For the validation, yes you have to run negative cases. This is to verify that tissue you know should not stain, does not do so. For example, let's say you are validation H.pylori. You have 10 cases where you know the patient has H.pylori bacteria in a gastric biopsy (positive staining). You also need to run 10 samples of normal gastric tissue to verify there is no staining (negative staining). What you are thinking about is negative reagent control which is used to determine if there is non-specific staining.
Lacy -----Original Message----- From: Heckford, Karen - SMMC-SF [mailto:karen.heckf...@dignityhealth.org] Sent: Friday, March 16, 2018 12:36 PM To: Normington Lacy Subject: RE: [Histonet] Antibody Validation CLIA Do you have to run the negatives if you are using a Polymer Detection system? Karen Heckford HT ASCP CE Lead Histology Technician St. Mary's Medical Center 450 Stanyan St. San Francisco, Ca. 94117 415-668-1000 ext. 6167 karen.heckf...@dignityhealth.org Caution: This email message, including all content and attachments, is CONFIDENTIAL and may be of a nature that is LEGALLY PRIVILEGED. The information contained in this email message is intended only for the use of the recipient(s) named above. If the reader of this message is not the intended recipient or an agent responsible for delivering it to the intended recipient, you have received this document in error. Any further review, dissemination, distribution, or copying of this message is strictly prohibited. If you have received this communication in error, please notify us immediately by reply email. Thank you -----Original Message----- From: Normington Lacy via Histonet [mailto:histonet@lists.utsouthwestern.edu] Sent: Friday, March 16, 2018 10:17 AM To: histonet@lists.utsouthwestern.edu Subject: Re: [Histonet] Antibody Validation CLIA Dignityhealth.org made the following annotations --------------------------------------------------------------------- STOP, THINK, READ. This is an external email. Exercise extra caution responding to it, opening attachments and following links. --------------------------------------------------------------------- CAP suggests running 10 negative and 10 positive cases for non-prognostic markers. CAP required running 20 negative and 20 positive cases for prognostic markers. In the event the case volume is less than the suggested 10 and 10 cases for non-prognostic markers, the reason for that decision should be stated in the validation. Ultimately, the decision is up to your director. Lacy Normington, HTL(ASCP)CM Manager, Surgical Pathology Lab Services UW Health 600 Highland Avenue Madison, WI 53792-2472 -----Original Message----- From: Paula via Histonet [mailto:histonet@lists.utsouthwestern.edu] Sent: Friday, March 16, 2018 8:55 AM To: histonet@lists.utsouthwestern.edu Subject: [Histonet] Antibody Validation CLIA WARNING: This email appears to have originated outside of the UW Health email system. DO NOT CLICK on links or attachments unless you recognize the sender and know the content is safe. Hello, We've been discussing about the quantity of slides to run as a validation for IHC antibodies. We are governed by CLIA, and we would like to know if there is a set number of slides to run for a particular antibody we would like to bring in-house for Validation. I think CAP requires 20 slides..? And so we are asking if there is a requirement with CLIA to run a certain number of slides, or is it up to us (the laboratory director) to decide how many slides to run for Validation/Verification. Thank you in advance Paula _______________________________________________ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet _______________________________________________ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet _______________________________________________ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
