I do not know much about why expiration dates were started, but I would assume that fear of being sued has a lot to do with it. A missed diagnosis and a lawyer could go after the lab, pathologist, doctor, and antibody manufacturer. A manufacturer would loose a lot more money in a lawsuit than they would make by short dating expiration dates on an antibody. This idea of a "stability guarantee date" might relieve the manufacturer of responsibility and place it on the technician, pathologist and lab.*
James Watson HT ASCP Facilities Manager of Histology GNF Genomics Institute of the Novartis Research Foundation Tel 858-332-4647 Fax 858-812-1915 [EMAIL PROTECTED] *Disclaimer: This post comes from someone in research that has no stake in this other than the being concerned about the high cost of healthcare and a proper diagnosis. -----Original Message----- From: [EMAIL PROTECTED] [mailto:[EMAIL PROTECTED] On Behalf Of Richard Cartun Sent: Friday, October 10, 2008 3:10 PM To: Jackie.O'[EMAIL PROTECTED]; [EMAIL PROTECTED]; Histonet Cc: 'ihcrg Group (E-mail)'; [EMAIL PROTECTED]; [EMAIL PROTECTED] Subject: [IHCRG] IHC antibody expiration question for CAP. . I have antibodies that work great 10-20 years after their expiration date. Once again, I propose that the manufactures eliminate the "expiration date" and use a "stability guarantee date". If the antibody is used after that date then the user would be responsible for validating its performance. Richard Richard W. Cartun, Ph.D. Director, Histology & Immunopathology Assistant Director, Anatomic Pathology Hartford Hospital 80 Seymour Street Hartford, CT 06102 (860) 545-1596 (860) 545-0174 Fax >>> Jackie M O'Connor <Jackie.O'[EMAIL PROTECTED]> 10/10/08 3:12 PM >>> When I was making and testing antibodies for a manufacturer, we had retest dates on all the lots. As each lot reached or was past it's expiration date, we would test it against a fresh antibody lot - if it still met the exact same standard, we would extend the expiration date 3 or 6 months. Most antibodies stored at 40C I tested were still good 6 months past expiration. ALL antibodies were still good 30 days past expiration, regardless of the storage conditions. There was a strict rule about thawing frozen aliquots - no more than 3x freeze-thaw cycles, as this did damage the antibody. Throwing away frozen aliquots because they have expired is nuts. If your results are still meeting standards, it's a waste. Jackie O' "Patsy Ruegg" <[EMAIL PROTECTED]> Sent by: [EMAIL PROTECTED] 10/10/2008 02:00 PM Please respond to [EMAIL PROTECTED] To <[EMAIL PROTECTED]>, <[EMAIL PROTECTED]>, "'ihcrg Group \(E-mail\)'" <[EMAIL PROTECTED]> cc Subject [IHCRG] Re: IHC antibody expiration question for CAP. . Charlene, This is new to me as well. Hadi can you give us the rule where it says you can use expired abs if you freeze aliquots before they expire? Folks, do not throw away expired antibodies. The IHCRG has a reagent bank, you can send them to me. We will even provide you with a fedex act. No to use to ship the reagents. I have a refrigerator full of these reagents labs being CAP inspected have sent me. We use them in research and for teaching purposes. If any of you members of the IHCRG want to check something out we have in the bank, perhaps before you purchase it for a research project, you can do that. Just send me a message asking if I have what you need. Patsy Patsy Ruegg, HT(ASCP)QIHC IHCtech 12635 Montview Blvd. #215 Aurora, CO 80045 720-859-4060 fax 720-859-4110 [EMAIL PROTECTED] www.ihctech.net www.ihcrg.org From: [EMAIL PROTECTED] [mailto:[EMAIL PROTECTED] On Behalf Of Henry, Charlene Sent: Friday, October 10, 2008 12:48 PM To: '[EMAIL PROTECTED]'; ihcrg Group (E-mail) Subject: [IHCRG] Re: IHC antibody expiration question for CAP. . What do you do when the antibody data sheet states "do not freeze" and if freezing the antibody is accepted by CAP wouldn't the CAP Checklist state that this practice is acceptable? Also I have been to a couple CAP workshops and this question was ask. The CAP instructors stated that the antibody cannot be used past the expiration date regardless if it is frozen or stored at -20°C. Charlene Henry HT (ASCP), QIHC Anatomic Pathology Section Head Department of Pathology St. Jude Children's Research Hospital 901-495-3191 fax 901-495-3100 From: [EMAIL PROTECTED] [mailto:[EMAIL PROTECTED] On Behalf Of Hadi Yaziji Sent: Friday, October 10, 2008 1:28 PM To: ihcrg Group (E-mail) Subject: [IHCRG] Re: IHC antibody expiration question for CAP. . You need to educate the inspectors that it's accepted by the CAP. Most inspectors don't even know about this, because it hardly ever comes up. ================================ Hadi Yaziji, M.D., Medical Director Vitro Molecular Laboratories President, Ancillary Pathways 7000 62nd Avenue, PH-C Miami, FL 33143 T 305-740-4440 F. 786-513-0175 www.vitromolecular.com www.ancillarypath.com On Oct 10, 2008, at 1:55 PM, Mark Tarango wrote: I'm a little skeptical too, but if this isn't allowed then it should be. On Fri, Oct 10, 2008 at 9:22 AM, Sebree Linda A. <[EMAIL PROTECTED]> wrote: Call me skeptical but I've never heard of CAP accepting this method of shelf-life extension. Linda A. Sebree University of Wisconsin Hospital & Clinics IHC/ISH Laboratory DB1-223 VAH 600 Highland Ave. Madison, WI 53792 (608)265-6596 -----Original Message----- From: [EMAIL PROTECTED] [mailto:[EMAIL PROTECTED] On Behalf Of [EMAIL PROTECTED] Sent: Friday, October 10, 2008 11:19 AM To: ihcrg Group (E-mail) Subject: [IHCRG] Re: IHC antibody expiration question for CAP There is a CAP-accepted way of working around this... If you aliquot the antibody before its expiration date and store it in -20 freezer, the clock is in effect "frozen" too. For example, if there are 6 months left before the antibody expires and you freeze the aliquots for 5 years, then if you thaw one of the frozen aliquots, the thawed aliquot will still be good for 6 months. Just make sure you don't thaw and re-freeze the aliquot. Hadi ================================ Hadi Yaziji, M.D., Medical Director Vitro Molecular Laboratories President, Ancillary Pathways 7000 62nd Avenue, PH-C Miami, FL 33143 T 305-740-4440 F. 786-513-0175 www.vitromolecular.com www.ancillarypath.com On Oct 10, 2008, at 12:15 PM, Swain, Frances L wrote: Hey everyone. I use outdated antibodies I work in a research service laboratory. The reason CAP has these rules is because of patient protection. If you use an outdated antibody and the specimen comes back negative and later it was discovered that the patient had the problem that the antibody was suppose to identify. Maybe the patient dies or is permanently ill for the rest of their lives. Can you live with that? CAP is suppose to make sure that all of the labs (clinical only right now) are working under the same guidelines. They are not making these rules to make you spend more money but to protect the patient and make sure the diagnosis is as correct as can be. I agree that it is unfair to destroy antibodies that are used only once or twice before they expire. Maybe the companies preparing these antibodies should extend their expiration times? Just thought I would put my two cents worth in. Frances L. Swain HT(ASCP) A. A. S. Special Procedures Technician Department of Orthopaedic Surgery Center for Orthopaedic Research Barton Research Building 2R28 4301 West Markham Street Little Rock AR 72205 (501) 686-8739 PHONE (501) 686-8987 FAX [EMAIL PROTECTED] email From: [EMAIL PROTECTED] [mailto:[EMAIL PROTECTED] On Behalf Of Mark Tarango Sent: Friday, October 10, 2008 11:10 AM To: [EMAIL PROTECTED] Cc: [EMAIL PROTECTED] Subject: [IHCRG] Re: IHC antibody expiration question for CAP The rules are the rules. We need to change them back. Mark On Fri, Oct 10, 2008 at 8:41 AM, Jason and Heather <[EMAIL PROTECTED] > wrote: CAP question ANP.22432 states: Are all immunohistochemical reagents used within their indicated expiration dates? I am wondering what labs across the country are doing to answer this question. IHC antibodies are very expensive and can be validated on every run that is made. Some of these concentrated antibodies are diluted out so far that only a very small portion of them are used before they expire. Are some labs still using outdated antibodies? If so how do you get away with it when you are inspected by CAP? Or are you paying the high prices to throw out the majority of your antibodies so you can answer this question yes? I thank you in advance to your response. Jason McGough HT(ASCP) Account Representative - Anatomic Pathology Clinical Laboratory of the Black Hills 2805 5th Street Suite 210 Rapid City, SD 57701 605-343-2267 Ext 127 605-718-3779 (Fax) [EMAIL PROTECTED] Confidentiality Notice: This e-mail message, including any attachments, is for the sole use of the intended recipient(s) and may contain confidential and privileged information. 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