time come out with any statement that the
use of outdated antibodies (or other reagents for that matter)was OK.

Please, if anyone knows of any further development on this issue in terms of
CAP regulations, let us know.  This would allow us to maintain antibodies in
our inventory that for now we have dropped due to low volume requests.  We
have a cutoff of 12 requests/year; anything less than this we drop from our
inventory because it is not cost effective to maintain, given the shelf life
limitations. 

Linda A. Sebree, HT(ASCP)
University of Wisconsin Hospital & Clinics
IHC/ISH Laboratory
A4/204-2472
600 Highland Ave.
Madison, WI 53792-2472
(608)265-6596
FAX: (608)262-7174


-----Original Message-----
From: Lee & Peggy Wenk [mailto:lpwenk@mail.netquest.com]
Sent: Thursday, January 31, 2002 6:47 PM
To: Smith, Sherry A. (Histology); histonet@pathology.swmed.edu
Subject: Re: Use of outdated antibodies


This is from the CAP checklist for IHC:

ANP.22450 Phase II

Are storage conditions of immunoreagents optimal for maintaining expected
shelf life?

COMMENTARY:

The storage conditions of the immunoreagents in use must be improved to
maintain their expected shelf life.

REFERENCES: 1) Tubbs RR, et al. Extension of useful reagent shelf life
beyond manufacturers' recommendations. Arch Pathol Lab Med.
1998;122:1051-1052; 2) Balaton AJ. Satisfactory performance of primary
antibodies beyond manufacturer's recommended expiration dates. Appl
Immunohisto Mol Pathol. 1999;7:221-225.



So, if I remember the articles correctly: yes, antibodies could to be used
beyond the manufacturer's recommended expiration dates. But you have to test
and
 document that the antibodies are still good. On a routine basis.

Hope these were what you were looking for.

Peggy A. Wenk, HTL(ASCP)SLS
William Beaumont Hospital
Royal Oak, MI 48073


----- Original Message -----
From: "Smith, Sherry A. (Histology)" 
To: 
Sent: Thursday, January 31, 2002 8:43 AM
Subject: Use of outdated antibodies


> Dear Histotechs.,
>
> Are there any known articles about the use of outdated antibodies??  I
> remember reading one article but can't seem to locate it now.  Any info.
> would be greatly appreciated.
>
> Thanks,
> Sherry Smith
> Presbyterian Hospital
>
>
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