From owner-diagnostics@net.bio.net Sun Jul 02 23:00:00 1995 Path: biosci!sasa.gov.uk!odonnell From: odonnell@sasa.gov.uk ("Kevin O'Donnell") Newsgroups: bionet.diagnostics Subject: Re: SOFTWARE: Chemical Inventory/Waste Management/Material Safety Data Date: 3 Jul 1995 02:08:54 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 33 Sender: daemon@net.bio.net Distribution: world Message-ID: References: <3t3r0o$80e@clarknet.clark.net> <> > THEN YOU SHOULD VISIT OUR WEB HOME PAGE!!! > Khem Products, Incorporated <> There are now few things that I am less likely to do! Please read the BIOSCI/bionet FAQ, available from http://www.bio.net/ = and periodically posted on bionet.announce. This explains why advertising= is not alowed on these newsgroups. Dr Kevin O'Donnell Diagnostics and Molecular Biology Scottish Agricultural Science Agency Edinburgh odonnell@sasa.gov.uk From owner-diagnostics@net.bio.net Sun Jul 02 23:00:00 1995 Path: biosci!MERCURY.UARK.EDU!DRHOADS From: DRHOADS@MERCURY.UARK.EDU ("Douglas Rhoads") Newsgroups: bionet.diagnostics Subject: Re: silver staining Date: 3 Jul 1995 06:58:08 -0700 Organization: University of Arkansas Lines: 43 Sender: daemon@net.bio.net Distribution: world Message-ID: <168889C48AD@mercury.uark.edu> > To: diagnost@net.bio.net > From: lpereira@usp.br (Lygia da Veiga Pereira) > Subject: silver staining > Date: 27 Jun 1995 10:32:58 -0700 > > I have tryed a few methods for silver staining DNA in polyacrilamide gels, > but they all give me high background. Can anyone send me their protocol for > this technique? > > Thanks! > > Lygia Pereira, Ph.D. > Universidade de Sao Paulo, Brazil Silver Stain for Nucleic Acids from M. Balas, Volcani Centre, Rehovot, Israel via E. Rybicki Univ. of Cape Town Short Procedure 1) Soak in 30% EtOH 10% HOAc 10' room temp. no shaking (can go overnight) 2) Soak 2x 10' in 10% EtOH 3) Wash 3x 5' in H2O 4) Soak 30' in 6 mM AgNO3 (50 ml/gel??) the quick rinse with H2O 5) Rinse rapidly in fresh 2.5% Na2CO3 0.02% HCHO then replace with fresh for 2' more. Replace with fresh solution and allow bands to develop. 6) Stop with 1% HOAc and store in same. Can destain with 2% NH4peroxydisulphate. Gels can be shrunk with 100% EtOH, then acetone and then air dried. Long Procedure 1) Soak gel in 50% EtOH 10% HOAc 1-3 hrs or overnight 2) Soak in 10% EtOH 1% HOAc 1 hr. then rinse 3x with H2O 3) Soak in 12 mM AgNO3 1 hr. rinse 3x 5' in H2O 4) Rinse rapidly in fresh 0.75 M KOH 0.28% HCHO, then replace with fresh and allow bands to develop 5) Stop with 0.07 M Na2CO3 or 5% HOAc. Store in 1% HOAc. //========================================================\\ ||Doug Rhoads || Dept. of Biological Sciences|| ||drhoads@mercury.uark.edu || 601 Science Engineering || ||drhoads@uafsysb.uark.edu || University of Arkansas || ||501-575-3251 || Fayetteville, AR 72701 || ==========================================================|| || My Dogma Just Got Run Over by Someone's Karma || \\========================================================// From owner-diagnostics@net.bio.net Sun Jul 02 23:00:00 1995 Path: biosci!bcm!cs.utexas.edu!howland.reston.ans.net!nntp.crl.com!decwrl!svc.portal.com!news1.best.com!usenet From: The Big Guy Newsgroups: bionet.diagnostics Subject: DRUG TESTING Date: 3 Jul 1995 11:10:08 GMT Organization: Organized? Who Me? Lines: 10 Message-ID: <3t8j6g$bcc@news1.best.com> NNTP-Posting-Host: sean.vip.best.com Mime-Version: 1.0 Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit X-Mailer: Mozilla 1.1N (Macintosh; I; 68K) To: biosci@net.bio.net/bionet.diagnostics X-URL: news:bionet.diagnostics Help please research project on phenolphthalein poisoning. Need info on false positive and false negative drug and food interactions on screening test of phenolphthalein with sodium hydroxide. Thank you Sean From owner-diagnostics@net.bio.net Sun Jul 02 23:00:00 1995 Path: biosci!bcm!cs.utexas.edu!swrinde!howland.reston.ans.net!nntp.crl.com!decwrl!svc.portal.com!news1.best.com!usenet From: The Big Guy Newsgroups: bionet.diagnostics Subject: DRUG TESTING Date: 3 Jul 1995 11:09:00 GMT Organization: Organized? Who Me? Lines: 10 Message-ID: <3t8j4c$bcc@news1.best.com> NNTP-Posting-Host: sean.vip.best.com Mime-Version: 1.0 Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit X-Mailer: Mozilla 1.1N (Macintosh; I; 68K) To: newspost.bionet.diagnostics X-URL: news:bionet.diagnostics Help please research project on phenolphthalein poisoning. Need info on false positive and false negative drug and food interactions on screening test of phenolphthalein with sodium hydroxide. Thank you Sean From owner-diagnostics@net.bio.net Mon Jul 03 23:00:00 1995 Newsgroups: bionet.diagnostics Path: biosci!agate!newsxfer.itd.umich.edu!zip.eecs.umich.edu!newshost.marcam.com!usc!crash!kiehl From: b3748@cts.com (Bryan Kiehl) Subject: Hepatitis C Testing Organization: CTSNET Date: Tue, 4 Jul 1995 01:09:13 GMT Message-ID: <3ta4bp$9k4_001@kiehl.cts.com> X-Newsreader: News Xpress Version 1.0 Beta #3 Sender: news@crash.cts.com (news subsystem) Nntp-Posting-Host: kiehl.cts.com Lines: 15 I understand that there either are or may be European regulations that require that human reagents be tested for Hepatitis C. I am aware that we must test for Hepatitis B and HIV. Can anyone clarify the rules. First are there such rules now? Do or will the rules require testing materials other than blood products? For example, I provide a product that uses human thyroglobulin. Obviously we cannot test the protein, but do we need to certify the donor as Hepatis C negative? Bryan Kiehl GenBio 15222-A Avenue of Science San Diego, CA 92128 (619) 592-9300, ext 309 (619) 592-9400 [FAX] From owner-diagnostics@net.bio.net Tue Jul 04 23:00:00 1995 Path: biosci!ZEUS.DATASRV.CO.IL!ila2027 From: ila2027@ZEUS.DATASRV.CO.IL (Falk Fish) Newsgroups: bionet.diagnostics Subject: Re: Hepatitis C Testing Date: 5 Jul 1995 00:12:21 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 10 Sender: daemon@net.bio.net Distribution: world Message-ID: References: <3ta4bp$9k4_001@kiehl.cts.com> Bryan, If not already required, Hepatitis C testing of blood will soon be required in all industrialized countries. So better be prepared for it now. Falk Fish From owner-diagnostics@net.bio.net Thu Jul 06 23:00:00 1995 Path: biosci!bcm!cs.utexas.edu!howland.reston.ans.net!news-e1a.megaweb.com!newstf01.news.aol.com!uunet!in1.uu.net!worm.inch.com!usenet From: IMS Newsgroups: bionet.diagnostics Subject: TEST Date: 6 Jul 1995 21:42:51 GMT Organization: The Internet Channel Lines: 2 Message-ID: <3thlcr$g5m@worm.inch.com> NNTP-Posting-Host: ims.dialup.inch.com Mime-Version: 1.0 Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit X-Mailer: Mozilla 1.1N (Windows; I; 16bit) This is a test From owner-diagnostics@net.bio.net Thu Jul 06 23:00:00 1995 Path: biosci!usp.br!lpereira From: lpereira@usp.br (Lygia da Veiga Pereira) Newsgroups: bionet.diagnostics Subject: HPV Date: 7 Jul 1995 16:54:35 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 11 Sender: daemon@net.bio.net Distribution: world Message-ID: NNTP-Posting-Host: net.bio.net I am trying to establish in our lab a PCR-based test to detect the 4 four carcinogenetic strains of human pappiloma virus. Can anybody send me references, or names of companies that sell kits for that? Thanks a lot, L.V. Pereira, Ph.D. University of Sao Paulo, Brazil PS: Does anyone know an e-mail address for Organon? From owner-diagnostics@net.bio.net Fri Jul 07 23:00:00 1995 Path: biosci!BEST.COM!sean From: sean@BEST.COM (The Big Guy) Newsgroups: bionet.diagnostics Subject: Phenolphthalein poisoning --Anthocyanins/fruit Date: 8 Jul 1995 05:10:25 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 25 Sender: daemon@net.bio.net Distribution: world Message-ID: NNTP-Posting-Host: net.bio.net I have a procedure for using anthocyanins of fruits especially the plum (prunus) family as pH/color indicators. Does any one else have any experience with this. (Ref-Rynearson,James. Curtright,Robert: Analysis of plant pigments of chromatography.) Help, please, research project on phenolphthalein poisoning. Need info on false positive and false negative drug and food interactions on screening test of phenolphthalein with sodium hydroxide. I have done extensive searches on Medline,MELVYL at UCSF,GLADIS at UCB, LOIS at LANE(Stanford),and NML. I have the test procedure but not any info regarding known drugs or foods such as anthocyanin(fruits) that cause false positive or false negative test results. I am involved in a personal situation and any info or help would be greatly appreciated. I have a medical and chemical educational background and am not looking to tread on any one's research projects. I need the information strictly for personal use. Thank you again ahead of time. Thank you Sean sean@best.com From owner-diagnostics@net.bio.net Sun Jul 09 23:00:00 1995 Path: biosci!aol.com!DjayR From: DjayR@aol.com Newsgroups: bionet.diagnostics Subject: FDA Questions Date: 10 Jul 1995 11:44:05 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 9 Sender: daemon@net.bio.net Distribution: world Message-ID: <950710143833_111729917@aol.com> NNTP-Posting-Host: net.bio.net Does anyone know if a newly developed PCR test needs FDA approval to get remimbursed from insurance companies? IF it is FDA approved and the test fails who is responsible? Is FDA approval required for all diagnostics tests on humans? Thanks for the info. Jay Rothstein, Ph.D. From owner-diagnostics@net.bio.net Sun Jul 09 23:00:00 1995 Path: biosci!cc.UManitoba.CA!fernand From: fernand@cc.UManitoba.CA (Marcel Fernandez) Newsgroups: bionet.diagnostics Subject: sequencing PCR products rich in GT microsatellite sequence Date: 10 Jul 1995 11:00:28 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 6 Sender: daemon@net.bio.net Distribution: world Message-ID: <9507101758.AA06716@castor.cc.umanitoba.ca> NNTP-Posting-Host: net.bio.net does anyone have a protocol for my subject thanks MAF From owner-diagnostics@net.bio.net Sun Jul 09 23:00:00 1995 Path: biosci!cc.UManitoba.CA!fernand From: fernand@cc.UManitoba.CA (Marcel Fernandez) Newsgroups: bionet.diagnostics Subject: sequencing PCR products rich in GT microsatellite sequence Date: 10 Jul 1995 11:00:34 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 6 Sender: daemon@net.bio.net Distribution: world Message-ID: <9507101758.AA06723@castor.cc.umanitoba.ca> NNTP-Posting-Host: net.bio.net does anyone have a protocol for my subject thanks MAF From owner-diagnostics@net.bio.net Sun Jul 09 23:00:00 1995 Path: biosci!CAMELOT.STANFORD.EDU!peterc From: peterc@CAMELOT.STANFORD.EDU ("Peter A. Covitz") Newsgroups: bionet.diagnostics Subject: Re: suggestions for antibody-chromophore Date: 10 Jul 1995 15:44:22 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 26 Sender: daemon@net.bio.net Distribution: world Message-ID: References: <199507102132.OAA23765@netcom22.netcom.com> NNTP-Posting-Host: net.bio.net On Mon, 10 Jul 1995, Claude Selitrennikoff wrote: > Dear Groups: > > We are trying to develop an antigen capture diagnostic test and would like > help in designing the "best" and easiest antibody-chromophore detection > antibody. We have an IgG and an IgM that we would like to couple > to a chromophore that can be easily seen. Suggestions would be greatly > appreciated. > > Thanks > > Claude Selitrennikoff > University of Colorado Health Sci Center > Denver, CO > > I suggest you call for a catalog from Molecular Probes, Inc. (503)465-8300. They have the latest and greatest chromophores for all types of applications. Peter Covitz Dept. Biological Sciences Stanford University From owner-diagnostics@net.bio.net Mon Jul 10 23:00:00 1995 Path: biosci!aol.com!MBYRON10 From: MBYRON10@aol.com Newsgroups: bionet.diagnostics Subject: Re: suggestions for antibody-chromophore Date: 10 Jul 1995 20:12:02 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 2 Sender: daemon@net.bio.net Distribution: world Message-ID: <950710230835_112099546@aol.com> NNTP-Posting-Host: net.bio.net Do you wish to use flourescence or absorbance? Do you wish max. sensitivity? etc. From owner-diagnostics@net.bio.net Tue Jul 11 23:00:00 1995 Path: biosci!bcm!cs.utexas.edu!news.sprintlink.net!uunet!in1.uu.net!news3.digex.net!access1.digex.net!rschifre From: Richard Schifreen Newsgroups: bionet.diagnostics Subject: Re: FDA Questions Date: Tue, 11 Jul 1995 21:46:44 -0400 Organization: Express Access Online Communications, USA Lines: 47 Message-ID: References: <950710143833_111729917@aol.com> NNTP-Posting-Host: access1.digex.net Mime-Version: 1.0 Content-Type: TEXT/PLAIN; charset=US-ASCII In-Reply-To: <950710143833_111729917@aol.com> FDA approval is required to sell any in vitro diagnostic assay in the United States. Assays are regulated as devices and fall into one of three classes, I, II or III. The specific requirements for approval depend on the class. Hospital or commercial reference laboratories which perform patient testing are regulated by the States and under Medicare per the Clinical Laboratory Improvement Act - CLIA. CLIA is administered by the Health Care Finance Administration -HCFA and agencies such as JCAH and CAP which have "deemed status" to act on behalf of HCFA. CLIA and corresponding State laws and regulations define the qualifications of lab directors and technicians and the requirements for offering tests for human diagnosis. Lab Directors may purchase FDA approved tests or in some cases may design and validate tests themselves - referred to as "homebrews." Homebrews are not regulated by the FDA, although that area is controversial and could change. Reimbursement is even more complicated with no one set of guidelines. In general, whoever pays the bill decides what they are willing to pay or not pay. Some insurers will pay for some "experimental" therapies or test, others won't. You need to ask the particular insurance carrier what their rules are. If you are thinking of offering a test for use in human diagnosis, get some solid advice from someone expert in the area before proceeding. You can get yourself and your institution in a lot of trouble if you fall outside of the regulations. Disclaimer: I am not an attorney or even an expert in FDA regulatory affairs. Please get advice from someone who is before offering any diagnostic testing. Rich Schifreen On 10 Jul 1995 DjayR@aol.com wrote: > Does anyone know if a newly developed PCR test needs FDA approval to get > remimbursed from insurance companies? IF it is FDA approved and the test > fails who is responsible? Is FDA approval required for all diagnostics tests > on humans? > Thanks for the info. > > Jay Rothstein, Ph.D. > > > > From owner-diagnostics@net.bio.net Tue Jul 11 23:00:00 1995 Path: biosci!MAILER.YORK.AC.UK!jpc4 From: jpc4@MAILER.YORK.AC.UK (JP Clapp) Newsgroups: bionet.diagnostics Subject: Mycobacterium Date: 12 Jul 1995 02:22:25 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 21 Sender: daemon@net.bio.net Distribution: world Message-ID: NNTP-Posting-Host: net.bio.net can anyone help us with the sequence for the 65-kDa antigen sequence of Mycobacterium avium as per Pao et al J Clin Micro 1990, 1877-1880. We are working up to studying TB in archaeological specimens and are currently using bird material. We have successfully amplifiyed a product and have sequenced it. Unfortunately, there is no sequence for avium in Genbank for this region. The matches we have are two bases different from M. paratuberculosis but this in itself tells us nothing without avium to compare to. Is someone out there sitting on such a sequences that they would be willing to share (in confidence if required). In hope. Dr J. P. Clapp Department of Biology, Po Box 373, Heslington, York, UK jpc4@york.ac.uk From owner-diagnostics@net.bio.net Tue Jul 11 23:00:00 1995 Newsgroups: bionet.diagnostics Path: biosci!bcm!cs.utexas.edu!howland.reston.ans.net!news.sprintlink.net!crash!kiehl From: b3748@cts.com (Bryan Kiehl) Subject: Re: FDA Questions Organization: CTSNET Date: Wed, 12 Jul 1995 16:59:56 GMT Message-ID: <3u0v2c$ea4_001@kiehl.cts.com> X-Newsreader: News Xpress Version 1.0 Beta #3 References: <950710143833_111729917@aol.com> Sender: news@crash.cts.com (news subsystem) Nntp-Posting-Host: kiehl.cts.com Lines: 26 >>> Does anyone know if a newly developed PCR test needs FDA approval to get >> remimbursed from insurance companies? IF it is FDA approved and the test >> fails who is responsible? Is FDA approval required for all diagnostics tests >> on humans? >> Thanks for the info. >> >> Jay Rothstein, Ph.D. >> If test kits are sold interstate (accross state lines) by a commercial company and are intended to be used for human diagnosis, then they do need some form of FDA review. If this is your intent, PCR is carefully regulated at FDA. I suggest that you call the office for small manufacturers. If needed, I could provide the number. This office is quite imformative. It is not always clear what is needed if a lab performs a test method developed in-house. Today this is not typically under the review of the FDA, but reimbursement is a different matter. Additionally, medically liability is the concern of the kit manufacturer, laboratory and clinician and not usually related to FDA reviews. Another problem you may also need to consider is liscensed used of PCR from Roche. >> >> From owner-diagnostics@net.bio.net Wed Jul 12 23:00:00 1995 Path: biosci!agate!newsxfer.itd.umich.edu!gatech!news.sprintlink.net!news.ais.net!usenet From: dbtinc@starnetinc.com (JJC) Newsgroups: bionet.diagnostics Subject: Re: FDA Questions Date: Thu, 13 Jul 1995 08:05:09 -500 Organization: >>DBT<< Lines: 34 Message-ID: <3u35r7$d64@news.ais.net> References: <950710143833_111729917@aol.com> <3u0v2c$ea4_001@kiehl.cts.com> NNTP-Posting-Host: ppp212.starnetinc.com Mime-Version: 1.0 Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit X-NewsReader: QNews v0.9b4 Beta 15 Apr 1994 Evaluation copy. You may also want to know that FDA may take action against an unapproved device in intrastate commerce if that product contains components shipped across state lines. In general if you are going to make an IVD for commercial distribution you should consider the approval process. In article <3u0v2c$ea4_001@kiehl.cts.com> Bryan Kiehl wrote: > > >>> Does anyone know if a newly developed PCR test needs FDA approval to get > >> remimbursed from insurance companies? IF it is FDA approved and the test > >> fails who is responsible? Is FDA approval required for all diagnostics > tests > >> on humans? > >> Thanks for the info. > >> > >> Jay Rothstein, Ph.D. > >> > If test kits are sold interstate (accross state lines) by a commercial > company and are intended to be used for human diagnosis, then they do need > some form of FDA review. If this is your intent, PCR is carefully regulated at > FDA. I suggest that you call the office for small manufacturers. If needed, I > could provide the number. This office is quite imformative. > > It is not always clear what is needed if a lab performs a test method > developed in-house. Today this is not typically under the review of the FDA, > but reimbursement is a different matter. Additionally, medically liability is > the concern of the kit manufacturer, laboratory and clinician and not usually > related to FDA reviews. > > Another problem you may also need to consider is liscensed used of PCR from > Roche. > >> > >> > From owner-diagnostics@net.bio.net Thu Jul 13 23:00:00 1995 Path: biosci!ESSEX.HSC.COLORADO.EDU!claudes From: claudes@ESSEX.HSC.COLORADO.EDU (Claude Selitrennikoff) Newsgroups: bionet.diagnostics Subject: help Date: 14 Jul 1995 09:03:17 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 9 Sender: daemon@net.bio.net Distribution: world Message-ID: NNTP-Posting-Host: net.bio.net Dear Group: Does anyone know of a commercial source for aminophenylthioether (APT) paper and/or diazophenylthioether paper? Thanks for your help. Claude Selitrennikoff From owner-diagnostics@net.bio.net Thu Jul 13 23:00:00 1995 Path: biosci!agate!howland.reston.ans.net!tank.news.pipex.net!pipex!demon!user From: steve@firthcom.demon.co.uk (Steve Firth) Newsgroups: bionet.diagnostics Subject: Re: FDA Questions Date: Fri, 14 Jul 1995 16:08:37 +0100 Organization: Firth Consulting Lines: 37 Distribution: world Message-ID: References: <950710143833_111729917@aol.com> NNTP-Posting-Host: firthcom.demon.co.uk X-NNTP-Posting-Host: firthcom.demon.co.uk In article <950710143833_111729917@aol.com>, DjayR@aol.com wrote: >IF it is FDA approved and the test >fails who is responsible? Is FDA approval required for all diagnostics tests >on humans? Responsibility is a line drawn in the sand by the legal profession. Determining responsibility after a misdiagnosis is often thrashed out by the lawyers representing the physician(s), diagnostics manufacturer and patient. I have been involved in preparing evidence for a diagnostics manufacturer defending themselves against a claim made by a physician. In this case, the diagnostics manufacturer was found to have no responsibility for the misdiagnosis as the physician had (a) misinterpreted the assay results (b) ignored the evidence obtained from a physical examination of the patient. It is my experience that every case is unique and the manufacturer is in a better position than the physician since the manufacturers records must be complete and traceable to get FDA approval and the physicians records are frequently a disorganised muddle. Hence a judge is inclined to think badly of the physician from the moment he sees the evidence. The FDA cannot be held responsible for any malpractise, they do not certify that the kit is a reliable diagnostic device, simply that the manufacturer has shown "due dilligence" in design and manufacture of the kit. Also the FDA and manufacturer do not have control over how a kit is used, and abuse of diagnostic materials by laboratories is still relatively common, for example some labs dilute all reagents 50:50 before use to reduce test costs. This ruins the analytical performance of the kit. ....................................................................... Stephen Firth . $$$ *MAKE*MONEY*FAST* $$$ steve@firthcom.demon.co.uk . $$$ Advertise on the Internet $$$ CIS: 100023,3414 . $$$ This Space Available for Your Ad. $$$ From owner-diagnostics@net.bio.net Thu Jul 13 23:00:00 1995 Path: biosci!SHANI.NET!ffish From: ffish@SHANI.NET (Falk Fish) Newsgroups: bionet.diagnostics Subject: Subscribe Date: 13 Jul 1995 23:41:36 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 6 Sender: daemon@net.bio.net Distribution: world Message-ID: NNTP-Posting-Host: net.bio.net subscribe Thank you, Falk Fish From owner-diagnostics@net.bio.net Sat Jul 15 23:00:00 1995 Path: biosci!agate!howland.reston.ans.net!news.sprintlink.net!uunet!in1.uu.net!news3.digex.net!access4.digex.net!rschifre From: Richard Schifreen Newsgroups: bionet.diagnostics Subject: Re: FDA approval for treatment Date: Sun, 16 Jul 1995 14:05:28 -0400 Organization: Express Access Online Communications, USA Lines: 17 Message-ID: References: <199507161432.WAA24999@einstein.technet.sg> NNTP-Posting-Host: access4.digex.net Mime-Version: 1.0 Content-Type: TEXT/PLAIN; charset=US-ASCII In-Reply-To: <199507161432.WAA24999@einstein.technet.sg> Any treatment offered for sale in the United States must get FDA approval. I can't speak to the regulations in Canada. Not all products need to be completely defined, but they will certainly ask how you insure that each and every lot is safe and effective. Rich Schifreen On 16 Jul 1995, Lim Pohyam wrote: > From the discussions generated from Jay's PCR note, I wonder if a treatment > regime for alcoholics should get FDA approval to be sold in the US or > Canada? We have been approach to try FDA approval for a Chinese herbal cure > for alcoholism. My main concern is that some herbal components may not be > defined in specific terms. Could anyone tell me? > > > From owner-diagnostics@net.bio.net Sat Jul 15 23:00:00 1995 Path: biosci!TECHNET.SG!pohyam From: pohyam@TECHNET.SG (Lim Pohyam) Newsgroups: bionet.diagnostics Subject: FDA approval for treatment Date: 16 Jul 1995 07:34:00 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 6 Sender: daemon@net.bio.net Distribution: world Message-ID: <199507161432.WAA24999@einstein.technet.sg> NNTP-Posting-Host: net.bio.net From the discussions generated from Jay's PCR note, I wonder if a treatment regime for alcoholics should get FDA approval to be sold in the US or Canada? We have been approach to try FDA approval for a Chinese herbal cure for alcoholism. My main concern is that some herbal components may not be defined in specific terms. Could anyone tell me? From owner-diagnostics@net.bio.net Sat Jul 15 23:00:00 1995 Path: biosci!TECHNET.SG!pohyam From: pohyam@TECHNET.SG (Lim Pohyam) Newsgroups: bionet.diagnostics Subject: Single substrate component for TMB Date: 16 Jul 1995 07:27:53 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 8 Sender: daemon@net.bio.net Distribution: world Message-ID: <199507161426.WAA27105@einstein.technet.sg> NNTP-Posting-Host: net.bio.net I have always been using the two component OPD and BCIP/NBT coupled with HRP for my ELISA assays. Recently, I read that a new single component TMB substrate for HRP is on sale. Has anyone tried this? Is it superior in terms of OD duplicity and stability of colour development? Can someone share their experience with me? From owner-diagnostics@net.bio.net Sat Jul 15 23:00:00 1995 Path: biosci!bloom-beacon.mit.edu!usc!elroy.jpl.nasa.gov!swrinde!howland.reston.ans.net!news.sprintlink.net!warp.cris.com!usenet From: jhpincus@cris.com (Jack H. Pincus) Newsgroups: bionet.diagnostics Subject: Re: FDA approval for treatment Date: 16 Jul 1995 23:44:03 GMT Organization: Concentric Research Corporation Lines: 26 Distribution: world Message-ID: <3uc883$n5i@warp.cris.com> References: <199507161432.WAA24999@einstein.technet.sg> NNTP-Posting-Host: crc3-fddi.cris.com Mime-Version: 1.0 Content-Type: Text/Plain; charset=ISO-8859-1 X-Newsreader: WinVN 0.99.5 In article <199507161432.WAA24999@einstein.technet.sg>, pohyam@TECHNET.SG says... > >From the discussions generated from Jay's PCR note, I wonder if a treatment >regime for alcoholics should get FDA approval to be sold in the US or >Canada? We have been approach to try FDA approval for a Chinese herbal cure >for alcoholism. My main concern is that some herbal components may not be >defined in specific terms. Could anyone tell me? > Getting the FDA to approve a herbal cure would be difficult because the herbal mixture is undefined. You would have to know the which are the active ingredients. In addition, approval will be more difficult to obtain if more than one ingredient is involved. Pharmaceutical and biotechnology companies are very interested in traditional medicine. However, the raw materials are only starting points. They pursue the active ingredient, purify it, and use it for clinical trials. Jack H. Pincus jhpincus@cris.com From owner-diagnostics@net.bio.net Sat Jul 15 23:00:00 1995 Path: biosci!agate!howland.reston.ans.net!ix.netcom.com!netnews From: amadeo pesce Newsgroups: bionet.diagnostics Subject: yor bbs Date: 16 Jul 1995 21:16:32 GMT Organization: Netcom Lines: 2 Distribution: world Message-ID: <3ubvjg$rl7@ixnews4.ix.netcom.com> NNTP-Posting-Host: ix-ir15-08.ix.netcom.com Mime-Version: 1.0 Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit X-Mailer: Mozilla 1.1PE (Windows; I; 16bit) To: bionet.diagnostics We located your newsgroup for the AACC. Looks interesting From owner-diagnostics@net.bio.net Sat Jul 15 23:00:00 1995 Path: biosci!bloom-beacon.mit.edu!usc!elroy.jpl.nasa.gov!swrinde!howland.reston.ans.net!ix.netcom.com!netnews From: amadeo pesce Newsgroups: bionet.diagnostics Subject: yor bbs Date: 16 Jul 1995 21:15:29 GMT Organization: Netcom Lines: 2 Distribution: world Message-ID: <3ubvhh$rl7@ixnews4.ix.netcom.com> NNTP-Posting-Host: ix-ir15-08.ix.netcom.com Mime-Version: 1.0 Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit X-Mailer: Mozilla 1.1PE (Windows; I; 16bit) To: bionet,organizers We located your newsgroup for the AACC. Looks interesting From owner-diagnostics@net.bio.net Sun Jul 16 23:00:00 1995 Path: biosci!IONET.NET!support From: support@IONET.NET (Dr. David Ralph, III) Newsgroups: bionet.diagnostics Subject: (none) Date: 17 Jul 1995 10:31:23 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 4 Sender: daemon@net.bio.net Distribution: world Message-ID: <199507171728.MAA04698@ion1.ionet.net> NNTP-Posting-Host: net.bio.net I am interested in subscribing to your bulletin board. Please E-mail more info. Thanks. From owner-diagnostics@net.bio.net Sun Jul 16 23:00:00 1995 Path: biosci!COMPUSERVE.COM!100416.735 From: 100416.735@COMPUSERVE.COM (Diagnostics Club) Newsgroups: bionet.diagnostics Subject: Diagnostics Transfer for Business - Stage 2 Date: 17 Jul 1995 08:11:27 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 9 Sender: daemon@net.bio.net Distribution: world Message-ID: <950717145947_100416.735_BHG84-1@CompuServe.COM> NNTP-Posting-Host: net.bio.net We are now at the second stage of the Diagnostics Transfer for Business meeting. This will be held at Earls Court, London, UK on 4th October 1995 If you wish to have a copy of the catalogue of technology available for funding, licensing or collaboration, then please contact Dr Valerie Owen at tel: +44 1908 647417, fax: +44 1908 271612, email 100416.735@compuserve.com. There are over 70 'diagnostic-related opportunities, but please note that this is a face-to-face meeting (like EUREKA meetings) so only request information if you are seriously considering, or are capable of attending. From owner-diagnostics@net.bio.net Sun Jul 16 23:00:00 1995 Path: biosci!daresbury!trane.uninett.no!Norway.EU.net!EU.net!howland.reston.ans.net!newsfeed.internetmci.com!news.compuserve.com!newsmaster From: Greg Svanas <76325.2506@compuserve.com> Newsgroups: bionet.diagnostics Subject: Re: FDA Questions Date: 17 Jul 1995 18:48:17 GMT Organization: Spectral Diagnostics Inc Lines: 19 Message-ID: <3ueb9h$s0t@dub-news-svc-3.compuserve.com> References: <950710143833_111729917@aol.com> NNTP-Posting-Host: dd13-004.compuserve.com Mime-Version: 1.0 Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit X-Mailer: Mozilla 1.1N (Windows; I; 16bit) To: DjayR@aol.com DjayR@aol.com wrote: >Does anyone know if a newly developed PCR test needs FDA approval to get >remimbursed from insurance companies? IF it is FDA approved and the test >fails who is responsible? Is FDA approval required for all diagnostics tests >on humans? >Thanks for the info. > >Jay Rothstein, Ph.D. > > Any test developed for routine diagnostic use with humans in the US has to be approved by the FDA. Experimental diagnostics fall into a special category, but they are still regulated. Not only the test needs to be approved, the manufacture of the test also has very strict requirements. If the test fails, the manufacturer is responsible, but the FDA will ensure that appropriate steps are taken to prevent loss of life, etc. Greg From owner-diagnostics@net.bio.net Wed Jul 19 23:00:00 1995 Path: biosci!bcm!cs.utexas.edu!news.sprintlink.net!uunet!in1.uu.net!newsflash.concordia.ca!news.mcgill.ca!news From: Graham Dellaire Newsgroups: bionet.diagnostics Subject: Info. Needed for GOOD FTP/WEB site for Shareware/Freeware Date: 20 Jul 1995 12:32:05 GMT Organization: McGill University (Exp. Medicine) Lines: 31 Message-ID: <3ulic5$7m0@sifon.cc.mcgill.ca> NNTP-Posting-Host: a-07.das.mcgill.ca X-Newsreader: AIR News 3.X (SPRY, Inc.) Hello All, I am trying to compile a list of molecular biology/genetics shareware(freeware) FTP and web sites If you have any favorites please send me there addresses. thank you in advance, Graham p.s. I invite you to check out my Dept. Web Page http://www.medcor.mcgill.ca/EXPMED/expmed.html all comments are welcome _______________________________________________________________________ Graham Dellaire Snail Mail: Red Cross, Research McGill University Montreal Blood Services Faculty of Medicine 3131 Sherbrooke St. East Div. of Experimental Medicine Montreal, QC, Canada E-mail: popa0206@po-box.mcgill.ca H1W 1B2 B2XE@musicb.mcgill.ca WWW Page: http://www.medcor.mcgill.ca/EXPMED/expmed.html Fax: (514) 525 0881 Voice: (514) 527 1501 ext 175 _______________________________________________________________________ From owner-diagnostics@net.bio.net Thu Jul 20 23:00:00 1995 Newsgroups: tsukuba.events,bionet.diagnostics,affrc.meetings Path: biosci!agate!howland.reston.ans.net!newsserver.jvnc.net!news.caren.net!news.join.ad.jp!wnoc-tyo-news!news.imnet.ad.jp!ap-a!news From: momotani@niah.affrc.go.jp Subject: Tsukuba Pathology Slide Seminar 104 Sender: news@ap-a.cc.affrc.go.jp Message-ID: Date: Fri, 21 Jul 1995 18:50:50 GMT Content-Type: TEXT/PLAIN; CHARSET=ISO-2022-JP Nntp-Posting-Host: pc202.niah.affrc.go.jp Mime-Version: 1.0 Organization: Agriculture,Forestry and Fisheries Research Council, Japan. X-Newsreader: NEWTNews & Chameleon -- TCP/IP for MS Windows from NetManage Lines: 31 Tsukuba Pathology Slide Seminar No.104 July 28, 1995 13:00-14:30 (AFIP WSC=14:30-17:00) Conference Room in NIAH main building , 2nd floor. 3-1-1, Kannondai, Tsukuba 305 Japan Following cases including clinical, epidemiological, gross and histopathological findings will be presented in the seminar. Cases: No.113: Rabbit viral hemorrhagic disease. (Dr. Itoh of Shizuoka prefecture) No.114: Interstitial pneumonia with fibrinous purulent pleuritis in pig. (Dr. Ono, JA Zen-noh Lab.) No.115: Chronic gastric ulcer and atrophic gastritis in man (Dr. Obana, Teijin) If you are ineresting in Pathology, Please join us! --------------------------------------------------- Name: Eiichi Momotani.DVM. PhD. $B!!(BPhone:0298-38-7781 Lab. of Immunopathology, NIAH,3-1-1 Kannondai,Tsukuba 305 Japan E-mail: momotani@niah.affrc.go.jp (for business!) $B!!!!!!!!(BNBA02413@niftyserve.or.jp (for private or week end!) My WWW home page: http://ss.niah.affrc.go.jp/~momotani/ 07/10/95 21:53:39 --- PC9801Ap/MS-WINDOWS/Chameleon/X--- -------------------------------------------------- From owner-diagnostics@net.bio.net Fri Jul 21 23:00:00 1995 Path: biosci!bcm!news.msfc.nasa.gov!newsfeed.internetmci.com!europa.chnt.gtegsc.com!howland.reston.ans.net!news-e1a.megaweb.com!newstf01.news.aol.com!newsbf02.news.aol.com!not-for-mail From: slrcmg@aol.com (SLRCmg) Newsgroups: bionet.diagnostics Subject: POSITION AVAIL: Rapid Immunoassay Process Dev't (LA, CA, US) Date: 21 Jul 1995 21:45:16 -0400 Organization: America Online, Inc. (1-800-827-6364) Lines: 30 Sender: root@newsbf02.news.aol.com Message-ID: <3upl7c$7rj@newsbf02.news.aol.com> Reply-To: slrcmg@aol.com (SLRCmg) NNTP-Posting-Host: newsbf02.mail.aol.com This is NOT a Head-hunter posting. Serious Responses ONLY, Please! Position Available: Head of Process Development Small Los Angeles area company is seeking a motivated, independent individual to supervise process development and manufacturing of rapid, one-step immunodiagnostic test kits. Successful candidate will have: * - 3+ years management and hands-on experience in one-step assay development and manufacturing interfacing. Expertise with lateral and tangential flow diagnostics is a MUST. * - Specific knowledge of materials and sources necessary for rapid assay development. * - Proven ability to plan and complete long-term projects in a team environment. * - Desire to advance and grow in a small company setting. We offer a salary/equity compensation package intended to take advantage of the company's rapid growth. Please respond by Email to: Mark Geisberg, Ph.D. Director of Research SLRC Email: SLRCmg@aol.com From owner-diagnostics@net.bio.net Fri Jul 21 23:00:00 1995 Path: biosci!agate!howland.reston.ans.net!ix.netcom.com!netnews From: t-bone13@ix.netcom.com (Dan Tisone ) Newsgroups: bionet.diagnostics Subject: Equipment for Rapid Diagnostic Test Kits Date: 22 Jul 1995 16:02:13 GMT Organization: Netcom Lines: 11 Distribution: world Message-ID: <3ur7e5$jdm@ixnews4.ix.netcom.com> NNTP-Posting-Host: ix-ir16-19.ix.netcom.com Our Company's product line includes cutters, laminators, and various types of dispensers used in the R&D or manufacturing of diagnostic test kits. We also provide consulting services on how to develop these kits as well as immunoassays. If we cam provide any assistance please contact me through my internet address, and I can send more information. Dan Tisone BioDot, Inc. t-bone13@ix.netcom.com From owner-diagnostics@net.bio.net Mon Jul 24 23:00:00 1995 Path: biosci!bloom-beacon.mit.edu!news.moneng.mei.com!uwm.edu!vixen.cso.uiuc.edu!howland.reston.ans.net!tank.news.pipex.net!pipex!dispatch.news.demon.net!demon!not-for-mail From: n.bevilacqua@agora.stm.it (Nazario Bevilacqua) Newsgroups: bionet.diagnostics Subject: AFM & SPM Microscopy Date: Tue, 25 Jul 1995 10:53:58 GMT Organization: by NB Lines: 7 Message-ID: <806669875.15685@hella.stm.it> NNTP-Posting-Host: hella.stm.it X-NNTP-Posting-Host: hella.stm.it X-Newsreader: Forte Free Agent 1.0.82 I would appreciate any information or reference for the theory and applications on biology and medicine of the Atomin Force Microscope ( or more generally on Scanning Probe Microscope). Thanks From owner-diagnostics@net.bio.net Mon Jul 24 23:00:00 1995 Path: biosci!SEQNET.DL.AC.UK!mbhjr From: mbhjr@SEQNET.DL.AC.UK Newsgroups: bionet.diagnostics Subject: unsubscribe Date: 25 Jul 1995 09:22:18 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 5 Sender: daemon@net.bio.net Distribution: world Message-ID: <9507251618.AA09910@s-crim1.dl.ac.uk> NNTP-Posting-Host: net.bio.net Could you remove me from the diagnostics emailing as my spce is getting too full thanks Hilary. From owner-diagnostics@net.bio.net Tue Jul 25 23:00:00 1995 Path: biosci!bcm!news.msfc.nasa.gov!newsfeed.internetmci.com!bloom-beacon.mit.edu!gatech!news.uoregon.edu!news.bc.net!rover.ucs.ualberta.ca!news From: kbeler@gpu.srv.ualberta.ca (KBeler) Newsgroups: bionet.diagnostics Subject: Information Request - Aids Testing Date: 26 Jul 1995 04:22:47 GMT Organization: University of Alberta Lines: 14 Message-ID: <3v4fun$13mq@rover.ucs.ualberta.ca> NNTP-Posting-Host: kbeler.remote.ualberta.ca X-Newsreader: WinVN 0.92.4 I am searching for information on OTC (over the counter) or home aids test kits. I would like to hear from anyone who has information on this topic. I would like to recieve info on what countries currently have approved the sales of these kits, any scientific data on the reliability and validity of these tests, and manufactuerers. I am also searching for info on this topic as it relates to Canada in particular. Info on Health Canada's actions in regards to these types of kits. Please respond by email to the address above. All data collected will be complied and posted to sci.med.aids within the next 30 days. Thank-You From owner-diagnostics@net.bio.net Wed Jul 26 23:00:00 1995 Path: biosci!bangslabs.com!leigh From: leigh@bangslabs.com ("Leigh") Newsgroups: bionet.diagnostics Subject: FWD>AFM & SPM Microscopy Date: 27 Jul 1995 12:21:51 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 39 Sender: daemon@net.bio.net Distribution: world Message-ID: NNTP-Posting-Host: net.bio.net Mail*Link¨ Remote FWD>AFM & SPM Microscopy Re the question on Atomic Force Microscopy: I suggest that you try Eric Henderson (e_henderson@molebio.iastate.edu) at Iowa State Univ. He also has his own company and can help you with references and maybe do samples for you. Leigh Bangs leigh@bangslabs.com Date: 7/27/95 11:11 From: Nazario Bevilacqua I would appreciate any information or reference for the theory and applications on biology and medicine of the Atomin Force Microscope ( or more generally on Scanning Probe Microscope). Thanks ------------------ RFC822 Header Follows ------------------ From net.bio.net!BIOSCI-REQUEST Thu Jul 27 11:05:48 1995 remote from dorite Received: from dorite1.iquest.net by dorite1.iquest.net with smtp (Smail3.1.28.1 #16) id m0sbVRT-001eQRC; Thu, 27 Jul 95 11:05 EST Received: from net.bio.net by dorite1.iquest.net with smtp (Smail3.1.28.1 #16) id m0sbVRK-001eQLC; Thu, 27 Jul 95 11:05 EST Received: (from daemon@localhost) by net.bio.net (8.6.12/8.6.6) id EAA12819 for diagnost-list; Tue, 25 Jul 1995 04:02:20 -0700 Received: (from news@localhost) by net.bio.net (8.6.12/8.6.6) id EAA12815 for diagnost-arpanet; Tue, 25 Jul 1995 04:02:19 -0700 To: diagnost@net.bio.net From: n.bevilacqua@agora.stm.it (Nazario Bevilacqua) Subject: AFM & SPM Microscopy Date: Tue, 25 Jul 1995 10:53:58 GMT Message-ID: <806669875.15685@hella.stm.it> NNTP-Posting-Host: hella.stm.it X-NNTP-Posting-Host: hella.stm.it X-Newsreader: Forte Free Agent 1.0.82 From owner-diagnostics@net.bio.net Thu Jul 27 23:00:00 1995 Path: biosci!MACC.WISC.EDU!FYHOU From: FYHOU@MACC.WISC.EDU (Fang-Yao Hou) Newsgroups: bionet.diagnostics Subject: subscribe Date: 28 Jul 1995 13:36:24 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1 Sender: daemon@net.bio.net Distribution: world Message-ID: <25072815342511@vms2.macc.wisc.edu> NNTP-Posting-Host: net.bio.net subscribe From owner-diagnostics@net.bio.net Fri Jul 28 23:00:00 1995 Path: biosci!daresbury!nntp-trd.UNINETT.no!Norway.EU.net!EU.net!howland.reston.ans.net!news.cac.psu.edu!news.math.psu.edu!psuvax1!news.eecs.nwu.edu!newsfeed.acns.nwu.edu!news.acns.nwu.edu!lucky142.acns.nwu.edu!user From: tko161@nwu.edu (Toyoaki Kondo) Newsgroups: bionet.diagnostics Subject: miscarriage Date: Thu, 27 Jul 1995 23:12:48 -0600 Organization: Northwestern University Lines: 6 Message-ID: NNTP-Posting-Host: lucky142.acns.nwu.edu Is there anyone who can give me some informatiion about symptoms of miscarriage in early stage (two month after inception) of pregnancies and what kind of medical attention should be given to the mother. Thank you in advance. TK From owner-diagnostics@net.bio.net Sun Jul 30 23:00:00 1995 Path: biosci!daresbury!nntp-trd.UNINETT.no!Norway.EU.net!EU.net!Germany.EU.net!zib-berlin.de!gs.dfn.de!news.gwdg.de!news From: usancke@gwdg.de (Uli Sancken) Newsgroups: bionet.diagnostics Subject: Re: miscarriage - winvn.hlp [2/3] Date: 30 Jul 1995 10:58:09 GMT Organization: Institut fuer Humangenetik Lines: 800 Message-ID: <3vfok1$4te@gwdu19.gwdg.de> References: NNTP-Posting-Host: unihg2.ukhg.gwdg.de Mime-Version: 1.0 Content-Type: message/partial; id="807132571@Uli Sancken"; number=2; total=3 X-Newsreader: WinVN 0.92.5 LmsAc2MubmFzYS4AZ292ACksIEoqaY0LdcgGbIsKACheZApALfAtAFIGb3cJ n+fAgC8TbQACU0cQXwfLCQGlBAQ7TkFTQS8AS2VubmVkeSBkU3CuASBD7wDa CQHikQM8cyBCTAcKBW8HCPUCLUESIGdvb/G8CoxkaQcrIYkykVgJCHBhctgh BDtQYYJ5FhsgRGF0YWcCMG5hZ2VXIWdMKFCARE1TLUlJKZJSmToLQWaGEFYR YWPhJzOesrkQIGGSC2oLBFQEbWEeBmV4dGVuonOXAiBlbikIY2IgxbALVDMC Vk4slwLaAkcTA6kVkLIgAZPtkWU2ZuQKLghUUSDKCzsCvu5dJm8GFAozGjYM 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<3vfoju$4te@gwdu19.gwdg.de> References: NNTP-Posting-Host: unihg2.ukhg.gwdg.de Mime-Version: 1.0 Content-Type: multipart/mixed; Boundary="*-*-*- Next Section -*-*-*" X-Newsreader: WinVN 0.92.5 --*-*-*- Next Section -*-*-* Content-Type: text/plain In article , tko161@nwu.edu (Toyoaki Kondo) says: > >Is there anyone who can give me some informatiion about symptoms of >miscarriage in early stage (two month after inception) of pregnancies and >what kind of medical attention should be given to the mother. > >Thank you in advance. >TK --*-*-*- Next Section -*-*-* Content-Type: message/partial; id="807132571@Uli Sancken"; number=1; total=3 Content-Type: Application/octet-stream Content-Transfer-Encoding: Base64 P18DAJQNAAD/////JykBAIQNAAB7DQAAAMsBAAHPDwAAmAOeA6EDEwQcBCIE JgQvBDcEWAR/BJoErwS2BMQE2gTfBOUE+wQhBScFNgVVBV0FYgVnBXYFgQWI BZAFnAWjBakFvQXKBdMF5wX+BRgGMwY6BkEGRQZOBlQGWgZiBnEGdwaJBpMG mQadBqEGswa6BtsG3wboBu8G9wYXBxwHLwc7B0gHTAdeB2YHaQduB3QHeweG 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