Meeting demands of your laboratory The ARCHITECT Family
Nadya Makhova Commercial Manager Area Europe
Abbott Forum, Sofia/ Bulgaria Commitment To Science May 2010
Company Confidential Š 2010 Abbott
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September 4, 2010
Abbott Global Diagnostics Three Business Areas Abbott Diagnostics Division (ADD)
Abbott Molecular
Point of Care
• >5,500 products • Direct sales/service in >70 countries
• 1,000 products • Direct sales/service in >30 countries
• Blood Gases/Coagulation • Cardiac • Chemistry
• • • •
Immunoassay Clinical Chemistry Hematology Blood Screening
– Infectious Disease – Oncology – Genetic Testing
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Abbott Diagnostics Around the Globe > 12,000 employees > 1,400 sales/service staff > 1,000 scientists
8 manufacturing / 9 R&D sites
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Abbott Diagnostics Division CORE Laboratory Solutions Hematology
Immunoassay
Chemistry
Hardware Automation
Software Automation
ARCHITECT Family
Low Volume Emerald
i1000SR
Ruby
ci4100*
c4000*
Sapphire & SMS
i2000SR
ci8200
c8000
Pre-Analytics
Hematology Automation
i4000SR
ci16200
c16000
Configurable Workcell
Very High Volume ACCELERATOR APS: Automation Processing Systems
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Middleware Options
You want to focus on the most important tasks in a laboratory
You demand quality and accuracy with every result
You want to diagnose more patients with fewer resources
You have to deliver the results always on time
You want to reduce time handling samples and reagents
You want to improve your laboratories overall productivity
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Maximising Maximising Productivity Productivity
Cost Cost effectiveness effectiveness
Positive Positive Working Working Environment Environment
= Allowing Allowing you you to to achieve achieve your your targets targets
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The Complete ARCHITECT Family Chemistry
Integration
Flexibility
Low
Medium
High
Immunoassay
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ARCHITECT - works for you Universal ARCHITECT Sample Carrier
Identical Software
Helps to improve workflow
Easy to use for laboratory personnell
Integration Common Clinical Chemistry Reagents
Reduces your Sample handling
Common Immunoassay Reagents
Minimise your inventory
Minimise your inventory
Commitment To Science May 2010
Company Confidential Š 2010 Abbott
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ARCHITECT - works for you Universal ARCHITECT Sample Carrier
Identical Software
Helps to improve workflow
Easy to use for laboratory personnell
Integration Common Clinical Chemistry Reagents
Reduces your Sample handling
Common Immunoassay Reagents
Minimise your inventory
Minimise your inventory
Commitment To Science May 2010
Company Confidential Š 2010 Abbott
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The ARCHITECT ci4100
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ARCHITECT ci4100
+
Easy to use Optimise workflow Accurate result on time
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ARCHITECT ci4100 – Closer look at features and benefits
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ARCHITECT ci4100 – Overview Throughput of the ARCHITECT c4000
• • •
Theoretical throughput is up to 400 t/hr photometric test Theoretical throughput ICT is up to 600 t/hr Actual throughput combined is approximately 425 t/hr
i1000SR
• •
Theoretical throughput is up to 100 t/hr Actual throughput is approximately 55 t/hr
Number of samples on Robotic Sample Handler c4000 – 100 samples i1000SR – 65 samples ci4100 – 180 samples
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ARCHITECT ci4100 – Overview 125 refrigerated reagent positions on the ci4100 c4000
• • •
single carousel 90 positions for both R1 and R2 Up to 55 different assays
i1000SR
• •
25 reagent positions “on-the-fly” loading through RSH
Water consumption On average only 15 l /h
Probe pressure monitoring Reagent Probes Sample Probes
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Integration Without Compromise True integration with a single control center Efficiency Fewer tubes, no aliquoting STATs quickly prioritized with the RSH
SmartWash technology controls sample-to-sample carryover (<0.1 ppm)
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Value of ARCHITECT Advanced Technology Be Productive
Gain Efficiency
Ensure Quality
Reduce Risk
Universal Carrier
Robotic Sample Handler
ICT Module Flex Rate
SmartWash
Serum Indices
Simplify processes fewer resource
STAT prioritized for a consistently fast turnaround time
• less time
• reduce interruptions and stress in lab • medical staff can make critical treatment decisions
handling and sorting samples • one tube for both IA and CC testing
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• Less maintains for ICT • Less reruns • Standardize sample integrity reporting • Safeguarding the integrity of results
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Reduce the risk of reporting incorrect results • < 0.1 ppm sample
carryover • clot, bubble, foam, and insufficient sample detection
Value of ARCHITECT Advanced Technology Be Productive Universal Carrier
Simplify processes to handle growing workloads with fewer resource • spend less time
handling and sorting samples • one tube for both IA and CC testing
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The sample carrier
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Pediatric Tube Handling Two customer studies:
• •
Rautenberg et al. Alexander et al.
ARCHITECT pipettes directly from pediatric- or microtainer-tubes
•
Eliminates mistakes due to manual aliquoting into sample cups
•
Less time consuming, increased efficiency
Pediatric tube direct sampling by the Abbott ARCHITECT Integrated ci8200 chemistry / immunochemistry analyser Rautenberg et al., Conference Poster, EuroMedLab 2005 Feasibility of Direct Sampling of Primary Pediatric Collection Tubes by the ARCHITECT ci8200 System Alexander et al., Conference Poster, IFCC/AACC 2005 Annual Meeting, Orlando, FL
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Value of ARCHITECT Advanced Technology Gain Efficiency Robotic Sample Handler
STAT samples prioritized for a consistently fast turnaround time • reduce interruptions and stress in lab • medical staff can make critical treatment decisions
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Improved Workflow and Better Patient Outcomes ARCHITECT Robotic Sample Handler (RSH) Spend less sorting sample At a glance sample status Fast and consistent STAT turnaround times
• •
Physicians can depend on you for critical results Minimizing the time patients spend in critical care and emergency departments
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ARCHITECT Integration – Superior STAT TAT Average Turn-Around-Time (TAT) – STAT Specimens* 50 45
40 ci8200 ci1600
33
Lxi 725 29
30
27
Minutes
In an independent study by Enterprise Analysis Corporation (EAC), the ci8200 delivered the fastest overall STAT TAT for integrated systems in the Mid volume segment
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20
21 1717
16 14
27
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18 14
28
29
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Modular 20
17
10
11
10
10
0
ci4100 Familiarization Throughput Study
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Average TAT STAT Chem
Average TAT STAT IA
Average TAT STAT Chem/IA
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17
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*Source EAC STAT TAT Study 2007 AR4187 Commitment To Science May 2010
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cobas 6000 Workcell
14
13
Average TAT STAT
DxC 600i DxC 880i
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24
20
28
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Value of ARCHITECT Advanced Technology Ensure Quality ICT Module Flex Rate Serum Indices
•Less maintains for ICT •Less reruns •Standardize sample integrity reporting • Safeguarding the integrity of results
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Integrated Chip Technology: Ease Of Use Long Lasting
• •
45,000 determinations 15,000 sample capacity Serum, Plasma, Urine
Discrete Sampling No Flushing or Continuous Calibration Indirect; 24 fold dilution Automated maintenance and easy to change
• •
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No delay in changing modules Simple for all staff
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Sample Interference Indices Hemolysis, Icterus, Lipemia HIL Provide awareness of the quality/integrity of specimens Aid in decisions to accept or reject specimens and/or results Objective vs. subjective Fast TAT
•
Minimal to no impact to throughput
Flexible reporting options
•
Semi-quantitative, Qualitative
Trigger comments, yield permanent documentation
Tool to visualize potential impact of HIL
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FlexRate for Superior CC Assay Linearity FlexRate •
Uses 2 absorbance read windows: Main read window Flex read window
•
If 3 consecutive points are within the main read window and linear, the final absorbance value is translated into numerical result
•
If the values are non-linear, then FlexRate uses the absorbance’s from an earlier read window to calculate the patient result.
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Flexrate and Specimen Reruns 700
# of Samples Needing Dilution/Per Year*
600 500
Abbott Ortho
400
Beckman Dade/Siemens
300
Roche
200
89% 89%reduction reductionin in specimen specimen dilutions dilutionswith with reduced reducedlabor labor time timeand andcost cost
100 0
3
4
0
0 AlkP
ALT
AST
CK
GGT
•FlexRate reduces sample reruns •RSH improves TAT for reruns
ARCHITECT ARCHITECTcSystems cSystemsreduce reducereruns rerunsand andimprove improveresult resultTAT TAT *An Evaluation of Extended Linearity Enzyme and β-hCG Assays with FlexRate on Abbott ARCHITECT Analyzer: C. Elizabeth Elefano, Jabeen Rukshana, J.R. Petersen, A.O. Okorodudu and Amin A. Mohammad, Department of Pathology, University of Texas Medical Branch, Galveston, TX; 38th Annual Oak Ridge Conference • April 20 – 21, 2006 • San Jose, CA Commitment To Science May 2010
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Value of ARCHITECT Advanced Technology Reduce Risk SmartWash
Built in safeguards reduce the risk of reporting incorrect results • < 0.1 ppm sample
carryover • clot, bubble, foam, and insufficient sample detection
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Reduce Risk â&#x20AC;&#x201C; Probe Smart Wash Patented probe wash design to reduce the risk of reporting a false positive result by preventing clinically significant sample to sample carryover Curve A: After optimized wash
Curve B: Before optimized wash
1.00 Upper Specification Limit: 0.1ppm
Between Sample Carryover (ppm)
0.90 1.69 ppm
0.80 0.70 0.60 0.50 0.40 0.30 0.20 0.10 0.00 0
10
20
30
40
50
60
70
80
-0.10
Pooled Normal Human Serum Replicates Each replicate was processed immediately following a concentrated contaminant
Optimized Sample Probe Wash on the Abbott ARCHITECT ci8200 Analyzer, T.H. Ravalico, C.W. Wilson, et al., Presented at the 18th International Congress of Clinical Chemistry and Laboratory Medicine, Oct 20-25, 2002 Commitment To Science May 2010
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90
Reduce Risk â&#x20AC;&#x201C; Clot, Bubble detection
- Clot, bubble, foam, fibrin and insufficient samples detection during sample aspiration assure reporting of correct results - Reagent Pressure Monitoring provides immediate detection of bubbles
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Instrument Reliability ARCHITECT c8000
• • •
Launch 2003 YTD ~2300 Instruments < 3 service calls per year
ARCHITECT c16000
• • •
Launch 2007 YTD ~ 200 Instruments < 4.5 service calls per year
ARCHITECT c4000
• • •
Launch July 2009 YTD > 200 Instruments < 3 service calls per year
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Value of ARCHITECT Advanced Technology Be Productive
Gain Efficiency
Ensure Quality
Reduce Risk
Universal Carrier
Robotic Sample Handler
ICT Module Flex Rate
SmartWash
Serum Indices
•Simplify processes •fewer resource • spend less time
handling and sorting samples • one tube for both IA and CC testing
STAT samples prioritized for a consistently fast turnaround time • reduce interruptions and stress in lab • medical staff can make critical treatment decisions
Commitment To Science May 2010
•Less maintains for ICT •Less reruns •Standardize sample integrity reporting • Safeguarding the integrity of results
Company Confidential © 2010 Abbott
32
Built in safeguards reduce the risk of reporting incorrect results • < 0.1 ppm sample
carryover • clot, bubble, foam, and insufficient sample detection
Adding value with the ARCHITECT Reagents
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ARCHITECT Immunoassay Reagents Immunoassay Reagents 100 test kits 500 test kits
25 On-Board Refrigerated Reagent Positions Color Coded, 2-D Bar-coded Reagents
Assay Name Lot Number Test Size Expiration Date Master Cal Curve Information
Minimum 30 Day Calibration Stability 30 Day On-board Stability Key Operator Benefit: Easy Inventory Management
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ARCHITECT Chemistry Reagents Liquid, Ready to Use Reagents 28-day average on-board and calibration stability Automatic reagent integrity checks Flexible kit reagent kit sizes to optimize efficiency 2-D barcodes
• • • • •
Lot # Expiration date On-board/cal stability tracking Reagent volume tracking 3rd party reagent barcode capabilities
Key Operator Benefit: Easy Inventory Management
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Menu Completion & New Markers Thyroid TSH T4 FT4 T3 FT3 T-Uptake Anti-TPO Anti-Tg
Cancer CEA AFP PSA Free PSA CA 19-9 CA 15-3 CA 125 SCC Pro-GRP HE4 CYFRA 21-1 NSE Thyroglobulin PIVKA
Fertility/ Pregnancy Estradiol LH FSH Prolactin Progesterone Testosterone DHEAS SHBG ßHCG Testosterone 2nd gen
Hepatitis/ Anemia/ Retrovirus/Other Metabolic/Renal Ferritin Infectious Diseases
Cardiac BNP Troponin CKMB Myoglobin Homocysteine MPO
B12 Folate Insulin Intact PTH Cortisol C-Peptide Anti-CCP NGAL Vitamin D Active B12
HBsAg HBsAg Conf. Anti-HBs Anti-HBcII (2008) Anti-HBc IgM HBe Anti-HBe HCV Anti-HAV IgM Anti-HAV IgG HIV Ag/Ab Syphilis TP rHTLV I/II HCV Antigen HBsAg II HBsAg ADV HCV Ag/Ab Chagas Malaria, EBV
TDM Theophylline Phenytoin Vancomycin Phenobarbital Digoxin Valproic Acid Carbamacep Gentamicin Methotrexate
Transplant Tacrolimus Sirolimus Cyclosporine
Congenitals Rubella IgG Rubella IgM CMV IgG CMV IgM CMV Avidity Toxo IgG Toxo Avidity Toxo M
>>84 84common commonassays assaysshared sharedacross acrossall alliSystems iSystems Commitment To Science May 2010
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Orange = Immunoassays in development / launch 2010, Yellow = Immunoassays beyond 2010 / in research
ARCHITECT cSystems Menu General Chemistries (43) Acid Phosphatase Albumin BCG Albumin BCP Alkaline Phosphatase ALT & Activated ALT~ AST & Activated AST~ Ammonia Amylase Amylase, pancreatic~ Bile Acids~ Bilirubin, Direct Bilirubin, Total Calcium Chloride Cholesterol Cholinesterase~ Cholinesterase, dibucaine~ CK CO2 Creatinine Creatinine, Enzymatic GGT Glucose HDL, Ultra HIL Iron Iron, Plasma Lactic Acid LD LDL, Direct
Lipase Magnesium Phosphorus Potassium TIBC Total Protein Triglyceride Sodium UIBC Urea Nitrogen Uric Acid CSF Applications (2) Glucose and Protein Urine Applications (13) Amylase Calcium Cl, K, Na Creatinine Creatinine, Enzymatic Glucose Magnesium Phosphorus Urea Nitrogen Uric Acid Total Protein
Proteins (23) A1AGP A1AT Apo A1 Apo B ASO B2M Ceruloplasmin C3 C4 CRP CRP Vario Haptoglobin IgA IgE IgG IgM Kappa lt chains~ Lambda lt chains~ Lp(a) Microalbumin Prealbumin RF Transferrin
DOA/TOX (15) Acetaminophen Amphetamines Barbiturates Benzodiazepines Benzodiazepines (S) Cannabinoids Cocaine Ecstasy Ethanol Methadone Opiates Phencyclidine Propoxyphene TCA Salicylate Other (5) Copper~ Cystatin C~ Fructosamine~ HBDH~ D-Dimer~
Cardiac (2) CK MB~ Myoglobin~ TDM (13) Amikacin Carbamazepine Digoxin Digitoxin~ Gentamicin Lithium Phenobarbital Phenytoin Quinidine Theophylline Tobramycin Valproic Acid Vancomycin Metabolic (2) Ferritin HbA1c
>>120 120common commonassays assaysshared sharedacross acrossall allcSystems cSystems
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~Available outside the US ONLY
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Menu expansion - 2010
1.
uNGAL
Early Detection of AKI
2.
HE4
Risk stratification/monitoring Ovarian Ca
3.
CYFRA 21-1
Differential diagnosis Lung Ca
4.
Testost. 2nd gen Suitable for women/children
5.
Active B12
Early detection B12 deficiency
6.
Vitamin D
25-OH Vitamin D (D2/D3) status
7.
Chagas
Detection of Chagas Disease
8.
Gentamicin
TDM Aminoglycoside
9.
Carbamazepin
TDM Antiepileptics
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Novel Markers in the Pipeline
Neuron Neuronspecific specificEnolase Enolase
Differential diagnosis small cell Lung Ca (with ProGRP)
PIVKA PIVKA
Diagnosis of Liver Cancer
NSE NSE
Protein Proteininduced inducedby byvit vitKKabsence absence
HBsAg HBsAg ADV ADV
Improved clincial sensitivity and mutant detection
EBV EBV EBNA EBNA VCA VCA IgG IgG VCA IgM VCA IgM
Differential Diagnosis and staging of Mononcucleosis
Troponin Troponin Next Next Gen Gen
Increased sensitivity
cPlGF cPlGF
Early diagnise of pre-eclapsia
Galectin Galectin 33
Advanced diagnosis of heart failure
Epstein-Barr-Virus Epstein-Barr-Virus
Placental PlacentalGrowth GrowthFactor Factor
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ARCHITECT ci4100
Efficiency Productivity
Optimize Workflow Reducing Risk
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Thank you
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