https://www.biomax.us/tissue-arrays/Breast/
theres the link, they have various kinds, so just choose the one that comes
with the IHC results
Vanessa Perez Garcia
Pathology Reference Lab
210-892-3746
210-892-3732
vpe...@pathreflab.com
-Original Message-
From: Martha Ward-Pathology [mailto:mw...@wakehealth.edu]
Sent: Wednesday, April 30, 2014 7:11 AM
To: Vanessa Perez
Subject: RE: CAP question ANP.22978 - Her2 assay validation
Thanks. I like the idea of the microarray slide as well. Where did you
purchase your slide?
martha
-Original Message-
From: Vanessa Perez [mailto:vpe...@pathreflab.com]
Sent: Tuesday, April 29, 2014 5:18 PM
To: Martha Ward-Pathology; histonet@lists.utsouthwestern.edu
Subject: RE: CAP question ANP.22978 - Her2 assay validation
From what I have read and understand you should be able to do a write up the
retroactive review based on the PT results. What we did here was bought a
microarray slide that came with the HER2/ER/PR results, ran them on our
machine, and compared our results to the ones that came with the slide.
Vanessa Perez Garcia
Pathology Reference Lab
210-892-3746
210-892-3732
vpe...@pathreflab.com
-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Martha
Ward-Pathology
Sent: Tuesday, April 29, 2014 2:47 PM
To: histonet@lists.utsouthwestern.edu
Subject: [Histonet] CAP question ANP.22978 - Her2 assay validation
Hello all,
I have been reading through the most recent revisions and want to see how
others are handling this question. The explanation states that it is for new
and existing assays and that if your validation does not meet current standards
that you must supplement and bring it into compliance. Furthermore if you do
not have any documentation from the initial validation the assay must be fully
revalidated and documented.
Our lab has been performing the Herceptest from Dako (FDA approved) since
before 2008 and participating in the HER2 proficiency testing since it was
first offered. We have our statistical results comparing our IHC patient
results to FISH Her2 results since 2008 and we have always done well on our CAP
proficiency testing (95%-100%).We do inter-pathologist result comparisons,
using know CAP slides and have 95% to 100% agreements.
What I do not have however is the original results of the slides that were
stained to set up the original assay. Under these circumstances will we need
to completely revalidate the assay, using the mandated 20+/20- cases, or can we
simply do a retroactive formal review and write up of our past performances on
our proficiency testing challenges?
Thanks in advance for your help with this!
Martha Ward, MT (ASCP) QIHC
Manager
Molecular Diagnostics Lab
Medical Center Boulevard \ Winston-Salem, NC 27157
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