[Histonet] CAP Question

[Morken, Timothy]

Shaundra,

The CAP requirements are for those who are starting ER/PR for the first time, or changing antibodies to a new clone. If you did the validation years ago before those recommendations came out and have a history of running it successfully then you do not have to re-validate the procedure.

If you change antibodies to new clones, then you would have to do the more extensive validation.

Tim Morken


-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu [mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Schaundra Walton
Sent: Monday, April 16, 2012 8:34 AM
To: Histonet
Subject: [Histonet] CAP Question



I have a question regarding a new CAP checklist question dealing with ER/PR validation.  The new question is ANP.22976 ER/PgR Validation and states: 
  
“If the laboratory performs immunohistochemistry for estrogen receptor (ER) and/or progesterone receptor (PgR) as a prognostic/predictive marker on breast carcinoma, the laboratory has documented appropriate validation for the assay(s).  
 Note: Initial test validation should include a minimum of 40 cases (20 positive and 20 negative cases) for FDA-approved/cleared tests; laboratories should consider using higher numbers of test cases if a Laboratory Developed or Laboratory Modified Test is to be validated.  Validation should be performed by comparing the laboratory’s results with another assay that has been appropriately validated. Acceptable concordance levels are 90% for positive results and 95% for negative results.  If significant changes are made to the testing methods (e.g.
antibody clones, antigen retrieval protocol or detection system) revalidation is required. “ 
  
Our original validation was done in 2005 and was performed with 20 cases.  Do we need to revalidate to be compliant with this question?  Should we start from scratch or just do an additional 20 cases?  
 
Any feedback is appreciated.
 
Thanks!
Schaundra Walton BS HTL(ASCP)
Histology Supervisor
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