[Histonet] Antibody Validation CLIA

Tim Higgins tim.higgins at cddmedical.com
Tue Mar 20 11:56:39 CDT 2018

Cap states, "should test a minimum of 10 positive and 10 negative tissues".  Does not state "cases" but "tissues", so we used a block for positive and negative from the same case.



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Subject: Histonet Digest, Vol 172, Issue 13

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Today's Topics:

   1. Leica ST5050 immunostainer (Matthew Fleming)
   2. Antibody Validation CLIA (Paula)


Message: 1
Date: Fri, 16 Mar 2018 08:00:00 -0500
From: Matthew Fleming <mgflem at gmail.com>
To: histonet at lists.utsouthwestern.edu
Subject: [Histonet] Leica ST5050 immunostainer
	<CAHL=4t6dHJHeJ7MaWOgv0RDdX27x17FXGwXGhbsroWtVbw_ntA at mail.gmail.com>
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I have a small dermatopathology lab and would like to introduce limited immunohistochemistry.  Initially I would probably just do MITF stains with red chromogen on a few cases per week. We could do this by hand but I've noticed a number of ST5050 immunostainers for sale at very low prices. I know they're quite old but we have a number of machines old or older that continue to serve us well. But so far I haven't been able to find a manual and am concerned about finding consumables. Leica apparently stopped supporting this model some time ago.  Is anyone out there still using it?
Anyone have a manual? Anyone like to comment as to whether it might be usable for a limited IH operation?

Thank you,

Matthew Fleming, MD
Fleming Dermatopathology
Milwaukee, WI


Message: 2
Date: Fri, 16 Mar 2018 06:54:30 -0700
From: "Paula" <plucas at biopath.org>
To: <histonet at lists.utsouthwestern.edu>
Subject: [Histonet] Antibody Validation CLIA
Message-ID: <001801d3bd2e$4f4b0c20$ede12460$@biopath.org>
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We've been discussing about the quantity of slides to run as a validation for IHC antibodies. We are governed by CLIA, and we would like to know if there is a set number of slides to run for a particular antibody we would like to bring in-house for Validation.  I think CAP requires 20 slides..?
And so we are asking if there is  a requirement with CLIA to run a certain number of slides, or is it up to us (the laboratory director) to decide how many slides to run for Validation/Verification.


Thank you in advance



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