[Histonet] Laboratory Developed Test LDT process example for antibodies, specifically P16

Morken, Timothy Timothy.Morken at ucsf.edu
Fri Oct 14 11:32:56 CDT 2016

Do you mean the list required by COM.40200, or a validation procedure?

The list is just a list of those test you have modified from manufacturer's instructions, or developed in-house from ASR's (any IHC test you do in which you modify dilutions, detection, AR etc).

For validation, The FDA LDT rule is not final yet (at least was not at NSH in September when we had a workshop on the topic). I suppose CAP could require additional validation beyond what CLIA already outlines (and is outlined in the COM items after 40200). CAP currently has a recommendations for ER, PR  and Her2:  in the range of 25-50 negative, 25-50 positive with a range of positive from weak to strong. Statistically concordant compared to known antibody results.

If FDA goes through with their proposal you can expect much more extensive validation (vendors run hundreds to thousands of cases to meet FDA validation requirements).

-----Original Message-----
From: Donna Emge via Histonet [mailto:histonet at lists.utsouthwestern.edu] 
Sent: Thursday, October 13, 2016 12:18 PM
To: histonet at lists.utsouthwestern.edu
Subject: [Histonet] Laboratory Developed Test LDT process example for antibodies, specifically P16

P16 antibody is soon to move from an FDA approved IVD to a LDT. I have not performed a LDT before. I read COM.4020. Would someone be willing to share one of their LDT workups for an antibody that meets CAP requirements? I want to make sure I am on the right track and do not miss anything.

*Donna J. Emge, HT(ASCP)*

Histology Manager

South Bend Medical Foundation

(574) 234-4176 ext. 1345

DEmge at sbmf.org

Djemge11 at gmail.com
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