[Histonet] Control block validation requirements

[Jan Shivers]

Denise,
When selecting infectious agent positive controls, I also select cases
which have been shown to be positive by other testing means (EM,
Bacteriology, Virology, PCR).

In addition, I run a cross-reactivity validation with my antibody on other
infectious agent positive control slides to make sure my antibody is
specific for the infectious agent and doesn't cross-react with other
viruses/bacteria, etc.  Results go into a table that is stored along with
the initial antibody validation/optimization logsheet(s).

When validating tissue antigens/tumor markers, I use the obvious normal
anatomic cell/tissue control for that antigen.  My anatomic pathologist
advisor signs off on the final optimization for all antibodies before the
IHC test can be put into public use.

Jan Shivers
Senior Scientist
IHC/Histology Section Head
Pathology Teaching Program
Veterinary Diagnostic Laboratory
University of Minnesota
1333 Gortner Ave.
St. Paul, MN  55108
612-624-7297
shive003 <@t> umn.edu



On Tue, Jul 15, 2014 at 2:05 PM, Long, Denise <denise.long <@t> uconn.edu> wrote:

> Same inspectors advised our special stain and IHC controls should have at
> least two if not three different validation means (PCR, micro, serology,
> etc.)
> Anyone out there actually doing this?
> Just so you know, I've spoken with a few suppliers on control slides and
> they do not do this type of validation on their control material (surprise,
> surprise!)
> Thanks,
>
> Denise M. Long, MS, HTL (ASCP), QIHC
> University of Connecticut
> Dept. of Pathobiology and Veterinary Sciences
> Connecticut Veterinary Medical Diagnostic Laboratory
> 61 N. Eagleville Road, Unit 3089
> Storrs, Connecticut 06269-3089
> (860) 486-0851
>
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