Re: Here I go again[Histonet] Expiration date (Joe Nocito)
Our policy for ICC and special stains is that we use the positive control
result as the standard marker. I commonly authorize for use special stain
reagents that are past their expiry data. I work in a GLP environment and
authorizing reagents for use that are beyond their expiry dates is
acceptable from a GLP perspective if there is a stated scientific
Sent by: cc:
firstname.lastname@example.org Subject: Re: Here I go again[Histonet] Expiration date (Joe Nocito)
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
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.
Biology In A New Form (c)
On Sun, 19 Jun 2005 12:00:23 -0500,
> 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"
> Subject: Here I go again[Histonet] Expiration date
> To: "Katia Cristina Catunda" , "histonet"
> Message-ID: <009701c5742a$118674c0$b4bd0b43@yourxhtr8hvc4p>
> Content-Type: text/plain; format=flowed; charset="iso-8859-1";
> I've been too quiet for too long. Here I go again.
> I am so tired of CAP and their ridiculous regulations. Every CAP
> I fight this same question. When I was supervising the Immuno lab at
> 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?
> 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
> is viable?
> I know companies have to put an expiration date on their products,
> come on. If an antibody expires June 30, 2005, does it automatically go
> 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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