[Histonet] FW: Antibody Validation CLIA

[Normington Lacy]

For the validation, yes you have to run negative cases.  This is to verify that tissue you know should not stain, does not do so.  For example, let's say you are validation H.pylori.  You have 10 cases where you know the patient has H.pylori bacteria in a gastric biopsy (positive staining).  You also need to run 10 samples of normal gastric tissue to verify there is no staining (negative staining). What you are thinking about is negative reagent control which is used to determine if there is non-specific staining.

Lacy    

-----Original Message-----
From: Heckford, Karen - SMMC-SF [mailto:Karen.Heckford at DignityHealth.org] 
Sent: Friday, March 16, 2018 12:36 PM
To: Normington Lacy
Subject: RE: [Histonet] Antibody Validation CLIA

Do you have to run the negatives if you are using a Polymer Detection system?

Karen Heckford HT ASCP CE
Lead Histology Technician
St. Mary's Medical Center
450 Stanyan St.
San Francisco, Ca. 94117
415-668-1000 ext. 6167  
karen.heckford at dignityhealth.org  

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-----Original Message-----
From: Normington Lacy via Histonet [mailto:histonet at lists.utsouthwestern.edu] 
Sent: Friday, March 16, 2018 10:17 AM
To: histonet at lists.utsouthwestern.edu
Subject: Re: [Histonet] Antibody Validation CLIA

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CAP suggests running 10 negative and 10 positive cases for non-prognostic markers.
CAP required running 20 negative and 20 positive cases for  prognostic markers.

In the event the case volume is less than the suggested 10 and 10 cases for non-prognostic markers, the reason for that decision should be stated in the validation.  Ultimately, the decision is up to your director.  


Lacy Normington, HTL(ASCP)CM
Manager, Surgical Pathology Lab Services UW Health
600 Highland Avenue
Madison, WI 53792-2472



-----Original Message-----
From: Paula via Histonet [mailto:histonet at lists.utsouthwestern.edu]
Sent: Friday, March 16, 2018 8:55 AM
To: histonet at lists.utsouthwestern.edu
Subject: [Histonet] Antibody Validation CLIA

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Hello,



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

Paula

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