biomérieux HIV-1 Viral Load Solution Novel approach to HIV viral load measurement in plasma and DBS

Save this PDF as:
 WORD  PNG  TXT  JPG

Size: px
Start display at page:

Download "biomérieux HIV-1 Viral Load Solution Novel approach to HIV viral load measurement in plasma and DBS"

Transcription

1 biomérieux HIV-1 Viral Load Solution Novel approach to HIV viral load measurement in plasma and DBS Véronique Baron-Wunderle

2 HIV & AIDS: A Global disease 5 new HIV infections every minute 4 AIDS-related deaths every minute Global report UNAIDS Dec

3 HIV & AIDS: Optimize Prevention & Patient Care It is critical to know as soon as possible the HIV status of the patient To improve patient care management To prevent the spread of the disease It is critical for all HIV/AIDS patients to get access to HIV testing To ensure their access to treatment To secure a future for them and their family 3

4 HIV Testing: Objectives Precocity of detection detect primary infection when patients are the most contagious Precocity of treatment in most cases it can increase quality of life and life expectancy Monitoring improve care management by optimizing treatment Monitoring and diagnosis of mother to prevent transmission to babies 4

5 Different Needs from Different Countries biomerieux has a Unique HIV Global Solution for Prevention Diagnosis Monitoring Meeting needs from Patients, Clinicians, GO / NGO and Laboratories 5

6 biomérieux HIV Testing solution Prevention & Diagnosis Monitoring DBS Off Site Rapid Testing Laboratory Blood Bank Viral Load Vironostika Extraction Amplification Detection Multiple solutions for HIV testing accessible to all labs 6

7 biomérieux HIV-1 Viral Load Solution 7

8 The solution Accessibility to patients Patients Accessibility Increase patient s access to HIV monitoring thanks to EasyQ HIV-1 VL assay (flexibility + alternative specimen collection Dry Blood Spot) Improve HIV/AIDS patient management (= reliable results) 8

9 The solution Flexibility to adapt to testing needs SPECIMEN COLLECTION AND PREPARATION DBS EXTRACTION AMPLIFICATION AND DETECTION Plasma RESULT ANALYSIS LIS Flexibility Same technology whatever the size of the lab (= 8 to 200 specimens per day / system) Scalable (= use of several instruments to reach 1,000s tests/day) Shortest Turn Around Time (= below 3 hours) NucliSENS menu, quality of EasyMAG extraction enabling downstream applications (= ex: genotyping) 9

10 NucliSENS EasyQ HIV-1 v2.0 Characteristics Large Subtype and CRF s reactivity Detectability and linearity have been demonstrated and are claimed for : A, B, C, D, F, G, H, J, CRF01_AE and CRF02_AG High sensitivity Early detection of potential treatment failure EasyQ HIV-1 v2.0 LoD (95% detection level), 1ml input volume 25 VQA cps/ml (corresponding to 14.4 IU/ml of v1.2 ) (1 IU = 1.74 cps) First HIV VL test with CE-marked protocol for Dry Blood Spot (DBS) Good accuracy of NASBA technology on Whole Blood EasyQ HIV Claimed LoD (95% detection level) Dried blood spot (2 spots = 0.1 ml) 802 VQA cps/ml 10

11 NucliSENS EasyQ HIV-1 v2.0 Technical features Validated Specimen Types Plasma Dry Blood Spot (Whole Blood) Specimen collection 50µl Whole Blood / spot on Whatman 903 Air dry Placed in individual ziplock bag with dessicant Store at room temperature Extraction 2 platforms according to throughput minimag or easymag Flexible sample input (100 µl to 1ml) Elution in 25 µl 15 µl used for amplification (extra volume for sequencing) Amplification/Detection packaging 8 x 6 enabling small and big series Calibrator added to each sample high accuracy On screen amplification curve From Sample Extraction to HIV VL Results 3 hours 11

12 NucliSENS EasyQ HIV-1 v2.0 Precision Precision Precision VQA copies / ml Input range Plasma Intra Inter Overall VQA copies / ml within run between runs intra+inter run < 79 0,38-0,44 10 Log 0,00-0,16 10 Log 0,38-0,45 10 Log ,20-0,23 10 Log 0,02-0,10 10 Log 0,21-0,24 10 Log Accuracy < Log >794 0,10-0,11 10 Log 0,03-0,05 10 Log 0,10-0,12 10 Log Very good Precision and accuracy Precision VQA copies / ml Input range DBS Intra Inter Overall VQA copies / ml within run between runs intra+inter run < Log Log Log Log Log Log > Log Log Log expressed in standard deviation Accuracy < Log Diagnostic specificity N = 261 (1ml EDTA plasma) N = 129 (0,1ml EDTA plama) N = 100 DBS Randomly selected healthy blood donors Non reactive for HIV-1 & HIV-2 Abs 1ml input Demonstrated high 0,1ml input Diagnostic Specificity 100% DBS Observed Specificity 100% 95% CI ( ) 100% 95% CI ( ) 95% CI ( ) 12

13 NucliSENS EasyQ HIV-1 v2.0 Linearity Comparison Abbott/NS EQ HIV v2.0 using BBI-Seracare panel PRD801 (results in VQA copies) Comparison Roche/NS EQ HIV v2.0 using Acrometrix OptiQuant HIV-1 panel Comparison Nuclisens/abbott (results in VQA copies/m l) HIV-1 linearity panel -Acrometrix Nuclisens (log copies/ml) perfect agrreement Output log IU/ml 8 NS 1ml 7 Roche 1ml 6 Linéaire (perfect agreement) Abbott (log copies/ml) Input log IU/ml * 1IU=1,48 VQA copies (Nuclisens) ** 1IU=0,588 copies (Roche) Good linearity as compared to competitors 13

14 QCMD 2010 Qualitative analysis EQ HIV1 v1.2 (1/23), v2.0 (22/23) EasyQ HIV1 v2.0 : very good detectability of the different subtypes Quantitative analysis EasyQ HIV1 v2.0 : good quantification of the different subtypes in full agreement with results obtained by other methods 14

15 Afssaps 2010 Qualitative analysis EasyQ HIV1 v2.0 : good specificity of the assay Quantitative analysis EasyQ HIV1 v2.0 : good quantification of the specimens as compared to other assays 15

16 NucliSENS EasyQ HIV-1 v2.0 Conclusion Increased Accessibility to HIV VL testing CE-marked protocol with DBS High Flexibility Platforms that can adapt to the testing needs Robust and easy-to-use High Quality High sensitivity CE-marked Applications Customer services Increase of patients access to quality HIV Viral Load while meeting lab s variable testing needs 16

17 biomérieux HIV-1 Viral Load Solution Dry Blood Spot (DBS) application 17

18 Public Health Context WHO and Government priorities Increase access to 1 st line (and 2 nd line) treatments Increase treated population as a mean of prevention Limit development of resistance in treated patients and optimize treatment Increase access for HIV/AIDS patients to HIV Viral Load even in remote areas Decrease childhood morbidity and mortality Increase the prevention of Mother to Child Transmission * Screening of pregnant women and infants * Early diagnosis and initiation of ART in HIV-infected infants 18

19 Dry Blood Spot Viral Load Monitoring The most sensitive technique for the detection of early treatment failure ( below 50 cps/ml) Early diagnosis in infants Only with HIV molecular-based viral detection assays due to persistent maternal HIV antibodies that preclude the use of Antibody detection tests ( from 6 weeks of age of molecular testing vs > 18 months for ELISA tests) Use of the molecular assays facilitated by Dry Blood Spot (DBS) samples Collection of blood on filter paper easier to implement than venipuncture large numbers of samples are easily stored and transported to labs for testing no compromise on sample quality Limited skills and no specific infrastructure required decentralization of sample collection 19

20 Technological requirements Detectable Nucleic Acid Plasma HIV RNA Whole blood (DBS) HIV RNA + proviral DNA* (* contained in WBC) Because DBS are made of Whole Blood, HIV RNA and Proviral DNA are present in the specimen. Assay requirements for testing from DBS HIV viral Load Monitoring No over-quantification due to proviral DNA DBS Infant Screening High Sensitivity High Specificity Good Repeatability and Reproducibility Use of a SINGLE viral detection assay of high quality to achieve diagnosis and VL monitoring simplifies technical requirements and investments 20

21 Impact of Technologies PCR RT-PCR HIV Viral Load (after DNAase pre-treatment to limit overquantification (Monleau et al, 2008)) Infant screening (with cut-off setting*) NASBA (with cut-off setting*) * To be determined by users ex: NIH recommendation (2008) for quantitative VL for diagnosis, to avoid FP threshold of < 10,000 cps/ml (4 log), or 5,100 IU/ml (3,7log) If < 4 log : repeat testing NASBA = 1 single technology allowing easy implementation of HIV VL and early diagnosis from DBS specimens = Only assay with CE-marked DBS application for VL 21

22 EasyQ HIV-1 & DBS Several recent peer-reviewed articles have been published on the use of DBS and bmx HIV VL solution. They demonstrate: the advantages of DBS to increase HIV VL accessibility and the performances of EQ HIV1 v2.0 with DBS for HIV VL * Van Deursen et al, JCV, 2010 the advantages of NASBA as compared to RT-PCR techniques for VL quantitation from DBS * Monleau et al, JAC, 2010 (bmx vs biocentric) * Garrido et al, JCM, 2009 (bmx vs Abbott) the performances of EQ HIV v1.1/v1.2 for HIV VL quantitation and infant screening * Johannessen et al, CAD, 2010 (HIV VL in Tanzania) * Leelawiwat et al, JVM, 2010 (HIV VL/infant screening in Thailand) * Lilian et al, JCV, 2010 (HIV infant screening in South Africa) 22

23 Conclusion Improved testing Accessibility and HIV/AIDS patient care Need efficient and rapid implementation of HIV VL and Infant screening from DBS Flexibility of bmx HIV molecular solution Easy adaptation to DBS applications Quality of bmx HIV molecular solution CE-marking of DBS HIV VL application for EasyQ HIV v2.0 accuracy of the results from DBS thanks to the NASBA technology DBS 2 applications Access to viral load testing of patients in remote areas Access to treatment & early detection of treatment failure Access to early diagnosis for infant < 18 months Access to early treatment initiation (*: infant screening must be validated by users) 1 solution* 23

24 24

25 25

26 NucliSENS EasyQ HIV-1 v2.0 Key advantages Internal calibrator in each well increased accuracy High Quality High Flexibility EasyMAG extraction best in class high instrument MTBF robust solution CE-marked DBS application protocol standardization Bench Top instruments adapted to all settings semi-manual (minimag) and automated extraction (EasyMAG), 8 to 200 tests/day/system high run flexibility generic extraction protocols (including DBS), different input volume simple application flexibility 144 results/shift, TAT < 3hrs fast results for patient management Cost control Limited Disposables and waste controlled cost/result Convenient storage conditions and lab space limited impact on lab organization 26

Validation of finger-prick Dried Blood Spot (DBS) for HIV viral load monitoring in a decentralised programme in Thyolo, Malawi

Validation of finger-prick Dried Blood Spot (DBS) for HIV viral load monitoring in a decentralised programme in Thyolo, Malawi Validation of finger-prick Dried Blood Spot (DBS) for HIV viral load monitoring in a decentralised programme in Thyolo, Malawi Dr. Laura Trivino Duran ( MedCo, MSF Malawi ) June 2012 Why do we use Viral

More information

Hepatitis and Retrovirus. LIAISON XL Accurate detection of HIV infection. HIV Ab/Ag FOR OUTSIDE THE US AND CANADA ONLY

Hepatitis and Retrovirus. LIAISON XL Accurate detection of HIV infection. HIV Ab/Ag FOR OUTSIDE THE US AND CANADA ONLY Hepatitis and Retrovirus LIAISON XL Accurate detection of HIV infection HIV Ab/Ag FOR OUTSIDE THE US AND CANADA ONLY LIAISON XL HIV Ab/Ag is Your solution LIAISON XL murex HIV Ab/Ag main features The LIAISON

More information

5èmes journées du Site ANRS-Cameroun Yaoundé, 3-4 juin 2013 ANRS-12235

5èmes journées du Site ANRS-Cameroun Yaoundé, 3-4 juin 2013 ANRS-12235 èmes journées du Site ANRS-Cameroun Yaoundé, -4 juin 201 ANRS-122 Le sang total séché sur papier filtre, DBS (Dried Blood Spot), est-il utilisable pour le suivi virologique en routine des patients VIH+

More information

Technical Brief on HIV Viral Load Technologies. (June 2010)

Technical Brief on HIV Viral Load Technologies. (June 2010) Technical Brief on HIV Viral Load Technologies (June 2010) Foreword Viral load assays have been widely evaluated by research laboratories and the results of the evaluations published in scientific literature;

More information

Introduction. Abstract. Key words. Silvia Bertagnolio 1, Neil T. Parkin 2, Michael Jordan 1,3, James Brooks 4 and J. Gerardo García-Lerma 5 1

Introduction. Abstract. Key words. Silvia Bertagnolio 1, Neil T. Parkin 2, Michael Jordan 1,3, James Brooks 4 and J. Gerardo García-Lerma 5 1 AIDS Rev. 2010;12:195-208 Silvia Bertagnolio, et al.: Dried Blood Spots for HIV-1 Drug Resistance and Viral Load Testing Dried blood spots for HIV-1 Drug Resistance and Viral Load Testing: A Review of

More information

Quantitative HBV DNA measurements and the management of infected health care workers

Quantitative HBV DNA measurements and the management of infected health care workers Quantitative HBV DNA measurements and the management of infected health care workers A.A. van der Eijk Department of Virology, Erasmus MC, Rotterdam, the Netherlands Introduction Worldwide since 1970s,

More information

REAL-TIME PCR KITS FOR DIAGNOSIS

REAL-TIME PCR KITS FOR DIAGNOSIS REAL-TIME PCR KITS FOR DIAGNOSIS 483 Reproducible, Sensitive and Precise Analysis Real Time PCR (qpcr) has revolutionized biological and medical sciences by providing quantitative detection of specific

More information

Mobile Lab-Diagnostik

Mobile Lab-Diagnostik Mobile Lab-Diagnostik Jenaer Technologietag 2013 Alere Technologies GmbH, Jena; 11.11.2013, Torsten Schulz ALERE TECHNOLOGIES Alere Technologies GmbH former CLONDIAG GmbH 1998/1999 Foundation; 2001 first

More information

LIAISON XL HCV Ab Accurate diagnosis of the early stage of HCV infection

LIAISON XL HCV Ab Accurate diagnosis of the early stage of HCV infection Hepatitis and Retrovirus LIAISON XL HCV Ab Accurate diagnosis of the early stage of HCV infection FOR OUTSIDE THE US AND CANADA ONLY LIAISON XL HCV Ab is Your solution LIAISON XL murex HCV Ab main features

More information

LIAISON XL HBsAg Quant

LIAISON XL HBsAg Quant Hepatitis and Retrovirus LIAISON XL HBsAg Quant Reliable detection of HBsAg mutants and genotypes for accurate differential diagnosis of the stage of infection FOR OUTSIDE THE US AND CANADA ONLY LIAISON

More information

Point of Care HIV Viral Load Testing:

Point of Care HIV Viral Load Testing: Point of Care HIV Viral Load Testing: Lesley Scott, Natasha Gous, Shuqi Chen *, Wendy Stevens Department of Molecular Medicine and Haematology University of the Witwatersrand, National Health Laboratory

More information

Molecular Assessment of Dried Blood Spot Quality during Development of a Novel Automated. Screening

Molecular Assessment of Dried Blood Spot Quality during Development of a Novel Automated. Screening Molecular Assessment of Dried Blood Spot Quality during Development of a Novel Automated in situ TREC qpcr Assay for SCID Screening J Bai, T Henry, J Benfer, S Berberich, T Kreman, and L DesJardin State

More information

Diagnosis of HIV Infection in children

Diagnosis of HIV Infection in children Diagnosis of HIV Infection in children by Associate Professor Kulkanya Chokephaibulkit Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University. Topic To Be Discussed WHO Testing

More information

Viral load testing. medical monitoring: viral load testing: 1

Viral load testing. medical monitoring: viral load testing: 1 medical monitoring: viral load testing: 1 medical monitoring: viral load testing Viral load testing medical monitoring: viral load testing: 2 Slide 1 Viral load The viral load test measures HIV in the

More information

Frequently Asked Questions on Xpert MTB/RIF assay

Frequently Asked Questions on Xpert MTB/RIF assay Frequently Asked Questions on Xpert MTB/RIF assay Contents How does the test work?... 2 How was the Xpert MTB/RIF test developed?... 2 What is the public health significance?... 2 What does it cost?...

More information

HIV Testing. Conventional laboratory tests and some new developments Molecular Diagnosis

HIV Testing. Conventional laboratory tests and some new developments Molecular Diagnosis HIV Testing Conventional laboratory tests and some new developments Molecular Diagnosis NSW State Reference Laboratory for HIV Centre for Applied Medical Research St Vincent s Hospital Sydney This presentation

More information

RealLine HCV PCR Qualitative - Uni-Format

RealLine HCV PCR Qualitative - Uni-Format Instructions for use PCR KIT FOR EXTRACTION OF RNA AND REAL TIME PCR DETECTION KIT FOR HEPATITIS C VIRUS RNA Research Use Only Qualitative Uni Format VBD0798 48 tests valid from: December 2013 Rev11122013

More information

HIV Laboratory Testing: a Resource for Health Professionals

HIV Laboratory Testing: a Resource for Health Professionals HIV Laboratory Testing: a Resource for Health Professionals Table of Contents Overview... 2 Window Periods and HIV Testing...2 Current HIV Testing System at Provincial Public Health Reference Laboratory...3

More information

Access to current products and innovation for the future. WHO & UNAIDS Annual Consultation 31 Oct-1 Nov 2011

Access to current products and innovation for the future. WHO & UNAIDS Annual Consultation 31 Oct-1 Nov 2011 Access to current products and innovation for the future WHO & UNAIDS Annual Consultation 31 Oct-1 Nov 2011 Specifications for resource-limited settings Affordable Effective (patients generally arrive

More information

RealStar HBV PCR Kit 1.0 11/2012

RealStar HBV PCR Kit 1.0 11/2012 RealStar HBV PCR Kit 1.0 11/2012 RealStar HBV PCR Kit 1.0 For research use only! (RUO) Product No.: 201003 96 rxns INS-201000-GB-02 Store at -25 C... -15 C November 2012 altona Diagnostics GmbH Mörkenstraße

More information

Coding and Billing for HIV Services in Healthcare Facilities

Coding and Billing for HIV Services in Healthcare Facilities P a g e 1 Coding and Billing for HIV Services in Healthcare Facilities The Hawai i State Department of Health STD/AIDS Prevention Branch is pleased to provide you information on billing and reimbursement

More information

Evaluation of Blood Screening Nucleic Acid Tests (NAT) for Detection of Various HCV and HIV Genotypes

Evaluation of Blood Screening Nucleic Acid Tests (NAT) for Detection of Various HCV and HIV Genotypes Evaluation of Blood Screening Nucleic Acid Tests (NAT) for Detection of Various HCV and HIV Genotypes Authors Boston Biomedica, Inc. Barbara J. Weiblen Alan Doty Sylvia Crush-Stanton Mark Manak Roche Yanfeng

More information

Molecular Diagnosis of Hepatitis B and Hepatitis D infections

Molecular Diagnosis of Hepatitis B and Hepatitis D infections Molecular Diagnosis of Hepatitis B and Hepatitis D infections Acute infection Detection of HBsAg in serum is a fundamental diagnostic marker of HBV infection HBsAg shows a strong correlation with HBV replication

More information

VALIDATION AND VERIFICATION OF DIAGNOSTIC TESTS IN VETERINARY MEDICINE

VALIDATION AND VERIFICATION OF DIAGNOSTIC TESTS IN VETERINARY MEDICINE VALIDATION AND VERIFICATION OF DIAGNOSTIC TESTS IN VETERINARY MEDICINE Life Sciences Quality Managers Forum Wednesday, 24 25 June 2014, West Lindfield NSW axel.colling@csiro.au New OIE prescribed tests

More information

BEIPH Final Report. QCMD 2010 Hepatitis B Virus DNA (HBVDNA10A) EQA Programme. William G MacKay on behalf of QCMD and its Scientific Council July 2010

BEIPH Final Report. QCMD 2010 Hepatitis B Virus DNA (HBVDNA10A) EQA Programme. William G MacKay on behalf of QCMD and its Scientific Council July 2010 QUALITY CONTROL for MOLECULAR DIAGNOSTICS The Altum Building, Todd Campus, West of Scotland Science Park, Glasgow, G20 0XA Scotland Tel: +44 (0) 141 945 6474 Fax: +44 (0) 141 945 5795 www.qcmd.org info@qcmd.org

More information

Suggested Reporting Language for the HIV Laboratory Diagnostic Testing Algorithm

Suggested Reporting Language for the HIV Laboratory Diagnostic Testing Algorithm Suggested Reporting Language for the HIV Laboratory Diagnostic Testing Algorithm November 2013 Introduction In March 2010, the Centers for Disease Control and Prevention (CDC) and the Association of Public

More information

Viral Hepatitis Case Report

Viral Hepatitis Case Report Page 1 of 9 Viral Hepatitis Case Report Perinatal Hepatitis B Virus Infection Michigan Department of Community Health Communicable Disease Division Investigation Information Investigation ID Onset Date

More information

Early detection of HIV infection in infants and children

Early detection of HIV infection in infants and children Early detection of HIV infection in infants and children Guidance note on the selection of technology for the early diagnosis of HIV in infants and children Summary of recommendations Because of the high

More information

Dosaggi Sierologici e Molecolari nelle Epatiti B e C METODI MOLECOLARI. Ombretta Turriziani Dipartimento di Medicina Molecolare

Dosaggi Sierologici e Molecolari nelle Epatiti B e C METODI MOLECOLARI. Ombretta Turriziani Dipartimento di Medicina Molecolare Dosaggi Sierologici e Molecolari nelle Epatiti B e C METODI MOLECOLARI Ombretta Turriziani Dipartimento di Medicina Molecolare Dosaggi Sierologici e Molecolari nelle Epatiti B e C Molecular Methods Key

More information

Pitfalls of PCR diagnosis of viral infections

Pitfalls of PCR diagnosis of viral infections Pitfalls of PCR diagnosis of viral infections David Whiley Queensland Paediatric Infectious Diseases Laboratory, QCMRI & SASVRC, Royal Children's Hospital, Brisbane. PCR & viral infections PCR technology

More information

NS5B Sequencing and Phenotypic Resistance Assays for HCV Subtypes 1a and 1b

NS5B Sequencing and Phenotypic Resistance Assays for HCV Subtypes 1a and 1b NS5B Sequencing and Phenotypic Resistance Assays for HCV Subtypes 1a and 1b 5th Intl. Workshop on Hepatitis C Resistance & New Compounds Jacqueline Reeves NS5B Resistance Assays for HCV Subtypes 1a and

More information

Dengue Virus Serology Testing

Dengue Virus Serology Testing Dengue Virus Serology Testing 40% of the world s population is at risk of dengue infection Focus Diagnostics has been a leader in the development of infectious disease immunology assays for more than 25

More information

FEDERAL PUBLIC SERVICE, HEALTH, FOOD CHAIN SECURITY AND ENVIRONMENT CLINICAL BIOLOGY COMMISSION CLINICAL BIOLOGY SECTION

FEDERAL PUBLIC SERVICE, HEALTH, FOOD CHAIN SECURITY AND ENVIRONMENT CLINICAL BIOLOGY COMMISSION CLINICAL BIOLOGY SECTION IPH J. Wytsmanstreet 14 B-1050 Brussels FEDERAL PUBLIC SERVICE, HEALTH, FOOD CHAIN SECURITY AND ENVIRONMENT CLINICAL BIOLOGY COMMISSION CLINICAL BIOLOGY SECTION External Quality Assessment for Molecular

More information

Anti-Treponema Syphilis IgM. Cat # 1464Z

Anti-Treponema Syphilis IgM. Cat # 1464Z DIAGNOSTIC AUTOMATION, INC. 23961 Craftsman Road, Suite D/E/F, Calabasas, CA 91302 Tel: (818) 591-3030 Fax: (818) 591-8383 onestep@rapidtest.com technicalsupport@rapidtest.com www.rapidtest.com See external

More information

Case Finding for Hepatitis B and Hepatitis C

Case Finding for Hepatitis B and Hepatitis C Case Finding for Hepatitis B and Hepatitis C John W. Ward, M.D. Division of Viral Hepatitis Centers for Disease Control and Prevention Atlanta, Georgia, USA Division of Viral Hepatitis National Center

More information

Clinical Evaluation of the Bio-Rad Geenius HIV 1/2 Supplemental Assay. Paul D. Swenson, Ph.D. Laboratory Director Public Health Seattle & King County

Clinical Evaluation of the Bio-Rad Geenius HIV 1/2 Supplemental Assay. Paul D. Swenson, Ph.D. Laboratory Director Public Health Seattle & King County Clinical Evaluation of the Bio-Rad Geenius HIV 1/2 Supplemental Assay Paul D. Swenson, Ph.D. Laboratory Director Public Health Seattle & King County HIV in the United States 1.1 million persons living

More information

Laboratory Considerations for Use of Cepheid Xpert MTB/RIF Assay

Laboratory Considerations for Use of Cepheid Xpert MTB/RIF Assay Fact sheet: cepheid xpert mtb/rif assay November 2013 Laboratory Considerations for Use of Cepheid Xpert MTB/RIF Assay This document is intended to guide laboratories on integrating the Cepheid Xpert MTB/RIF

More information

Laboratory Challenges to Viral Load Implementation in Resource-Limited Settings. 5 May, 2014 Lusaka, Zambia

Laboratory Challenges to Viral Load Implementation in Resource-Limited Settings. 5 May, 2014 Lusaka, Zambia Laboratory Challenges to Viral Load Implementation in Resource-Limited Settings 5 May, 2014 Lusaka, Zambia Many African countries are considering greater viral load use in public ART programs Mali Viral

More information

Antiretroviral therapy for HIV infection in infants and children: Towards universal access

Antiretroviral therapy for HIV infection in infants and children: Towards universal access Antiretroviral therapy for HIV infection in infants and children: Towards universal access Executive summary of recommendations Preliminary version for program planning 2010 Executive summary Tremendous

More information

WHO/HIVRESNET HIV DRUG RESISTANCE LABORATORY STRATEGY

WHO/HIVRESNET HIV DRUG RESISTANCE LABORATORY STRATEGY WHO/HIVRESNET HIV DRUG RESISTANCE LABORATORY STRATEGY JULY, 2010 1 Table of Contents Abbreviations... 4 1. WHO/HIVResNet Global HIV Drug Resistance Strategy... 5 1.1. NATIONAL HIVDR WORKING GROUP...6 1.2.

More information

An Overview of NYS Hepatitis C Testing Law. Statewide Stakeholder Meetings

An Overview of NYS Hepatitis C Testing Law. Statewide Stakeholder Meetings An Overview of NYS Hepatitis C Testing Law Statewide Stakeholder Meetings Agenda Overview of Hepatitis C virus (HCV) CDC HCV screening recommendations Review of HCV screening and diagnostic tests CDC HCV

More information

Treatment Action Campaign UNDETECTABLE HOW VIRAL LOAD MONITORING CAN IMPROVE HIV TREATMENT IN DEVELOPING COUNTRIES. www.msfaccess.

Treatment Action Campaign UNDETECTABLE HOW VIRAL LOAD MONITORING CAN IMPROVE HIV TREATMENT IN DEVELOPING COUNTRIES. www.msfaccess. Treatment Action Campaign UNDETECTABLE HOW VIRAL LOAD MONITORING CAN IMPROVE HIV TREATMENT IN DEVELOPING COUNTRIES www.msfaccess.org Table of Contents 3 Executive Summary 4 Introduction 5 MSF HIV/AIDS

More information

TRANSFER OF HIV MONITORING TECHNOLOGIES INTO RESOURCE-POOR SETTINGS: MOVING THE FIELD FORWARD

TRANSFER OF HIV MONITORING TECHNOLOGIES INTO RESOURCE-POOR SETTINGS: MOVING THE FIELD FORWARD TRANSFER OF HIV MONITORING TECHNOLOGIES INTO RESOURCE-POOR SETTINGS: MOVING THE FIELD FORWARD REPORT OF A FORUM FOR COLLABORATIVE HIV RESEARCH WORKSHOP FEBRUARY 26, 2005; WASHINGTON DC FORUM FOR COLLABORATIVE

More information

MagNA Pure 96 System. Nucleic Acid Purification with Real High Throughput

MagNA Pure 96 System. Nucleic Acid Purification with Real High Throughput MagNA Pure 96 System Nucleic Acid Purification with Real High Throughput The MagNA Pure 96 System purifies DNA, RNA, and viral nucleic acids from a wide range of starting materials using magnetic glass

More information

Viral Hepatitis. 2009 APHL survey report

Viral Hepatitis. 2009 APHL survey report Issues in Brief: viral hepatitis testing Association of Public Health Laboratories May Viral Hepatitis Testing 9 APHL survey report In order to characterize the role that the nation s public health laboratories

More information

STANDARD OPERATING PROCEDURE

STANDARD OPERATING PROCEDURE TAKING BLOOD FROM INFANTS FOR THE HIV DNA PCR TEST STANDARD OPERATING PROCEDURE ACRONYMS ARV CCMT DBS Antiretrovirals Comprehensive care, management and treatment Dried blood spots This Standard Operating

More information

Detection of Multiple Double-Stranded DNA Viruses after Cord Blood Transplantation is Frequent and Persistent

Detection of Multiple Double-Stranded DNA Viruses after Cord Blood Transplantation is Frequent and Persistent Detection of Multiple Double-Stranded DNA Viruses after Cord Blood Transplantation is Frequent and Persistent Joshua A Hill, MD Bryan Mayer, PhD Hu Xie, MS Wendy Leisenring, PhD Filippo Milano, MD Meei-Li

More information

EZValidation Online Tool. The easy way to apply guidelines. The EZValidation Online Tool. The implementation of new tests

EZValidation Online Tool. The easy way to apply guidelines. The EZValidation Online Tool. The implementation of new tests The implementation of new tests The EZValidation Online Tool Since 999, AcroMetrix has provided quality control requires validation or verification studies that meet is a comprehensive tool specifically

More information

ONE WORKFLOW. ONE PARTNER. ACTIONABLE INSIGHTS. Sample to Insight

ONE WORKFLOW. ONE PARTNER. ACTIONABLE INSIGHTS. Sample to Insight ONE WORKFLOW. ONE PARTNER. ACTIONABLE INSIGHTS. Sample to Insight (NGS) Nucleic Acid More actionable data and insights in one go. More confidence at one glance. A small step for you, a giant leap for your

More information

HIV testing. Authors Brian Eley: James Nuttall: Contributing authors Reené Naidoo Patti Apolles

HIV testing. Authors Brian Eley: James Nuttall: Contributing authors Reené Naidoo Patti Apolles Authors Brian Eley: Brian.Eley@uct.ac.za James Nuttall: James.Nuttall@uct.ac.za Contributing authors Reené Naidoo Patti Apolles HIV testing Posted 30 June 2011 Introduction Testing of children for HIV

More information

bitter is de pil Linos Vandekerckhove, MD, PhD

bitter is de pil Linos Vandekerckhove, MD, PhD 4//24 Current HIV care HIV copies/ ml plasma Viral load Welcome to the Digital droplet PCR age! bitter is de pil Linos Vandekerckhove, MD, PhD Latent HIV reservoir Time at Ghent University Hospital 2 HIV

More information

Challenges in Implementing HIV Load Testing in South Africa

Challenges in Implementing HIV Load Testing in South Africa SUPPLEMENT ARTICLE Challenges in Implementing HIV Load Testing in South Africa Wendy S. Stevens 1 and Theresa M. Marshall 2 1 Department of Molecular Medicine and Haematology and 2 National Institute for

More information

cobas s 201 system The first multi-dye NAT screening system

cobas s 201 system The first multi-dye NAT screening system cobas s 201 system The first multi-dye NAT screening system cobas s 201 system Making NAT screening easy A complete NAT system with state-of-the-art components: Automated real-time PCR, with multi-dye

More information

Guidance on supply chain planning for implementation of Prevention of Mother to Child Transmission (PMTCT) of HIV infection

Guidance on supply chain planning for implementation of Prevention of Mother to Child Transmission (PMTCT) of HIV infection Guidance on supply chain planning for implementation of Prevention of Mother to Child Transmission (PMTCT) of HIV infection 1. Objective This document outlines general principles for program and supply

More information

INTERPRETATION INFORMATION SHEET

INTERPRETATION INFORMATION SHEET Creative Testing Solutions 2424 West Erie Dr. 2205 Highway 121 10100 Martin Luther King Jr. St. No. Tempe, AZ 85282 Bedford, TX 76021 St. Petersburg, FL 33716 INTERPRETATION INFORMATION SHEET Human Immunodeficiency

More information

Diagnosis of HIV infection in children

Diagnosis of HIV infection in children Diagnosis of HIV infection in children James Nuttall Paediatric Infectious Diseases Unit Red Cross Children s Hospital Basics of PaediatricHIV Prevention and Care, 18-19 April 2012, Upper Eastside Hotel,

More information

FULLY AUTOMATED AND VALIDATED HIGH VOLUME DNA EXTRACTION USING CHEMAGEN MAGNETIC BEADS BASED KITS

FULLY AUTOMATED AND VALIDATED HIGH VOLUME DNA EXTRACTION USING CHEMAGEN MAGNETIC BEADS BASED KITS FULLY AUTOMATED AND VALIDATED HIGH VOLUME DNA EXTRACTION USING CHEMAGEN MAGNETIC BEADS BASED KITS Tom Janssens & Ivo Salden UZ Gasthuisberg, Center for Human Genetics, Leuven Perkin Elmer Webinar 27th

More information

BLOOD SAMPLE PREPARATION

BLOOD SAMPLE PREPARATION BLOOD SAMPLE PREPARATION The New Standard in RNA Purification, Best-in-Class, Pure & Simple Purification of inhibitor-free RNA, microrna and genomic DNA for any application An ISO 13485:2003, ISO 9001:2008

More information

Samsung POINT OF CARE Systems - Cardiac/Acute Care Biomarkers LABGEO IB Clinical Chemistry Analytes LABGEO PT

Samsung POINT OF CARE Systems - Cardiac/Acute Care Biomarkers LABGEO IB Clinical Chemistry Analytes LABGEO PT Samsung POINT OF CARE Systems - Cardiac/Acute Care Biomarkers LABGEO IB Clinical Chemistry Analytes LABGEO PT Alexander Belenky, PhD Director -Product Development Samsung - Nexus-Dx Edward Brennan, PhD

More information

The technician from the Central Lab came in with these Western blot results:

The technician from the Central Lab came in with these Western blot results: Scenario 4: Mysterious HIV Algorithm Results Materials and Directions: ASPIRE Follow-Up Algorithm COBAS AmpliPrep/COBAS TaqMan HIV-1 Test Error Codes Appendix Scenarios: Read and complete each part separately.

More information

IMPLEMENTING HIV VIRAL LOAD TESTING

IMPLEMENTING HIV VIRAL LOAD TESTING INTERIM TECHNICAL UPDATE TECHNICAL AND OPERATIONAL CONSIDERATIONS FOR IMPLEMENTING HIV VIRAL LOAD TESTING JULY 2014 ACCESS TO HIV DIAGNOSTICS WHO Library Cataloguing-in-Publication Data: Technical and

More information

The clearest path to the most meaningful results The cobas HPV Test delivers clinical value with workflow efficiencies every step of the way

The clearest path to the most meaningful results The cobas HPV Test delivers clinical value with workflow efficiencies every step of the way The clearest path to the most meaningful results The cobas HPV Test delivers clinical value with workflow efficiencies every step of the way The cobas HPV Test KNOW THE RISK Help guide clinical decision

More information

IMPLEMENTING HIV VIRAL LOAD TESTING

IMPLEMENTING HIV VIRAL LOAD TESTING INTERIM TECHNICAL UPDATE TECHNICAL AND OPERATIONAL CONSIDERATIONS FOR IMPLEMENTING HIV VIRAL LOAD TESTING JULY 2014 ACCESS TO HIV DIAGNOSTICS WHO Library Cataloguing-in-Publication Data: Technical and

More information

Early infant diagnosis of HIV infection in South Africa: 2008 to 2010

Early infant diagnosis of HIV infection in South Africa: 2008 to 2010 Early infant diagnosis of HIV infection in South Africa: 28 to 21 Gayle Sherman a,b*, Rivka Lilian b a National Health Laboratory Service and Department of Molecular Medicine and Haematology, University

More information

Creating Standard Curves with Genomic DNA or Plasmid DNA Templates for Use in Quantitative PCR

Creating Standard Curves with Genomic DNA or Plasmid DNA Templates for Use in Quantitative PCR Creating Standard Curves with Genomic DNA or Plasmid DNA Templates for Use in Quantitative PCR Overview Genomic DNA (gdna) and plasmids containing cloned target sequences are commonly used as standards

More information

Management of infants born to an HIV Positive Mother

Management of infants born to an HIV Positive Mother SOUTHERN WEST MIDLANDS NEWBORN NETWORK Hereford, Worcester, Birmingham, Sandwell & Solihull Title Management of infants born to an HIV Positive Mother Author Dr Steve Welch Date Guideline Agreed: May 2009

More information

HBV DNA < monitoring interferon Rx

HBV DNA < monitoring interferon Rx Hepatitis B Virus Suspected acute hepatitis >>Order: Acute Unknown hepatitis screen Suspected chronic hepatitis >>Order: Chronic unknown hepatitis screen Acute HBV or Delayed Anti HBs response after acute

More information

Introduction To Real Time Quantitative PCR (qpcr)

Introduction To Real Time Quantitative PCR (qpcr) Introduction To Real Time Quantitative PCR (qpcr) SABiosciences, A QIAGEN Company www.sabiosciences.com The Seminar Topics The advantages of qpcr versus conventional PCR Work flow & applications Factors

More information

LightCycler 480 Real-Time PCR System: Innovative Solutions for High-Throughput PCR

LightCycler 480 Real-Time PCR System: Innovative Solutions for High-Throughput PCR LightCycler 480 Real-Time PCR System: Innovative Solutions for High-Throughput PCR Options for High-Throughput PCR Robotics Automated plate loading Ready-to-use and stable reagents Increasing throughput

More information

Real-Time PCR Vs. Traditional PCR

Real-Time PCR Vs. Traditional PCR Real-Time PCR Vs. Traditional PCR Description This tutorial will discuss the evolution of traditional PCR methods towards the use of Real-Time chemistry and instrumentation for accurate quantitation. Objectives

More information

VIH/SIDA en Pediatría: Epidemiología Mundial, Transmisión Perinatal, Manejo Integral.

VIH/SIDA en Pediatría: Epidemiología Mundial, Transmisión Perinatal, Manejo Integral. VIH/SIDA en Pediatría: Epidemiología Mundial, Transmisión Perinatal, Manejo Integral. Juan Carlos Salazar, M.D. Universidad de Connecticut, EE.UU. End-1998 global estimates Children (

More information

Early Infant Diagnosis Data Transmission System Using Mobile Phones in Zimbabwe

Early Infant Diagnosis Data Transmission System Using Mobile Phones in Zimbabwe Early Infant Diagnosis Data Transmission System Using Mobile Phones in Zimbabwe 5-7 May, 2015 9th INTEREST Workshop Harare, Zimbabwe Henry Chidawanyika, MSc hchidawanyika@zimhisp.rti.org Rita Sembajwe,

More information

HIV-1 Load Comparison Using Four Commercial Real-Time Assays

HIV-1 Load Comparison Using Four Commercial Real-Time Assays JOURNAL OF CLINICAL MICROBIOLOGY, Jan. 2011, p. 292 297 Vol. 49, No. 1 0095-1137/11/$12.00 doi:10.1128/jcm.01688-10 Copyright 2011, American Society for Microbiology. All Rights Reserved. HIV-1 Load Comparison

More information

Application Guide... 2

Application Guide... 2 Protocol for GenomePlex Whole Genome Amplification from Formalin-Fixed Parrafin-Embedded (FFPE) tissue Application Guide... 2 I. Description... 2 II. Product Components... 2 III. Materials to be Supplied

More information

BD Affirm VPIII. Microbial Identification System

BD Affirm VPIII. Microbial Identification System BD Affirm VPIII Microbial Identification System The Only Diagnostic Test that Differentiates and Identifies 3 Vaginitis Pathogens from a Single Sample, with DNA Certainty. Translating the power and the

More information

Coding guide for routine HIV testing in health care settings

Coding guide for routine HIV testing in health care settings Coding guide f routine HIV testing in health care settings Background In September of 2006, CDC issued recommendations f Human immunodeficiency virus (HIV) testing in health care settings. The Revised

More information

HISTO TYPE SSP Immunogenetic Diagnostics. Robust and fast - validated Taq Polymerase included

HISTO TYPE SSP Immunogenetic Diagnostics. Robust and fast - validated Taq Polymerase included HISTO TYPE SSP Immunogenetic Diagnostics Robust and fast - validated Taq Polymerase included BAG Health Care the experts for HLA and blood group diagnostics HISTO TYPE SSP Diagnostics Highly standardised

More information

ncounter Leukemia Fusion Gene Expression Assay Molecules That Count Product Highlights ncounter Leukemia Fusion Gene Expression Assay Overview

ncounter Leukemia Fusion Gene Expression Assay Molecules That Count Product Highlights ncounter Leukemia Fusion Gene Expression Assay Overview ncounter Leukemia Fusion Gene Expression Assay Product Highlights Simultaneous detection and quantification of 25 fusion gene isoforms and 23 additional mrnas related to leukemia Compatible with a variety

More information

In vitro Device Regulation

In vitro Device Regulation In vitro Device Regulation Molecular Pathologists Reagent (Analyte) Manufacturers High Complexity Clinical Labs Commercial Academic in Vitro Diagnostics Manufacturers Drug Developers large & small 2 States

More information

The GeneAmp PCR System 9700. Results you can trust. A PCR platform you can grow with. GeneAmp. PCR System 9700

The GeneAmp PCR System 9700. Results you can trust. A PCR platform you can grow with. GeneAmp. PCR System 9700 The GeneAmp PCR System 9700 Results you can trust. A PCR platform you can grow with. GeneAmp PCR System 9700 The GeneAmp PCR System 9700 fits your lab bench, your applications and your budget. The GeneAmp

More information

Definition of Minimum Performance Requirements for Analytical Methods of GMO Testing European Network of GMO Laboratories (ENGL)

Definition of Minimum Performance Requirements for Analytical Methods of GMO Testing European Network of GMO Laboratories (ENGL) Definition of Minimum Performance Requirements for Analytical Methods of GMO Testing European Network of GMO Laboratories (ENGL) 13 October 2008 Date of application: 13 April 2009 INTRODUCTION The scope

More information

4A. Types of Laboratory Tests Available and Specimens Required. Three main types of laboratory tests are used for diagnosing CHIK: virus

4A. Types of Laboratory Tests Available and Specimens Required. Three main types of laboratory tests are used for diagnosing CHIK: virus 4. LABORATORY 4A. Types of Laboratory Tests Available and Specimens Required Three main types of laboratory tests are used for diagnosing CHIK: virus isolation, reverse transcriptase-polymerase chain reaction

More information

Viral Safety of Plasma-Derived Products

Viral Safety of Plasma-Derived Products Viral Safety of Plasma-Derived Products SLIDE 1 This presentation will cover viral validation studies for plasma-derived products. FDA requires that the manufacturing process for biopharmaceutical products

More information

in hiv diagnostics the role of phls

in hiv diagnostics the role of phls Issues in Brief: HIV Diagnostics UPDATE Association of Public Health Laboratories August 2011 Conference calls Focus on New trends in hiv diagnostics the role of phls In February 2011, the Association

More information

HPV DNA Testing: Clinical vs. Analytical Sensitivity

HPV DNA Testing: Clinical vs. Analytical Sensitivity HPV DNA Testing: Clinical vs. Analytical Sensitivity The digene HPV Test Sample & Assay Technologies How to validate an HPV test for optimal clinical performance Clinical sensitivity more accurately represents

More information

how low can we go? in Low- and Middle-Income Countries

how low can we go? in Low- and Middle-Income Countries ISSUE BRIEF Médecins Sans Frontières ACCESS CAMPAIGN how low can we go? Pricing for HIV Viral Load Testing in Low- and Middle-Income Countries Viral load testing is the gold standard in HIV treatment monitoring

More information

HCA Connect Users Guide

HCA Connect Users Guide HCA Connect Users Guide For Testing & Treatment Site Users Release Date: 6/5/2015 Revised: 08/30/2016 1 P a g e Hep C Training Brochure For Testing & Treatment Site Users https://hcaconnect.net/openemr/

More information

Assay Migration Studies for In Vitro Diagnostic Devices Guidance for Industry and FDA Staff

Assay Migration Studies for In Vitro Diagnostic Devices Guidance for Industry and FDA Staff Assay Migration Studies for In Vitro Diagnostic Devices Guidance for Industry and FDA Staff Document issued on: April 25, 2013 The draft of this document was issued on January 5, 2009. For questions regarding

More information

Regulatory Issues for Rapid Tests in the U.S.

Regulatory Issues for Rapid Tests in the U.S. Regulatory Issues for Rapid Tests in the U.S. 2nd International Workshop Accessible and Quality Assured In Vitro Diagnostic Tests for Public Health Programs November 19, 2012 Elliot P. Cowan, Ph.D. Disclaimer

More information

The EliA System Time for the essentials Cost efficient and flexible A boost in service for your laboratory and your clinicians

The EliA System Time for the essentials Cost efficient and flexible A boost in service for your laboratory and your clinicians CCP The EliA System Time for the essentials completely automated (true walk-away, overnight runs) easy instrument management by Phadia Data Manager (IDM) software barcode-reader protocols, QC and raw data

More information

Laboratory diagnosis of HIV infection

Laboratory diagnosis of HIV infection 14 Laboratory diagnosis of HIV infection Kamal Kishore Head of Department of Health Sciences Associate Professor in Medical Microbiology Fiji School of Medicine, Fiji Philip Cunningham Chief Operating

More information

Verification/Validation of Non- FDA Approved Tests

Verification/Validation of Non- FDA Approved Tests Verification/Validation of Non- FDA Approved Tests Michael Loeffelholz, Ph.D. ABMM Professor, Dept. Pathology Director, Clinical Microbiology Laboratory University of Texas Medical Branch, Galveston 1

More information

Overview of HIV Testing

Overview of HIV Testing Overview of HIV Testing Mark Gilbert, MD Director, Applied Epidemiology Unit Ontario HIV Treatment Network October 26 2015 Harm Reduction Conference Objectives To answer the following questions: 1. What

More information

Branched DNA Technology in Molecular Diagnostics

Branched DNA Technology in Molecular Diagnostics Microbiology and Infectious Disease / BRANCHED DNA DIAGNOSTICS Branched DNA Technology in Molecular Diagnostics Gregory J. Tsongalis, PhD Key Words: Microbiology; Virology; Molecular diagnostics DOI: 10.1309/90BU6KDXANFLN4RJ

More information

CLINICAL PRACTICE DIAGNOSTIC TESTING. Approved: Department Director, Senior Leader. Ernest Holburt, Medical Director, Approval Date: 5/9/2012

CLINICAL PRACTICE DIAGNOSTIC TESTING. Approved: Department Director, Senior Leader. Ernest Holburt, Medical Director, Approval Date: 5/9/2012 CLINICAL PRACTICE DIAGNOSTIC TESTING Approved: Department Director, Senior Leader Ernest Holburt, Medical Director, Policy Policy & Procedure Standardized Procedure Approval Date: 5/9/2012 Issued: 7/2005

More information

Quantifiler Human DNA Quantification Kit Quantifiler Y Human Male DNA Quantification Kit

Quantifiler Human DNA Quantification Kit Quantifiler Y Human Male DNA Quantification Kit Product Bulletin Human Identification Quantifiler Human DNA Quantification Kit Quantifiler Y Human Male DNA Quantification Kit The Quantifiler kits produce reliable and reproducible results, helping to

More information

Specimen and Data Repository for TB Diagnostic Research in Children. Sharon Nachman SUNY Stony Brook

Specimen and Data Repository for TB Diagnostic Research in Children. Sharon Nachman SUNY Stony Brook Specimen and Data Repository for TB Diagnostic Research in Children Sharon Nachman SUNY Stony Brook Why have repositories? We need to develop a prospective system that will allow for collection of data

More information

Routine HIV Monitoring

Routine HIV Monitoring Routine HIV Monitoring Guideline of the HIV/AIDS Division at San Francisco General Hospital Statement of Guideline: Patients will be routinely evaluated and monitored for HIV parameters, antiretroviral

More information

Anti-Treponema Syphilis IgM Cat # 1464Z

Anti-Treponema Syphilis IgM Cat # 1464Z DIAGNOSTIC AUTOMATION, INC. 23961 Craftsman Road, Suite E/F, Calabasas, CA 91302 Tel: (818) 591-3030 Fax: (818) 591-8383 onestep@rapidtest.com technicalsupport@rapidtest.com www.rapidtest.com See external

More information

Document title: Hepatitis B Neonatal and Infant Protocols. Verified by: Matthew Dominey, Screening and Immunisation Manager

Document title: Hepatitis B Neonatal and Infant Protocols. Verified by: Matthew Dominey, Screening and Immunisation Manager South West PHE Screening and Immunisation Team Good Practice Guidance for the management of the NHS Hepatitis B Neonatal and Infant Immunisation Programme Document title: Hepatitis B Neonatal and Infant

More information