Placement of Biomarker Analysis in a CLIA or Bioanalytical Laboratory
|
|
- Gavin Gallagher
- 6 years ago
- Views:
Transcription
1 Placement of Biomarker Analysis in a CLIA or Bioanalytical Laboratory SQA National Meeting 29Mar2017 Carolyn Eberhardt, Principal Consultant, QC2 Mark Stiles, Senior Consultant, QC2
2 Comparison of Quality Systems for Bioanalytical vs. CAP/CLIA Laboratories Method Validation Batch Acceptance Criteria Staff training QA oversight
3 Bioanalytical Method Validation Guidelines FDA Guidance for Industry: Bioanalytical Method Validation (May 2001) EMA Guideline on Bioanalytical Method Validation (Feb 2012)
4 Bioanalytical Validation Assessments Accuracy RE 15% (LC MS/MS) RE 20% (ligand binding or hybrid technologies) Precision CV 15% (LC MS/MS) CV 20% (ligand binding or hybrid technologies)
5 Bioanalytical Validation Assessments (Cont.) Sensitivity LLOQ CV & RE 20% (LC MS/MS) LLOQ CV & RE 25% (ligand binding) Selectivity and Matrix Effects At least 6 lots of matrix Hemolyzed and Hyperlipemic
6 Bioanalytical Validation Assessments (Cont.) Dilution Integrity Solution Stability Stock standard Working standard solutions Matrix Stability Benchtop Freeze Thaw Long term Storage
7 Fit for Purpose Validation Assessments Any of the above! Typically Precision and Accuracy Expanded acceptance criteria.
8 CAP/CLIA Method Validation Assessments For unmodified, FDA cleared or approved tests, CLIA requires the laboratory to verify the manufacturer s performance specifications provided in the package insert before reporting patient test results. This applies when the laboratory replaces an instrument (with the same model or a different model) adds a new test to the instrument, or changes instrument manufacturers
9 CLIA LTD Validation parameters For Laboratory Developed Tests (LTDs), CLIA requires the laboratory to establish performance specifications and to validate method performance for the following method characteristics: accuracy precision (within run, between run, between day) reportable range analytical sensitivity and specificity reference intervals CLIA rules and guidances are silent on minimum requirements for validation protocols; however, validation plans, experiments, results and conclusions are reviewed for scientific merit and integrity.
10 CLIA Validation and stability Validation should cover the complete analytical process preanalytical, analytical, and postanalytical However, often times, CLIA laboratories do not assess stability whole blood, freeze/thaw or BTS or LTS
11 State of New York Clinical Trials and Research Tests Not Approved by the FDA Tests performed on specimens from trial participants for participant management under IRB approved research or clinical trials protocols, where the results are reported and are used for clinical decision making. Examples of testing performed for participant management include those that influence enrollment (exclusion or inclusion), safety, or dosing. If results of the tests are used in participant management as described follow the instructions for either commercially distributed or laboratory developed assays, as appropriate. If the results of the tests are not used in participant management, then permit and assay approval is not required. Examples of tests that do not require review and approval include retrospective biomarkers measurements or assays to measure drug concentrations for pharmacokinetic/pharmacodynamics evaluation, and are used to collect aggregate data on drug or treatment efficacy.
12 NYS Validation Once a NYS Permit is obtained for the testing facility, validation packages for all assays conducted at that facility must be reviewed by CLEP (Clinical Laboratory Evaluation Program) If you are unsure if your biomarker assay falls under this purview, you may for guidance: clepcert@health.ny.gov
13 Bioanalytical Batch Acceptance Criteria The traditional accuracy criteria Chromatography assays 15% for standards and QCs, 20% for LLOQ 75% of standards and 67% of QCs (with at least one of each concentration) must be acceptable Ligand binding assays 20% for standards and QCs, 25% for LLOQ 75% of standards and 67% of QCs (with at least one of each concentration) must be acceptable
14 Bioanalytical Batch Acceptance Criteria (Cont.) Total Error (TE) Summation of accuracy (% Bias) and precision (% CV) Used primarily in ligand binding analysis Example: Total Error 30% Std 1 has a CV% = 12 % and a Bias% = 14%; TE = 26% Std 2 has a CV% = 15% and a Bias% = 16%; TE = 31% Action Std 2 fails TE criteria
15 CAP/CLIA Batch Acceptance Criteria QCs at two levels (sometimes three) are placed on the run, not necessarily at any specified intervals Westgard Rules for QCs Uses multi rule criteria Per James Westgard First, a non technical description. When my daughter Kristin was young and living at home, she liked to party. One day when she told me she was again intending to be out late, I felt the need to exert some parental control over her hours. So I told her that if she was out once after three, twice after two, or four times after one, she was in big trouble. That's multirule control.
16 CAP/CLIA Batch Acceptance Criteria (Cont.) Westgard Rules
17 Bioanalytical Staff Training Safety (Chemical Hygiene and Bloodborne Pathogens) Regulatory (GLP, GCP, ERES) Technical (use of equipment and software) Method Training on various extraction techniques such as L L, PPT, and SPE) Qualification on specific method
18 CAP/CLIA Staff Training Safety (Chemical Hygiene and Bloodborne Pathogens) Technical (use of equipment and software) SOP reading Initial method training, on the job mentorship 6 month competency and annual thereafter per CAP
19 CAP/CLIA Assay Performance CAP has a requirement to assess each assay through a Proficiency Testing (PT) Program or an Alternative Assessment if a PT program is not available This is in addition to QCs run on each batch Testing done in a blinded fashion and compared against other laboratories
20 Bioanalytical QA Facility and Process audit Vendor audits Study based audits Protocols/plans Critical phase In Process Data Report
21 CAP/CLIA QA Biannual inspections by CAP/CLIA Internal assessments on off years CAP checklists Usually do NOT conduct study based audits Facility and Process audit Third party laboratory audits Vendor audits
22 Thank You! Contact us at:
4/10/2017. Placement of Biomarker Analysis in a CLIA or Bioanalytical Laboratory
Placement of Biomarker Analysis in a CLIA or Bioanalytical Laboratory SQA National Meeting 29Mar2017 Carolyn Eberhardt, Principal Consultant, QC2 Mark Stiles, Senior Consultant, QC2 Comparison of Quality
More informationGUIDANCE DOCUMENTS CONTAINING THE COMMON PROVISIONS ON THE CONDUCT OF GCP INSPECTIONS BY COMPETENT AUTHORITIES OF THE DIFFERENT MEMBER STATES
EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Consumer goods Pharmaceuticals Brussels, 5 November 2008 ENTR/F/2/SF D(2008) 34957 GUIDANCE DOCUMENTS CONTAINING THE COMMON PROVISIONS ON
More informationBioanalytical Issues when. Brigitte Pellerin Bioanalytical Associate Director
Bioanalytical Issues when Dealing with Phase II/III Studies Brigitte Pellerin Bioanalytical Associate Director 17-NOV-2015 Agenda Different phases of clinical trials Phase I to IV Challenges with Phase
More informationIt s Just a Waived Glucose, Isn t It?
It s Just a Waived Glucose, Isn t It? What Is the Next Step? Becky Damiani, MT (ASCP), Senior Inspection Specialist Laboratory Accreditation Program Objectives Understand the CLIA requirements surrounding
More informationSelecting a Risk-Based SQC Procedure for a HbA1c Total QC Plan
729488DSTXXX10.1177/1932296817729488Journal of Diabetes Science and TechnologyWestgard et al research-article2017 Original Article Selecting a Risk-Based SQC Procedure for a HbA1c Total QC Plan Journal
More informationQuality Assurance Standard. Implemented 1991 Revised Version 3.0
Implemented 1991 Revised 2006 Version 3.0 IQPP Contents I. Introduction... 3 II. Definitions... 4 III. PPTA Source Quality Assurance Principles... 4 IV. Audits and Compliance Verification... 5 Page 2 IQPP
More informationAssay Cross Validation
Assay Cross Validation Recent experiences in transferring bioanalytical assays from sponsor to CRO partners and between CROs Stephen White EBF Open Symposium Barcelona 20 th Nov 2013 Assay Cross Validation
More information2014 Continuing Compliance Master Series Best Practices in Alternative Assessment of Performance
2014 Continuing Compliance Master Series Best Practices in Alternative Assessment of Performance Brad S. Karon, MD, PhD, FCAP November 19, 2014 www.cap.org Today s Presenter Brad S. Karon, MD, PhD, FCAP
More informationCurrent Developments in Guidance for Regulatory Bioanalysis
Current Developments in Guidance for Regulatory Bioanalysis Dr Gerry McGuire Resolution Analytical Consultancy Ltd Edinburgh, Scotland UK gerry@resolutioneurope.com 1st MENA Regulatory Conference on Bioequivalence,
More informationDisclosures. Relevant Financial Relationship(s): Nothing to Disclose. Off Label Usage: Nothing to Disclose 9/19/2017. Proficiency Testing
September 11, 2017 Teri Ross, Quality Specialist II Doreen Ryan, MA, MT; Quality Operations Supervisor Deborah J. Wells, MPA, MT(ASCP)SH, Quality Management Coordinator Disclosures Relevant Financial Relationship(s):
More informationDOELAP On-Site Assessment Requirements Checklist Page 1 of 24 Participant:
DOELAP On-Site Assessment Requirements Checklist Page 1 of 24 General Requirements Y, N, N/A Demonstration of Conformance G.1 Latest version of protocols or procedures G.2 Latest version of dosimeter specifications
More informationHemostasis Test Validation, Performance and Reference Intervals
Hemostasis Test Validation, Performance and Reference Intervals Richard A. Marlar, Ph.D. Pathology and Laboratory Medicine Oklahoma City VA Medical Center University of Oklahoma Health Sciences Center
More informationCase Studies, or Verification Vignettes
Case Studies, or Verification Vignettes 1 Vignette #1 Change from One Automated AST to Another Your lab is changing from one FDA-cleared automated AST to another Is a verification study required? 2 Yes
More informationGLP Update and Hot Topics
GLP Update and Hot Topics RQA Annual Conference Mark Goodwin 9 Nov 2016 Introduction International GLP Updates OECD including MAD Agreement EC/ EMA US FDA & US EPA UK GLP Update MHRA MHRA GLP Deficiencies
More informationAAPS Views on Bioanalytical Method Validation Harmonization (on Behalf of AAPS Bioanalytical Community)
AAPS Views on Bioanalytical Method Validation Harmonization (on Behalf of AAPS Bioanalytical Community) Faye Vazvaei, Roche Innovation Center New York The 8th JBF Meeting, 8-9 February 2017 Background
More informationUpdate on ANVISA Bioanalytical Method Validation (BMV) Guideline
Av. Andrade Neves, 295 - Sala 184 - Ed. Torre São Paulo - Centro - Campinas/SP CEP: 13013-160 - F:(+55-19)3231 8146 acbio@acbio.org.br - www.acbio.org.br Update on ANVISA Bioanalytical Method Validation
More informationMETHOD VALIDATION: WHY, HOW AND WHEN?
METHOD VALIDATION: WHY, HOW AND WHEN? Linear-Data Plotter a,b s y/x,r Regression Statistics mean SD,CV Distribution Statistics Comparison Plot Histogram Plot SD Calculator Bias SD Diff t Paired t-test
More informationChallenges in Development and Validation of an Intracellular Cytokine Staining assay
Challenges in Development and Validation of an Intracellular Cytokine Staining assay Jenny Hendriks, Crucell Hatching @ EBF, Brussels, June 202 www.crucell.com Vaccines vs Protein therapeutics Protein
More informationPROFICIENCY TESTING POLICY
Supersedes Prepared by: APPROVALS in this section Approved by: Date: Laboratory Director RECORD OF REVIEWS Date Signature Title Procedural Changes/Review VERSION HISTORY Revision # 0 Section #/Changes
More informationIt s a Gas! Issues in the Blood Gas Laboratory. D. Robert Dufour, MD, FCAP Consultant Pathologist VA Medical Center, Washington DC
It s a Gas! Issues in the Blood Gas Laboratory D. Robert Dufour, MD, FCAP Consultant Pathologist VA Medical Center, Washington DC Learning Objectives After participating in this session, you will be able
More informationProgress to Date in A3: Method Transfer, Partial Validation and Cross validation
Progress to Date in A3: Method Transfer, Partial Validation and Cross validation A3: Method Transfer, partial and cross validation Team members: Team lead Ray Briggs EU Other members Richard Abbott-EU
More informationA Practical Example of CLSI C60 in Action: Vitamins and Hormones
A Practical Example of CLSI C60 in Action: Vitamins and Hormones Lorin Bachmann, Ph.D., DABCC Assistant Professor, Pathology Virginia Commonwealth University lbachmann@mcvh-vcu.edu AACC Conference-Mass
More informationFarouk AL Quadan lecture 3 Implentation of
How to implement a program? Establish written policies and procedures Assign responsibility for monitoring and reviewing Train staff Obtain control materials Collect data Set target values (mean, SD) Establish
More informationWHO Prequalification of In Vitro Diagnostics Programme
WHO Prequalification of In Vitro Diagnostics Programme International HIV/Viral Hepatitis Co-Infection Satellite Meeting 19 July 2014, Melbourne Anita Sands Prequalification Diagnostics Team Department
More informationNew Annex 15 Updated Requirements & Approach to Validation. Presented by Ashley Isbel 10 th August 2015
New Annex 15 Updated Requirements & Approach to Validation Presented by Ashley Isbel 10 th August 2015 EU GMP Guide Annex 15 Qualification & Validation 2001 Current version of Annex 15 published Nov 2012
More informationThe Virtues and Pitfalls of Implementing a New Test
The Virtues and Pitfalls of Implementing a New Test James H. Nichols, Ph.D., DABCC, FACB Professor of Clinical Pathology, Microbiology and Immunology Associate Medical Director for Clinical Operations
More informationSummary of Analytical Method for Quantitative Estimation of Fingolimod and Fingolimod Phosphate from Human Whole Blood Samples
Fingolimod Whole Blood Analysis Summary of Analytical Method for Quantitative Estimation of Fingolimod and Fingolimod Phosphate from Human Whole Blood Samples Study Detail: - Determination of Fingolimod
More informationCOMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP)
European Medicines Agency Pre-authorisation Evaluation of Medicines for Human Use London, 21 September 2006 EMEA/CHMP/BWP/298390/2005 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON
More informationSetting up deviation, incident, nonconformance. Presented by Debbie Parker 4 July, 2016
Setting up deviation, incident, nonconformance systems Presented by Debbie Parker 4 July, 2016 Introduction This session will cover: Regulations Definitions Process Case Study Setting up a new system Common
More informationBioanalytical Method Development and Validation: from the USFDA 2001 to the USFDA 2018 Guidance for Industry
Journal of Applied Bioanalysis http://dx.doi.org/10.17145/jab.18.010 COMMENTARY Bioanalytical Method Development and Validation: from the USFDA 2001 to the USFDA 2018 Guidance for Industry Roland J.W.
More informationMethod Comparison Report Semi-Annual 1/5/2018
Method Comparison Report Semi-Annual 1/5/2018 Prepared for Carl Commissioner Regularatory Commission 123 Commission Drive Anytown, XX, 12345 Prepared by Dr. Mark Mainstay Clinical Laboratory Kennett Community
More informationPERIOSTIN ELISA CONTENTS
PERIOSTIN ELISA for the quantitative determination of Periostin in human serum, EDTA plasma, heparin plasma, and citrate plasma Cat. No. BI-20433. 12 x 8 tests CONTENTS ASSAY CHARACTERISTICS Summary...
More informationNJ RAPID HIV TESTING SUPPORT PROGRAM
PROGRAM OVERVIEW Program Description: Point of Care testing may seem, on its face, simple and 'fool proof', but in a study conducted by HCFA in Colorado and Ohio, quality problems were identified in more
More informationProtocols for Laboratory Verification of Performance of the FilmArray Respiratory Panel (RP)
Protocols for Laboratory Verification of Performance of the FilmArray Respiratory Panel (RP) Purpose The Clinical Laboratory Improvement Amendments (CLIA), passed in 1988, establishes quality standards
More information25-Hydroxy Vitamin D TOTAL (25HD) on Liaison XL
25-Hydroxy Vitamin D TOTAL (25HD) on Liaison XL I. PRINCIPLE The role of vitamin D in bone and mineral metabolism was recognized from its first identification as a factor that could cure rickets. However,
More informationGLOBAL BIOANALYSIS CONSORTIUM
GLOBAL BIOANALYSIS CONSORTIUM Scope and Regulations Harmonization Team: A1 (Work in Progress) John Smeraglia on behalf of the HT-A1 A1: Scope and regulations Team members: Team lead Region Expertise Surendra
More informationAAPS/PSCW 2010 APQ Open Forum
AAPS/PSCW 2010 APQ Open Forum Harmonization of Global Bioanalytical Regulations Scientific Perspective and Update on Developments 18 November 2010 Steve Lowes, Ph.D. Advion BioServices Inc Ithaca, NY Introduction
More informationHelmut Schütz. Satellite Short Course Budapest, 5 October
Multi-Group and Multi-Site Studies. To pool or not to pool? Helmut Schütz Satellite Short Course Budapest, 5 October 2017 1 Group Effect Sometimes subjects are split into two or more groups Reasons Lacking
More informationMETHOD VALIDATION CASE
METHOD VALIDATION CASE METHOD VALIDATION PROTOCOL CLIA Regulation 493.1253 (2) 1.Accuracy (closeness to true/comparative method) 2.Precision (reproducibility) 3.Reference Interval 4.Reportable range (linearity,
More informationCustomer Bulletin. Questions/Comments? Please call Customer Service at (Direct) or (Toll-free inside USA).
Customer Bulletin Assignment of Ranges for PTS Panels Multi-Chemistry Controls (Cat. No./REF 721) and PTS Panels Controls (Cat. No./REF 722) Background: PTS Panels Multi-Chemistry Controls and Controls
More informationRapid Detection FAQs
Rapid Detection FAQs 3M Rapid Detection Reader What are the dimensions of the Rapid Detection Reader? The Rapid Detection Reader includes the Control Module and the Test Module. The Control Module is 185
More informationPublic Health Service Food and Drug Administration Dallas District 4040 North Central Expressway Dallas, Texas
Department of Health and Human Services Public Health Service Food and Drug Administration Dallas District 4040 North Central Expressway Dallas, Texas 75204-3128 March 30, 2010 2010-DAL-WL-08 CERTIFIED
More informationComparability and quality of experimental data under different quality systems. S. Caroli Istituto Superiore di Sanità Rome
Comparability and quality of experimental data under different quality systems S. Caroli Istituto Superiore di Sanità Rome Programme of this presentation Part I. Background information Part II. Key aspects
More informationRegulated bioanalysis status in Japan and notable points of the draft Japanese guideline
Regulated bioanalysis status in Japan and notable points of the draft Japanese guideline EBF 5th Open Meeting Old Battles, New Horizons, November, 16, 2012, Barcelona Noriko Katori, PhD National Institute
More informationLC/MS Biomarker Assay Validation Strategies Using Surrogate Matrix and Surrogate Analyte Approaches
LC/MS Biomarker Assay Validation Strategies Using Surrogate Matrix and Surrogate Analyte Approaches Barry R. Jones 1, Gary A. Schultz 1, Steve Lowes 1, James A. Eckstein 2, Barry S. Lutzke 2, Bradley L.
More informationPolymer Technology Systems, Inc. CardioChek PA Comparison Study
Polymer Technology Systems, Inc. CardioChek PA Comparison Study Evaluation Protocol: Accuracy Precision Clinical Correlation PTS Panels Lipid Panel Test Strips For Use in Comparisons to a Reference Laboratory
More informationWhite Paper. For reprint orders, please contact
White Paper For reprint orders, please contact reprints@future-science.com The European Bioanalysis Forum community s evaluation, interpretation and implementation of the European Medicines Agency guideline
More informationExendin-4 (Exenatide) ELISA Kit
Exendin-4 (Exenatide) ELISA Kit Catalog: DEIABL227 For the quantitative determination of Exendin-4 in serum or plasma using competitive ELISA method For Research Use Only. Protocol Provided for Informational
More informationC30-A2 ISBN ISSN Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities; Approved Guideline Second Edition
ISBN 1-56238-471-6 ISSN 0273-3099 Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities; Approved Guideline Second Edition Volume 22 Number 17 David B. Sacks, M.D., Chairholder Patricia
More informationTwo Important Statistics
Two Important Statistics 70% 40% 0 Quality Control & YOU David Plaut Fall, 2012 davidplaut@yahoo.com 1 11 Why do physicians order laboratory tests? 2 2 Why do Physicians Order Laboratory Tests? 1. Patients
More information8. Quality Assurance Guidelines (Includes Appendices A-G)
8. Quality Assurance Guidelines (Includes Appendices A-G) Quality Assurance Guidelines for Testing Using the OraQuick HCV Rapid Antibody Test This document has been modified by OraSure Technologies from
More informationAnalytical method validation. Presented by Debbie Parker 4 July, 2016
Analytical method validation Presented by Debbie Parker 4 July, 2016 Introduction This session will cover: Guidance and references The types of test methods Validation requirements Summary Slide 2 PharmOut
More informationyour bioassay is in good hands: transfer from a CRO perspective MIKE MERGES March 4, 2013
your bioassay is in good hands: transfer from a CRO perspective MIKE MERGES March 4, 2013 Contact Information Michael Merges, M.S. Director Analytical Development Solutions Development & Clinical Services
More informationCollege of American Pathologists
College of American Pathologists Comments to the Food and Drug Administration on the draft guidance In Vitro Companion Diagnostics Devices October 12, 2011 College of American Pathologists 1350 I Street,
More informationEBF Tiered approach final. Validation criteria. Philip Timmerman, on behalf of the EBF 8 th EBF Open Symposium
EBF Tiered approach final recommendation of Scientific Validation criteria Philip Timmerman, on behalf of the EBF 8 th EBF Open Symposium - 2015 The problem statement 1990 CC-I 2001 FDA Further refinement,
More informationQuality Management Aspects of Sperm and Testicular Tissue Cryobanking
ESHRE Campus, Granada (Spain), 25-26 March 2010 Quality Management Aspects of Sperm and Testicular Tissue Cryobanking Dr David Mortimer, PhD Oozoa Biomedical Inc Vancouver, BC, Canada Commercial Conflicts
More informationCompliance Issues in Off-Label Use of Blood Glucose Monitors
Compliance Issues in Off-Label Use of Blood Glucose Monitors Ann Snyder, MT(ASCP) Medical Technologist Center for Medicare & Medicaid Services (Baltimore, MD) April 28, 2016 Disclosures I have nothing
More informationControl of Foot-and-Mouth Disease
Control of Foot-and-Mouth Disease Detect and confirm outbreaks Investigate outbreaks (source, spread, serotype..) Estimate incidence of the disease Estimate vaccination coverage and efficiency Surveillance
More informationQuantitation by High Resolution Mass Spectrometry: Case Study of TOF MS for the Quantitation of Allopurinol from Human Plasma
Quantitation by High Resolution Mass Spectrometry: Case Study of TOF MS for the Quantitation of Allopurinol from Human Plasma Shaokun Pang 1, Weixing Sun 2, Adrien Musuku 2, Xavier J. Misonne 1 1 SCIEX,
More informationLC-MS/MS for the quantification of Peptide biomarker and mixture of closely related Protein in formulation
EUROPEAN BIOANALYSIS FORUM Barcelona, November 14-16, 2012 LC-MS/MS for the quantification of Peptide biomarker and mixture of closely related Protein in formulation Luc-Alain SAVOY CONTENT Part I: SGS
More informationReporting to the IRB Part 2
Webinar Series Reporting to the IRB Part 2 Frequently Asked Questions December 4, 2013 Presented by: James MacFarlane Director of Board Services About Schulman Associates IRB Established in 1983 US and
More informationStatistical Analysis Plans
Statistical Analysis Plans PROFESSOR CARROL GAMBLE UNIVERSITY OF LIVERPOOL Clinical Trials Lots of different types of clinical trials Various interventions Pharmaceutical/drugs regulated Regulated environment
More informationA Successful HIV Testing Quality Assurance Program: New York State Experience
A Successful HIV Testing Quality Assurance Program: New York State Experience Mara San Antonio-Gaddy, RN, MSN NYS DOH AIDS Institute Division of HIV Prevention 2010 HIV Diagnostics Conference March 24,
More informationQuantitative Image Analysis of HER2 Immunohistochemistry for Breast Cancer
Quantitative Image Analysis of HER2 Immunohistochemistry for Breast Cancer Guideline from the College of American Pathologists Early Online Release Publication: Archives of Pathology & Laboratory Medicine
More informationPFC Industry Courses and Certifications
PFC Industry Courses and Certifications Americans for Safe Access (ASA) has been a trusted source of cannabis education and training for over 15 years. As a leader in medical cannabis education since 2002,
More informationInsulin Aspart ELISA Kit
Insulin Aspart ELISA Kit Catalogue DEIABL215 For the qualitative determination of antibodies to insulin aspart in human serum and plasma FOR RESEARCH USE ONLY Creative Diagnostics. All rights reserved
More informationDigital Pathology and CAP Guidelines
Digital Pathology and CAP Guidelines Frequently asked questions The VENTANA family of digital pathology products empowers you with the convenience of a comprehensive image and workflow solution. When used
More informationWelcome to Celerion s Dinner and Discussion Program Tokyo, Japan Apr 2, 2015
Welcome to Celerion s Dinner and Discussion Program Tokyo, Japan Apr 2, 2015 Fast to Patient: The Push For Earlier Signals of Efficacy in Clinical Research J. Fred Pritchard, Ph.D. Vice President, Global
More informationChallenges in Performing a Scientifically Meaningful Lipemic Plasma Test in Bioanalytical Method Validation
Challenges in Performing a Scientifically Meaningful Lipemic Plasma Test in Bioanalytical Method Validation Laurence Mayrand-Provencher, Milton Furtado, Jean- Nicholas Mess, Josée Michon, Annik Bergeron,
More informationWHO PUBLIC INSPECTION REPORT (WHOPIR) Contract Research Organization
SOP 408.4 Annex C 20, avenue Appia CH-1211 Geneva 27 Switzerland Tel central +41 22 791 2111 Fax central +41 22 791 3111 www.who.int Part 1: General information WHO PUBLIC INSPECTION REPORT (WHOPIR) Contract
More informationPatricia C. Fallest-Strobl, 1 Elin Olafsdottir, 2 Donald A. Wiebe, 1 and James O. Westgard 1 * Lipoproteins
Clinical Chemistry 43:11 2164 2168 (1997) Lipids and Lipoproteins Comparison of NCEP performance specifications for triglycerides, HDL-, and LDL-cholesterol with operating specifications based on NCEP
More informationBovine Insulin ELISA
Bovine Insulin ELISA For quantitative determination of insulin in bovine serum and plasma. For Research Use Only. Not For Use In Diagnostic Procedures. Catalog Number: 80-INSBO-E01 Size: 96 wells Version:
More informationMedidée Services SA. Nano-Tera.ch. 05 February 2015 part 4. Intro ISO GMP - GLP Pierre-Alain Sommer
Nano-Tera.ch 05 February 2015 part 4 Intro ISO GMP - GLP Pierre-Alain Sommer Pierre-alain.sommer@medidee.com www.medidee.com Nano-Tera 2015 05.02.2015 Introduction to ISO 13485, cgmp s and GLP s Context
More informationThe Adiponectin Turbidimetric Immunoassay Reagent Kit
The Adiponectin Turbidimetric Immunoassay Reagent Kit Catalogue number: 51010 For the quantitative determination of Adiponectin in human serum and plasma This package insert must be read in its entirety
More informationProtocols for Laboratory Verification of Performance of the FilmArray Respiratory Panel 2 plus (RP2plus)
Protocols for Laboratory Verification of Performance of the FilmArray Respiratory Panel 2 plus (RP2plus) Purpose The Clinical Laboratory Improvement Amendments (CLIA), passed in 1988, establishes quality
More informationEPA REGULATORY UPDATE
SOCIETY OF QUALITY ASSURANCE REGULATORY FORUM EPA REGULATORY UPDATE Linthicum Heights, Maryland January 24, 2008 Robert Cypher United States Environmental Protection Agency 2/13/2008 SQA Baltimore 1 ANY
More informationCap Laboratory Accreditation Manual Appendix B
Cap Laboratory Accreditation Manual Appendix B Appendix B Environmental Holding Times. 144 Screening Manual: A Guide for Health Departments and Providers. (Sept. 2013). Critical bottle with the water sample
More informationPilot studies with reference specimens
Pilot studies with reference specimens HUPO: Plasma Proteome Project Workshop July 16-17, 17, 2003 Daniel W. Chan, Ph.D.,DABCC Professor of Pathology, Oncology, Radiology & Urology Director of Clinical
More informationForum for Collaborative HIV Research External Validation of CD4 and Viral Load Assays Paris, France June 29, 2007
Forum for Collaborative HIV Research External Validation of CD4 and Viral Load Assays Paris, France June 29, 2007 Thomas J. Spira, M.D. International Laboratory Branch Global AIDS Program Centers for Disease
More informationMETHOD VALIDATION CASE
METHOD VALIDATION CASE METHOD VALIDATION PROTOCOL CLIA Regulation 493.1253 (2) 1.Accuracy (closeness to true/comparative method) 2.Precision (reproducibility) 3.Reference Interval 4.Reportable range (linearity,
More informationNon-GLP Bioanalysis. Introduction. Lab Space and Instrumentation
Non-GLP Bioanalysis Introduction Founded in 2006, WuXi AppTec s non-glp bioanalytical service has established a state-of-the-art LC-MS/MS platform for bioanalysis in the drug discovery field. Over the
More informationNear Real Time Safety Air and Process Monitoring Solutions. Standardizing Process Monitoring with MINICAMS
Standardizing Process Monitoring with MINICAMS DPG has over 300 units ECBC has over 200 units Why MINICAMS? The DA has invested heavily in this technology Must take advantage of this resource during its
More informationBNP Fragment EIA (Cat.No. BI-20852W) For the Determination of BNP Fragment in Human Samples
BNP Fragment EIA (Cat.No. BI-20852W) For the Determination of BNP Fragment in Human Samples ASSAY CHARACTERISTICS Method Competitive Enzyme Immunoassay, HRP/TMB. Microtiter plates are coated with a polyclonal
More informationReducing Sample Volume and Increasing Sensitivity for the Quantification of Human Insulin and 5 Analogs in Human Plasma Using ionkey/ms
Reducing Sample Volume and Increasing Sensitivity for the Quantification of Human Insulin and 5 Analogs in Human Plasma Using ionkey/ms Erin E. Chambers and Kenneth J. Fountain Waters Corporation, Milford,
More informationRethinking Traditional Lab QA/QC:
Rethinking Traditional Lab QA/QC: Understanding Weaknesses in Existing Requirements and Mastering Useful Methods and Metrics to Raise Your Lab s Analytical Accuracy October 1 st, 2013 Laboratory Quality
More informationClinical Trial Endpoints from Mobile Technology: Regulatory Considerations September 29, 2016
Clinical Trial Endpoints from Mobile Technology: Regulatory Considerations September 29, 2016 Elektra J. Papadopoulos, MD, MPH Clinical Outcome Assessments Staff Office of New Drugs Center for Drug Evaluation
More informationImplementation Guide for the DoseControl Dosimetry System
1.0 SCOPE The GEX DoseControl System is intended for use as a single dosimetry system solution, specifically developed to satisfy the generic dosimetry needs of radiation sterilization application users
More informationWHO Prequalification of In Vitro Diagnostics Programme PUBLIC REPORT. Product: SURE CHECK HIV 1/2 Assay Number: PQDx
WHO Prequalification of In Vitro Diagnostics Programme PUBLIC REPORT Product: SURE CHECK HIV 1/2 Assay Number: PQDx 0054-006-00 Abstract SURE CHECK HIV 1/2 Assay with product code HIV201, manufactured
More informationStatistical Analysis of Biomarker Data
Statistical Analysis of Biomarker Data Gary M. Clark, Ph.D. Vice President Biostatistics & Data Management Array BioPharma Inc. Boulder, CO NCIC Clinical Trials Group New Investigator Clinical Trials Course
More informationOverview of Matrix Effects in Bioanalysis
Overview of Matrix Effects in Bioanalysis Patrick Bennett & Jing Tu PPD Laboratories 31March2017 Outline 1. Definitions 2. Overview of Matrix Effects 3. Regulatory guidance on matrix effect(s): FDA and
More informationRecommendations on biomarker bioanalytical method validation by GCC
White Paper Special Focus Issue: Bioanalysis of biomarkers For reprint orders, please contact reprints@future-science.com Recommendations on biomarker bioanalytical method validation by GCC The 5th GCC
More informationIndividual Lab Report Ci-Trol Nov,2016. Abnormal Fibrinogen (mg/dl) Abnormal Fbg Control - Lot# LFC Your Lab
Individual Lab Report Ci-Trol Nov,2016 ST VINCENT MEDICAL CENTER LABORATORY(LAB# 7300 ) 2131 WEST THIRD STREET LOS ANGELES CA USA 90057 Abnormal Fibrinogen (mg/dl) Abnormal Fbg Control - Lot# LFC SYSMEX
More informationBiomarker classification: a philosophical introduction.
Biomarker classification: a philosophical introduction. Philip Timmerman, on behalf of the EBF biomarker team (TT-14) 16 November 2011, Barcelona, Spain Background A few no-brainers to start the conference
More informationPFC Training Courses & Programs. Course Descriptions. 1. Core Cannabis Training (CCT) [pre-requisite for all PFC Courses]
PFC Training Courses & Programs Core Cannabis Training (CCT) National Cannabis Standards Courses (NCST) State Specific Compliance Training (SSCT) PFC Enrichment Courses (PFCEC) PFC Verified Professional
More informationCarnitine / Acylcarnitines Dried Blood Spots LC-MS/MS Analysis Kit User Manual
Page 1 / 14 Carnitine / Acylcarnitines Dried Blood Spots LC-MS/MS Analysis Kit User Manual ZV-3051-0200-15 200 Page 2 / 14 Table of Contents 1. INTENDED USE... 3 2. SUMMARY AND EXPLANATION... 3 3. TEST
More informationAKA Good Manufacturing Practice (GMP) Certification Program
AKA Good Manufacturing Practice (GMP) Certification Program Preamble The American Kratom Association (AKA) is establishing this program to assure the safety and integrity of kratom dietary supplements
More informationWorkshop on Proficiency Testing for Medical Laboratories. Daniel W. Tholen, M.S. March 13, 2013
Workshop on Proficiency Testing for Medical Laboratories Daniel W. Tholen, M.S. March 13, 2013 Workshop Schedule It s a Workshop! not a lecture Discussion expected My background in PT for medical laboratories
More informationSQA-V Gold Semiannual Validation/Proficiency/QC Recommendations
MEDICAL ELECTRONIC SYSTEMS 5757 W. Century Blvd. Suite 805 Los Angeles, CA. 90045 Remember, it ALL Started with a Sperm! www.mes global.com SQA-V Gold Semiannual Validation/Proficiency/QC Recommendations
More informationSAMPLE. Glucose Monitoring in Settings Without Laboratory Support
POCT13c Glucose Monitoring in Settings Without Laboratory Support This guideline focuses on performance of point-of-care glucose monitoring systems, with an emphasis on safety practices, quality control,
More informationExcellence in Trial Management
Excellence in Trial Management COMPANY OVERVIEW Privately held company Founded in 2007 Contract Research Organization HQ in Montréal, Canada Specialized in Clinical Development & Trial Management Client
More information