VITROS® Solutions

Because Results Matter

PIONEERS
IN DIAGNOSTICS

Ortho Clinical Diagnostics is a pioneering provider of

accurate, timely and cost effective in-vitro diagnostic
solutions for screening, diagnosing, monitoring and
confirming diseases.

Proven VITROS® waterless technology releases clinical

chemistry laboratories from the need for highly purified
water which impacts costs, waste disposal and the
environment.

We continue to serve the global clinical laboratory and

transfusion medicine community and are committed to
partnering with laboratories to deliver quality test
results which doctors and patients need.

VITROS® Solutions | 02
 ADDRESSING
YOUR CHALLENGES

Built-in More patient

The right result,
savings, not results from
first time
hidden costs precious
staff time

VITROS® Solutions | 04
THE
DIAGNOSTIC JOURNEY
From the time the patient sample is taken until reporting of
the test result, we seek out opportunities to improve your
diagnostic process, focusing on the areas that matter.

The right result, Built-in savings, More patients

The Patient
first time not hidden costs results from
precious staff
Whether the test request is a result of a GP
time visit or a suspected myocardial infarction in
the emergency department, it is vital to get
the right result first time.

Laboratory Management The Sample

Laboratory and hospital management must have Automatic checking of sample quality and
solutions they can completely rely on to provide a accurate dispensing of sample volumes are
high quality clinical service at a predictable cost. critical to get the right result, first time.

Laboratory Operations Systems & Technologies

Maximising the value added time of technical staff In an environment where cost is critical and
is critical to laboratory efficiency and staff morale. workload never stops growing, it is key to
choose efficient and durable solutions with
negligible impact on the environment.

VITROS® Solutions | 06
THE
PATIENT

For more than 30 years, Ortho Clinical Diagnostics Choosing the right Diagnostic Solution can enhance
has been focusing on the quality and efficiency of patient care and laboratory efficiency:
results. Because results matter.

First Pass Yield (FPY) is a key measure of lab Jim Price

Opera Singer, Adventurous
efficiency and clinical service for the patient. Heart attack survivor
Early release from hospital
VITROS® Systems have been shown to deliver
on average 12 percent higher FPY vs other non- Maximised
VITROS systems.®
throughput Reduced
& turnaround costs
1 million tests in one year mean an additional time
120,000 tests are delivered without error or delay , 1

First Pass Yield

impacting on approximately 15,000 patients.*
% tubes with no intervention*

%
Those extra results really matter. They matter to 96 %
100 Alberto Vasquez
Jennifer Campbell
patients facing health issues which could change Daughter, Brave 88 84 % 12 % Dad, Husband
Diabetic
their lives. They matter to doctors who need to Juvenile diabetic
76 More timely
Less GP revisits
treatment
make decisions. They matter to hospitals trying to 64

manage bed occupancy. Jennifer Campbell, 52

Juvenile Diabetic.
40
* assuming 8 tests per patient Non-VITROS® VITROS®

1 See final page for data source information

Increased Reduced
productivity & interventions
staff time & reruns

Jamar Rogers
Singer, Activist
HIV positive
Earlier diagnosis

See final page for data source information

VITROS® Solutions | 08
THE SAMPLE THE VITROS® SOLUTION:
Fewer interventions Unique technologies eliminate the need for
begin here! visual checking or repeat testing because
sample quality issues are avoided or flagged.

THE CHALLENGE:
VITROS® MicroSlide
Managing poor quality samples caused by
Technology
the presence of endogenous interferences,
VITROS® MicroSlide spreading layer filters out proteins and lipids
clots or bubbles.
when appropriate, which minimises endogenous interferences

VITROS® MicroSensor
Typical prevalence of endogenous interferences
Technology
% of samples with HIT
%

14 VITROS® MicroSensor Technology detects endogenous

12.8
12
interferences. This is done through a fibre-optic wavelength
10
8 scan of the sample. Results affected by hemolysis, icterus, and
6.3
6 turbidity (HIT) are detected. Each VITROS® Assay has assigned
4 4.2 Data on file from workshop, John F. Chapman,
Jr., DrPH, DABCC, FACB, Professor, Pathology HIT limits to ensure appropriate assay results are reported.
2
and Laboratory Medicine, University of North Sample results are flagged for review if any HIT Limits are
0 Carolina School of Medicine
Hemolysis Icterus Turbidity exceeded. This is done without the need for extra sample or
reagent and with no effect on turnaround time (TAT).

Example of impact on Creatinine results caused by Icterus (effect of Bilirubin)

VITROS® Intellicheck®
% Non-VITROS Systems
®
% VITROS Systems
®
Technology Normal
(Final/original results)x100

(Final/original results)x100

200 200 aspiration

180 180
160 160 VITROS® Intellicheck® technology verifies and documents
140 140 Positive
120 120
diagnostic checks throughout sample processing.
pressure Abnormal
100 100 Smart metering, one such check, uses disposable tips to avoid detects aspiration
80 Sys. A* 80
60 60
carryover and pressure level sensing to detect clots & bubbles.
Sys. C* Sys. B* Negative
40 40 Preventing the reporting of negatively affected results.
pressure
.05 .10 .15 .20 .25 .30 .35 .40 .45 .50 .55 .60 .05 .10 .15 .20 .25 .30 .35 .40 .45 .50 .55 .60
aspirates
Bilirubin added (g/L) Bilirubin added (g/L)

*Data Source: CLIN. CHEM. 32/3, 470-475

Prevalence of clotted samples 1 THE LABORATORY IMPACT:

Tubes per year
Tubes per year
2500
2087 2500 For a laboratory with
2087 The right result, Built-in savings, More patients results
2000
1543
2000 an annual volume of first time not hidden costs from precious staff time
1500 1543
6.3 % 1500 1 million tests.
1000 6.3 % Rigorous sample Built-in savings More patient results
1000
545
500 304 241 500
quality checks and as fewer reagents from precious staff
0
0 0 accurate dispensing are wasted on time by minimising
Non-VITROS® Systems
VITROS® Systems minimise re-runs re-runs time spent in
Number of tubes with clots Clotted tubes detected by analyser
and generates verifying and re-
Clotted tubes detected by operator Clotted tubes detected during results review confidence in results running samples

1 See final page for data source information

VITROS® Solutions | 10
SYSTEMS & TECHNOLOGIES
Low interventions deliver high
First Pass Yield (FPY)
THE CHALLENGE:
Minimising the potential for system error and
delays that can negatively impact FPY.
FIRST PASS YIELD (% tubes with no intervention) 1
Non-VITROS®
Systems
1 See final page for data source information
For a laboratory with an annual volume of
1,000,000 tests, it’s a difference of 120,000
tests per year impacting 15,000 patients1.
THE VITROS® SOLUTION:
System design and built-in technologies eliminate
the need for interventions, driving First Pass Yield
to 96%, which is 12% higher than the average non-
VITROS® systems.
Examples of typical interventions VITROS® Solution
Visually inspect samples, add VITROS® MicroSlide spreading layer filters
comments, re-run samples due out proteins and lipids when appropriate,
to endogenous interferences. which minimises endogenous interferences.
VITROS® MicroSensor technology flags
assay specific HIT on each sample.
Re-run atypical samples for electrolytes VITROS® Direct Potentiometry is NOT
due to lack of confidence in results impacted by dilution, proteins, lipids.
with indirect potentiometry.
Re-run samples due to lack of VITROS® Intellicheck verifies and
confidence in e.g. volume dispensing, documents for accurate result reporting.
VITROS®
temperature control, ...
Systems
Re-run samples due to bubbles VITROS® SMART Metering pressure level
or clots. sensing technology detects bubbles/clots.
Re-run samples due to carryover risks. VITROS® disposable tip for sample and
reagent dispensing eliminate carryover.
Re-run samples due to erroneous VITROS® analysers don’t need water.
results caused by bad water quality. Just a PLUG!
THE LABORATORY IMPACT:
The right result, Built-in savings, More patients results
first time not hidden costs from precious staff time
Optimum first Built-in savings Greater efficiency
pass yield benefits as fewer reagents in staff utilisation
laboratory and are wasted on with minimal time
patient alike, re-runs spent managing
ensuring earliest re-runs
diagnosis and
treatment
VITROS® Solutions | 12
LABORATORY OPERATIONS THE VITROS® SOLUTION:
Get more of the uptime VITROS® Analysers require significantly less daily
you pay for. maintenance and their simplified calibration frequency
allows for “Best in Class” analyser uptime.

THE CHALLENGE:
Analyser downtime: Minutes
Ensuring continuous reliability and achieving per system, per day1

maximum system uptime. VITROS® 5600 is on average available

Non-VITROS®
90 minutes more per day for
VITROS® 5600 analysing patient results compared to
Non-VITROS®.

Proactive and predictive alerts by means of innovative use of a secure Maintenance

Internet connection (e-Connectivity™ Technology) to monitor the Calibrations / Quality Control
performance of VITROS® x600 Series Systems can minimise downtime Service Downtime

In our Predictive Technologies Centres (PTC) in Strasbourg, Singapore

and New York, we are staffed and equipped to monitor analysers Number of calibrations p.a.1 Calibration Frequency:
worldwide on a daily basis. Predicting a potential breakdown of a critical
module could save a lot of time and labs are even in a position to 189 days
5,000
schedule interventions ahead of time! 84 days
4,000 VITROS® 60 days
3,000 For a typical lab of 5600 56 days
≈ 1 million tests p.a. 42 days
2,000 30 days
Traditional Break-Fix Model 28 days
1,000
14 days
Non-
0 7 days
VITROS®
Non-VITROS® VITROS® Daily
BREAK CALL TRAVEL FIELD PLAN FIX Systems
CENTRE DIAGNOSE Systems Systems Lot
7 or 28
Expected
Actual
Lot specific calibration frequency
UNSCHEDULED typically means every 6 months
DOWNTIME DOWNTIME with VITROS® MicroSlide technology.
1 See fi al page for data source information

THE LABORATORY IMPACT:

Ortho Clinical Diagnostics PTC Model

The right result, Built-in savings,

first time not hidden costs
PREDICT SCHEDULE RESOLVE
Increased number Less reagents
of samples which wasted on non-
get the right result value added
first time as analyser calibrations
UPTIME SCHEDULED
MONITOR downtime is kept to
DOWNTIME
a minimum

VITROS® Solutions | 14
LABORATORY MANAGEMENT THE VITROS® SOLUTION:
Get more of the resources VITROS® Systems allow for more reportable results
you pay for. from reagents purchased due to the minimal need
for calibrations, quality controls and re-runs.

THE CHALLENGE:
% Reagent effi ciency (# of reagents used for reportable results/total # of reagents used)1
Maximising staff productivity and avoiding
hidden costs. Non-VITROS® 84.4%

VITROS® 5600 93.7%

1 See final page for data source information

Where does valuable technician time
typically get used up?

Assay calibrations
Required interventions - sample issues
Daily maintenance and start up
Up to 10% more tests that can run on
VITROS® systems to generate reportable
Average Annual Maintenance per Analyser 1
results compared to other systems.
Non-VITROS ®

81 days
VITROS® 5600 24 days For a laboratory with an annual volume of
1,000,000 tests, it’s a difference of 100,000
What else could a skilled technician achieve with an extra 57 days per year?
more tests per year that could be performed
for running patient results instead of quality
1 See final page for data source information
control, calibrations or reruns.

THE LABORATORY IMPACT:

Built-in savings, More patients results
not hidden costs from precious staff time

Built-in savings Greater efficiency in

through a minimal staff, because limited
need of resources time is needed for
(reagents and staff) analyser maintenance,
to operate the troubleshooting or
analysers. calibration and QC.

VITROS® Solutions | 16
LABORATORY MANAGEMENT THE VITROS® SOLUTION:
Maximising your most valuable VITROS® Solutions in partnership with TCAutomation™
resource: your people. from Thermo Fisher Scientific™ and Data Innovations
Middleware drives efficiency and reliability at all stages
of sample handling.
THE CHALLENGE:
Delivering greater productivity when faced
Removing non-value added processes
with ever increasing workloads.
Saving precious staff time
Handling repetitive tasks
Ensuring workloads flow
Right through to refrigerated storage, retrieval and sample disposal
Changes in Test Volume

Scalable solutions
3,000,000
2,500,000
“We have relied on Ortho
2,000,000
Clinical Diagnostics and Thermo
1,500,000 through a decade of successful
1,000,000 upgrades, reconfiguration and
relocation. Their durability and
500,000
adaptability has proved to be
0 crucial.” Lab Manager, Belgium
2006 2007 2008 2009

Central Ohio Primary Care doubled their workload The power of middleware solutions Refrigerated storage, retrieval & disposal

from 1.5 to 3 million over two years with no increase At Marion General Hospital Data Innovations

in staff numbers Middleware in combination with VITROS®

Systems achieved auto-verification rates of
90%+ with no input from staff.

Data Source:
Data Innovations LLC Case Study, Marion General Hospital, Indiana, USA,
Document ID: 7892, Version 1.
Manual Step Count: Automation reduced manual
Specimen Arrival to Patient Report
handling from 19 to 6 steps,
20
a saving of 1.1 minutes per
THE LABORATORY IMPACT:
15 sample in staff time.
10 19 The right result, Built-in savings, More patients results
first time not hidden costs from precious staff time
5 For a lab processing 500
6 Automation Greater Frees up staff
0
samples per day this equates provides more productivity for more critical
Before After to an annual saving of approx consistency from your activities
Automation Automation
of results by most valuable
300 full-time equivalent (FTE) eliminating assets
days based on an 8 hr shift human error
Laboratory Automation Case Study:
Automation Readies Ohio Clinical Lab for
Rapid Growth. OCD Publication

VITROS® Solutions | 18
VITROS® Waterless Technology THE VITROS® SOLUTION:
Reducing costs - Waterless technology has a huge impact for the
benefitting the environment. clinical laboratory:

THE CHALLENGE: Removes water as a potential source of poor quality results

No cost involved for water purification systems
No resource needed for testing water quality
Increasing demands to reduce water consumption The impact of any future legislation driving up the costs of
and waste. water usage and liquid waste disposal will be avoided

And... easy to implement:

• No drains
• No plumbing
Non-VITROS® systems require large quantities of highly purified • Just a plug
water - impacting costs, waste disposal and the environment

Water consumption by system, in Litres per Hour*:

Architect ci8200 25
Cobas 6000 (c/e) 70
Unicel DxC800 16
Unicel DxC8001 16
AU680 28
Dimension EXL wLM 5
Advia 1800 12
Vista 1500 21.6
VITROS® 0

How much water does one VITROS® System save?

On average 160,000 litres of water per year are

saved with one VITROS® System.

160.000
THE LABORATORY IMPACT:
That is enough water for a family of 4 to survive
The right results, Built-in savings,
on for over 20 YEARS. first time not hidden costs

Eliminates water Eliminates

On average a person needs a minimum of five liters of water per day to survive quality issues expensive water
in a moderate climate at an average activity level ** which could purification
impact result systems and
accuracy maintenance

*CAP Today July, 2013 www.captodayonline.com/productguides

** Jan 2014: http://www.pacinst.org/reports/water_fact_sheet/

VITROS® Solutions | 20
VITROS®
Technologies

VITROS® MicroSlide Upper Slide Mount

VITROS® MicroWell
Technology Spreading Layer
Technology

No reagent preparation required. VITROS® MicroWell Technology uses proprietary

Reagent Layer
• No water, plumbing or drains required Enhanced Chemiluminescence Detection Technology
• No electrodes to maintain to deliver the VITROS® Immunoassay menu
Indicator Layer
• Long calibration stability • Requires small sample volumes (10-80µL)
• Wide dynamic ranges • Minimises waste with a small MicroWell
• Requires small sample volume Support Layer • Ready to use reagents
(5.5µL to 11µL per test) • No water requirements
Lower Slide Mount • Calibration stability of 28 days

Enhanced Chemiluminescence Detection

Technology delivers:
• High signal (light) output
• Excellent sensitivity and precision
VITROS® MicroTip • Broad dynamic range
Technology

VITROS® MicroTip Technology simplifies traditional and complex wet chemistry

to deliver extended menu with specific proteins, TDM’s and Drugs of Abuse.
• Liquid, ready-to-use reagents need no preparation
• Refrigerated storage maximises on-system stability
• Reagent packs are automatically opened and closed
- Limits contamination, evaporation, and reagent cross-talk
- Enhances reagent and calibration stability
• Single-use sample and reagent tips address carryover concerns
• Disposable cuvettes
• Requires small sample volume (2.5µL to 16.7µL per test)
• 3-point cuvette read: detects bubbles and other imperfections to avoid erroneous results
VITROS® MicroSensor
Technology
VITROS® MicroSensor Technology detects endogenous
interferences. This is done through a fiber-optic wavelength
scan of the sample. Results affected by hemolysis, icterus, and
turbidity (HIT) are detected. Each VITROS® Assay has assigned
HIT limits to ensure appropriate assay results are reported.
Sample results are flagged for review if any HIT Limits are
exceeded. This is done without the need for extra sample or
reagent and with no effect on TAT.

VITROS® Intellicheck®
Technology VITROS® Waterless
Technology
VITROS® Intellicheck® Technology monitors,
verifies and documents diagnostic checks
VITROS® Technologies helping to lower the laboratory’s
throughout sample and assay processing for
eco footprint.
accurate and efficient result reporting:

VITROS® Solutions | 22
VITROS®
Analysers
CHEMISTRY INTEGRATED

VITROS® 350 System VITROS® 5600 System

Compact chemistry system designed to High-capacity system, uniquely designed to integrate clinical chemistry
allow you to optimise space utilisation. and immunoassay testing on one system using proven VITROS® technologies.

VITROS® 4600 System

• High-capacity chemistry system with parallel processing

• For your routine and speciality testing

IMMUNODIAGNOSTICS

VITROS® ECiQ System

High result integrity makes this your

optimal solution for laboratories performing
immunodiagnostic testing.

VITROS® Waterless
Technology
VITROS® 3600 System
VITROS® Technologies helping to lower the laboratory’s
High-capacity immunoassay system for your eco footprint.
routine and specialty immunoassay testing
using proven VITROS® technologies.

VITROS® Solutions | 24
 With VITROS® Solutions
You get so much more...

SOURCE OF DATA:

VITROS® vs non-VITROS® comparative data in this document

are sourced from ORTHO VALUATORSM data from more than 120
Pioneers in Diagnostics on-site studies in multiple countries, commissioned by Ortho
Clinical Diagnostics.
Data were gathered utilizing Six Sigma standardized methodologies and techniques

• Strict guidelines and operational definitions were created and followed to ensure data

collection was standardised at each site

• A minimum of five sites studied for each vendor/model with on-going studies being
Advanced performed
Building
Laboratory
the future • A third party (EAC, Enterprise Analysis Corporation verified the methodology used for
Solutions
Built-in comparisons. An attestation letter from EAC is available (CL10647)
savings, not
hidden cost

Techniques used for gathering data:

More patients
The right result,, results from • Interviewing lab personnel
first time precious staff
• Data compiling and recording
time
• Direct observation

• Manufacturer labelling

Comprehensive Progressive
Customer Partnerships Please consult your Ortho Clinical Diagnostics sales representative for the optimal VITROS® System solution
Support to accommodate your specific needs.
Product availability is subject to local regulatory and support requirements.

All trademarks are the property of their respective owners.

© 2016 Ortho-Clinical Diagnostics, Inc.

VITROS® Solutions | 26
 To learn more about our business and our commitments, please visit:

www.orthoclinical.com

No part or the whole of this document may be reproduced, translated, or transmitted by any means, electronic,
mechanical, photocopying, recording, or otherwise, including posting on the internet, without prior and written
permission of Ortho Clinical Diagnostics.

All trademarks are the property of Ortho Clinical Diagnostics, Inc.

©Ortho-Clinical Diagnostics 2003-2016 PR-02708

Product availability is subject to fulfilment of regulatory requirements in each market.