Linearity Verifiers

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.”

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

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

Product Portfolio

Cardiac Markers Specific Proteins Therapeutic Drugs

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

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

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

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

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

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

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

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

Software Overview

Simple navigation using side

menu

Software Overview

Simple configuration process:

Step 1 – Confirm lab details

Software Overview

Step 2 – Select analyser make and model from the drop down menu provided

Software Overview

Step 3 – Select product and lot number from the pre-defined drop down menus

Software Overview

Step 4 – Give your study a name and select the tests you wish to enter results for

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

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

Software Overview

Reports can be exported to PDF and printed for internal records

A performance evaluation statement is provided

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

The End