Vendor view on expiration dates RE: Here I go again[Histonet] Ex piration date (Joe Nocito)

[Morken, Tim - Labvision]

Just a note about expiration dates from the vendor viewpoint. The expiration
date is not a date that a vendor expects an antibody to go bad, rather it is
the longest date the vendor is willing to GUARANTEE  that an antibody will
work. If the antibody quits working before that date the customer gets a new
antibody lot. After that date the vendor cannot be held  responsible for
performance. So it's more of a financial equation and a way for the vendor
to avoid eternal responsibility for a product than anything else. 

I agree that the CAP is being too strict about the expiration dates and I
have had the same experience as others in using 10-y.o. frozen aliquots that
work just as well as the first one.  If the antibody is aliquoted and frozen
and sucessfully QC'd regularly, there is no reason it cannot be used. I
think the problem the CAP is addressing is more of a QC issue than an
antibody longevity. I the past a lab could simply do QC testing of each lot
and show it worked and keep it in use. Why that was dropped is not clear.
Maybe the CAP simply does not trust labortory QC methods. My own feeling
about CAP is that they make up rules and see how people react to them, then
changes them according to the reaction. So maybe this topic needs a strong
reaction. 



Tim Morken
Lab Vision - Neomarkers
www.labvision.com

Free webhosting for US State Histotechnology Societies:
http://www.labvisioncorp.com/demowebsite/index.cfm




-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu
[mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Todd Sherman
Sent: Sunday, June 19, 2005 1:41 PM
To: histonet <@t> lists.utsouthwestern.edu
Subject: Re: Here I go again[Histonet] Expiration date (Joe Nocito)


Joe,

Regarding "If an antibody expires June 30, 2005, does it automatically go  
dead on July 1?" - according to the corporate legal teams and their  
liability concerns, of course. ;)

But in all seriousness, you bring up a good point. I can understand a  
manufacturer needing to maintain QC and establish liability limits, not to  
mention bump potential premature boosts in sales from the dumping of  
viable product by enduser, but some modification should be considered. You  
mention a nice protocol of aliquoting, inventorying, and testing that  
seems entirely reasonable. Consider another lab that dumps lots according  
to date but that doesn't aliquot properly and lets an undiluted lot freeze  
and thaw such that it "expires" before the label date would indicate it  
has deteriorated. Would such a scenario be better? Obviously a more scaled  
weighting that considers the continual QC testing against positive and  
negative controls should be incorporated since that is the fundamental  
concern.

If a lab can produce a series of time-dated QC test samples/slides  
associated with a particular lot/vial/aliquot that proves efficacy, then I  
should think that the Ab is still "good". Granted, the manufacturers  
should not be held responsible for extended usage beyond what they deem  
reasonable/optimal; however, thoughtless disposal of good product should  
not be a mandate by the governing histological agency either.

$0.02 worth of validation.

Regards,
Todd


Todd Sherman
President
HistoSoft Corporation

www.histosoft.com
Biology In A New Form (c)


On Sun, 19 Jun 2005 12:00:23 -0500,  
<histonet-request <@t> lists.utsouthwestern.edu> wrote:
>
> Today's Topics:
>
>    1. Here I go again[Histonet] Expiration date (Joe Nocito)
>
> ----------------------------------------------------------------------
>
> Message: 1
> Date: Sat, 18 Jun 2005 12:20:47 -0500
> From: "Joe Nocito" <jnocito <@t> satx.rr.com>
> Subject: Here I go again[Histonet] Expiration date
> To: "Katia Cristina Catunda" <kccatunda <@t> uol.com.br>, "histonet"
> 	<histonet <@t> pathology.swmed.edu>
> Message-ID: <009701c5742a$118674c0$b4bd0b43 <@t> yourxhtr8hvc4p>
> Content-Type: text/plain; format=flowed; charset="iso-8859-1";
> 	reply-type=response
>
> Okay,
> I've been too quiet for too long. Here I go again.
>
> I am so tired of CAP and their ridiculous regulations. Every CAP
> inspection
> I fight this same question. When I was supervising the Immuno lab at  
> AFIP,
> we froze concentrated antibodies at -70 for years. Antibodies that were
> frozen in 1080, were still viable in 1990. That means we were running
> immunos in 1990 with 1980 prices. What is so wrong about that?
>     We also ran a known positive control with each batch. If the positive
> control worked, guess what? The antibody was still good. If the positive
> control did not work, we threw out that lot number and repeated it with
> another lot number. When we saw that there was a drop in the staining
> intensity, we  tossed that lot and started another. My experience with
> antibodies is that they just don't go bad over night, they start staining
> with less intensity.
>     I think that the CAP board members have stocks in the biochemical
> companies. Please don't get me wrong, I have many close friends that  
> work in
> the biochemical side of this, but why would this drastic change in view?  
> The
> FDA? I doubt it.
>     Maybe I'm too one sides on this issue, but give me a break! If the
> positive control works in any other antibody, doesn't that mean the  
> antibody
> is viable?
>     I know companies have to put an expiration date on their products,  
> but
> come on. If an antibody expires June 30, 2005, does it automatically go  
> dead
> on July 1?
>     As managers and supervisors, we are continuously bashed about saving
> money. This would be a great place to start, don't you think?
>     That is all. Thank you
>
> Joe Nocito BS, HT(ASCP)QIHC
> Histology Manager
> Pathology Reference Lab
> San Antonio, TX


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