[Histonet] Re: Histonet Digest, Vol 78, Issue 8

[Stephanie Rodriguez]

Tonia,

If you are interested in sending specimens out for validation, our
laboratory currently provides this service for HER2 testing by IHC and FISH.
Information is on our website at www.phenopath.com, under ŒDiagnostic
Services¹ at the top of the home page.

Good luck!

Stephanie Rodriguez, BS, HTL(ASCP), QIHC
Senior Molecular Technologist, FISH
IHC Technologist III
Phenopath Laboratories
Seattle, WA


On 5/7/10 5:47 AM, "histonet-request <@t> lists.utsouthwestern.edu"
<histonet-request <@t> lists.utsouthwestern.edu> wrote:

> Message: 7
> Date: Thu, 6 May 2010 11:38:42 -0700
> From: "Morken, Tim" <Timothy.Morken <@t> ucsfmedctr.org>
> Subject: RE: [Histonet] Responses to IHC CAP Validation question
> To: "tonia.richmond <@t> gracepathology.com"
>  <tonia.richmond <@t> gracepathology.com>, "McMahon, Loralee A"
>  <Loralee_Mcmahon <@t> URMC.Rochester.edu>
> Cc: "histonet <@t> lists.utsouthwestern.edu"
>  <histonet <@t> lists.utsouthwestern.edu>, "thisisann <@t> aol.com"
>  <thisisann <@t> aol.com>
> Message-ID:
>  <1AAF670737F193429070841C6B2ADD4C018766A4C1 <@t> EXMBMCB15.ucsfmedicalcenter.org>
>  
> Content-Type: text/plain; charset=utf-8
> 
> Tonia, obviously you have to validate your systems so you need to do some
> validation ahead of time with non-patient samples. You can validate your
> instruments and reagents on tissue arrays (you can even get commercial
> validated arrays for ER, PR and Her2). I suggest Pantomics (www.pantomics.com)
> for excellent quality arrays of all kinds.
> 
> To validate the actual test, once you start up you will have to do some
> parallel testing by testing in-house and sending paired samples out to be
> tested. Then document the results of each. When you can show concordance of
> results over a set of samples (for most antibodies, 10 or more, 5 pos and 5
> negative) that test can be considered validated. For ER, PR and Her2 you will
> need to have concordance on many more samples (25 - 100). I suggest, if
> possible, taking extra tissue from patient samples and making either tissue
> arrays or sausage arrays to do this testing. It will drastically lower the
> number of slides you have to test in house and to send out to be tested.
> 
> It may be possible to partner with another lab to do this testing. As part of
> proficiency testing you can ask other labs for samples (wet tissue or
> unstained slides) to validate your results against theirs. Some labs are
> looking for partners to do this kind of testing. You then each validate each
> others tests.
> 
> Tim Morken
> Supervisor, Histology / IPOX
> UCSF Medical Center
> San Francisco, CA
> 
> -----Original Message-----
> From: histonet-bounces <@t> lists.utsouthwestern.edu
> [mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of
> tonia.richmond <@t> gracepathology.com
> Sent: Thursday, May 06, 2010 8:28 AM
> To: McMahon, Loralee A
> Cc: histonet <@t> lists.utsouthwestern.edu; thisisann <@t> aol.com
> Subject: RE: [Histonet] Responses to IHC CAP Validation question
> 
> 
>    If  you  are a brand new lab, how do you validate IHC if you are no=
>    yet  receiving patient specimens?  Can the validation be done on cont   rol
> tissues only?
> 
> 
> 
> 
>    Sincerely,
> 
> 
>    Tonia Richmond, AS, HT (ASCP)
>    Chief Operations Officer =aboratory
>    Grace Pathology
>    PH:  (501) 765-7367
>    Email: =]tonia.=chmond <@t> gracepathology.com



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