EC CERTIFICATE. National Institute for Biological Standards and Control (NIBSC) Blanche Lane South Mimms Potters Bar Hertfordshire EN6 3QG UK
|
|
|
- Daniela Stafford
- 5 years ago
- Views:
Transcription
1 National Institute for Biological Standards and Control (NIBSC) EC Certificate - Full Quality Assurance System Approval Certificate Annex IV (excluding sections 4 and 6) of Council Directive 98/79/EC on In Vitro Diagnostic Medical Devices Scope of Certificate: The design and manufacture of biological standards and controls used for the control of anti-blood group quantitation, HLA tissue typing and markers for Hepatitis B Virus, Hepatitis C Virus, Human Immunodeficiency Virus, Human Cytomegalovirus, Rubella virus and Toxoplasma gondii Device Classification: and List B Device Descriptions: See Attachments 1-5 Model Type: See Attachments 1-5 We hereby declare that an examination of the full quality assurance system has been carried out per report , following the requirements of the national legislation to which the undersigned is subject, transposing Annex IV (with the exemption of sections 4 and 6) of Council Directive 98/79/EC on In Vitro Diagnostic Medical Devices. We certify that the full quality assurance system conforms with the relevant provisions of the aforementioned directive and is subject to periodic surveillance as required by 98/79/EC, Annex IV, Section 5. For Annex II, List A devices where they are covered by this certificate, an EC Design Examination certificate according to 98/79/EC, Annex IV, Section 4 is required. This certificate is issued with 5 attachments listing model numbers listing additional locations covered by this certificate.
2 Attachment 1 of 5 British Working Standard for HBsAg 07/288-xxx 0.2 IU/mL NIBSC Monitor Sample for HBsAg 07/286-xxx 0.051U/mL British Working Standard for Anti-HIV-1 99/750-xxx British Working Standard for Anti-HIV-1 99/710-xxx 1 in 5 Dilution Monitor Sample for Anti-HIV-2 99/674-xxx Monitor Sample for Anti-HTLV-1 03/104 xxx British Working Standard for Anti-HCV 14/240-xxx British Working Standard for Anti-HCV 10/154-xxx 1 in 8 Dilution British Working Standard for Anti-HCV 14/242-xxx 1 in 8 Dilution The British Standard for Anti-D antibodies 73/515 and 73/517 Annex II List B The British Standard for Anti-c antibodies 84/628 Annex II List B 2nd British Standard for Anti-Rubella Serum, 67/182 Annex II List B Human HLA-A Genotyping Panel 05/208-xxx Annex II List B HLA-DRB1 Genotyping Reference Panel 10/136-xxx Annex II List B
3 Attachment 2 of 5 HCV RNA Working Reagent for Nucleic Acid 02/264-xxx Amplification Techniques (genotype 3) Hepatitis B Virus DNA Working Reagent for 11/182-xxx Nucleic Acid Amplification Techniques HIV-1 RNA Working Reagent 99/634-xxx HIV-1 RNA Working Reagent 99/636-xxx HBV, HCV and HIV Triplex Reagent (NAT) 14/198-xxx Human Cytomegalovirus for Nucleic Acid 08/314-xxx Annex II List B Amplification Techniques Clinical Virology MultiplexI: 15/130-xxx Annex II List B Immunodeficiencypanel working reagent for Nucleic Acid Amplification Tests (NAT)
4 Attachment 3 of 5 Anti-HIV-1: Quality Control Serum: QCRHIV1QC1 Anti-HIV-1: Quality Control Serum: Sample 2 QCRHIV1QC2 Anti-HIV-1: Quality Control Serum: Sample 3 QCRHIV1QC3 Anti-HIV-1: Quality Control Serum: Sample 5 QCRHIV1QC5 HIV1 p24 Antigen: Quality Control Serum: QCRHIV1P24QC1 H!V1 p24 Antigen: Quality Control Serum: QCRHIV1P24QC2 Sample 2 Anti-HIV-2: Quality Control Serum: Sample 2 QCRHIV2QC2 Anti-HIV-2: Quality Control Serum: Sample 3 QCRHIV2QC3 Anti-HCV Quality Control Serum: QCRHCVQC1 Anti-HBs Quality Control Serum: QCRHBsQC1 HBsAg Quality Control Serum: QCRHBsGQC1 HBsAg Quality Control Serum: Sample 2 QCRHBsGQC2
5 Attachment 4 of 5 Anti-HBe Quality Control Serum: QCRHBeQC1 Total Anti-HBc Quality Control Serum: QCRTHBcQC1 Total Anti-HBc Quality Control Serum: QCRTHBcQC2 Sample 2 lgm Anti-HBc Quality Control Serum: QCRHBclgMQC1 HIV-1 Rapid Test Device: Quality Control QCRHIVRTDQC1 Serum: Anti-CMV Quality Control Serum : QCRCMVQC1 Annex II List B IgM Anti-CMV Quality Control Reagent 1 QCRCMVIgMQC1 Annex II List B Anti-Rubella Quality Control Serum: QCRRUBQC1 Annex II List B Anti-Toxoplasma Quality Control Serum: QCRTOXOQC1 Annex II List B Anti-Rubella Quality Control Serum Sample 2 QCRRUBQC2 Annex II List B Anti-Rubella lgm Quality Control Serum QCRRUBlgMQC1 Annex II List B
6 Attachment 5 of 5 IgM Anti-Toxoplasma gondii Quality Control Reagent 1 QCRTOXOIgMQC1 Annex II List B
Official Journal of the European Communities COMMISSION
16.5.2002 EN Official Journal of the European Communities L 131/17 COMMISSION COMMISSION DECISION of 7 May 2002 on common technical specifications for in vitro-diagnostic medical devices (notified under
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
2002D0364 EN 01.07.2012 002.001 1 This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents B COMMISSION DECISION of 7 May 2002 on common technical
Non-reproductive tissues and cells
Colour key Tested pathogen VIRAL Minimum requirements as set out in Directive 2004/23/EC More stringent testing - legy binding on national level More stringent testing - recommended on national level Not
QUALITY CONTROL Infectious Disease
QUALITY CONTROL Infectious Disease 1 Infectious Disease Quality Control The human based material used in the production of our Quality Controls is sourced from the Taiwan Blood Services Foundation (TBSF).
to be notified: all parties involved in the graduated plan procedure. Annexes
Paul-Ehrlich-Institut Postfach 63207 Langen, Germany To all marketing authorisation holders of cellular blood preparations and therapeutic single plasmas as well as authorisation holders of stem cells
Non-reproductive tissues and cells
Colour key Minimum requirements as set out in Directive 2004/23/EC More stringent - legy binding on national level More stringent - recommended on national level Not legy binding and not recommended on
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK
Schedule of Accreditation 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK National Infection Service, Public Health England Colindale 61 Colindale Avenue London NW9 5EQ Contact: Dr Sanjiv
Non-reproductive tissues and cells Recommending authority/ association
Colour key Minimum requirements as set out in Directive 2004/23/EC More stringent - legy binding More stringent - recommended Not legy binding and not recommended Tested pathogen Donor test/ technique
Schedule of Accreditation
Schedule of Accreditation Organisation Name National Virus Reference Laboratory INAB Reg No 326MT Contact Name Eimear Malone Address University College Dublin, Belfield, Dublin Contact Phone No 01-7161319
Structure and duties of Blood service
NATIONAL CENTER FOR TRANSFUSION MEDICINE Prevalence of infectious diseases among Mongolian blood donors Namjil Erdenebayar General director of The National Center for Transfusion Medicine, Mongolia NCTM,
Non-reproductive tissues and cells
Colour key Minimum requirements as set out in Directive 2004/23/EC More stringent testing - legally binding on national level More stringent testing - recommended on national level Not legally binding
Laboratory Diagnosis of Viral Infections. G. Jamjoom 2005
Laboratory Diagnosis of Viral Infections G. Jamjoom 2005 Five Main Techniques: Virus Culture and Isolation Serology Rapid Detection of Viral Antigens Detection of Viral Nucleic Acid Electron Microscopy
Non-reproductive tissues and cells
Ministry of Health: Institute for Transplantation and Biomedicine / Colour key VIRAL HIV 1 and HIV 2 Hepatitis B Minimum requirements as set out in Directive 2004/23/EC More stringent - legy binding More
Negative Hepatitis C Reporting and Linkage to Care Outreach
Negative Hepatitis C Reporting and Linkage to Care Outreach NASTAD 7 th National Hepatitis Technical Assistance Meeting November 28-30, 2017 Angelica Bocour, MPH Director of Viral Hepatitis Surveillance
Non-reproductive tissues and cells Recommending authority/ association
Colour key Minimum requirements as set out in Directive 2004/23/EC More stringent testing - legy binding on national level More stringent testing - recomd on national level Not legy binding and not recomd
For information only: all participants in the graduated plan procedure. 7 January 2013
Paul-Ehrlich-Institut P.O. Box 63207 Langen, Germany To: All marketing authorisation holders of cellular blood products and therapeutic single plasma as well as holders of an authorisation for stem cells
The Hepatitis B-e antigen-positive
The Hepatitis B-e antigen-positive Dental Student Developing an Equitable Policy Hepatitis B Virus Serology 1 HBsAg A protein on the surface of HBV; it can be detected in high levels in serum during acute
June EQA schemes closed. Information on sample properties. Prof. Dr. Heinz Zeichhardt. Dr. Martin Kammel
June 2018 EQA schemes closed Information on sample properties Prof. Dr. Heinz Zeichhardt Dr. Martin Kammel Issued by: INSTAND Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laborarien
HEPATITIS B NON-IMMEDIATE NOTIFICATION EPIDEMIOLOGY PROGRAM
HEPATITIS B NON-IMMEDIATE NOTIFICATION EPIDEMIOLOGY PROGRAM Event Name: Event Time Period: ACUTE Clinical Presentation (CDC 2012): CDC Event (2012): HEPB Lifelong immunity An acute illness with a discrete
Non-reproductive tissues and cells
Colour key Minimum requirements as set out in Directive 2004/23/EC and its technical Directives (particularly 2006/17/EC) More stringent -legally binding, applies for all donations and all donor profiles
The New Regulations - Special IVD Issues
The New Regulations - Special IVD Issues Dirk Stynen, Ph. D. President - Principal Consultant Qarad Geel, Belgium RMD Brussels October 2018 The IVD Regulation 2017/746 October 29, 2018 www.qarad.com 2
Non-reproductive tissues and cells
Colour key Minimum requirements as set out in Directive 2004/23/EC More stringent testing - legally binding on national level More stringent testing - recommended on national level Not legally binding
Donor Screening in The Region. Vincini GA NRL, Melbourne, Australia
Donor Screening in The Region Vincini GA NRL, Melbourne, Australia NRL Established in 1985 Not-for-profit organisation that exists to support laboratories that perform testing for the diagnosis and management
Controls & Calibrators. Disease Quality Controls
Controls & Calibrators Infectious Disease Quality Controls Infectious Disease Quality Controls A broad selection of controls designed to monitor assay precision of hepatitis, retrovirus, sexually transmitted
Diagnostic Methods of HBV and HDV infections
Diagnostic Methods of HBV and HDV infections Zohreh Sharifi,ph.D Blood Transfusion Research Center, High Institute for Research and Education in Transfusion Medicine Hepatitis B-laboratory diagnosis Detection
Annex II (excluding section 4) of Council Directive 93/42/EEC concerning medical devices
Full Quality Assurance System Approval Certificate Annex II (excluding section 4) of Council Directive 93/42/EEC concerning medical devices Scope of Certificate: Design and Manufacture of Stainless Steel
Diagnostic Methods of HBV infection. Zohreh Sharifi,ph.D of Virology Research center, Iranian Blood Transfusion Organization (IBTO)
Diagnostic Methods of HBV infection Zohreh Sharifi,ph.D of Virology Research center, Iranian Blood Transfusion Organization (IBTO) Hepatitis B-laboratory diagnosis Detection of HBV infection involves
HIV Basics: Clinical Tests and Guidelines
HIV Basics: Clinical Tests and Guidelines ACTHIV 2010 Zelalem Temesgen MD Mayo Clinic Topics Baseline laboratory evaluation Laboratory monitoring through the continuum of care Patients not on antiretroviral
READ HIGHLIGHTED CHANGES
BIO-FLASH anti-hbs 3000-8581 100 tests The BIO-FLASH anti-hbs is a fully automated chemiluminescent simultaneous immunoassay for quantitative measurement of antibodies to Hepatitis B surface antigen (anti-hbs)
Instructions for Use (Version 3-14 th May 2003) Changes from previous version are shown in Red, deletions are shown as ^
Page 1 of 5 Page 1 of 5, 97/656 WHO 1 st International Standard for HIV-1 RNA for Nucleic Acid-Based Techniques (NAT) NIBSC code: 97/656 Instructions for Use (Version 3-14 th May 2003) Changes from previous
Trends in molecular diagnostics
Trends in molecular diagnostics Detection of target genes of interest Quantification Infectious diseases HIV Hepatitis C & B TB / MAC Cytomegalovirus Herpes simplex Varicella zoster CT/GC HPV Profiling
Toronto Declaration: Strategies to control and eliminate viral hepatitis globally. A call for coordinated action
Toronto Declaration: Strategies to control and eliminate viral hepatitis globally A call for coordinated action Hepatitis B National Action Plan All countries should develop a national and/or regional
Public Health, Infections and Transplantation
Public Health, Infections and Transplantation Dr Kerry Chant Chief Health Officer & Deputy Director General Population and Public Health NSW Ministry of Health May2014 Public Health Infection and Transplantation
PROPOSAL FOR THE DEVELOPMENT OF AN INTERNATIONAL REFERENCE PREPARATION FOR HEPATITIS D VIRUS RNA
PROPOSAL FOR THE DEVELOPMENT OF AN INTERNATIONAL REFERENCE PREPARATION FOR HEPATITIS D VIRUS RNA SoGAT Clinical Diagnostics II 30 September / 1 October 2009, Istanbul Michael Chudy Julia Kreß C. Micha
Isolated Hepatitis B Core Antibody
NORTHWEST AIDS EDUCATION AND TRAINING CENTER Isolated Hepatitis B Core Antibody Nina Kim, MD MSc Associate Professor of Medicine November 13, 2014 Isolated Core Antibody Virology & terminology Definition
Human diagnostics. Better be Sure: Quantify HDV & HBV viral load. RoboGene product family
Human diagnostics Better be Sure: Quantify HDV & HBV viral load. RoboGene product family 2 RoboGene Product Family Improved patient management: Standardized monitoring of HBV DNA and HDV RNA viral load.
Viral Hepatitis Diagnosis and Management
Viral Hepatitis Diagnosis and Management CLINICAL BACKGROUND Viral hepatitis is a relatively common disease (25 per 100,000 individuals in the United States) caused by a diverse group of hepatotropic agents
Considerations for Antiretroviral Use in Patients with Hepatitis B Virus & Human Immunodeficiency Syndrome Coinfection
Considerations for Antiretroviral Use in Patients with Hepatitis B Virus & Human Immunodeficiency Syndrome Coinfection Mahnaz Arian, MD Assistant Professor in infectious Disease Mashhad university of Medical
DS-EIA-ANTI-HIV-UNIF (Ab) I DS-EIA-ANTI-HIV-UNIF (Ab) I DS-EIA-ANTI-HIV-UNIF (Ab) I
* Sensitivity HIV DS-EIA-ANTI-HIV-UNIF (Ab) I-153 96 115 24 DS-EIA-ANTI-HIV-UNIF (Ab) I-150 192 115 24 DS-EIA-ANTI-HIV-UNIF (Ab) I-155 480 115 24 DS-EIA-HIV-AG-SCREEN I-1452 96 115 12 0.025 IU/ml DS-EIA-HIV-AGAB-SCREEN
INSTAND e.v. in cooperation with:
Pre-evaluation of the EQA Schemes in Virus Diagnostics June 2015 Corrected version: 10 August 2015 (See Table 3; program 346) INSTAND e.v. in cooperation with: Deutsche Vereinigung zur Bekämpfung der Viruskrankheiten
DEVELOPMENT OF AN INTERNATIONAL REFERENCE PREPARATION FOR HEPATITIS D VIRUS RNA - UPDATE
DEVELOPMENT OF AN INTERNATIONAL REFERENCE PREPARATION FOR HEPATITIS D VIRUS RNA - UPDATE SoGAT Clinical Diagnostics III 12-13 January 2011, London Michael Chudy Julia Kreß Micha Nübling Paul-Ehrlich-Institut
OCCUPATIONAL HEALTH PROTOCOL
Faculty of Medicine and Surgery OCCUPATIONAL HEALTH PROTOCOL (Applicable to applicants for the Doctor of Medicine and Surgery M.D. - Degree Course) Applicability for Courses commencing in October 2015
The Technical Aspects of Pathogen Testing in Canada. Nancy Angus Canadian Blood Services Director, Testing
PERMISSON TO USE: Please note that, by making their presentations available on-line, primary authors have agreed to share their presentations. However, should you want to use some of the data or slides
June Pre-evaluation of the External Quality Assessment Schemes in Virus Diagnostics. Prof. Dr. Heinz Zeichhardt. Dr.
June 2018 Pre-evaluation of the External Quality Assessment Schemes in Virus Diagnostics Prof. Dr. Heinz Zeichhardt Dr. Martin Kammel Issued by: INSTAND Gesellschaft zur Förderung der Qualitätssicherung
OCCUPATIONAL HEALTH PROTOCOL
Faculty of Dental Surgery OCCUPATIONAL HEALTH PROTOCOL Applicable to applicants for the: Master of Dental Surgery Course Bachelor of Science (Honours) in Dental Hygiene Course Bachelor of Science (Honours)
The ABC s (and D & E s) of the Viral Hepatitides Part 2 DIAGNOSTIC TESTS 3/7/2013
The ABC s (and D & E s) of the Viral Hepatitides Part 2 Thomas Novicki PhD DABMM Clinical Microbiologist Division of Laboratory Medicine novicki.thomas@marshfieldclinic.org Objectives 2 1. Explain the
Primary Sample Manual Infectious Serology Issue No Effective Date: 20/09/17 Page 1 of 15 EUROFINS BIOMNIS
Issue No. 2.02 Effective Date: 20/09/17 Page 1 of 15 Written / Revised By: Dr. Mike Louw, Medical Director Date: Reviewed By: Date: Dr. Sinead Kelly, Infectious Serology Consultant Authorised By: Jean-Sébastien
Product List Autobio Diagnostics. Autobio. autobio diagnostics an autobio group company
Product List Autobio Diagnostics Autobio.. autobio diagnostics an autobio group company www.autobio-diagnostics.com Autobio Diagnostics Co., Ltd. was established in 1998 and has become one of the largest
The Alphabet Soup of Viral Hepatitis Testing
The Alphabet Soup of Viral Hepatitis Testing August 18, 2011 Patricia Slev, PhD, DABCC Medical Director, Serologic Hepatitis and Retrovirus Laboratory, ARUP Laboratories Assistant Professor of Pathology,
Standardization: Calibration of. International Standards, reference preparations and working standards. Micha Nübling, PEI
Standardization: Calibration of International Standards, reference preparations and working standards Micha Nübling, PEI Paul-Ehrlich-Institut Governmental Authority for biological medicinal products Blood
Memo No: Date: 25-Nov NEW Serology and Virology Testing
Memo No: 2014-61 Date: 25-Nov-2014 www.hicl.on.ca Re: NEW Serology and Virology Testing In Common Laboratories has been working hard to expand our test menu. We are pleased to announce the availability
The testing of Donated Blood and Components at NHSBT
The testing of Donated Blood and Components at NHSBT NHSBT is responsible for collecting all donated blood and platelets in England, then processing into components before issuing to client hospitals.
الحترمونا من خري الدعاء
الحترمونا من خري الدعاء Instructions for candidates The examination consists of 30 multiple choice questions, each divided into 5 different parts. Each part contains a statement which could be true or
Plasma for fractionation: South African Plasma Requirements
Plasma for fractionation: South African Plasma Requirements Dr Jeh-han Omarjee Head: Microbiological Sciences NBI is a "not for profit" company committed to providing safe, cost effective, quality medicinal
WHO GUIDELINES ON ESTIMATION OF RESIDUAL RISK OF HIV, HBV OR HCV INFECTIONS VIA CELLULAR BLOOD COMPONENTS AND PLASMA
ENGLISH ONLY EXPERT COMMITTEE ON BIOLOGICAL STANDARDIZATION Geneva, 17 to 21 October 2016 WHO GUIDELINES ON ESTIMATION OF RESIDUAL RISK OF HIV, HBV OR HCV INFECTIONS VIA CELLULAR BLOOD COMPONENTS AND PLASMA
Viral hepatitis. Supervised by: Dr.Gaith. presented by: Shaima a & Anas & Ala a
Viral hepatitis Supervised by: Dr.Gaith presented by: Shaima a & Anas & Ala a Etiology Common: Hepatitis A Hepatitis B Hepatitis C Hepatitis D Hepatitis E Less common: Cytomegalovirus EBV Rare: Herpes
BIO-FLASH. BIOKIT, S.A. - Can Malé s/n Lliçà d Amunt - Barcelona - SPAIN
READ HIGHLIGHTED CHANGES BIO-FLASH anti-hbc 3000-8578 100 tests The BIO-FLASH anti-hbc is a fully automated chemiluminescent two-step immunoassay for qualitative measurement of total antibodies to hepatitis
Non-reproductive tissues and cells Recommending authority/ association
Colour key Minimum requirements as set out in Directive 2004/23/EC More stringent - legy binding More stringent - recommended Not legy binding and not recommended Non-reproductive tissues and cells VIRAL
Guidance for Industry
Guidance for Industry Advisement for the Use of Gen-Probe Procleix Ultrio Plus Assay for NAT Testing on Cadaveric Donors Release Date: 08/03/14 American Medical Education and Research Association 4757
The use of QCMD proficiency testing panels in clinical virology.
The use of QCMD proficiency testing panels in clinical virology. Prof.dr. Bert Niesters Department of Medical Microbiology Division of Clinical Virology UMC Groningen Disease Disease Management Viral Load
The cost-effectiveness of NAT for HIV, HCV, and HBV in whole-blood donations Jackson B R, Busch M P, Stramer S L, AuBuchon J P
The cost-effectiveness of NAT for HIV, HCV, and HBV in whole-blood donations Jackson B R, Busch M P, Stramer S L, AuBuchon J P Record Status This is a critical abstract of an economic evaluation that meets
Screening donors and donations for transfusion transmissible infectious agents. Alan Kitchen
Screening donors and donations for transfusion transmissible infectious agents Alan Kitchen Aim Not to teach you microbiology To provide and awareness of the big picture To provide an understanding of
Proposed 1 st IS for Hepatitis E Virus RNA WHO/BS/
www.pei.de Proposed 1 st IS for Hepatitis E Virus RNA WHO/BS/09.2126 S. Baylis, Division of Virology, Paul-Ehrlich-Institut, Langen, Germany SoGAT XXII 14 th -15 th April 2011, Rome, Italy Presented at:
Glecaprevir-Pibrentasvir in HCV GT 1 or 4 & Prior DAA Treatment MAGELLAN-1 (Part 2)
Phase 3 Treatment-Experienced in HCV GT 1 or 4 & Prior DAA Treatment MAGELLAN-1 (Part 2) in HCV GT 1 or 4 & Prior DAA Treatment MAGELLAN-1 (Part 2): Study Features MAGELLAN-1 (Part 2) Trial Design: Randomized,
Frequency of occult hepatitis B in HBsAg seronegative blood donors in a tertiary care hospital in kerala,south India.
Frequency of occult hepatitis B in HBsAg seronegative blood donors in a tertiary care hospital in kerala,south India. Cinzia Keechilot, Veena Shenoy 1,V Anil kumar 2,Lalita Biswas 3. MBBS student * Transfusion
Blood Screening Assays. CTS lab locations where assays are performed are indicated by alpha codes D, P, and T.
Blood Screening Assays CTS lab locations where assays are performed are indicated by alpha codes D, P, and T. D= performed in Dallas lab FEI: 3002580251 P= performed in Phoenix lab FEI: 3000204058 T= performed
Non-reproductive tissues and cells Recommending authority/ association
Colour key Minimum requirements as set out in Directive 2004/23/EC More stringent - legally binding More stringent - recommended Not legally binding and not recommended Non-reproductive tissues and cells
Hepatitis B and C Overview, Outbreaks, and Recommendations. Viral Hepatitis Language. Types of Viral Hepatitis 7/1/2013
Hepatitis B and C Overview, Outbreaks, and Recommendations Elizabeth Lawlor, MS Healthy Kansans living in safe and sustainable environments. Viral Hepatitis Language Acute infection is when the infection
CORD BLOOD TRANSPLANTATION STUDY CBU EXCLUSION AND QUARANTINE RELEASE FORM
(Any answer of Yes indicates exclusion) 1. Informed Consent and Maternal/Infant Demographics a. Lack of confirmation of signed and witnessed informed consent 1 Yes 2 No Is the following information missing
AccuSet HBV Worldwide Performance Panel
PACKAGE INSERT 0805-033 INTENDED USE The is intended for use by diagnostic manufacturers, researchers, and clinical laboratories to develop, evaluate, or troubleshoot HBV test methods. Characterized samples
Currently, the Department of Epidemiology has 5 rooms / offices undertake various professional roles:
National Institute of Hygiene and Epidemiology (NIHE) Hanoi Vietnam Department of Epidemiology Currently, the Department of Epidemiology has 5 rooms / offices undertake various professional roles: Room
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP)
European Medicines Agency Pre-authorisation Evaluation of Medicines for Human Use London, 21 September 2006 EMEA/CHMP/BWP/298390/2005 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON
With the aim of continuous improvement of our products, Biokit increases the shelf life of bioelisa HIV 1+2 Ag/Ab from 10 to 12 months.
1 NEWS BK NEWS # 377 /MKT DATE : 18-01-2016 TITLE : SHELF-LIFE EXTENSION OF bioelisa HIV 1+2 Ag/Ab With the aim of continuous improvement of our products, Biokit increases the shelf life of bioelisa HIV
Impact of Testing Strategies to Reduce Transmission Risk for HBV. Ravi Reddy, M Vermeulen South African National Blood Service (SANBS) 29 July 2013
Impact of Testing Strategies to Reduce Transmission Risk for HBV Ravi Reddy, M Vermeulen South African National Blood Service (SANBS) 29 July 2013 Overview of SANBS SANBS is a private not for profit company
Reporting from Council of Europe member states on the collection, testing and use of blood and blood components in Europe The 2006 Survey
Reporting from Council of Europe member states on the collection, testing and use of blood and blood components in Europe The 2006 Survey This questionnaire consists of three sections: A. Collection and
Evaluation of run controls for cobas 6800 MPX and HEV assay
Evaluation of run controls for cobas 6800 MPX and HEV assay Marco Koppelman Head of Nucleic Acid testing (NAT) laboratory, National Screening laboratory of Sanquin (NSS) in the Netherlands Satellite Meeting
INSTAND e.v. in cooperation with:
Pre-evaluation of the EQA Schemes in Virus Diagnostics November/December 2014 INSTAND e.v. in cooperation with: Deutsche Vereinigung zur Bekämpfung der Viruskrankheiten (DVV) Gesellschaft für Virologie
AccuVert HBV Seroconversion Panel PHM941(M) ( )
PACKAGE INSERT PHM941(M) (0605-0061) INTENDED USE PHM941(M) (0605-0061) is a group of serial bleeds from an individual plasma donor during HBV seroconversion. This panel is intended for use by diagnostics
DEPARTMENT OF MICROBIOLOGY IMPORTANT NOTICE TO USERS Turnaround Times (TATs) for Microbiology Investigations
Dear User, ISSUE: M008 DEPARTMENT OF MICROBIOLOGY IMPORTANT NOTICE TO USERS Turnaround Times (TATs) for Microbiology Investigations In order to comply with national quality guidance and as part of our
PLUNGER ( ) Not applicable. Field Safety Corrective Action (FSCA)
Urgent Field Safety Notice SBN-CPS-2018-002 CPS / Serum Work Area Version 4 xx-mar-2018 cobas e 801 syringe plunger issue Product Name Affected Instrument Part GMMI / Part No cobas 8000 modular analyzer
Microbiology EQA Product Portfolio
Labquality EQAS Microbiology EQA Product Portfolio Clinically relevant external quality assessment program for microbiology Bacterial serology Bacteriology Mycology Parasitology Preanalytics Virology Labquality
Elecsys HBsAg II. R2 Anti-HBsAg-Ab~Ru (bpy) 3
REF SYSTEM 07251076119 07251076500 300 cobas e 801 English System information Short name ACN (application code number) HBSAG 2 10049 Intended Use Immunoassay for the in vitro qualitative determination
Ministry of Health, Screening and Vaccination Requirements from 1 January 2019
Ministry of Health, Screening and Vaccination Requirements from 1 January 2019 Mumps, Measles and Rubella (MMR) All students should be immune or vaccinated. Documented proof of vaccination (2-dose series);
MKT/BF/328
19.06.2013 MKT/BF/328 BIO-FLASH posters presented at ECCMID, 23rd Congress of Clinical Microbiology and Infectious Diseases Evaluation of HBV/HCV/HIV 1+2 Evaluation of TORC panel As you know this year
MOLECULAR DIAGNOSTIC PANELS and REAGENT KITS for NUCLEIC ACID EXTRACTION and RT-PCR of INFECTIOUS DISEASES and GENOMICS. Sep 2018
MOLECULAR DIAGNOSTIC PANELS and REAGENT KITS for NUCLEIC ACID EXTRACTION and RT-PCR of INFECTIOUS DISEASES and GENOMICS Sep 2018 STANDARDISED & EASY APPROACH TO PCR DIAGNOSTICS The diagnostic kits of MOLgen
ELISA kits for infections (HIV; Hepatitis A, B, C, D, E; Syphilis, ToRCH and others), hormone pathologies and tumor markers.
DSI S.r.l. DSI S.r.l. is one of the European leaders in the field of immunodiagnostic tests manufacturing. We are a research-focused company with the long-term microbiological scientific traditions. Our
DAT-B 2015 Direct Antiglobulin Test
EVALUATION DAT-B 2015 Direct Antiglobulin Test INSTITUTION: ATTENTION: CAP NUMBER: 7181660-01 Kit# 1 KIT INFORMATION: Kit ID: 28002258 10/12/2015 11/16/2015 Next Mailing Date: 2/22/2016 COPIED TO: LAP
Innovative diagnostics for HIV, HBV and HCV
Innovative diagnostics for HIV, HBV and HCV Dan Otelea National Institute for Infectious Diseases Bucharest, Romania Disclaimer No conflicts of interest Innovative diagnostics for HIV, HBV and HCV - is
Bible Class: Hepatitis B Virus Infection
Bible Class: Hepatitis B Virus Infection Nasser Semmo UVCM, Hepatology What is the HBV prevalence? 2 Hepatitis B Worldwide approx. 350 Mio. chronically infected with HBV Approx. 40% of the world population:
Undergraduate Medical Education
Undergraduate Medical Education Communicable Disease Screening Protocol Student Conduct Component: Procedure #SC 08P Corresponding Policy: Policy #SC-08 Supersedes: none Lead Writer: Communicable Disease
United Kingdom National External Quality Assessment Service for Microbiology [Established 1971]
![United Kingdom National External Quality Assessment Service for Microbiology [Established 1971]](/thumbs/95/123501270.jpg "United Kingdom National External Quality Assessment Service for Microbiology [Established 1971]")
United Kingdom National External Quality Assessment Service for Microbiology [Established 97] UK NEQAS covers Andrology Chemistry Genetics Haematology Histopathology Immunology Leucocyte Immunophenotyping
Answering your daily challenges. in the ELISA technology I N FECTI OUS DISEASES. bioelisa
Answering your daily challenges in the ELISA technology I N FECTI OUS DISEASES bioelisa RETROVIRUS HIV is the cause of the most important global pandemic. Due to the lack of vaccination, early diagnosis
Within 14 days at 2-8⁰C. DO NOT FREEZE WHOLE BLOOD Micro Typing Systems 50 µl plasma
Test Name *Minimum Collection Tubes Sample Stability ABO/Rh Blood Typing 50 µl cells EDTA whole blood (lavender-top) Within 14 days at 2-8⁰C. DO NOT FREEZE WHOLE BLOOD Micro Typing Systems 50 µl plasma
Serology for Biochemists
Serology for Biochemists Dr Ronda Greaves Diagram from: http://www.cdc.gov/hepatitis/resources/professionals/training/serology/training.htm Overview Part A: GENERAL SEROLOGY IgG vs IgM Definitions The
QSEAL Recovered Plasma Specification
QSEAL Recovered Plasma Specification Background The is part of a series of standards that comprise the Plasma Protein Therapeutics Association (PPTA) QSEAL Standards Program. PPTA's Voluntary Standards
2014/LSIF/PD/025 Malaysia s Approach to Testing Strategies
2014/LSIF/PD/025 Malaysia s Approach to Testing Strategies Submitted by: Malaysia Policy Dialogue and Workshop on Attaining a Safe and Sustainable Blood Supply Chain Manila, Philippines 30 September 1
Khalid Alquthami (Correspondence) Regional Lab, Makkah. Saudi Arabia
1 Regional Lab, Makkah. Saudi Arabia stract: Clinical specificity and genotype/subtype detection of viruses using the Cobas TaqScreen MPX system V 2.0, which is a nucleic acid test (NAT) that uses multiples
Biokit Label Catalog. Living Immunoassay Excellence
Living Immunoassay Excellence Biokit Label Catalog Biokit is a privately owned biotechnological company that is part of Werfen. It was founded in 1973 and is aimed at the research, development, manufacture
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK
2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK West of Scotland Specialist Virology Centre New Lister Building Level 5 Glasgow Royal Infirmary 10-16 Alexandra Parade Glasgow G31 2ER Contact: