Hi All, I have a validation question - we are looking into buying an RUO rated IHC stainer for a future multiplexing project. Roche's Discovery Ultra to be specific.
I have a pathologist that is convinced that we can run our clinical antibodies on it as an LDT and still bill for the work. The material I have read up to this point regarding that instrument explicitly states that no slides can be run for diagnostic purposes. The instrument has software that allows you to use it to mimic the IVD instruments' software capabilities so you can validate a protocol on it, then move it right over to the Benchmark so I can see why the idea that it can run our IVD items seems plausable. However what I need to know is which is correct? I do not want to do something that I am uncomfortable doing without checking with others in my field first. Thanks! -- Erin McCarthy, HT (ASCP) Histotechnician Tempus Labs 600 W. Chicago Ave. Chicago IL 60654 Ph:(312) 638-6344 Ext.3835 -- This email and any attachments may contain privileged and confidential information and/or protected health information (PHI) that is protected by federal and state privacy laws. It is intended solely for the use of Tempus Labs and the recipient(s) named above. Nothing contained in this communication and any attachments thereto is intended to waive any privileges or rights of confidentiality. If you are not the recipient, or the employee or agent responsible for delivering this message to the intended recipient, you are hereby notified that any review, dissemination, distribution, printing or copying of this email message and/or any attachments is strictly prohibited. * If you have received this transmission in error, please notify us immediately at **(855)-442-8305** and permanently delete this email and any attachments*. _______________________________________________ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet