[Histonet] Xylene/substitutes Validation/verification
Liz, You are correct. If you bring in an FDA-approved test with NO modifications, all that is required is verification; you simply have to verify that the test works in your lab when you follow the recommended procedure. Validation, which is required for laboratory-developed tests as well as laboratory-modified FDA-approved tests, is, indeed, a much lengthier process. Stephanie Rodriguez, HTL(ASCP), QIHC Lead Molecular Technologist-FISH IHC Technologist III Phenopath Laboratories Seattle, WA (206) 374-9000 On 9/27/11 9:49 AM, histonet-requ...@lists.utsouthwestern.edu histonet-requ...@lists.utsouthwestern.edu wrote: Message: 8 Date: Tue, 27 Sep 2011 10:32:07 -0600 From: Elizabeth Chlipala l...@premierlab.com Subject: RE: [Histonet] Xylene sensitivity To: 'Rene J Buesa' rjbu...@yahoo.com, Histonet Listserv (E-mail) histonet@lists.utsouthwestern.edu, ShelleyD'Attilio sdatt...@stormontvail.org, Loralee AMcMahon loralee_mcma...@urmc.rochester.edu Message-ID: 14E2C6176416974295479C64A11CB9AE1DECBA0A63@SBS2K8.premierlab.local Content-Type: text/plain; charset=iso-8859-1 Rene Rene Loralee is correct in some aspects and you have addressed this already with mentioning validation. This basically has to do with the internal validation that is required when you bring these kits into the laboratory. When you modify a 510K cleared kit or FDA approved kit it becomes a LDT or Laboratory Developed Test there is significant additional validation required because by changing the process you have essentially increased the risk. Additional validation is required as defined by CLIA. The manufacturer of the kit has gone through a process that essentially has decreased the laboratory risk when then get a kit FDA cleared or approved, if the lab chooses to modify this kit they essentially have increased their risk significantly and are required to do additional validation, more than would be required if you used the kit as recommended. I'm thinking that all that is required if you use a cleared or approved kit is verification and not validation, but I may be incorrect. Validation is a more intense process. Patty from Phenopath or Beth Shepard from Ventana would be able to comment on this process also. Liz Elizabeth A. Chlipala, BS, HTL(ASCP)QIHC Manager Premier Laboratory, LLC PO Box 18592 Boulder, CO 80308-1592 (303) 682-3949 office (303) 682-9060 fax (303) 881-0763 cell www.premierlab.com Ship to address: 1567 Skyway Drive, Unit E Longmont, CO 80504 This e-mail message, including any attachments, is for the sole use of the intended recipients and may contain privileged information. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by e-mail and destroy all copies of the original message, or you may call PhenoPath Laboratories, Seattle, WA U.S.A. at (206) 374-9000. ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
[Histonet] Re: Histonet Digest, Vol 83, Issue 4
Barb, Eric, all- We also use a diamond pen/pencil-and they do contain an industrial grade diamond, so they are quite reasonably priced; I looked one up on the VWR website (just as a reference, not necessarily an endorsement! :o) and they run about $20-30 each. They last a very long time, too-We¹ve had ours for several years. We use them for our direct IFs, FISH, anything dark field. Stephanie Stephanie Rodriguez, HTL(ASCP), QIHC Lead Molecular Technologist-FISH IHC Technologist III Phenopath Laboratories Seattle, WA (206) 374-9000 On 10/5/10 10:15 AM, histonet-requ...@lists.utsouthwestern.edu histonet-requ...@lists.utsouthwestern.edu wrote: Message: 11 Date: Tue, 5 Oct 2010 10:53:36 -0400 From: Gagnon, Eric gagn...@kgh.kari.net Subject: [Histonet] Direct immunofluorescence question To: histonet@lists.utsouthwestern.edu Message-ID: f93bd6329fc3ae4c8db116b985fbc31327c3a...@kghmail.kgh.on.ca Content-Type: text/plain; charset=iso-8859-1 Barb, Have you tried a diamond pencil? Available from a variety of sources, these pencils can be used to etch a circle or other shape around the tissue to be viewed. I believe they use lesser-quality industrial diamonds to make the tips on the pencils (i.e. not the diamond ring quality). Coming across the etched line under the fluorescent microscope produces brightness that helps the pathologist find the tissue. We circle our DIF's on the back of the slide - it won't wash off and won't interfere with reagents this way, but is still visible in a darkened room. Hope this helps, Eric Gagnon MLT Histology Laboratory Kingston General Hospital Kingston, Ontario, Canada _ Message: 1 Date: Mon, 4 Oct 2010 12:49:44 -0500 From: ba...@gundluth.org Subject: [Histonet] Direct immunofluoresent question To: histonet@lists.utsouthwestern.edu Message-ID: of9419a09e.870a453a-on862577b2.00614e6b-862577b2.0061e...@gundluth.org Content-Type: text/plain; charset=US-ASCII Hi all - The pathologist that reads our direct IF slides likes to have the sections of tissue circled on the slide so that they are easier to find. We currently use black marker on the back of the slide, but find that many times it smears and are looking for a better solution. What kind of slides do others use, and if you circle your sections what marker/pen/etcher do you use? Any thoughts are greatly appreciated! Barb Moe Gundersen Lutheran Medical Center La Crosse WI This e-mail message, including any attachments, is for the sole use of the intended recipients and may contain privileged information. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by e-mail and destroy all copies of the original message, or you may call PhenoPath Laboratories, Seattle, WA U.S.A. at (206) 374-9000. ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
[Histonet] Re: Histonet Digest, Vol 82, Issue 29
We use ADT. I don¹t know where you¹re located, so I don¹t know if that¹s an option for you, but we¹ve used them for at least 8 years, and they¹ve always been excellent. Stephanie Stephanie Rodriguez, HTL(ASCP), QIHC Lead Molecular Technologist-FISH IHC Technologist III Phenopath Laboratories Seattle, WA (206) 374-9000 On 9/21/10 10:06 AM, histonet-requ...@lists.utsouthwestern.edu histonet-requ...@lists.utsouthwestern.edu wrote: Message: 10 Date: Tue, 21 Sep 2010 11:12:24 -0400 From: karen adams kadams...@gmail.com Subject: [Histonet] Freezer alarm To: Histonet@lists.utsouthwestern.edu Message-ID: aanlktikma+q4fmapd7krdzgdh_jq2gzp9wux7bv5r...@mail.gmail.com Content-Type: text/plain; charset=ISO-8859-1 Good Morning.. Can anyone make a recommendation for an alrm system that will call me if the power goes out to our freezer??? Thanks! This e-mail message, including any attachments, is for the sole use of the intended recipients and may contain privileged information. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by e-mail and destroy all copies of the original message, or you may call PhenoPath Laboratories, Seattle, WA U.S.A. at (206) 374-9000. ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
[Histonet] Re: Histonet Digest, Vol 80, Issue 26
As do we. Stephanie Rodriguez, HTL(ASCP), QIHC Senior Molecular Technologist-FISH IHC Technologist III Phenopath Laboratories Seattle, WA (206) 374-9000 On 7/22/10 10:04 AM, histonet-requ...@lists.utsouthwestern.edu histonet-requ...@lists.utsouthwestern.edu wrote: Message: 4 Date: Thu, 22 Jul 2010 08:18:27 -0700 From: Tench, Bill bill.te...@pph.org Subject: [Histonet] hpv testing on head and neck ca's To: histonet@lists.utsouthwestern.edu Message-ID: 2820431bf953bb4da3e9e1a5882265fd034a5...@mail1.pph.local Content-Type: text/plain; charset=us-ascii We do p16 on squamous ca of the head and neck region routinely Bill Tench Associate Dir. Laboratory Services Chief, Cytology Services Palomar Medical Center 555 E. Valley Parkway Escondido, California 92025 bill.te...@pph.org Voice: 760- 739-3037 Fax: 760-739-2604 This e-mail message, including any attachments, is for the sole use of the intended recipients and may contain privileged information. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by e-mail and destroy all copies of the original message, or you may call PhenoPath Laboratories, Seattle, WA U.S.A. at (206) 374-9000. ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
[Histonet] Re: Histonet Digest, Vol 78, Issue 18
Hi Bernadette, I don¹t know how complicated it would be for you to send something to the US, but we run CD56 and all sorts of other hematologic markers on a routine basis...(we¹re a reference lab, too!) You can find information about specimen submission and the tests we have available at our website: www.phenopath.com. Thanks, and good luck! Stephanie Rodriguez, HTL(ASCP), QIHC Senior Molecular Technologist-FISH IHC Technologist III Phenopath Laboratories Seattle, WA On 5/13/10 11:14 AM, histonet-requ...@lists.utsouthwestern.edu histonet-requ...@lists.utsouthwestern.edu wrote: Message: 3 Date: Thu, 13 May 2010 08:01:52 -0700 (PDT) From: Bernadette del Rosario badzros...@yahoo.com Subject: [Histonet] (no subject) To: Histonet@lists.utsouthwestern.edu Message-ID: 270439.80623...@web52101.mail.re2.yahoo.com Content-Type: text/plain; charset=us-ascii HELLO..I wonder what reference lab i can send unstained slide for nk cells marker like cd 56 etc...im n bahrain.. This e-mail message, including any attachments, is for the sole use of the intended recipients and may contain privileged information. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by e-mail and destroy all copies of the original message, or you may call PhenoPath Laboratories, Seattle, WA U.S.A. at (206) 374-9000. ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
[Histonet] Re: Histonet Digest, Vol 78, Issue 12
We use this clone also. It is distributed by Invitrogen, but the company that makes it is CalTag. (Maybe Invitrogen owns them.) We use AR of ph 9.0 Tris (0.5mM)/EDTA (0.1mM) for 20 min, dilution of 1:2000, and detection of Dako Flex+. It is not an IVD, by the way; it¹s still RUO. Stephanie Rodriguez, HTL(ASCP), QIHC Senior Molecular Tech/IHC Tech III Phenopath Laboratories Seattle, WA On 5/10/10 10:43 AM, histonet-requ...@lists.utsouthwestern.edu histonet-requ...@lists.utsouthwestern.edu wrote: Message: 2 Date: Mon, 10 May 2010 13:26:20 +0200 From: Heather McCleod heather.mcl...@uct.ac.za Subject: Re: [Histonet] IgG4 source To: Joao Pessoa jphistol...@gmail.com, histonet@lists.utsouthwestern.edu Message-ID: 4be8097c02cb00035...@gwiasmtp.uct.ac.za Content-Type: text/plain; charset=US-ASCII I have used invitrogen - mouse anti-human IgG4 Clone HP6025 (successfully) AR in 1mm EDTA Dilution 1:400 Control - tonsil (or Sjogren's Syndrome) Joao Pessoa jphistol...@gmail.com 2010/05/07 11:50 PM I need to find a source for an IgG4 antibody for use with IHC studies on human FFPE tissue. Any ideas? My preference would be for a concentrated IVD. Thanks, Joao Histo Tech ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet This e-mail message, including any attachments, is for the sole use of the intended recipients and may contain privileged information. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by e-mail and destroy all copies of the original message, or you may call PhenoPath Laboratories, Seattle, WA U.S.A. at (206) 374-9000. ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
[Histonet] Re: Histonet Digest, Vol 78, Issue 8
Tonia, If you are interested in sending specimens out for validation, our laboratory currently provides this service for HER2 testing by IHC and FISH. Information is on our website at www.phenopath.com, under Diagnostic Services¹ at the top of the home page. Good luck! Stephanie Rodriguez, BS, HTL(ASCP), QIHC Senior Molecular Technologist, FISH IHC Technologist III Phenopath Laboratories Seattle, WA On 5/7/10 5:47 AM, histonet-requ...@lists.utsouthwestern.edu histonet-requ...@lists.utsouthwestern.edu wrote: Message: 7 Date: Thu, 6 May 2010 11:38:42 -0700 From: Morken, Tim timothy.mor...@ucsfmedctr.org Subject: RE: [Histonet] Responses to IHC CAP Validation question To: tonia.richm...@gracepathology.com tonia.richm...@gracepathology.com, McMahon, Loralee A loralee_mcma...@urmc.rochester.edu Cc: histonet@lists.utsouthwestern.edu histonet@lists.utsouthwestern.edu, thisis...@aol.com thisis...@aol.com Message-ID: 1aaf670737f193429070841c6b2add4c018766a...@exmbmcb15.ucsfmedicalcenter.org Content-Type: text/plain; charset=utf-8 Tonia, obviously you have to validate your systems so you need to do some validation ahead of time with non-patient samples. You can validate your instruments and reagents on tissue arrays (you can even get commercial validated arrays for ER, PR and Her2). I suggest Pantomics (www.pantomics.com) for excellent quality arrays of all kinds. To validate the actual test, once you start up you will have to do some parallel testing by testing in-house and sending paired samples out to be tested. Then document the results of each. When you can show concordance of results over a set of samples (for most antibodies, 10 or more, 5 pos and 5 negative) that test can be considered validated. For ER, PR and Her2 you will need to have concordance on many more samples (25 - 100). I suggest, if possible, taking extra tissue from patient samples and making either tissue arrays or sausage arrays to do this testing. It will drastically lower the number of slides you have to test in house and to send out to be tested. It may be possible to partner with another lab to do this testing. As part of proficiency testing you can ask other labs for samples (wet tissue or unstained slides) to validate your results against theirs. Some labs are looking for partners to do this kind of testing. You then each validate each others tests. Tim Morken Supervisor, Histology / IPOX UCSF Medical Center San Francisco, CA -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of tonia.richm...@gracepathology.com Sent: Thursday, May 06, 2010 8:28 AM To: McMahon, Loralee A Cc: histonet@lists.utsouthwestern.edu; thisis...@aol.com Subject: RE: [Histonet] Responses to IHC CAP Validation question If you are a brand new lab, how do you validate IHC if you are no= yet receiving patient specimens? Can the validation be done on cont rol tissues only? Sincerely, Tonia Richmond, AS, HT (ASCP) Chief Operations Officer =aboratory Grace Pathology PH: (501) 765-7367 Email: =]tonia.=chm...@gracepathology.com This e-mail message, including any attachments, is for the sole use of the intended recipients and may contain privileged information. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by e-mail and destroy all copies of the original message, or you may call PhenoPath Laboratories, Seattle, WA U.S.A. at (206) 374-9000. ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
[Histonet] Re: Histonet Digest, Vol 76, Issue 2
Hi Martha, We offer this antibody. Visit our website: www.phenopath.com or call (206) 374-9000 and ask for Client Services for information on specimen submission. Thanks, Stephanie Rodriguez, HTL(ASCP), QIHC IHC Tech III/Clinical Molecular Tech Phenopath Laboratories Seattle, WA On 3/2/10 7:03 AM, histonet-requ...@lists.utsouthwestern.edu histonet-requ...@lists.utsouthwestern.edu wrote: Message: 4 Date: Mon, 1 Mar 2010 13:56:17 -0500 From: Martha Ward mw...@wfubmc.edu Subject: [Histonet] IgG4 To: histonet@lists.utsouthwestern.edu Message-ID: 61135f0455d33347b5aae209b903a30433deb...@exchvs2.medctr.ad.wfubmc.edu Content-Type: text/plain; charset=us-ascii Hello all, I am looking for a lab that offers this antibody on ffpe tissues. One of my Pathologists is interested in it and has a surgical case she has been asked to stain for IgG4. Thanks in advance for your help! Martha Ward, MT (ASCP) QIHC Assistant Manager, Molecular Diagnostics Lab Wake Forest University Baptist Medical Center 336-716-2104 This e-mail message, including any attachments, is for the sole use of the intended recipients and may contain privileged information. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by e-mail and destroy all copies of the original message, or you may call PhenoPath Laboratories, Seattle, WA U.S.A. at (206) 374-9000. ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
[Histonet] Re: Histonet Digest, Vol 73, Issue 26
Hi Linda, We routinely run this antibody, and would be happy to perform it for you. Feel free to contact our Client Services department at the phone number below regarding specimen submission. Stephanie Rodriguez, HTL(ASCP), QIHC IHC Tech III Phenopath Laboratories 551 N. 34th St Ste 100 Seattle, WA 98103 (206) 374-9000 Message: 8 Date: Thu, 17 Dec 2009 09:13:40 -0600 From: Sebree Linda A lseb...@uwhealth.org Subject: [Histonet] hsNFS(INI1) antibody To: Histonet histo...@pathology.swmed.edu Message-ID: 8c023b4ab999614ba4791baeb26e27381bf...@uwhc-mail01.uwhis.hosp.wisc.edu Content-Type: text/plain; charset=us-ascii Hi, I'm looking for a reference lab that performs an IHC stain for this antigen. Its used for diagnosing malignant rhabdoid tumor where this antigen is lost. It is expressed in normal tissue. Thanks, Linda A. Sebree University of Wisconsin Hospital Clinics IHC/ISH Laboratory DB1-223 VAH 600 Highland Ave. Madison, WI 53792 (608)265-6596 This e-mail message, including any attachments, is for the sole use of the intended recipients and may contain privileged information. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by e-mail and destroy all copies of the original message, or you may call PhenoPath Laboratories, Seattle, WA U.S.A. at (206) 374-9000. ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
