This document discusses linearity verification materials from Randox. It provides an overview of the product portfolio, which includes solutions for assessing linearity of cardiac markers, specific proteins, and therapeutic drugs on various analyzer platforms. The linearity materials are supplied in a liquid ready-to-use format for convenience. The document also highlights the data reduction software, which automatically generates reports and allows real-time review of peer group data through an intuitive interface.

1. Linearity Verifiers

2. 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.”

3. 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

4. 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

5. Product Portfolio
Cardiac Markers Specific Proteins Therapeutic Drugs

6. 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

7. 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 & Benefits
CK-MB Mass Liquid ready-to-use
D-Dimer 6 levels provided
Myoglobin 30 day open vial stability at 2-8oC
NT-proBNP
TnT
hsTNT

8. Specific Proteins
Solutions for Beckman AU analysers
Specific Proteins 1
Analytes Features & Benefits
ASO Liquid ready-to-use
Complement C3 5 levels provided
Complement C4 30 day open vial stability at 2-8oC
CRP Shelf life of 3 years
Ferritin
IgA
IgG
IgM
Prealbumin
Transferrin

9. Specific Proteins
Solutions for Beckman AU analysers
Specific Proteins 2
Analytes 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

10. Specific Proteins
Solutions for Roche Cobas analysers
Specific Proteins 1
Analytes 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 2-8oC
IgG Shelf life of 3 years
IgM
Transferrin
Specific Proteins 2
Analytes 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

11. Specific Proteins
Solutions for Roche Cobas analysers
Specific Proteins 3
Analytes 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 4
Analytes Features & Benefits
Albumin Liquid ready-to-use
Prealbumin 6 levels provided (5 for RF)
RF 30 day open vial stability
Shelf life of 3 years

12. Therapeutic Drugs
Solutions for Beckman AU analysers
Analytes Features & Benefits
Acetaminophen Liquid ready-to-use
Amikacin 5 levels provided
Caffeine 14 day open vial stability at 2-8oC
Carbamazepine Shelf life of 3 years
Digoxin
Disopyramide
Ethosuximide
Gentamicin
Lidocaine
Lithium
N-Acetylprocainamide
Phenobarbital
Phenytoin
Primidone
Procainamide
Quinidine
Salicylate
Theophylline
Tobramycin
Valproic Acid
Vancomycin

13. 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

14. Software Overview
Simple
navigation
using side
menu

15. Software Overview
Simple
configuration
process:
Step 1 –
Confirm lab
details

16. Software Overview
Step 2 –
Select
analyser
make and
model from
the drop
down menu
provided

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

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

19. 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

20. 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

21. Software Overview
Reports can
be exported
to PDF and
printed for
internal
records
A
performance
evaluation
statement is
provided

22. 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

23. The End