acusera verify presentation
TRANSCRIPT
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Linearity Verifiers
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Calibration Verification / Linearity Assessment
CLIA define Calibration verification as
“The assaying of materials of known concentration in the same manner as patient samples to substantiate the
instrument or test system’s calibration throughout the reportable range for patient test results.”
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CLIA Requirements • CLIA require all labs perform and document calibration verification at least twice per
year and/or in the event of the following:
– Change of reagents
– Instrument maintenance
– Poor QC results
– New instrument validation
• As well as assessing calibration verification twice per year CLIA also recommend:
– At least 3 levels to challenge the instruments complete reportable range
– At least 2 replicates of each level must be performed
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CLIA Requirements
• Linearity is the ability of the instrument to provide results that are directly
proportional to the concentration of the analyte in the test sample.
• It is assessed by plotting results alongside the target values supplied by the
manufacturer
– If results fall within the pre-established limit they are acceptable
– Measure of linearity is the degree to which the plotted curve conforms to a straight line
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Product Portfolio
Cardiac Markers Specific Proteins Therapeutic Drugs
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Key Messages • Supplied liquid ready-to-use
– Minimal preparation required – convenient and easy to use saving precious laboratory time – Convenient 2-8oC storage and reduced shipping costs (no dry ice)
• Instrument dedicated material – Solutions for both Roche Cobas and Beckman analysers – Designed to meet specific instrument requirements– Additional instruments coming soon
• Minimum of 5 levels – No manual dilution required – Challenges the instruments complete reportable range– Meets CLIA requirements of at least 3 levels
• 2 year shelf life from date of manufacture
• Consolidation – Unique combination of analytes may reduce the number of individual products required – Reduced costs and time
• Complimentary data reduction software – Instant access to automatically generated reports– Real-time peer group data – updated live for immediate troubleshooting – Unique traffic light system for at-a-glance performance assessment
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Cardiac Markers Solutions for Beckman analysers
Analytes Features & Benefits CK-MB Mass Liquid ready-to-use Myoglobin 5 levels provided TnI 30 day open vial stability at 2-8oC
Solutions for Roche Cobas analysers
Analytes Features & BenefitsCK-MB Mass Liquid ready-to-use D-Dimer 6 levels provided Myoglobin 30 day open vial stability at 2-8oCNT-proBNPTnThsTNT
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Specific ProteinsSolutions for Beckman AU analysers
Specific Proteins 1Analytes Features & Benefits ASO Liquid ready-to-use Complement C3 5 levels provided Complement C4 30 day open vial stability at 2-8oCCRP Shelf life of 3 years FerritinIgAIgGIgMPrealbuminTransferrin
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Specific ProteinsSolutions for Beckman AU analysers
Specific Proteins 2Analytes Features & Benefits Alpha-1-Acid Glycoprotein Liquid ready-to-use Alpha-1-Antitrypsin 5 levels provided B-2-Microglobulin 30 day open vial stability Ceruloplasmin Shelf life of 3 years Haptoglobin
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Specific ProteinsSolutions for Roche Cobas analysers
Specific Proteins 1Analytes Features & Benefits Complement C3 Liquid ready-to-use Complement C4 5 levels provided (6 for IgA, IgG & IgM)IgA 30 day open vial stability at 2-8oCIgG Shelf life of 3 years IgMTransferrin
Specific Proteins 2Analytes Features & BenefitsAlpha-1-Acid Glycoprotein Liquid ready-to-use Alpha-1-Antitrypsin 5 levels providedB-2-Microglobulin 30 day open vial stability Ceruloplasmin Shelf life of 3 years
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Specific ProteinsSolutions for Roche Cobas analysers
Specific Proteins 3Analytes Features & Benefits ASO Liquid ready-to-use CRP 6 levels provided (5 for Haptoglobin)Haptoglobin 30 day open vial stability at 2-8oC
Shelf life of 3 years
Specific Proteins 4Analytes Features & BenefitsAlbumin Liquid ready-to-use Prealbumin 6 levels provided (5 for RF)RF 30 day open vial stability
Shelf life of 3 years
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Therapeutic Drugs Solutions for Beckman AU analysers
Analytes Features & Benefits Acetaminophen Liquid ready-to-useAmikacin 5 levels providedCaffeine 14 day open vial stability at 2-8oCCarbamazepine Shelf life of 3 years DigoxinDisopyramideEthosuximideGentamicinLidocaineLithiumN-AcetylprocainamidePhenobarbitalPhenytoinPrimidoneProcainamide QuinidineSalicylateTheophyllineTobramycinValproic AcidVancomycin
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Data Reduction Software• Supplied FOC with all Randox Linearity Sets
• User-friendly, intuitive user interface
• Online access anytime
• Peer group data updated live in real-time
• Automatically generated charts and statistics
• Unique traffic light system enables performance assessment at-a-glance
• Meets CLIA requirements for documentation of calibration verification
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Software Overview
Simple navigation using side
menu
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Software Overview
Simple configuration process:
Step 1 – Confirm lab details
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Software Overview
Step 2 – Select analyser make and model from the drop down menu provided
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Software Overview
Step 3 – Select product and lot number from the pre-defined drop down menus
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Software Overview
Step 4 – Give your study a name and select the tests you wish to enter results for
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Software Overview
Once configured the lab is ready to enter results
Select the study from the drop down menu
Enter results for each lot number and as many replicates as needed
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Software Overview
To review charts & peer data select your study from the drop down menu
Add or remove data using legend beside each chart
Unique traffic light system indicates at-a-glance if the assay is linear
Statistics are automatically calculated for all lots. Peer group data is updated live
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Software Overview
Reports can be exported to PDF and printed for internal records
A performance evaluation statement is provided
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Summary • Linearity material for Cardiac Markers, Proteins and Therapeutic
Drugs
• User-friendly liquid ready-to-use format
• Instrument dedicated material to meet specific instrument requirements
• Consolidation
• Innovative and Intuitive data reduction software
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The End