[Histonet] RE: How are you applying this?

[Morken, Timothy]

Yes, the ASR validation wording is easily applicable to clinical chemistry because they work with known amounts of an anylate but not exactly applicable to qualitative IHC without some explanation of the terms. I gave an NSH workshop addressing this and it is not easy to put in a quick email . Basically for ASR's you need to do a full validation of the antibody. You need to design the validation, document it, and then document that the antibody works as you expected. This takes some literature reading. By law a vendor cannot give you any information about how to do the test. That is all on the lab. 

The references below will give you what you need to know. 

The most recent recommendations: 
Principles of Analytic Validation of Immunohistochemical Assays: Guideline From the College of American Pathologists Pathology and Laboratory Quality Center
Patrick L. Fitzgibbons (Arch Pathol Lab Med. 2014;138:1432–1443)

Available free online: http://www.archivesofpathology.org/doi/pdf/10.5858/arpa.2013-0610-CP

An older one, but sill applicable:
Recommendations for Improved Standardization of Immunohistochemistry, Goldstein, NS, et.al., and members of Ad-Hoc Committee on Immunohistochemical Standardization, Appl Immunohistochem Mol Morph, 2007 15(2): 124-133

Book: (excellent discussion of validation and relation of validation terms to IHC)
Theoretical and Practical Aspects of Test Performance, in Immunohistology: A Diagnostic Tool for the Surgical Pathologist. 3rd. Ed., Volume 19 in Major Problems in Pathology, Taylor CR and Cote RJ, Eds., W.B Saunders, Philadelphia, 2005


Tim Morken
Supervisor, Histology, Electron Microscopy and Neuromuscular Special Studies
UC San Francisco Medical Center
San Francisco, CA

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-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu [mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Borowicz,Wanda
Sent: Tuesday, January 13, 2015 1:03 PM
To: 'histonet <@t> lists.utsouthwestern.edu'
Subject: [Histonet] How are you applying this?

Hi All,

Below is a copy of the revised COM.40000 CAP checklist question.  Now that Anatomic Pathology is having to comply with the All Common checklist, how are you applying this to your Immunohistochemistry ASR’s which are not FDA approved. We do new antibody validation and parallel testing with new lot numbers and clones.  Is this enough?  Can’t really see how the highlighted area pertains to this. Any advice would be appreciated. Thank.



REVISED**       04/21/2014

COM.40000


Method Validation/Verification Approval


Phase II




There is a summary statement, signed by the laboratory director (or designee who meets CAP director qualifications) prior to use in patient testing, documenting evaluation of validation/verification studies and approval of each test for clinical use.

NOTE:  This checklist item is applicable only to tests implemented after June 15, 2009.

The summary statement must include a written assessment of the validation/verification study, including the acceptability of the data. The summary must also include a statement approving the test for clinical use with the approval signature such as, "This validation study has been reviewed, and the performance of the method is considered acceptable for patient testing."

For an FDA-cleared/approved test, a summary of the verification data must address analytic performance specifications, including analytic accuracy, precision, interferences, and reportable range, as applicable.

In addition, for modified FDA-cleared/approved tests or LDTs, the summary must address analytical sensitivity, analytical specificity and any other parameter that is considered important to assure that the analytical performance of a test (e.g. specimen stability, reagent stability, linearity, carryover, and cross-contamination, etc.), as appropriate and applicable.

If the laboratory makes clinical claims about its tests, the summary must address the validation of these claims.

See the Method Performance Specifications section for details concerning validation/verification.

Evidence of Compliance:

✓      Summary of validation/verification studies with review and approval

REFERENCES

1)


Lawrence Jennings, Vivianna M. Van Deerlin, Margaret L. Gulley (2009) Recommended Principles and Practices for Validating Clinical Molecular Pathology Tests. Archives of Pathology & Laboratory Medicine: Vol. 133, No. 5, pp. 743-755






Wanda Borowicz HT(ASCP)
Histology Supervisor
Sanford Health North
1720 S. University Dr.
Route 1902
Fargo, ND 58103
Ph-701 417 4930
Fax-701 417 4399
wanda.borowicz <@t> sanfordhealth.org<mailto:wanda.borowicz <@t> sanfordhealth.org>

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