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