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

Size: px
Start display at page:

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

Transcription

1 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 CEO Samsung - Nexus-Dx October 3, 2013 XVII Forum - National Days of Laboratory Medicine of Russia-2013

2 Presentation objectives Point of Care Testing (POCT) LABGEO IB10, role in POCT and cardiac assays performance LABGEO PT10, role in POCT and clinical chemistry performance

3 Worldwide IVD Market 2010 Sector Sales ($ Billions) Share (%) U.S Europe Asia ROW Total Asia Japan, India, China Source: Biotechnology Associates, 2011

4 IVD Market Size and Growth Worldwide POC In-Vitro Diagnostics Market,

5 BACKGROUND Not all patients can be tested rapidly in a hospital with comprehensive Central Laboratory (CL) capabilities - 24 hrs per day; 7 days a week Studies show that CL turnaround time (TAT) for results is at least 2X longer than Point-of-Care (POC) Testing There is a medical need for portable, light-weight, accurate, easy-to-use equipment with seamless data management The Samsung LABGEO family of Analyzers is designed to fulfill these requirements

6 Potential Near Patient Alternate Sites In-Hospital Emergency Department Operating room Intensive care units Pediatric intensive care units Outpatient Clinics (e.g. diabetes, Coag) Radiology suites Outside the Hospital

7 Why is POC important? Time POC testing generates information quickly, near the patient and healthcare professional Action (intervention) The patient alone (SBGM) or the doctor can take immediate action (pharmaceuticals e.g.) and improve outcomes Behavior Change The patient and physician can use the quick results to discuss changes the patient needs to implement for improved outcomes Support where infrastructure is lacking Decreased patient morbidity and mortality Smaller risk of errors (Pre-analytical error rate: POC- 32%, Lab 88%) Lead to PST (Patient Self Test) opportunity for chronic disease management

8 LABGEO IB10 Immunochemistry Analyzer

9 Basic Technology- How it Works

10 Disc Assay Architecture Whole Blood Separated Packed Red Blood Cells Plasma Whole Blood (500 µl) Disc Spins (Centrifuge) 10

11 Multi-analyte testing: up to 3 analytes can be measured simultaneously using single disc

12 Current Analyte Menu Troponin I Test CHF Test NT-proBNP Cardiac 3-in-1 Panel Test Troponin / CK-MB / Myoglobin CHF Plus Test Troponin I / NT-proBNP D-Dimer Test Others in Development

13 Benefits of Samsung s LABGEO IB Test System Technology: Time-tested /proven centrifugation and immunochromatography Simplified test system = data reliability Quantitative on-board data processing (mostly with 5PL (w) algorithm) Analyzer: Fully automated and simple to use; internal self-testing True portability/mobility of analyze r = Independence of centralized electricity/water supply = suitable for emergency/catastrophic situations Built-in controls for temperature, centrifugal force, optical parameters, and time; discs have internal control system for sample volume accuracy, plasma separation and proper completion of reaction Each control system functions independently and reports error when value of controlled parameter(s) exceeds specified limits. Test devices: Self-contained calibrated test devices/each includes internal control Dry and stable

14 LABGEO IB vs. Central Lab/Overview LABGEO IB10 CENTRAL Central Lab LAB Menu of essential cardio-vascular biomarkers IA Intended use Clinical sensitivity and specificity Analytical sensitivity Comparable Equivalent Comparable Comparable Precision Intermediate: total CVs 8-15% High: total CVs 6-8% Reportable range Reduced; within clinically relevant limits Wider Sample type Plasma and blood Plasma and serum/no blood (typically) Throughput Limited High Results reporting and availability Direct/immediate Indirect Training Simple Complex Operation Simple Complex Maintenance Simple, inexpensive Complex and expensive Instrument cost Low to intermediate High Mobility/Portability High Low Dependence on reagents and supplies Low High

15 Characteristics of CVD assays Excellent precision Reference ranges comparable to other methods <75 yrs = 125 pg/ml >75 yrs = 450 pg/ml

16 Method comparison data

17 Method Comparison Blood vs. Plasma

18 Summary and Conclusions LABGEO IB10 The Samsung LABGEO IB tests provide a rapid, portable and easy to use system for measuring cardiac analytes in any near patient location These tests are a critical part of the diagnostic protocols required in acute care situations, especially cardiac These tests provide key information required to make immediate and cost effective informed decisions. The results of short and long term monitoring of patients guide clinicians in administration of acute and chronic treatment including pharmaceutical and surgical intervention

19 Samsung LABGEO PT10 Chemistry Analyzer

20 Samsung LABGEO PT10 Chemistry Analyzer

21 Features of the LABGEO PT10 Clinical Chemistry Analyzer Dry film chemistry eliminates liquid waste Dry film chemistry allows ambient temperature storage of tests Rapid test results (7 min) Up to 14 analytes simultaneously using 70μL whole blood Analytical performance comparable to central lab mainframe

22 Samsung LABGEO PT10 Blood Analyzer Up to 11 panel cartridges available in multiple configurations Current menu up to 22 analytes - liver, renal, lipid panels, HbA1c

23 Operation of the LABGEO PT10 Chemistry Analyzer 70 μl

24

25 Performance of LABGEO PT10 Hepatic Test 9 vs. Roche Cobas 8000 central lab system

26 Validation of Hepatic Test 9 Panel Test menu (9) AST ALT ALP GGT Glucose Total bilirubin Direct bilirubin Total protein Albumin

27 Hepatic Panel -Performance Validation Accepted CLSI evaluation protocols used EP-5-A2- Precision Performance EP-6A Linearity EP-9A2- Method comparison and bias EP-14-A2 Evaluation of Matrix effects Matrices tested included - Lithium heparin whole blood - Lithium heparin plasma - Serum-serum separator tube Predicate instrument was Roche Cobas Modular 8000 N=60 patients

28 Precision: Using Bio-Rad Controls Duplicates, 2 times/day, 20 days N=80 All CV s below 10%

29 Method comparison-

30 Method comparison-

31 Comparison among different sample types

32 Summary and Conclusions The LABGEO PT10 is a small POC instrument with performance characteristics comparable to the central lab Results from Asan Medical Center using the Hepatic test 9 cartridge demonstrate: Total precision ranging from 2-9% Regression slopes to the Cobas 8000 ranging from Comparisons between whole blood, plasma and serum show no statistical, correlation or regression slope differences when different matrices are used The LABGEO PT10 Analyzer and tests provides an easy to use, accurate and efficient system for the rapid measurement of clinical chemistry analytes in near patient settings both within and outside the hospital.

33 Easy Connectivity and Data Management

34 Benefits of Samsung s LABGEO Test System Technology: Validated Systems and test menu Simplified test system = data reliability Quantitative on-board data processing Analyzer: Fully automated and simple to use; internal self-testing True portability/mobility of analyzer=independence of centralized electri city/water supply=suitable for emergency/catastrophic situations Built-in controls for temperature, optical parameters, and time; positive and blank Each control system functions independently and reports error when value of controlled parameter(s) exceeds specified limits. Data Connectivity Test devices: Self-contained calibrated test devices/each includes internal control Dry and stable

Biochemistry Validation Form

Biochemistry Validation Form Biochemistry Validation Form Method: Piccolo Xpress Chemistry 13 panel Manufacturer: Abaxis Cat no: 400-0029 CE marked: Yes: x No: Location of bench book: X:\Bio\Patricia\Piccollo Xpress evaluation (August

More information

An important first step in identifying those at risk for Cardiovascular disease The Accutrend Plus system: from the makers of the ACCU-CHEK and

An important first step in identifying those at risk for Cardiovascular disease The Accutrend Plus system: from the makers of the ACCU-CHEK and An important first step in identifying those at risk for Cardiovascular disease The Accutrend Plus system: from the makers of the ACCU-CHEK and CoaguChek systems Cardiovascular disease: the #1 killer in

More information

Urinalysis Compliance Tools. POCC Webinar January 19, 2011 Dr. Susan Selgren

Urinalysis Compliance Tools. POCC Webinar January 19, 2011 Dr. Susan Selgren Urinalysis Compliance Tools POCC Webinar January 19, 2011 Dr. Susan Selgren Learning Objectives Be able to review and improve upon a laboratory plan for compliance including: Competency Documentation Proficiency

More information

FDA Evaluation of Point of Care Blood Glucose Meters

FDA Evaluation of Point of Care Blood Glucose Meters FDA Evaluation of Point of Care Blood Glucose Meters Denise N. Johnson-Lyles, Ph.D., Scientific Reviewer Office of in Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

More information

Unaccredited Point-of-Care Laboratory Testing Guideline for Physicians

Unaccredited Point-of-Care Laboratory Testing Guideline for Physicians Unaccredited Point-of-Care Laboratory Testing Guideline for Physicians Prepared by the Advisory Committee on Laboratory Medicine College of Physicians & Surgeons of Alberta Serving the Public by guiding

More information

cobas 8100 automated workflow series 3-D intelligence in lab automation

cobas 8100 automated workflow series 3-D intelligence in lab automation cobas 8100 automated workflow series 3-D intelligence in lab automation Personalized Lab Automation Maximizing Testing Efficiency and Medical Value At Roche, laboratory automated solutions deliver the

More information

phealthlab, a need for effective phealthcare!

phealthlab, a need for effective phealthcare! phealthlab, a need for effective phealthcare! Define an unmet need! Provide a simple solution for the user!! Lars-Olof Hansson Karolinska University Laboratory Karolinska Institution Stockholm, Sweden

More information

Labor im Zentrifugenröhrchen zur dezentralen patientennahen Diagnostik

Labor im Zentrifugenröhrchen zur dezentralen patientennahen Diagnostik Labor im Zentrifugenröhrchen zur dezentralen patientennahen Diagnostik Felix von Stetten HSG-IMIT, Georges Köhler Alle 103, Freiburg, Germany 13.11.2013 - Mobile Diagnostik am Point-of-Care, DGBMT, Düsseldorf

More information

Managing POCT: Trying to Control Testing in an Out-of-Control Environment. William Clarke, PhD, MBA, DABCC Johns Hopkins School of Medicine 3/24/11

Managing POCT: Trying to Control Testing in an Out-of-Control Environment. William Clarke, PhD, MBA, DABCC Johns Hopkins School of Medicine 3/24/11 Managing POCT: Trying to Control Testing in an Out-of-Control Environment William Clarke, PhD, MBA, DABCC Johns Hopkins School of Medicine 3/24/11 Learning Objectives Participants should be able to: Discuss

More information

PoCT Troponin Improving Patient Outcomes in Rural and Remote Settings

PoCT Troponin Improving Patient Outcomes in Rural and Remote Settings PoCT Troponin Improving Patient Outcomes in Rural and Remote Settings Dr Philip Tideman FRACP Cardiologist and Clinical Director Integrated Cardiovascular Clinical Network Country Health South Australia

More information

Unleash Your Potential

Unleash Your Potential Unleash Your Potential Efficiency. Power. Flexibility. Small In Size Big In Performance. The respons 910 vet A Leap Forward For Your Laboratory. System solution consisting of the respons 910 vet analyzer,

More information

Implementing a region program for POCT service to emergency departments

Implementing a region program for POCT service to emergency departments Implementing a region program for POCT service to emergency departments Per Simonsson MD, PhD Medical POCT coordinator Department of Clinical Chemistry University and Regional laboratories Region Skåne

More information

CTSC Clinical Laboratory. Clinical Laboratory Services CTSC. Clinical & Translational Science Center

CTSC Clinical Laboratory. Clinical Laboratory Services CTSC. Clinical & Translational Science Center Clinical Laboratory The Clinical Laboratory develops and carries out research-related sample analyses to UNM HSC investigators, researchers throughout the United States and world, as well as corporate

More information

Course outline. Code: MLS211 Title: Medical Biochemistry

Course outline. Code: MLS211 Title: Medical Biochemistry Course outline Code: MLS211 Title: Medical Biochemistry Faculty of: Science, Health, Education and Engineering Teaching Session: Semester 2 Year: 2015 Course Coordinator: Dr Mark Holmes Tel: 5430 2844

More information

Accu-Chek Inform II system. Professional glucose testing for the wireless age

Accu-Chek Inform II system. Professional glucose testing for the wireless age Accu-Chek Inform II system Professional glucose testing for the wireless age The Accu-Chek Inform II system Real time control The Accu-Chek Inform II System overview Quality Advanced chemistry with multiple

More information

USING CLSI GUIDELINES TO PERFORM METHOD EVALUATION STUDIES IN YOUR LABORATORY

USING CLSI GUIDELINES TO PERFORM METHOD EVALUATION STUDIES IN YOUR LABORATORY USING CLSI GUIDELINES TO PERFORM METHOD EVALUATION STUDIES IN YOUR LABORATORY Breakout Session 3B Tuesday, May 1 8:30 10 am James Blackwood, MS, CLSI David D. Koch, PhD, FACB, DABCC, Pathology & Laboratory

More information

cobas connection modules (CCM) Sample flow solutions for high-throughput laboratories

cobas connection modules (CCM) Sample flow solutions for high-throughput laboratories cobas connection modules (CCM) Sample flow solutions for high-throughput laboratories Expert workflow management The fast track to sample flow efficiency Professional management of laboratory processes

More information

Room Temp: 8 Hr. Room Temp: 8Hr. Room Temp: ASAP. Refrigerated (2-8C): 3D. Room Temp: ASAP. Refrigerated (2-8C): 3D

Room Temp: 8 Hr. Room Temp: 8Hr. Room Temp: ASAP. Refrigerated (2-8C): 3D. Room Temp: ASAP. Refrigerated (2-8C): 3D Diabetes Chem Panel (Glu, Trig, Chol, HDL, LDL, Chol:HDL Ratio, AST, ALT, BUN, Creat, GFR, Na, K, Cl, CO2, Ca) ANMC Lab Test Requirements Updated 4/7/15 Key: Room Temp (20-25C), Refrigerated (2-8C), (-15

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

cobas h 232 POC system On-the-spot care & share

cobas h 232 POC system On-the-spot care & share cobas h 232 POC system On-the-spot care & share Confident on-the-spot diagnosis of patients presenting with life-threatening chest pain or dyspnea. Plus wireless connectivity for immediate, streamlined

More information

SAMPLE. Effects of Different Sample Types on Glucose Measurements

SAMPLE. Effects of Different Sample Types on Glucose Measurements 1st Edition POCT06 Effects of Different Sample Types on Glucose Measurements This report provides information to assist the clinical and point-ofcare staff in result and measurement procedure comparisons

More information

SureStep Pro Linearity Test Kit and Analytical Measurement Range Verification (AMR)

SureStep Pro Linearity Test Kit and Analytical Measurement Range Verification (AMR) WHITE PAPER SureStep Pro Linearity Test Kit and Analytical Measurement Range Verification (AMR) LifeScan developed the SureStep Pro Linearity Solutions to assist institutional customers in meeting regulatory

More information

Welcome to the fully integrated autoimmune laboratory. Saves time by reducing hands-on functions NOVA Lite Barcoded IFA Slides

Welcome to the fully integrated autoimmune laboratory. Saves time by reducing hands-on functions NOVA Lite Barcoded IFA Slides The Integrated Lab Connected Welcome to the fully integrated autoimmune laboratory. Saves time by reducing hands-on functions NOVA Lite Barcoded IFA Slides NOVA View Reduces costs with automation efficiencies

More information

SMF Awareness Seminar 2014

SMF Awareness Seminar 2014 SMF Awareness Seminar 2014 Clinical Evaluation for In Vitro Diagnostic Medical Devices Dr Jiang Naxin Health Sciences Authority Medical Device Branch 1 In vitro diagnostic product means Definition of IVD

More information

Contents. Abstract...i. Committee Membership... iii. Foreword... vii. 1 Scope...1

Contents. Abstract...i. Committee Membership... iii. Foreword... vii. 1 Scope...1 ISBN 1-56238-584-4 Volume 25 Number 27 ISSN 0273-3099 Interference Testing in Clinical Chemistry; Approved Guideline Second Edition Robert J. McEnroe, PhD Mary F. Burritt, PhD Donald M. Powers, PhD Douglas

More information

cobas connection modules (CCM) Sample flow solutions for high-throughput laboratories

cobas connection modules (CCM) Sample flow solutions for high-throughput laboratories cobas connection modules (CCM) Sample flow solutions for high-throughput laboratories Expert workflow management The fast track to sample flow efficiency Professional management of laboratory processes

More information

Application Sheet for Rivaroxaban (Xarelto ) Standard Range with. BIOPHEN Heparin LRT (#221011/221013) RUO

Application Sheet for Rivaroxaban (Xarelto ) Standard Range with. BIOPHEN Heparin LRT (#221011/221013) RUO Instrument Adaptation The attached instrument adaptation has been prepared and validated by the reagent manufacturer, Hyphen-Biomed. Instrument Siemens BCS-XP Product BIOPHEN Heparin LRT Analyte Rivaroxaban

More information

Product: Point-of-care immunoassay system yielding rapid labquality quantitative blood test results with unprecedented ease-ofuse.

Product: Point-of-care immunoassay system yielding rapid labquality quantitative blood test results with unprecedented ease-ofuse. Mission Provide Clinicians, Patients and Payors with a Point-of-Care Diagnostic Solution Coupling Clinically Relevant Performance with Unparalleled Ease-of-Use and Cost Effectiveness Product: Point-of-care

More information

NEO. High Throughput Full Automation

NEO. High Throughput Full Automation NEO High Throughput Full Automation NEO gives your laboratory the ability to achieve exceptional performance, enhanced speed, and unprecedented flexibility. Transfuse Transplant Transform a life NEO s

More information

i STAT Creatinine Chemistry China Basin

i STAT Creatinine Chemistry China Basin Creatinine is measured amperometrically. Creatinine is hydrolyzed to creatine in a reaction catalyzed by the enzyme creatinine amidohydrolase. Creatine is then hydrolyzed to sarcosine in a reaction catalyzed

More information

for patient monitoring

for patient monitoring Thermo Scientific Indiko Reagents for Immunosuppressant Drug Testing Complete solutions for patient monitoring The cost-effective Thermo Scientific Indiko benchtop analyzer and bar-coded reagent is designed

More information

cobas c 111 analyzer Small box. Big performance

cobas c 111 analyzer Small box. Big performance cobas c 111 analyzer Small box. Big performance His journey back to health begins in your laboratory cobas solutions making a difference when it matters most Every patient prognosis depends on several

More information

ADMINISTRATIVE MANUAL Policy and Procedure

ADMINISTRATIVE MANUAL Policy and Procedure ADMINISTRATIVE MANUAL Policy and Procedure TITLE: Point of Care Testing NUMBER: CH 30-111 (Laboratory Diagnostic Bedside Testing) Effective Date: January 2014 Page 1 of 6 Applies To: Holders of Administrative

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

How to Maximize Your Lab s Value to Cardiac Care Sammie Sue Hendrix Laboratory Director Citizens Medical Center, Victoria Texas

How to Maximize Your Lab s Value to Cardiac Care Sammie Sue Hendrix Laboratory Director Citizens Medical Center, Victoria Texas How to Maximize Your Lab s Value to Cardiac Care Laboratory Director Citizens Medical Center, Victoria Texas All rights reserved. Today s Presentation This presentation is sponsored by Siemens Healthcare

More information

4/24/2015. Urgent, STAT, Super STAT, ASAP! Achieving timely lab testing for the Emergency Department. Learning Objectives.

4/24/2015. Urgent, STAT, Super STAT, ASAP! Achieving timely lab testing for the Emergency Department. Learning Objectives. Urgent, STAT, Super STAT, ASAP! Achieving timely lab testing for the Emergency Department Nichole Korpi-Steiner, PhD, DABCC, FACB University of North Carolina Chapel Hill, NC Learning Objectives Describe

More information

Special Feature: Growth Model of an Agile Company

Special Feature: Growth Model of an Agile Company Special Feature: Growth Model of an Agile Company 15 Sysmex s Global Strategy From the time of its establishment, Sysmex has followed a steady growth trajectory, and the Group now provides products and

More information

What Does Having a FDA Cleared Pregnancy Test Mean?

What Does Having a FDA Cleared Pregnancy Test Mean? What Does Having a FDA Cleared Pregnancy Test Mean? Clinical Trials Transformation Initiative (CTTI) July 15-16, 2013 Denise N. Johnson-Lyles, Ph.D. Toxicology Branch Chief Division of Chemistry and Toxicology

More information

Management for the World Module: Assessing point-of-care diagnostics for resource-limited settings

Management for the World Module: Assessing point-of-care diagnostics for resource-limited settings Point-of-care diagnostics are medical tools or devices that can diagnose disease in a patient s community, generally outside of a formal clinic setting. By shifting disease diagnosis to the community level,

More information

FDA Public Hearing on Clinical Accuracy Requirements for Point of Care Blood Glucose Meters (BGMs)

FDA Public Hearing on Clinical Accuracy Requirements for Point of Care Blood Glucose Meters (BGMs) FDA Public Hearing on Clinical Accuracy Requirements for Point of Care Blood Glucose Meters (BGMs) Barriers to Overcoming Interferences and Limitations Alan T. Cariski, MD, JD, and Mike Flis, AdvaMed BGM

More information

510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K092353 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY B. Purpose for Submission: This is a new 510k application for a new indication for the MONOLISA Anti-HAV IgM EIA

More information

History of Innovation

History of Innovation 1 History of Innovation Only Immucor consistently delivers the next-generation of blood bank automation to labs worldwide ABS HV Galileo NEO 1998 1999 2004 2007 2010 ABS2000 ABS Precis Echo 2 Innovation

More information

Quality Requirements of a Point of Care Testing Service

Quality Requirements of a Point of Care Testing Service Quality Requirements of a Point of Care Testing Service Adil I. Khan MSc, PhD Assistant Professor of Pathology Director of Point of Care Testing & Clinical Chemistry Laboratory, Temple University Episcopal

More information

Connecting solutions of excellence

Connecting solutions of excellence MODULAR PRE-ANALYTICS EVO analyzer Connecting solutions of excellence COBAS, COBAS C, COBAS E, COBAS P, LIFE NEEDS ANSWERS, MODULAR ANALYTICS EVO, MODULAR PRE-ANALYTICS EVO, MODULAR, ELECSYS and COBAS

More information

JOINT COMMISSION INTERNATIONAL ACCREDITATION STANDARDS FOR. 2nd Edition

JOINT COMMISSION INTERNATIONAL ACCREDITATION STANDARDS FOR. 2nd Edition JOINT COMMISSION INTERNATIONAL ACCREDITATION STANDARDS FOR CliniCAl laboratories 2nd Edition Effective 1 April 2010 International Patient Safety Goals (IPSG) Goals The following is a list of all goals.

More information

Abbott Diagnostics. Durable Growth Business

Abbott Diagnostics. Durable Growth Business Abbott Diagnostics Durable Growth Business Forward-Looking Statement Some statements in this presentation may be forward-looking statements for purposes of the Private Securities Litigation Reform Act

More information

University Hospital Ulm Ulm, Germany. Prof. Dr. Dr. Dr. h.c. Max G. Bachem, Director Kerstin Stöhrer, Technical Supervisor

University Hospital Ulm Ulm, Germany. Prof. Dr. Dr. Dr. h.c. Max G. Bachem, Director Kerstin Stöhrer, Technical Supervisor University Hospital Ulm Ulm, Germany Prof. Dr. Dr. Dr. h.c. Max G. Bachem, Director Kerstin Stöhrer, Technical Supervisor The University Hospital Ulm was founded in 1982. In 30 years it has built an enviable

More information

Quality Forward. UniCel DxI Access Immunoassay Systems

Quality Forward. UniCel DxI Access Immunoassay Systems Quality Forward CONSISTENCY Forward LAB FORWARD UniCel DxI Access Immunoassay Systems When it comes to immunoassay testing, mid- to high-volume laboratories have specific needs:» Exceptional productivity»

More information

CAP Point of Care Checklist Frequently Asked Questions Roger D. Klein, MD Sheldon Campbell, MD, PhD Peter J. Howanitz, MD

CAP Point of Care Checklist Frequently Asked Questions Roger D. Klein, MD Sheldon Campbell, MD, PhD Peter J. Howanitz, MD CAP Point of Care Checklist Frequently Asked Questions Roger D. Klein, MD Sheldon Campbell, MD, PhD Peter J. Howanitz, MD TABLE OF CONTENTS Introduction Applicability General Topics Proficiency Testing

More information

cobas 6500 urine analyzer series Fully automated urine work area on a modular platform

cobas 6500 urine analyzer series Fully automated urine work area on a modular platform cobas 6500 urine analyzer series Fully automated urine work area on a modular platform cobas 6500 urine analyzer series Fully automated urine work area on a modular platform cobas 6500 urine analyzer series

More information

Dr Paul Mundill Innostics Innostics Oy

Dr Paul Mundill Innostics Innostics Oy Dr Paul Mundill Innostics Oy Future Diagnostics Finland Ideas for Query 2009 The aim was to assess the future directions and needs of the Finnish in vitro diagnostics industry and to collect foresights

More information

YSI 2900 Series Biochemistry Analyzers FERMENTATION CONTROL FOOD & BEVERAGE CLINICAL RESEARCH

YSI 2900 Series Biochemistry Analyzers FERMENTATION CONTROL FOOD & BEVERAGE CLINICAL RESEARCH YSI 2900 Series Biochemistry Analyzers FERMENTATION CONTROL FOOD & BEVERAGE CLINICAL RESEARCH Fast and Accurate: The YSI Gold Standard YSI has earned a reputation as the Gold Standard in bio-analytical

More information

Pointe Scientific, Inc. Instrument Application

Pointe Scientific, Inc. Instrument Application Pointe Scientific, nc. nstrument Application Analyzer: Chemwell Test: Albumin Catalog # : A7502 Options: Assignment Order: 8-way in groups of 4 Optimized order execution Temperature Control to 37C Dispense

More information

Technical Bulletin Number: 054-869A Date Prepared: 6/97

Technical Bulletin Number: 054-869A Date Prepared: 6/97 Calibration Verification Technical Bulletin Number: 054-869A Date Prepared: 6/97 Purpose This technical bulletin is intended to provide a basic protocol for performing calibration verification of the SureStepPro

More information

Lean Strategies Used to Optimize Automation. Why Lean Six Sigma? Laboratory Goals. Decreased TAT. Accurate Results. LEAN Goals.

Lean Strategies Used to Optimize Automation. Why Lean Six Sigma? Laboratory Goals. Decreased TAT. Accurate Results. LEAN Goals. Lean Strategies Used to Optimize Automation Linda Stubbs, ASQ CSSBB Senior Workflow Specialist Why LEAN Six Sigma? Why Lean Six Sigma? Laboratory Goals Decreased TAT Accurate Results LEAN Goals Increase

More information

Rat Creatine Kinase MB isoenzyme,ck-mb ELISA Kit

Rat Creatine Kinase MB isoenzyme,ck-mb ELISA Kit Rat Creatine Kinase MB isoenzyme,ck-mb ELISA Kit Catalog No: E0479r 96 Tests Operating instructions www.eiaab.com FOR RESEARCH USE ONLY; NOT FOR THERAPEUTIC OR DIAGNOSTIC APPLICATIONS! PLEASE READ THROUGH

More information

Centro de Salud México España Centro de Salud San Francisco Culhuacán Mexico City, Mexico

Centro de Salud México España Centro de Salud San Francisco Culhuacán Mexico City, Mexico Centro de Salud México España Centro de Salud San Francisco Culhuacán Mexico City, Mexico Mexico City is one of the largest cities in the world and home to over 21 million people. The population is culturally

More information

Quality Control of the Future: Risk Management and Individual Quality Control Plans (IQCPs)

Quality Control of the Future: Risk Management and Individual Quality Control Plans (IQCPs) Quality Control of the Future: Risk Management and Individual Quality Control Plans (IQCPs) James H. Nichols, PhD, DABCC, FACB Professor of Pathology, Microbiology, and Immunology Medical Director, Clinical

More information

Accuracy Test Omnitest 3 Blood Glucose Monitoring System. B. Braun Diabetes Care

Accuracy Test Omnitest 3 Blood Glucose Monitoring System. B. Braun Diabetes Care Accuracy Test Omnitest Blood Glucose Monitoring System B. Braun Diabetes Care Accuracy Test Omnitest blood glucose monitoring system according to ISO 97 The accuracy study of Omnitest blood glucose monitoring

More information

Human Free Testosterone(F-TESTO) ELISA Kit

Human Free Testosterone(F-TESTO) ELISA Kit Human Free Testosterone(F-TESTO) ELISA Kit Catalog Number. MBS700040 For the quantitative determination of human free testosterone(f-testo) concentrations in serum, plasma. This package insert must be

More information

2014 European AKI Diagnostics Market Product Leadership Award

2014 European AKI Diagnostics Market Product Leadership Award 2014 European AKI Diagnostics Market Product Leadership Award Contents Letter of Congratulations... 3 Background and Company Performance... 4 Industry Challenges... 4 Conclusion... 6 Significance of Technology

More information

CentraLink Data Management System

CentraLink Data Management System www.siemens.com/diagnostics CentraLink Data Management System Delivering quality lab results faster for better patient care Answers for life. CentraLink Data Management System Delivering quality lab results

More information

Thyroid Stimulating Hormone on Architect i2000 In-Use Date: May 1, 2016

Thyroid Stimulating Hormone on Architect i2000 In-Use Date: May 1, 2016 Thyroid Stimulating Hormone on Architect i2000 In-Use Date: May 1, 2016 I. PRINCIPLE The ARCHITECT TSH assay is a two-step immunoassay to determine the presence of Thyroid Stimulating Hormone (TSH) in

More information

MEDICAL NUTRITION THERAPY (MNT) CLINICAL NUTRITION THERAPY Service Time CPT Code

MEDICAL NUTRITION THERAPY (MNT) CLINICAL NUTRITION THERAPY Service Time CPT Code MEDICAL NUTRITION THERAPY (MNT) CLINICAL NUTRITION THERAPY Service Time CPT Code Initial Assessment And Intervention This Code Can Be Used Only Once A Year For First Appointment Medical Nutrition Therapy

More information

Organization of Primary Care Clinics

Organization of Primary Care Clinics Component 1: Introduction to Health Care and Public Health in the U.S. 1.3: Unit 3: Delivering Healthcare (Part 2) 1.3e: Organization Of Primary Care Clinics Organization of Primary Care Clinics Organization

More information

Creatine Kinase Assay Kit

Creatine Kinase Assay Kit Creatine Kinase Assay Kit Catalog Number KA1665 100 assays Version: 03 Intended for research use only www.abnova.com Table of Contents Introduction... 3 Intended Use... 3 Background... 3 Principle of the

More information

MultiQuant Software 2.0 for Targeted Protein / Peptide Quantification

MultiQuant Software 2.0 for Targeted Protein / Peptide Quantification MultiQuant Software 2.0 for Targeted Protein / Peptide Quantification Gold Standard for Quantitative Data Processing Because of the sensitivity, selectivity, speed and throughput at which MRM assays can

More information

TOTAL PROTEIN FIBRINOGEN

TOTAL PROTEIN FIBRINOGEN UNIT: Proteins 16tproteins.wpd Task Determination of Total Protein, Albumin and Globulins Objectives Upon completion of this exercise, the student will be able to: 1. Explain the ratio of albumin and globulin

More information

Products and Solutions 2015 Roche Diagnostics

Products and Solutions 2015 Roche Diagnostics Products and Solutions 2015 Roche Diagnostics I i I a I i healthy At Roche Diagnostics, we re giving you the answers today for a healthier tomorrow. We give you The Power of Knowing Diseases raise many

More information

Hepatitis C. Laboratory Tests and Hepatitis C

Hepatitis C. Laboratory Tests and Hepatitis C Hepatitis C Laboratory Tests and Hepatitis C If you have hepatitis C, your doctor will use laboratory tests to check your health. This handout will help you understand what the major tests are and what

More information

BG MEDICINE. Corporate Presentation February 2013

BG MEDICINE. Corporate Presentation February 2013 BG MEDICINE Corporate Presentation February 2013 CONFIDENTIAL Oct 9, 2007 Forward-Looking Statements This presentation contains forward-looking statements regarding future events or the future financial

More information

Inc. Wuhan. Quantity Pre-coated, ready to use 96-well strip plate 1 Plate sealer for 96 wells 4 Standard (liquid) 2

Inc. Wuhan. Quantity Pre-coated, ready to use 96-well strip plate 1 Plate sealer for 96 wells 4 Standard (liquid) 2 Uscn Life Science Inc. Wuhan Website: www.uscnk.com Phone: +86 27 84259552 Fax: +86 27 84259551 E-mail: uscnk@uscnk.com ELISA Kit for Human Prostaglandin E1(PG-E1) Instruction manual Cat. No.: E0904Hu

More information

Point-of-care (POC) versus central laboratory instrumentation for monitoring oral anticoagulation

Point-of-care (POC) versus central laboratory instrumentation for monitoring oral anticoagulation Point-of-care (POC) versus central laboratory instrumentation for monitoring oral anticoagulation David M Dorfman a, Ellen M Goonan a, M Kay Boutilier a, Petr Jarolim a, Milenko Tanasijevic a and Samuel

More information

Human Inositol 1,4,5,-Trisphosphate (IP 3 )ELISA Kit

Human Inositol 1,4,5,-Trisphosphate (IP 3 )ELISA Kit Human Inositol 1,4,5,-Trisphosphate (IP 3 )ELISA Kit Catalog No. CSB-E12636h (96T) This immunoassay kit allows for the in vitro quantitative determination of human IP 3 concentrations in serum, plasma

More information

EPF Position Statement on the European Commission s proposal for a Regulation on In Vitro Medical Devices

EPF Position Statement on the European Commission s proposal for a Regulation on In Vitro Medical Devices EPF Position Statement on the European Commission s proposal for a Regulation on In Vitro Medical 03/09/2013 In Vitro Diagnostic medical devices include all tests performed to provide a diagnosis by assessing

More information

EiCon G.m.b.H. Diagnostic Healthcare Consulting. Amtsgericht Lörrach : HRB-Nr.3002. E-Mail : info@eiconnet.de. Home page: http://www.eiconnet.

EiCon G.m.b.H. Diagnostic Healthcare Consulting. Amtsgericht Lörrach : HRB-Nr.3002. E-Mail : info@eiconnet.de. Home page: http://www.eiconnet. EiCon G.m.b.H. Diagnostic Healthcare Consulting Amtsgericht Lörrach : HRB-Nr.3002 Unterbaselweg 55 D -79576 Weil am Rhein Germany Phone : (49) - 7621-798373 Fax : (49) - 7621-798374 Hauptstrasse 160 D-79576

More information

SAMPLE. Verification of Comparability of Patient Results Within One Health Care System; Approved Guideline (Interim Revision)

SAMPLE. Verification of Comparability of Patient Results Within One Health Care System; Approved Guideline (Interim Revision) August 2012 Verification of Comparability of Patient Results Within One Health Care System; Approved Guideline (Interim Revision) This document provides guidance on how to verify comparability of quantitative

More information

Biomarker-based diagnostics. Andras Apjok, CEO. Budapest, 17 February 2015 Innovation is GREAT Britain

Biomarker-based diagnostics. Andras Apjok, CEO. Budapest, 17 February 2015 Innovation is GREAT Britain Biomarker-based diagnostics Andras Apjok, CEO Budapest, 17 February 2015 Innovation is GREAT Britain Introduction: MDR and disease focus MDQuest is a spin off company of SOLVO Biotechnology (Hungary) MDQUEST

More information

Discover Your Potential

Discover Your Potential Discover Your Potential Efficiency. Power. Flexibility. Small In Size Big In Performance. respons 910 A Leap Forward For Your Laboratory. Superior system solution including respons system reagents, analyzer,

More information

Discover Your Potential

Discover Your Potential Discover Your Potential Efficiency. Power. Flexibility. Small In Size Big In Performance. respons 910 A Leap Forward For Your Laboratory. System solution consisting of respons 910 analyzer, intuitive software,

More information

I know my value. CoaguChek XS Plus system Smart INR monitoring at your practice. 1 of 6

I know my value. CoaguChek XS Plus system Smart INR monitoring at your practice. 1 of 6 I know my value CoaguChek XS Plus system Smart INR monitoring at your practice 1 of 6 CoaguChek XS Plus system A better choice for your patients and your practice There has been an extraordinary increase

More information

Extraction of Epinephrine, Norepinephrine and Dopamine from Human Plasma Using EVOLUTE EXPRESS WCX Prior to LC-MS/MS Analysis

Extraction of Epinephrine, Norepinephrine and Dopamine from Human Plasma Using EVOLUTE EXPRESS WCX Prior to LC-MS/MS Analysis Application Note AN844 Extraction of, and from Human Plasma Using EVOLUTE EXPRESS WCX Page 1 Extraction of, and from Human Plasma Using EVOLUTE EXPRESS WCX Prior to LC-MS/MS Analysis Introduction Catecholamines

More information

Human Luteinizing Hormone (LH) Custom Kit

Human Luteinizing Hormone (LH) Custom Kit Human Luteinizing Hormone (LH) Custom Kit 18089-v2-2015Jan 1 MSD Toxicology Assays Human Luteinizing Hormone (LH) Custom Kit This package insert must be read in its entirety before using this product.

More information

Professional Certificate in Primary Care Psychology

Professional Certificate in Primary Care Psychology Professional Certificate in Primary Care Psychology The NAPPP Primary Care Psychology Certificate training program requires the completion of 10 courses. Each course awards 15 CE credit hours. NAPPP is

More information

Simultaneous Qualitative and Quantitative Data Acquisition for Research of Diabetes Drugs

Simultaneous Qualitative and Quantitative Data Acquisition for Research of Diabetes Drugs Liquid Chromatography Mass Spectrometry SSI-LCMS-068 Simultaneous Qualitative and Quantitative Data Acquisition for Research of Diabetes Drugs LCMS-8050 Summary By utilizing the LCMS-8050 s ultrafast scan

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

Overview. Purpose. Methods. Results

Overview. Purpose. Methods. Results A ovel Approach to Quantify Unbound Cisplatin, Carboplatin, and xaliplatin in Human Plasma Ultrafiltrate by Measuring Platinum-DDTC Complex Using LC/M/M Min Meng, Ryan Kuntz, Al Fontanet, and Patrick K.

More information

510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: k103555 B. Purpose for Submission: New submission C. Measurand: Platelet aggregation D. Type of Test: Platelet aggregometer

More information

FULL LABORATORY to HOT LABORATORY DR. DAVID OLEESKY

FULL LABORATORY to HOT LABORATORY DR. DAVID OLEESKY FULL LABORATORY to HOT LABORATORY Remodelling the biochemistry service at Macclesfield District General Hospital within a hub and spoke managed network --------------------------------------------------------------------------------------------

More information

PRINCIPLE. REF 442635 (200 tests/cartridge) REF 476836 (400 tests/cartridge) ANNUAL REVIEW Reviewed by: Date. Date INTENDED USE

PRINCIPLE. REF 442635 (200 tests/cartridge) REF 476836 (400 tests/cartridge) ANNUAL REVIEW Reviewed by: Date. Date INTENDED USE SYNCHRON System(s) Chemistry Information Sheet Copyright 2010 Beckman Coulter, Inc. Creatine Kinase REF 442635 (200 tests/cartridge) REF 476836 (400 tests/cartridge) For In Vitro Diagnostic Use ANNUAL

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

POCT in diagnosing and monitoring of Diabetes Mellitus. 13th EFLM Continuous Postgraduate Course, Sverre Sandberg, Noklus / EFLM

POCT in diagnosing and monitoring of Diabetes Mellitus. 13th EFLM Continuous Postgraduate Course, Sverre Sandberg, Noklus / EFLM POCT in diagnosing and monitoring of Diabetes Mellitus - 13th EFLM Continuous Postgraduate Course, Sverre Sandberg, Noklus / EFLM The most important constituents - Glucose monitoring and diagnosing - U-albumin

More information

FDA Regulation of Whole Slide Imaging (WSI) Devices: Current Thoughts

FDA Regulation of Whole Slide Imaging (WSI) Devices: Current Thoughts FDA Regulation of Whole Slide Imaging (WSI) Devices: Current Thoughts Clinical Laboratory Improvement Advisory Committee Meeting Centers for Disease Control and Prevention February 15, 2012 Tremel A. Faison,

More information

Technical Report. Automatic Identification and Semi-quantitative Analysis of Psychotropic Drugs in Serum Using GC/MS Forensic Toxicological Database

Technical Report. Automatic Identification and Semi-quantitative Analysis of Psychotropic Drugs in Serum Using GC/MS Forensic Toxicological Database C146-E175A Technical Report Automatic Identification and Semi-quantitative Analysis of Psychotropic Drugs in Serum Using GC/MS Forensic Toxicological Database Hitoshi Tsuchihashi 1 Abstract: A sample consisting

More information

Canine creatine kinase MB isoenzyme (CK-MB)ELISA Kit

Canine creatine kinase MB isoenzyme (CK-MB)ELISA Kit Canine creatine kinase MB isoenzyme (CK-MB)ELISA Kit Catalog No. CSB-E15852c (96T) This immunoassay kit allows for the in vitro quantitative determination of canine CK-MB concentrations in serum and plasma.

More information

Basic Lessons in Laboratory Quality Control

Basic Lessons in Laboratory Quality Control Bio-Rad Laboratories QC education Basic Lessons in Laboratory Quality Control QC Workbook Basic Lessons in Laboratory Quality Control Written by Greg Cooper, CLS, MHA Manager of Clinical Standards and

More information

Medical technology makes healthcare smart. Frederik Horemans DSP Valley

Medical technology makes healthcare smart. Frederik Horemans DSP Valley Medical technology makes healthcare smart Frederik Horemans DSP Valley DSP Valley, the cluster of excellence in smart electronic systems, acts as matchmaker for open innovation Strong technology focus

More information

Albumin. Prothrombin time. Total protein

Albumin. Prothrombin time. Total protein Hepatitis C Fact Sheet February 2016 www.hepatitis.va.gov Laboratory Tests and Hepatitis If you have hepatitis C, your doctor will use laboratory tests to about learn more about your individual hepatitis

More information

The Sievers 900 Series TOC Analyzers

The Sievers 900 Series TOC Analyzers GE Water & Process Technologies Analytical Instruments The Sievers 900 Series TOC Analyzers imagination at work Delivering Next-Generation Ease of Use, Productivity, and Reliability The Sievers* 900 Series

More information