Trends in molecular diagnostics

Size: px
Start display at page:

Download "Trends in molecular diagnostics"

Transcription

1 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 mutations associated with disease outcome Hepatitis C genotype HIV drug resistance genotype Host genetic factors Thrombophilia CyP450 drug metabolism HLA type

2 Key developments Technology Uptake in diagnostic arena Alternative methods to PCR SDA, TMA, LCR, NASBA, bdna Availability of Analyte Specific Reagents (ASR) Trend to real time or kinetic formats Automation Contamination and inhibitor control

3 ? What is driving commercial NAT platform development Reduce sources of error Reduce tedious processes Improve time to result Improved analytical range Improve limit of detection Improve specificity

4 Volumetric errors amplified Tedious manual, repetitive Specimen integrity Pre amplification - extraction

5

6 Post amplification & detection Endpoint detection Volumetric error Fragment size vs. probe hybridisation Time to result Automation calibration issues Result calculations

7 Signal amplification - bdna Comparison of Amplification Methods Virus, bacterium or cell Target RNA or DNA TMA PCR bdna Add primers Add primers & enzymes & enzymes Copies (RNA) 1 detection probe per copy Copies (DNA) 1 detection probe per amplified copy Add probes and branched DNA Multiple detection probes per target HIV, HBV, HCV, CMV Standard curve Amplify signal of label no amplicon issues Overnight High throughput Limited extraction

8 Kinetic / real time product detection

9 Monitoring in Real time Agarose Gel Blotting FRET

10 Real time PCR

11 Real Time PCR with 5 5 Nuclease Assay Product detection during amplification Primer hγ R Q Probe Fluorescence Emission Quenched R Q Q hγ R Fluorescence Emission Detected

12 HIV viral load tests Manufacturer Principle Results Availability Analytical range Roche RT-PCR (gag) copies/ml Widely <50 100,000 (COBAS HIV MONITOR v1.5) (6 hours to result) < ,000 Bayer HIV Branched DNA 3.0 (bdna) (pol) copies./ml (results 2x less than Roche) (36 hours to result) NSW, Vic <50 800,000 Biomerieux HIV-1 QT NASBA (gag) Copies/mL (6 hours to result) NSW <400 1,000,000 <80 500,000 Roche Real time (Taqman) Copies/mL Widely <40 10,000,000 (gag) (4-6 hours to result) Biomerieux EasyQ HIV-1 real time TMA (gag) Copies/mL & IU/mL (4-5 hours to results) 1 lab <40 10,000,000 Abbott Celera Realtime PCR m2000 (pol integrase) copies/ml Widely <40 10,000,000 Artus Realtime PCR Rotorgene Copies/mL Unregistered <40 10,000,000

13 Selected Applications Primary HIV diagnosis & enhanced surveillance Infant HIV diagnosis HIV treatment & progression monitoring

14

15 HIV Testing Direct Detection of Virus p24 antigen detection serology p24 only assays qualitative and quantitative p24 in combination with antibody Serum Virus isolation - culture Nucleic acid detection - (NAT) HIV DNA or RNA? DNA qualitative proviral (cellular) resolution of inconclusive serology diagnosis in infants - maternal antibodies acute infection (pre-seroconversion) RNA quantitative monitoring / serial viral load drug resistance monitoring subtyping treatment and surveillance

16 gp160 gp120 p68 p55 p53 gp41-45 p40 p34 p24 p18 p12 acute established late DNA PCR RNA PCR p24 Ag EIA 3 rd /4 th gen ELISA 1st gen ELISA Incidence EIA 1wk 2wk 3wk 2mo 6mo 1yr 2yr 3yr +8yr

17 Minipool NAT testing in blood donors mini pools of 6 samples each 4 mini pools combined and tested (total = 24 samples in single test)

18 HIV drug resistance testing

19 Breakthrough of resistance

20 DNA sequencing

21

22

23 Neonatal HIV diagnosis

24 Serologic assays Neonatal HIV diagnosis Maternal antibodies persist up to 18 months postpartum Antibody tests not helpful in newborn diagnosis Sero-reversion (pos neg) in serial samples HIV-1 p24 antigen limited value complexed by Ab Virologic assays Virus culture from PBMC Maternal HIV-1 RNA in obstetric setting is useful in predicting risk of perinatal transmission HIV DNA and RNA useful in infant Detection in infant is diagnostic for perinatal HIV infection Useful in timing of transmission (in utero, intrapartum, post partum) Monitoring response to therapy in infected infant

25 48h 14d 1-2mo HIV infection reasonably excluded in non-breast fed infant if negative in 2 or more 1month and 4months 3-6mo 6-12mo >2 negative HIV Ab tests (<1month apart) Loss Ab/ neg DNA = un-infected Infant still Ab+ at 12mo retest 15-18mo >15-18mo Positive 48h (likely intrauterine Infection - early) Positive 14d (likely intrapartum Infection - late) Months post partum HIV RNA/CD HIV Ab+ >18mo = HIV infection? consider cease ZDV px aggressive ARV

26 CASE STUDY

27 BA,RI HIV serology HIV-1/2 Ab/Ag 4 th gen EIA reactive HIV-1/2 3 rd generation EIA - reactive HIV-1/2 rapid test (X2) reactive HIV-1 western blot POSITIVE N P gp160 gp120 p68 p55/51 gp41 p40 HIV direct detection HIV-1 p24 antigen not detected HIV proviral DNA PCR not detected HIV RNA (gag) PCR not detected p34 p24 p18 α-huigg

28 BA,RI 30 y/o African male Ghana Immigration detention centre NSW Heterosexual Exposure FSW 1 year ago Currently 1 1 syphilis Recurrent episodes malaria treated as outpatient several times over last few years

29 What next? Follow up sample and detailed history! HIV serology testing strategies Supplementary EIAs CD4 lymphocyte count 480 (normal) HIV-2 2 serology Negative to specific gp 36 antigens HIV RNA (pol) Not detected by bdna RNA test HIV culture - virus isolation CD8 depleted, IL2 enriched, PHA stimulated PBMC co-culture gp140 gp105 p68 p56 gp36 p34 p26 p16

Complicated viral infections

Complicated viral infections Complicated viral infections Clinical case discussion Diagnostic dilemmas NSW State Reference Laboratory for HIV St Vincent s Hospital Sydney Diagnostic dilemmas Indeterminate or discordant serology (western

More information

Molecular Diagnosis Future Directions

Molecular Diagnosis Future Directions Molecular Diagnosis Future Directions Philip Cunningham NSW State Reference Laboratory for HIV/AIDS & Molecular Diagnostic Medicine Laboratory, SydPath St Vincent s Hospital Sydney Update on Molecular

More information

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) 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

More information

RNA PCR, Proviral DNA and Emerging Trends in Infant HIV Diagnosis

RNA PCR, Proviral DNA and Emerging Trends in Infant HIV Diagnosis RNA PCR, Proviral DNA and Emerging Trends in Infant HIV Diagnosis 1 B R E N D A N M C M U L L A N I N F E C T I O U S D I S E A S E S, S Y D N E Y C H I L D R E N S H O S P I T A L S C H O O L O F W O

More information

HIV Diagnostic Testing

HIV Diagnostic Testing In The name of God HIV Diagnostic Testing By : Dr. Shahzamani PhD of Medical virology Purpose of HIV Testing To identify asymptomatic individuals To diagnose HIV infection in those who practice high risk

More information

2/10/2015. Experiences and opportunities in the use of dried blood spot specimens in resource limited settings. Presentation

2/10/2015. Experiences and opportunities in the use of dried blood spot specimens in resource limited settings. Presentation Presentation Experiences and opportunities in the use of dried blood spot specimens in resource limited settings Why Dried Blood Spots? Screening newborns / childbearing women (EID) Needle Exchange Surveillance

More information

New HIV Tests and Algorithm: A change we can believe in

New HIV Tests and Algorithm: A change we can believe in New HIV Tests and Algorithm: A change we can believe in Esther Babady, PhD, D (ABMM) Memorial Sloan-Kettering Cancer Center New York, New York Learning Objectives After this presentation you should be

More information

HBV PUBLIC HEALTH IMPLICATIONS

HBV PUBLIC HEALTH IMPLICATIONS جزايری دکتر سيد محمد آزمايشگاه ھپاتيت B -دانشکده بھداشت ويروس شناسی- گروه دانشگاه علوم پزشکی تھران کنگره ارتقا کيفيت- ١٣٩٢ HBV PUBLIC HEALTH IMPLICATIONS 2 billion people have been infected by HBV worldwide.

More information

CALIBRATION OF ANALYTICAL STANDARDS FOR HBV-DNA, HCV-RNA AND HIV-1 RNA IN GENOME COPIES BY A REFERENCE METHOD

CALIBRATION OF ANALYTICAL STANDARDS FOR HBV-DNA, HCV-RNA AND HIV-1 RNA IN GENOME COPIES BY A REFERENCE METHOD CALIBRATION OF ANALYTICAL STANDARDS FOR HBV-DNA, HCV-RNA AND HIV-1 RNA IN GENOME COPIES BY A REFERENCE METHOD AAJ van Drimmelen, E.R. Bax and W.G.V. Quint, BioQControl (BQC), Delft Diagnostic Laboratories

More information

WHO recommendations. Diagnostic testing in infants

WHO recommendations. Diagnostic testing in infants WHO recommendations Diagnostic testing in infants Recommendations 2- testing in infants Intervention Reco QoE Comment At or around 6 weeks of age is most efficient time at which to perform a viral test

More information

HIV Update in Laboratory Testing. Patricia Slev, PhD, D(ABCC)

HIV Update in Laboratory Testing. Patricia Slev, PhD, D(ABCC) HIV Update in Laboratory Testing Patricia Slev, PhD, D(ABCC) Objectives Explain the advances in HIV diagnostics, including fourth generation Ag/Ab combination HIV screening assays Describe the new CDC

More information

QUANTITATIVE HIV RNA (VIRAL LOAD)

QUANTITATIVE HIV RNA (VIRAL LOAD) CLINICAL GUIDELINES For use with the UnitedHealthcare Laboratory Benefit Management Program, administered by BeaconLBS QUANTITATIVE HIV RNA (VIRAL LOAD) Policy Number: PDS - 008 Effective Date: October

More information

Micropathology Ltd. University of Warwick Science Park, Venture Centre, Sir William Lyons Road, Coventry CV4 7EZ

Micropathology Ltd. University of Warwick Science Park, Venture Centre, Sir William Lyons Road, Coventry CV4 7EZ www.micropathology.com info@micropathology.com Micropathology Ltd Tel 24hrs: +44 (0) 24-76 323222 Fax / Ans: +44 (0) 24-76 - 323333 University of Warwick Science Park, Venture Centre, Sir William Lyons

More information

CMV Diagnostic Strategies: Current and Future

CMV Diagnostic Strategies: Current and Future CMV Diagnostic Strategies: Current and Future Tony Mazzulli, MD, FRCPC, FACP Microbiologist-in-Chief Mount Sinai Hospital & University Health Network, Toronto Faculty/Presenter Disclosure Relationships

More information

Obstetrics and HIV An Update. Jennifer Van Horn MD University of Utah

Obstetrics and HIV An Update. Jennifer Van Horn MD University of Utah Obstetrics and HIV An Update Jennifer Van Horn MD University of Utah Obstetrics and HIV Perinatal transmission Testing Antiretroviral therapy Antepartum management Intrapartum management Postpartum management

More information

(DNA) Real-time PCR. Exicycler 96 Rotor-Gene Q/6000 PCR

(DNA) Real-time PCR. Exicycler 96 Rotor-Gene Q/6000 PCR Real-Time (DNA) Real-time Exicycler 96 Rotor-Gene Q/6000 IU Mix1 Mix2 IU/μl IU/μl IU/μl IU/μl IU/μl IPC NTC C 1 Lot# 2 Freeze & thawing 1 MSDS: Material Safety Data Sheets (TaqMan Real-time ' FAM ' BHQ1

More information

Non-competitive Internal Control Concept for PCR-based Qualitative Assays

Non-competitive Internal Control Concept for PCR-based Qualitative Assays Christian O. Simon Roche Molecular Diagnostics Rotkreuz, CH Non-competitive Internal Control Concept for PCR-based Qualitative Assays 23 rd SoGAT Meeting, 16 th 17 th April, 2012, Vilnius, Lithuania Design

More information

Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK

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:

More information

Laboratory diagnosis of congenital infections

Laboratory diagnosis of congenital infections Laboratory diagnosis of congenital infections Laboratory diagnosis of HSV Direct staining Tzanck test Immunostaining HSV isolation Serology PCR Tzanck test Cell scrape from base of the lesion smear on

More information

Viral Hepatitis Diagnosis and Management

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

More information

Learning Objectives. New HIV Testing Algorithm from CDC. Overview of HIV infection and disease 3/15/2016

Learning Objectives. New HIV Testing Algorithm from CDC. Overview of HIV infection and disease 3/15/2016 New HIV Testing Algorithm from CDC ASCLS-Michigan March 31, 2016 Dr. Kathleen Hoag Learning Objectives Following attendance and review of material provided, attendees will be able to: 1. Describe the new

More information

Biomarkers for Infectious Disease Diagnostics in the Developing World:

Biomarkers for Infectious Disease Diagnostics in the Developing World: Biomarkers for Infectious Disease Diagnostics in the Developing World: Diagnosis of HIV Infection in Infants Less than Eighteen Months of Age Katherine Tynan, Paul Neuwald, Laura Penny, Mickey Urdea, and

More information

Assays to Address Emerging Threats to Blood Safety

Assays to Address Emerging Threats to Blood Safety Assays to Address Emerging Threats to Blood Safety Jeffrey M. Linnen, Ph.D. Director, Product Development Gen-Probe Incorporated San Diego, CA The IPFA/PEI 17th Workshop on Surveillance and Screening of

More information

HUMAN IMMUNODEFICIENCY VIRUS (HIV) NON-IMMEDIATE NOTIFICATION STD PROGRAM. Version

HUMAN IMMUNODEFICIENCY VIRUS (HIV) NON-IMMEDIATE NOTIFICATION STD PROGRAM. Version 1 HUMAN IMMUNODEFICIENCY VIRUS (HIV) NON-IMMEDIATE NOTIFICATION STD PROGRAM Event Name: Event Time Period: ADULT HIV 900 (AIDS.gov 12/31/2015) HIV Lifelong HIV (human immunodeficiency virus) is a retrovirus

More information

Quantification of HBV, HCV genotype and HIV subtype panels

Quantification of HBV, HCV genotype and HIV subtype panels Quantification of HBV, HCV genotype and HIV subtype panels Harry van Drimmelen 1,2, Wim Quint 2, Nico Lelie 3 and the international NAT study group 1. Biologicals Quality Control, 2. DDL Diagnostic Laboratory,

More information

Table of Contents (continued)

Table of Contents (continued) Emerging Molecular and Immunohematology Blood Typing, Grouping And Infectious Disease NAT Screening Assays And Companies Developing New Technologies and Products Table of Contents 1. Blood Typing and Grouping

More information

EC CERTIFICATE. National Institute for Biological Standards and Control (NIBSC) Blanche Lane South Mimms Potters Bar Hertfordshire EN6 3QG UK

EC CERTIFICATE. National Institute for Biological Standards and Control (NIBSC) Blanche Lane South Mimms Potters Bar Hertfordshire EN6 3QG UK 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

More information

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. 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

More information

Simple Solutions for Patient Monitoring. Maximum Flexibility 2 Configuration: 8 to 1000 viral load tests/day 2 Sample: Plasma/DBS

Simple Solutions for Patient Monitoring. Maximum Flexibility 2 Configuration: 8 to 1000 viral load tests/day 2 Sample: Plasma/DBS Simple Solutions for Patient Monitoring What is the interest of having a high level of sensitivity? Higher sensitivity means you are able to offer better patient monitoring, particularly in the low viral

More information

Donor Screening in The Region. Vincini GA NRL, Melbourne, Australia

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

More information

Results of the College of American Pathologists (CAP) Proficiency Program for CMV, EBV, and BKV Viral Load Testing

Results of the College of American Pathologists (CAP) Proficiency Program for CMV, EBV, and BKV Viral Load Testing 2009 College of American Pathologists. The College does not permit reproduction of any substantial portion of the material in this Report without its written authorization. The College hereby authorizes

More information

Laboratory diagnostics CH/HIV/0052/17/10/2017

Laboratory diagnostics CH/HIV/0052/17/10/2017 Laboratory diagnostics CH/HIV/0052/17/10/2017 This slide set was created by ViiV Healthcare GmbH with great care in order to provide balanced information about ViiV products and / or application areas.

More information

Diagnostic Methods of HBV and HDV infections

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

More information

Khalid Alquthami (Correspondence) Regional Lab, Makkah. Saudi Arabia

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

More information

Opportunities Created by Diagnostic HCV and HIV Nucleic Acid Tests

Opportunities Created by Diagnostic HCV and HIV Nucleic Acid Tests Opportunities Created by Diagnostic HCV and HIV Nucleic Acid Tests Ann Winters, MD Medical Director, Viral Hepatitis Program, Bureau of Communicable Disease, New York City Department of Health and Mental

More information

(DNA) Real-time PCR. Exicycler 96 Rotor-Gene Q/6000 PCR

(DNA) Real-time PCR. Exicycler 96 Rotor-Gene Q/6000 PCR Real-Time (DNA) Real-time Exicycler 96 Rotor-Gene Q/6000 IU Mix1 Mix2 IU/μl IU/μl IU/μl IU/μl IU/μl IPC NTC C 1 Lot# 2 Freeze & thawing 1 MSDS: Material Safety Data Sheets Real- (TaqMan time ' FAM ' BHQ1

More information

Laboratory Testing for West Nile Virus Infections Testing Human & Non-Human Tissues

Laboratory Testing for West Nile Virus Infections Testing Human & Non-Human Tissues Laboratory Testing for West Nile Virus Infections Testing Human & Non-Human Tissues Robert S Lanciotti Chief; Diagnostic & Reference Laboratory Arbovirus Diseases Branch Fort Collins, Colorado Presentation

More information

Memo No: Date: 25-Nov NEW Serology and Virology Testing

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

More information

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 Standardization: Calibration of International Standards, reference preparations and working standards Micha Nübling, PEI Paul-Ehrlich-Institut Governmental Authority for biological medicinal products Blood

More information

Adventures in Discordance- HIV Testing

Adventures in Discordance- HIV Testing Anne Gaynor, PhD On behalf of Monica M. Parker, PhD Director, Bloodborne Viruses Laboratory Wadsworth Center, NYSDOH Adventures in Discordance- HIV Testing HIV Laboratory Testing Algorithm HIV-1/2 antigen/antibody

More information

POSITIONING OF TB DX : TIERED SYSTEM, INTEGRATED APPROACH

POSITIONING OF TB DX : TIERED SYSTEM, INTEGRATED APPROACH POSITIONING OF TB DX : TIERED SYSTEM, INTEGRATED APPROACH Akos Somoskövi, M.D., Ph.D. and Giorgio Roscigno, M.D. ANNUAL GLI MEETING, 4 th OCTOBER 2010 MERIEUX FOUNDATION, ANNECY Integrated Laboratory Network

More information

in pregnancy Document Review History Version Review Date Reviewed By Approved By

in pregnancy Document Review History Version Review Date Reviewed By Approved By GYNAECOLOGY/ ANTENATAL CARE WIRRAL WOMEN & CHILDREN S HOSPITAL Guideline No: Hepatitis B management in pregnancy VERSION 1 AMENDMENTS MADE: N/A DATE OF ISSUE: May 2012 DATE OF REVIEW: May 2015 REVIEW INTERVAL:

More information

الحترمونا من خري الدعاء

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

More information

ealth/infectious_diseases/cmv/ Hyde TB et al. (2010) RevMed. Virol.20:

ealth/infectious_diseases/cmv/ Hyde TB et al. (2010) RevMed. Virol.20: Genetic variability of HCMV strains isolated from Polish pregnant women, their fetuses and newborns W. Wujcicka 1, M. Rycel 1, B. Zawilińska 3, E. Paradowska 4, P. Suski 4, Z. Gaj 1, J. Wilczyński 1,2,

More information

Confirmatory Testing Algorithm. Routine Donor Testing Algorithm

Confirmatory Testing Algorithm. Routine Donor Testing Algorithm Confirmatory Testing Algorithm Blood Confirmatory ABO/Rh Beckman Coulter PK-ABO/Rh Immucor NEO ABO/Rh Immucor NEO ABO/Rh Immucor Manual ABO/Rh Typing Immucor Manual ABO/Rh Typing Discrepancy Resolution

More information

ARCHITECT HIV Ag/Ab Combo: Moving HIV Diagnostics Forward in the U.S.

ARCHITECT HIV Ag/Ab Combo: Moving HIV Diagnostics Forward in the U.S. ARCHITECT HIV Ag/Ab Combo: Moving HIV Diagnostics Forward in the U.S. Catherine Brennan, Ph.D. Research Fellow Infectious Diseases Research Abbott Diagnostics 1 Agenda ARCHITECT HIV Ag/Ab Combo Assay What

More information

Calibration and stability of WHO and secondary viral standards

Calibration and stability of WHO and secondary viral standards Calibration and stability of WHO and secondary viral standards Nico Lelie, Harry van Drimmelen and the International NAT Study Group Facilities DDL Diagnostic Laboratories Outline Calibration of WHO and

More information

QUANTITATIVE HIV RNA (VIRAL LOAD)

QUANTITATIVE HIV RNA (VIRAL LOAD) CLINICAL GUIDELINES For use with the UnitedHealthcare Laboratory Benefit Management Program, administered by BeaconLBS QUANTITATIVE HIV RNA (VIRAL LOAD) Policy Number: PDS - 008 Effective Date: January

More information

Experience with Standardisation of Blood Virology NAT. Clare Morris Division of Retrovirology National Institute for Biological Standards and Control

Experience with Standardisation of Blood Virology NAT. Clare Morris Division of Retrovirology National Institute for Biological Standards and Control Experience with Standardisation of Blood Virology NAT Clare Morris Division of Retrovirology National Institute for Biological Standards and Control Background of Blood Virology Standardisation In the

More information

Technical Bulletin No. 162

Technical Bulletin No. 162 CPAL Central Pennsylvania Alliance Laboratory Technical Bulletin No. 162 cobas 6800 HCV Viral Load Assay - New Platform - June 1, 2017 Contact: Heather Habig, MLS (ASCP) CM, MB CM, 717-851-1422 Operations

More information

AccuVert HBV Seroconversion Panel PHM941(M) ( )

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

More information

HEV Assay Development Update

HEV Assay Development Update HEV Assay Development Update Jeffrey M. Linnen, Ph.D. Senior Director, Research & Development Hologic Gen-Probe, San Diego, California USA IPFA/PEI 20th International Workshop on Surveillance and Screening

More information

NAT Screening of Blood Donations in NBC, TRCS

NAT Screening of Blood Donations in NBC, TRCS IPFA/PEI, Italy NAT Screening of Blood Donations in NBC, TRCS 2000-2001 Clinical evaluation using COBAS AmpliiScreen HIV & HCV assays, (MP24) window period rate - 1 : 108,768 for HIV-1 and HCV 2002 Routine

More information

Update from ISS on following EQA studies: ISS EQA Tri-NAT (HCV, HIV and HBV) 2012 ISS EQA NAT HBV 2012 ISS EQA NAT WNV 2012

Update from ISS on following EQA studies: ISS EQA Tri-NAT (HCV, HIV and HBV) 2012 ISS EQA NAT HBV 2012 ISS EQA NAT WNV 2012 Update from ISS on following EQA studies: ISS EQA Tri-NAT (HCV, HIV and HBV) 2012 ISS EQA NAT HBV 2012 ISS EQA NAT WNV 2012 SOGAT XXIV Ljubljana, 8-9 May 2013 2012 ISS EQAs for NAT ISS EQA Tri-NAT (HCV,

More information

Official Journal of the European Communities COMMISSION

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

More information

HEPATITIS B NON-IMMEDIATE NOTIFICATION EPIDEMIOLOGY PROGRAM

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

More information

SEROLOGICAL DIAGNOSIS OF VIRAL INFECTIONS:

SEROLOGICAL DIAGNOSIS OF VIRAL INFECTIONS: SEROLOGICAL DIAGNOSIS OF VIRAL INFECTIONS: POSSIBILITIES OF SEROLOGICAL DIAGNOSIS TYPES OF SEROLOGICAL REACTIONS SEROLOGICAL REACTIONS Ag-Ab reactions used for the detection of unknown Ag or Ab, in vitro

More information

Multiplex-PCR in clinical virology benefits and limitations. Weihenstephan Multiplex-PCR the concept:

Multiplex-PCR in clinical virology benefits and limitations. Weihenstephan Multiplex-PCR the concept: Multiplex-PCR in clinical virology benefits and limitations ans itschko, elga Mairhofer, Anna-Lena Winkler Max von Pettenkofer-Institute Department of Virology Ludwig-Maximilians-University, Munich Weihenstephan

More information

Evaluation of run controls for cobas 6800 MPX and HEV assay

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

More information

HIV-1 Genemer Detection Kit Ready to Use Amplification Kit for HIV-1 Specific DNA Fragment Analysis

HIV-1 Genemer Detection Kit Ready to Use Amplification Kit for HIV-1 Specific DNA Fragment Analysis Product Manual HIV-1 Genemer Detection Kit Ready to Use Amplification Kit for HIV-1 Specific DNA Fragment Analysis For research use only. Not for use in diagnostic procedures for clinical purposes Catalog

More information

Use of Viral Load Testing in Managing CMV Infections in SOTR

Use of Viral Load Testing in Managing CMV Infections in SOTR Use of Viral Load Testing in Managing CMV Infections in SOTR Angela M. Caliendo, MD, PhD, FIDSA Professor and Vice Chair, Medicine Alpert Medical School of Brown University Providence, RI Disclosures Scientific

More information

Ergebnisse der Abfrage zu NAT-only positiven Befunden beim Blutspendescreening (NAT yield) Micha Nübling, PEI

Ergebnisse der Abfrage zu NAT-only positiven Befunden beim Blutspendescreening (NAT yield) Micha Nübling, PEI Ergebnisse der Abfrage zu NAT-only positiven Befunden beim Blutspendescreening (NAT yield) Micha Nübling, PEI NAT for cellular blood components in Germany Definition of minimal NAT sensitivity limit (ID)

More information

Situation of XMRV and Blood Transfusion. Celso Bianco, MD ISBT Working Party on TTID Lisbon, June 19, 2011

Situation of XMRV and Blood Transfusion. Celso Bianco, MD ISBT Working Party on TTID Lisbon, June 19, 2011 Situation of XMRV and Blood Transfusion Celso Bianco, MD ISBT Working Party on TTID Lisbon, June 19, 2011 Lombardi et al. Science 326, 585 (2009) Conclusions: CFS and XMRV XMRV found in 67% of CFS patients

More information

TEST REQUEST INFORMATION- VIROLOGY

TEST REQUEST INFORMATION- VIROLOGY Chlamydia/ Gonorrhea Nucleic Acid Amplification VC75 Qualitative Nucleic Acid Amplification SPECIMEN: Genital swab or first catch urine CONTAINER:GEN-PROBE APTIMA 2 Combo swab transport tube or urine transport

More information

Evaluation of the new Abbott mplus feature: Impact on clinical laboratory efficiencies with Abbott RealTime HIV-1, HCV, HBV and CT/NG assays

Evaluation of the new Abbott mplus feature: Impact on clinical laboratory efficiencies with Abbott RealTime HIV-1, HCV, HBV and CT/NG assays JCM Accepts, published online ahead of print on 2 October 2013 J. Clin. Microbiol. doi:10.1128/jcm.01672-13 Copyright 2013, American Society for Microbiology. All Rights Reserved. 1 2 3 4 5 Evaluation

More information

HIV Basics: Clinical Tests and Guidelines

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

More information

Impact of multi-dye multiplex technology on testing algorithm

Impact of multi-dye multiplex technology on testing algorithm Impact of multi-dye multiplex technology on testing algorithm Lydia Blanco. Mª Isabel Gonzalez-Fraile Centro de Hemoterapia y Hemodonación de Castilla y León, España TTI EPIDEMIOLOGICAL DATA IN SPAIN NAT

More information

National Screening laboratory Sanquin The use of NAT in blood donation screening in The Netherlands. TransMed conference Bhopal 18 November 2016

National Screening laboratory Sanquin The use of NAT in blood donation screening in The Netherlands. TransMed conference Bhopal 18 November 2016 Dr. Anton van Weert National Screening laboratory Sanquin The use of NAT in blood donation screening in The Netherlands TransMed conference Bhopal 18 Introduction Thank you! Anton van Weert, PhD, MBA Manager

More information

The Study of Congenital Infections. A/Prof. William Rawlinson Dr. Sian Munro

The Study of Congenital Infections. A/Prof. William Rawlinson Dr. Sian Munro The Study of Congenital Infections A/Prof. William Rawlinson Dr. Sian Munro Current Studies SCIP Study of Cytomegalovirus (CMV) Infection in Pregnancy ASCI Amniotic Fluid Study of Congenital Infections

More information

Schedule of Accreditation

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

More information

AccuVert HIV-1 Seroconversion Panel PRB974 ( )

AccuVert HIV-1 Seroconversion Panel PRB974 ( ) PACKAGE INSERT PRB974 (0600-0258) INTENDED USE PRB974 (0600-0258) is a group of serial bleeds from an individual plasma donor during seroconversion. This panel is intended for use by diagnostics manufacturers

More information

Non-reproductive tissues and cells Recommending authority/ association

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

More information

List the steps in the fourth generation HIV screening algorithm Describe the relationship between rapid HIV antibody tests and the fourth generation

List the steps in the fourth generation HIV screening algorithm Describe the relationship between rapid HIV antibody tests and the fourth generation Alere (honoraria) List the steps in the fourth generation HIV screening algorithm Describe the relationship between rapid HIV antibody tests and the fourth generation testing algorithm Interpret challenging

More information

INTERPROFESSIONAL PROTOCOL - MUHC

INTERPROFESSIONAL PROTOCOL - MUHC INTERPROFESSIONAL PROTOCOL - MUHC Medication included No Medication included THIS IS NOT A MEDICAL ORDER Title: PREVENTION OF MATERNAL TO INFANT HIV INFECTION Intrapartum, Peripartum, and Postpartum Antiretroviral

More information

Analysis of HIV-1 Resistance Mutations from various Compartments of the Peripheral Blood in Patients with Low-Level Viremia

Analysis of HIV-1 Resistance Mutations from various Compartments of the Peripheral Blood in Patients with Low-Level Viremia Andrea Freystetter / Christian Paar / Herbert Stekel / Jörg Berg Analysis of HIV-1 Resistance Mutations from various Compartments of the Peripheral Blood in Patients with Low-Level Viremia 107 - Translationale

More information

Technical Bulletin No. 161

Technical Bulletin No. 161 CPAL Central Pennsylvania Alliance Laboratory Technical Bulletin No. 161 cobas 6800 HIV-1 Viral Load Assay - New Platform - June 1, 2017 Contact: Heather Habig, MLS (ASCP) CM, MB CM, 717-851-1422 Operations

More information

The Technical Aspects of Pathogen Testing in Canada. Nancy Angus Canadian Blood Services Director, Testing

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

More information

June Monthly Update, Quest Diagnostics Nichols Institute, Valencia

June Monthly Update, Quest Diagnostics Nichols Institute, Valencia June 2013 - Monthly Update, NEW TESTS Please Note: Not all test codes assigned to each assay are listed in the table of contents. Please refer to the complete listing on the page numbers indicated. Test

More information

The Alphabet Soup of Viral Hepatitis Testing

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,

More information

Routine Use of Mini-Pool Nucleic Acid Testing (MP-NAT) Multiplex Assay for Sero-Negative Blood Donors

Routine Use of Mini-Pool Nucleic Acid Testing (MP-NAT) Multiplex Assay for Sero-Negative Blood Donors Journal of the Egyptian Society of Haematology & Research, Vol. 7, No. 2, September: 1-5, 2011 Routine Use of Mini-Pool Nucleic Acid Testing (MP-NAT) Multiplex Assay for Sero-Negative Blood Donors HISHAM

More information

Human Immunodeficiency Virus-1 (HIV-1) Genemer. Primer Pair for amplification of HIV-1 Specific DNA Fragment

Human Immunodeficiency Virus-1 (HIV-1) Genemer. Primer Pair for amplification of HIV-1 Specific DNA Fragment Product Manual Human Immunodeficiency Virus-1 (HIV-1) Genemer Primer Pair for amplification of HIV-1 Specific DNA Fragment Catalog No.: 60-2002-10 Store at 20 o C For research use only. Not for use in

More information

HIV-1 AccuVert TM Seroconversion Panel

HIV-1 AccuVert TM Seroconversion Panel PACKAGE INSERT PRB954 (0600-0238) INTENDED USE The is intended for use by diagnostic manufacturers, researchers, and clinical laboratories to develop, evaluate, or troubleshoot test methods. Characterized

More information

This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents

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

More information

Interpreting quantitative HBV, HCV and HIV-1 nucleic acid testing

Interpreting quantitative HBV, HCV and HIV-1 nucleic acid testing ISSN : 0974-7435 Volume 10 Issue 24 Interpreting quantitative HBV, HCV and HIV-1 nucleic acid testing Manoj K.Rajput National Institute of Biologicals, Noida 201309, (INDIA) E-mail : mkrajput@hotmail.com

More information

Evaluation of Dried Blood Spots (DBS) for Human Immunodeficiency Virus (HIV-1) Drug Resistance Testing

Evaluation of Dried Blood Spots (DBS) for Human Immunodeficiency Virus (HIV-1) Drug Resistance Testing Evaluation of Dried Blood Spots (DBS) for Human Immunodeficiency Virus (HIV-1) Drug Resistance Testing Dawit Assefa 2, Woldaregay E.Abegaz 3, Teferi Gedif 2, Belete Tegbaru 1, Dereje Teshome 1, Tesfaye

More information

HBV-DNA reference panels

HBV-DNA reference panels HBV-DNA reference panels The kit insert contains a detailed protocol and should be read carefully before testing the run control to ensure optimal performance Table of contents Overview HBV-DNA panels

More information

Real-Time PCR Detects Viral Nucleic Acids in Universal Transport Medium (UTM-RT) with Flocked Swabs

Real-Time PCR Detects Viral Nucleic Acids in Universal Transport Medium (UTM-RT) with Flocked Swabs Real-Time PCR Detects Viral Nucleic Acids in Universal Transport Medium (UTM-RT) with Flocked Swabs S. CASTRICIANO*, A. PETRICH, M. SMIEJA and M.A. CHERNESKY Departments of Pathology & Molecular Medicine,

More information

Supplementary Figure 1

Supplementary Figure 1 Supplementary Figure 1 Supplementary Figure 1: Cryopreservation alters CD62L expression by CD4 T cells. Freshly isolated (left) or cryopreserved PBMCs (right) were stained with the mix of antibodies described

More information

Screening and Diagnosis of Hepatitis Virus Infections

Screening and Diagnosis of Hepatitis Virus Infections Screening and Diagnosis of Hepatitis Virus Infections Prof. Jean-Michel Pawlotsky, MD, PhD National Reference Center for Viral Hepatitis B, C and delta Department of Virology & INSERM U955 Henri Mondor

More information

HIV AND LYMPHADENOPATHY

HIV AND LYMPHADENOPATHY HIV AND LYMPHADENOPATHY Sagren Naidoo Research report submitted to the Faculty of Health Sciences, University of the Witwatersrand, in partial fulfillment of the requirements for the degree of Master of

More information

Consolidated Donor Funded Procurement of HIV Diagnostics

Consolidated Donor Funded Procurement of HIV Diagnostics Consolidated Donor Funded Procurement of HIV Diagnostics Meeting on HIV Diagnostic Global Demand Forecast Geneva, 9 April 2015 Mercedes Perez Gonzalez Prequalification Team Diagnostics Assessment Department

More information

2018 HIV and HCV Diagnostic Testing Survey

2018 HIV and HCV Diagnostic Testing Survey 2018 HIV and HCV Diagnostic Testing Survey This survey is designed to capture the 2017 HIV and HCV testing practices in state and local public health laboratories (PHL). The results of the survey will

More information

HIV Viral Load Quality Assessment Program Summary for Panel HIVVL 2018Oct26

HIV Viral Load Quality Assessment Program Summary for Panel HIVVL 2018Oct26 1 National Laboratory for HIV Reference Services National HIV and Retrovirology Laboratories National Microbiology Laboratory Public Health Agency of Canada HIV Viral Load Quality Assessment Program Summary

More information

Transfusion-transmitted Cytomegalovirus

Transfusion-transmitted Cytomegalovirus Transfusion-transmitted Cytomegalovirus Can you confidently abandon CMV seronegative products in the modern era of pre-storage leukoreduction? Jeannie Callum, BA, MD, FRCPC Really? Are we still talking

More information

Laboratory for Clinical and Biological Studies, University of Miami Miller School of Medicine, Miami, FL, USA.

Laboratory for Clinical and Biological Studies, University of Miami Miller School of Medicine, Miami, FL, USA. 000000 00000 0000 000 00 0 bdna () 00000 0000 000 00 0 Nuclisens () 000 00 0 000000 00000 0000 000 00 0 Amplicor () Comparison of Amplicor HIV- monitor Test, NucliSens HIV- QT and bdna Versant HIV RNA

More information

WHO Prequalification of In Vitro Diagnostics PUBLIC REPORT. Product: Alere q HIV-1/2 Detect WHO reference number: PQDx

WHO Prequalification of In Vitro Diagnostics PUBLIC REPORT. Product: Alere q HIV-1/2 Detect WHO reference number: PQDx WHO Prequalification of In Vitro Diagnostics PUBLIC REPORT Product: Alere q HIV-1/2 Detect WHO reference number: PQDx 0226-032-00 Alere q HIV-1/2 Detect with product codes 270110050, 270110010 and 270300001,

More information

Study of ChLIA and ELISA for TTI Markers in Blood Donors

Study of ChLIA and ELISA for TTI Markers in Blood Donors Study of ChLIA and ELISA for TTI Markers in Blood Donors Presenting Author - Miss Kiran Kachhadiya (Co-authors: Dr. Vachhani N., Mrs. Bhatt J, Dr. Jani F., Dr. Nandani S.) Life Blood Centre (Formerly known

More information

HIV-1 Seroconversion Panel PRB975

HIV-1 Seroconversion Panel PRB975 Seroconversion OVERVIEW is a five member HIV Seroconversion collected from a single donor over a 14 day period in 2002, prior to antibody seroconversion. -03 is a challenging sample for HIV RNA assays,

More information

HIV-RNA reference panels

HIV-RNA reference panels The kit insert contains a detailed protocol and should be read carefully before testing the run control to ensure optimal performance Table of contents Overview HIV-RNA panels for sensitivity analysis...

More information

Routine NAT-screening for West Nile Virus Infections in Germany: Being prepared

Routine NAT-screening for West Nile Virus Infections in Germany: Being prepared Routine NAT-screening for West Nile Virus Infections in Germany: Being prepared R. Thermann, W. K. Roth IPFA / PEI 18 th international workshop on Surveillance and screening of blood borne pathogens Budapest,

More information