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

Donna Emge djemge11 at gmail.com
Thu Oct 13 14:17:59 CDT 2016

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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