Re: Revalidating immuno reagents

From:Connie McManus <>


This is probably more in the "For What It's Worth" dept than any real
help to you, but here goes ...

 I used to be a QC  microbiologist for a company that made medical
devices (i.e. serum and biotech supplies) that was under the watchful
eye of the FDA.  It was my job to identify bacteria found in our clean
room and production core.  I used Bio Merieaux's identification strips.
with each new lot received, I would use the suggested control organisms
to test the product.  If that passed the test, then I would be able to
use them until gone.  However, sometimes the strips and reagents would
expire before I had used them up.  It was deemed OK to use these expired
reagents IF and only IF I ran control organisms concurrently with the
cultures under test and the control organisms produced the expected
results.  If there was ambiguity in the control organisms, or if they
just didn't work, then I had to use a new lot of reagents and kits.  I
couldn't not simply test the kits and assign a new expiration date to
them.  At the time I worked for that company, this satisfied the FDA and
our QC guidelines.  

The moral of this story is, it seems to me that if you can demonstrate
that your expired antibodies and reagents are working, you should be
able to use them.  However, I have never dealt with CLIA, nor do I know
what their guidelines are (I don't work in a clinical lab).  In fact,
where I presently work, no one cares if I use old stuff or new... just
so long as it works.  But, I think it is in my best interest to work as
though I was under the watchful eye of some regulatory agency.

more 2 pennies worth from me today.. wow, it's pennys from Utah (as
opposed to Heaven)!  *G*

Connie McManus

"Nocito, Joseph" wrote:
> Good morning all,
>         During the last two days, we have been inspected by CLIA. The
> inspector found an expired immuno reagent in the refrigerator (I know, shame
> on me).  I explained to this person that although the reagent is expired, I
> always run a known positive control with each run.  If the control didn't
> work, the case is repeated with another lot number. This was not good enough
> for this person. She wanted proof.  Short of performing a short immuno run
> in front of this person, I couldn't site any references.
>         Does any one have a procedure that can be referenced dealing with
> validaing and re-validating reagents?  I'll also mention that each primary
> antibody gets titered upon receipt and each new detection kit gets tested
> and the results recorded before it is put into use.
>         Thanks in advance.
> Joe Nocito, B.S., HT(ASCP)QIHC
> Histology Supervisor
> Christus Santa Rosa Hospitals
> San Antonio, Texas


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