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

[Donna Emge]

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
<https://mail2.sbmf.org/OWA/redir.aspx?C=biI4W5xzTka-60sR9XBFkE9Ouem199II19bmalF5G-FUMz5F7d_bww_j_NcIdtoKydOEv4I-ZLU.&URL=mailto%3aDEmge%40sbmf.org>

Djemge11 at gmail.com