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  • Created 25 Jun 2015

IHC Validation Working Group

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Overview

  1. clinical assays
  2. clinical trials
  3. IHC
  4. Immunofluorescence
  5. Immunohistochemistry
  6. qIFA

About the Group

Public Description

This group is an instance of the overall assay validation effort of the Cancer Diagnosis Program, NCI and many other elements of both the NCI and the external community.  The group's purpose is to improve the reliability and reproducibility of IHC for use as a qualitative and semi-quantitative assay for clinical trials.   This is the first working group for the Assay Validation initiative that will embrace other types of assays.  It will focus on lessons learned and ways to facilitate the validation of IHC assays for CTEP and other NCI trials.

Created by Kim Jessup Last Modified n/a by Kim Jessup

Comments

  1. 0 Like 0 Dislike

    Lawrence D True

    I am interested in what we think should be the minimum specificity criteria for an antibody to be used on FFPE tissue in a clinical IHC lab, i.e. (1) one (and only one) band on a Western at the size of the full length analyte (2) immunohistochemical reactivity in the majority of cells in at least one FFPE tissue known to express the mRNA of the analyte (3) lack of immunohistochemical reactivity in more than "occasional" cells in at least two FFPE tissues known not to express the mRNA of the analyte. Should we add (4) abolition of immunohistochemical reactivity in the majority of cells in an FFPE tissue known to express the analyte by IHC by preincubating the analyte with 10 fold molar excess of pure analyte? Should we include (5) a negative control - abolition of immunohistochemical reactivity in animal tissue (or cell lines) known to express the analyte by IHC by siRNA?

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    1. 0 Like 0 Dislike

      Romil Saxena

      I like points 4 and 5 - These would be requirements at the pre-marketing stage, or data which would be made available by the vendor?

      Point 4 - do you mean preincubating "antibody" with the analyte?

       

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  2. 0 Like 0 Dislike

    Magdalena Thurin

    I am interested in quantitative aspect of IHC and multi marker IHC

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  3. 0 Like 0 Dislike

    Hala Makhlouf

    I am interested in IHC scoring algorithm

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  4. 0 Like 0 Dislike

    Bert Gold

    I am uploading the CLIA101 PowerPoint presentation that I gave in Gaithersburg on September 8th….  I think it complements Magda's anti-PD-L1 antibody presentation nicely.  Thanks to Stephen Hewitt and Lisa Brailey for their critical comments.

    CLIA101-IHCr.pptx

    168 MBClick to download

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