RE: Revalidating immuno reagents
|From:||"Morken, Tim" <firstname.lastname@example.org>|
Joe, CLIA was satisfied with our records showing previous uses of
antibodies. I developed a database that keeps track of all experiments and
can collate all uses of any antibody into an "antibody information sheet."
This sheet shows all information about a particular antibody, including all
previous uses of that antibody, slide by slide, and the results of those
uses, including comments about performance.
Tim Morken, BA, EMT(MSA), HTL(ASCP)
Infectious Disease Pathology Activity
Centers for Disease Control and Prevention
1600 Clifton Road
Atlanta, GA 30333
From: Nocito, Joseph [mailto:email@example.com]
Sent: Thursday, April 05, 2001 8:38 AM
Subject: Revalidating immuno reagents
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
Christus Santa Rosa Hospitals
San Antonio, Texas
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