Standardization of NAT Extraction Methods Paul D. Neuwald, PhD AcroMetrix Corporation, Benicia, CA SoGAT XVIII Bethesda, MD, USA May 24, 2005.

Slides:

Advertisements

Similar presentations

Sandra G. Adams, MD, MS Pulmonary Diseases / Critical Care Medicine University of Texas Health Science Center at San Antonio South Texas Veterans Healthcare.

Advertisements

Hospital-Based Careers for Doctoral Scientists Bob Fader, Ph.D. D(ABMM) Section Chief, Microbiology/Virology Scott & White Healthcare Temple, TX

Extended Range NIR Wavelength Standard Gabor J. Kemeny, Ph.D. Kemtek Analytical, Inc. PAT Subcommittee February 25th 2002.

SACHDNC Meeting January 26/27, 2012 Nomination and Prioritization Workgroup Report on 22q11.2 Deletion Syndrome (22q11.2DS; DiGeorge Syndrome, DGS-1) Dietrich.

Yi-Chen Yang, Drug Biology Division Bureau of Food and Drug Analysis Department of Health, Taiwan Collaborative study for establishment of the first national.

External Peer Review of the FDA Office of Regulatory Affairs Pesticide Program FDA Science Board Advisory Committee Meeting Nov. 4, 2005.

Mayo Clinic College of Medicine Rochester Higher Education Development Committee August 19, 2005.

Use of CAHPS Surveys in Assessing the Patient- Centeredness of Cancer Care: NCI-AHRQ-CMS Collaborations Neeraj K. Arora, Ph.D. National Cancer Institute,

Linearity Panels HIV RNA, HCV RNA, HBV DNA, and CMV DNA

XVIII SoGAT Washington 24 May 2005 SoGAT and HIV NAT Standards - 2 nd International Standard for HIV-1 RNA Harvey Holmes*, Clare Davis* and Alan Heath**

Coordinator Coffee Break: An introduction to UMi2b2 Cohort June 2, 2011.

Innovative Funding Streams Driving Health Laurel Lee - Vice President, Member & Community Engagement State of Reform January 8, 2015.

Complementary and Alternative Medicine Curriculum: Who Needs It? Educational Challenges and Strategies Victor S. Sierpina, MD W.D. and Laura Nell Nicholson.

About The Physicians Foundation June 15, Board members and affiliations Louis J. Goodman, PhD, Texas Medical Association Alan Plummer, MD, Medical.

The OSU HHMI Med into Grad Scholars Program Joanna Groden Ph.D. COM, Associate Dean for Basic Science Ginny Bumgardner M.D., Ph.D. COM, Associate Dean.

Task Force Kick-Off Meeting March Agenda What is Faculty Forward? Why the emphasis on job satisfaction? How can our organization benefit? How will.

R Diagnostics June 19, 2003 WNV FDA BPAC MeetingPCR NAT Blood Screening TaqScreen West Nile Virus Program - Roche Update James L. Gallarda, Ph.D. Roche.

Sarnoff Cardiovascular Research Foundation

Diagnostic Assays to Plan Specific Drug Treatment Elizabeth Hammond MD.

Resident Stress Survey Lija Joseph M.D. Boston University School of Medicine.

HIV Clinical Pharmacology and Implementation Research in YRG CARE, India S. Saravanan, PhD 4 th Annual Workshop on.

Cytology: cy·tol·o·gy the study of the microscopic appearance of cells, especially for the diagnosis of abnormalities and malignancies.

HIV, HCV, and HBV NAT Controls Formulation, Stability and Performance Mark Manak BBI Diagnostics, Inc. A Division of SeraCare Life Sciences, Inc. SoGAT.

Vanderbilt University NascaBIG ® TBPT Face-to-Face Meeting December 6-7, 2011 Nashville, TN caBIG ® TBPT Face-to-Face Meeting December 6-7, 2011 Vanderbilt.

Desirable Surveillance Network National Prion Disease Pathology Surveillance Center Locations Regularly Performing.

CareFirst BlueCross BlueShield is the shared business name of CareFirst of Maryland, Inc. and Group Hospitalization and Medical Services, Inc. which are.

ASCP & Global Outreach. ASCP would like to thank the following for their support and interest: 2 The Center for Disease Control & Prevention– Central.

LEGEND Public Health Schools Law Schools Medical & Other Schools Public Health Schools Teaching Public Health Law As of July 1, 2012.

JOINT ADVISORY COMMITTEE ON COMMUNICATIONS CAPABILITIES OF EMERGENCY MEDICAL AND PUBLIC HEALTH CARE FACILITIES Structure for Advisory Committee.

Yi-Chen Yang, Yu-Hsuan Chen, Show-Lan Chiu, Hwei-Fang Cheng Drug Biology Division, Bureau of Food and Drug Analysis Department of Health, Taiwan, ROC National.

Monitoring the Performance of Nucleic Acid Tests using Data Generated from EDCNet and DigitalPT Wayne Dimech, Darren Jardine, Thu-Anh Pham and the staff.

National Institute for Biological Standards and Control Assuring the quality of biological medicines Human Cytomegalovirus (HCMV) Proposed 1 st International.

Genboree Discovery Process Integration Aleksandar Milosavljevic, PhD Baylor College of Medicine January 10 th, 2008; modified April 1 st 2008.

History of ILC Involvement in NAT Standardization 1998: Inter-Organization Discussion for the Establishment of Standard Reference Material for Nucleic.

KIDS GEORGIA (Kids and Families Impacting Disease through Science) Child Life Department: June 17 th, 2015.

Cancer Prevention and Control Research Network (CPCRN) Case Studies of Local and National Partnerships Putting Evidence into Practice CDC Cancer Partners.

Elisa Moretti Process and Analytical Development KEDRION S.p.A SoGAT XVI Paul Ehrlich Institut - Langen, Germany 3 rd July 2003 Automated Extraction for.

Ted DeVries – Exan Group. To give direction on the continual growth of axiUm To build strong relationships with colleagues To learn from each other through.

GPiBS (Graduate Program in Biomedical Sciences) is offered through the Graduate College at the University of Oklahoma Health Sciences Center. GPiBS (Graduate.

KLMK January 16, 2014 – Scott Davidson, AIA: HGA Architects and Engineers.

U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only.

Design of Patient-Centered Care Health IT Patient Advisor involvement in ePHR Design and Outcomes Research Patricia Sodomka, FACHE Senior Vice President,

CI-1 Lenalidomide Myelodysplastic Syndromes (Revlimid ®, CC-5013, CDC-501) Graham Burton, MD Senior Vice President Regulatory Affairs Celgene Corporation.

SciLifeLab Science for Life Laboratory Eva Molin, PhD, MEd Project coordinator.

SoGAT May 2005 Are conversion factors to international units assay related? Marco Koppelman, Henk Reesink, Nico Lelie, Theo Cuypers.

Progress on Study to Validate Synthetic Materials for Use as Calibrators and References SoGAT XIX Bern, 14 June 2006 Roberta M. Madej Roche Molecular Diagnostics.

Harold I Perl, PhD Center for the Clinical Trials Network National Institute on Drug Abuse 8 th Conference of INEBRIA Boston, MA September 23, 2011.

Date of download: 6/3/2016 From: U.S. Trends in Antiretroviral Therapy Use, HIV RNA Plasma Viral Loads, and CD4 T-Lymphocyte Cell Counts Among HIV-Infected.

Quantification of Parvovirus B19 DNA Using COBAS AmpliPrep Automated Sample Preparation and LightCycler Real-Time PCR Stefan Schorling, Gunnar Schalasta,

Managing a Laboratory Sponsored by: ASPET's Women in Pharmacology Committee APS Women in Physiology Committee Monday 4 April 2005.

The BioSense Influenza Module Craig Hales MD MPH, Roseanne English BS, Paul McMurray MDS, Michelle Podgornik MPH, Jerome Tokars MD MPH Centers for Disease.

How we started: A group of highly motivated students came together through a series of conferences including the Society of Teachers of Family Medicine.

1 st Year General Cardiology Fellows Medical University of South Carolina.

IRBchoice Connections Call: June 10, 2016

Department of Pathology & Laboratory Medicine

Chicago College of Osteopathic Medicine

Physicians per 1,000 Persons

Science and Engineering Apprentice Program

American Public Health Association November 5, 2007 Session #3196

Where do dental school graduates end up locating?

Supplementary Data Tables, Trends in Overall Health Care Market

Representativeness of Emergency Department Data Reported to the BioSense System Patrick Minor, M.S.P.H., Roseanne English, B.S., Jerome Tokars, M.D, M.P.H.

Feasibility of Synthetic Materials as Primary Standards

Research Orientation & Training for Investigators and Research Staff

Research and Data Use Agreement

Correction Mayo Clinic Proceedings Volume 79, Issue 2, (February 2004)

From Innovation to Commercialization Access to Data

21st Century Women's Health

Jens Eldrup-Jorgensen, MD SVS PSO Medical Director

Presentation transcript:

Standardization of NAT Extraction Methods Paul D. Neuwald, PhD AcroMetrix Corporation, Benicia, CA SoGAT XVIII Bethesda, MD, USA May 24, 2005

Standardization of NAT Extraction Methods Overview Potential sources of variation in NAT assays:  Specimen type  Platform / Procedure  Operator / Laboratory  Calibrators / Standards  Assay reagents  Extraction method

Standardization of NAT Extraction Methods Overview Potential sources of variation in NAT assays:  Specimen type  Platform / Procedure  Operator / Laboratory  Calibrators / Standards  Assay reagents  Extraction method

Example: CMV Assay Comparison Study Study Design Each participating laboratory:  Extracted CMV positive reference panel members using its standard method for clinical specimens  Tested the panel members as unknowns in replicates of 4 using its standard CMV DNA assay method and calibrators  Returned quantification results for analysis and comparison to results from other labs (N = 23)

Example: CMV Assay Comparison Study Reference Panel OptiQuant™ CMV DNA Panel Panel MemberNominal CMV DNA Copies/mL* , , ,000 *Value assignment based upon quantification using the COBAS AMPLICOR CMV MONITOR ® Test

CMV DNA Assay Comparison Study Interlaboratory Comparison Overall Results for 23 Laboratories

CMV DNA Assay Comparison Study Interlaboratory Comparison Examples from 3 Individual Laboratories

Methods used in CMV DNA Assay Study

CMV DNA Assay Comparison Study Interlaboratory Comparison LightCycler: Different Extraction Methods

CMV DNA Assay Comparison Study Interlaboratory Comparison ABI 7000 Series: Different Extraction Methods

Parvovirus B19 DNA Assay Extraction Comparison

Standardization of NAT Extraction Methods Future Considerations  Need for better controlled collaborative studies to compare extraction methods for: Different specimen types / calibrators Different platforms / instruments / procedures Different assay methods / reagents Different operators / laboratories  Initially, conduct a study that focuses on comparing extraction methods for one specimen type, on one platform, using common calibrators and reagents  AcroMetrix is willing to coordinate such a study

Acknowledgments AcroMetrix Corporation Association for Molecular Pathology Laboratories Participating in the CMV DNA Assay Comparison Study: Advocate Lutheran General Hosp Children’s Mercy Hosp Baylor University Med Center Carolinas HealthCare System Children’s Hosp Loma Linda Mercantile Mayo Clinic Medical College of Virginia Medical University of South Carolina Medicine University of Rochester Med Center Molecular Pathology Network, Inc Oregon Health & Sciences University Sharp Memorial Hosp Spectrum Health St Barnabas Med Center The Methodist Hosp The Nebraska Med Center UMDNJ/NJ Medical School University of Florida University of North Carolina University of Pitts/Magee Women’s Hosp University of Texas SW Med Center University of Washington Med Center Washington Hosp Center