VITROS® Solutions

Because excellent patient care

relies on exceptional labs.
 Pioneers in Diagnostics
The Diagnostic Journey
Addressing your challenges
The Patient
The Sample
Systems & Technologies
Laboratory Operations
Laboratory Management
VITROS® Solutions
VITROS® Solutions Portfolio
VITROS® Assay Menu
VITROS® Ecological Solutions
Summary
Ortho VITROS® Solutions Deliver
Improved Patient Care
2 | OrthoClinicalDiagnostics.com
4
6
8
10
At Ortho Clinical Diagnostics our tests are more than
12
procedure and process. They are pivotal moments in
14 patients’ lives.
We are a pioneering provider of world-class in-vitro
diagnostic solutions for screening, diagnosing, monitoring
and confirming diseases.
16 Proven VITROS® waterless technology frees clinical
laboratories from the need for high quality purified water
18 which impacts costs, waste disposal and the environment.
20
For 80 years Ortho has served and continues to serve the
global clinical laboratory and transfusion medicine
community and are committed to making labs more efficient
in delivering the quality test results which doctors need. And
which patients, and their loved ones, rely on.
24
Because Every Test Is A Life™ | 3
 The Diagnostic Journey

The right result, first time

Built-in savings,
not hidden costs

More patient results from

precious staff time

Addressing your Challenges

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.
Systems & Technologies
In an environment where cost is critical and workload never
stops growing, it is key to choose efficient and durable
solutions with negligible impact on the environment.

The Sample Laboratory Operations

Automatic checking of sample quality and accurate Maximising the value added time of technical staff is
dispensing of sample volumes are critical to get the critical to laboratory efficiency and workforce morale.
right result, first time.

The Patient
Laboratory Management
Whether the test request is a result of a GP visit or a Laboratory and hospital management must have
suspected myocardial infarction in the emergency solutions they can completely rely on to provide a
department, it is vital to get the right result first time. high quality clinical service at a predictable cost.

4 | OrthoClinicalDiagnostics.com Because Every Test Is A Life™ | 5

 The Diagnostic Journey

Ortho understands that at the end of every test is

The Patient
Laying a foundation for the future
Diagnostics play a critical role in achieving healthcare optimisation.
While it represents a very small portion of healthcare spend,
diagnostics sits at a critical point of convergence – an intersection
between the clinical and financial realms. Diagnostics results are
highly relevant to optimising a patient’s care and diagnostics are
estimated to influence 70% of all medical decisions and 70-80% of a
patient’s medical record data.
The population continues to age, demand for testing is
ever-increasing, and there is growing focus on prevention and risk
prediction as well as diagnosis. As a result, the pressure on your lab
to diagnose earlier, quicker, and to deliver the right result first time
will rise exponentially.
a patient who is waiting for results that will ensure
they receive the right treatment. Accuracy and
speed are therefore absolutely critical.
Our VITROS® Solutions give you the confidence to
know that you will release the right result to
clinicians, when they need it.
The Challenge
Delivering more accurate, reproducible
results.
Choosing the right diagnostic solution can enhance LIFE EXPECTANCY GLOBAL POPULATION
patient care and laboratory efficiency: 74.7 years by 2023 8.5 billion by 2030
2020 global health care Outlook_ Deloitte Insights

Labs who select our analyzers benefit from a rigorous and comprehensive
early-life service which we call Hypercare. This is delivered through our
technical solutions centre, and supported by field engineers, laboratory
specialists and account managers.

6 | OrthoClinicalDiagnostics.com Because
BecauseEvery
EveryTest Life | 7
TestIsIsAALife™
 The Diagnostic Journey

The Sample The Challenge

Minimise the impact of interferences Up to 5% of Clinical Laboratory test
results are potentially affected as a
ELECTROLYTE EXCLUSION EFFECT | How to assure the right result
result of common interferences.*
for electrolytes also at abnormal levels of proteins/lipids?

THE VITROS® SOLUTION

Electrolyte Exclusion Effect with Indirect ISE VITROS® MicroSlides for NA, K+, CL-
The Laboratory
THE CHALLENGE

With Indirect ISE, Samples are diluted. Samples with Single-use DIRECT Ion specific electrode (ISE), no
increased fraction of solid phase result in a more dilute
liquid phase and the concentration of electrolyte is
dilution of the sample, no Electrolyte Exclusion Effect.
Other advantages are one set of electrodes per test
Impact
underestimated. Potential misclassification leading to and no electrode maintenance.
incorrect patient management of critical care patients.
The right result, first time

Rigorous sample quality checks and

accurate dispensing minimise re-runs
and generates confidence in results.
HEMOLYSIS, ICTERUS, LIPEMIA | How to avoid falsely reported results due to Hemolysis, Icterus or Lipemia (HIL)?

THE VITROS® SOLUTION

HIL is a common challenge and can contribute to poor laboratory results VITROS® MicroSlides Built-in savings,
not hidden costs
THE CHALLENGE

% OF SAMPLES WITH HIL (average based on multiple references*) Spreading layer filters out the potentially interfering
hemoglobin, bilirubin or lipids for chemistry assays.
Built-in savings as fewer reagents are

6% 7.6% 7.4% VITROS® MicroSensor Technology

Flags results in case of endogenous interferences for homo-
and heterogenous immunoassays with no additional sample,
wasted on re-runs.

Hemolysis Icterus Lipemia reagent or consumable and no Impact on TAT.

More patients results from
precious staff time

PARAPROTEINS | How To Avoid Falsely Elevated Or Decreased Results On A Variety Of Assays Due To Paraproteins? More patient results from precious
staff time by minimising time spent in
verifying and rerunning samples.

THE VITROS® SOLUTION

Paraproteinemia occurs in a variety of conditions, including multiple myeloma,
Waldenström’s macroglobulinaemia, plasmacytoma, amyloidosis, and monoclonal
THE CHALLENGE

gammopathy of undetermined significance (MGUS).

VITROS® MicroSlides
The overall prevalence of paraproteinemia has not been rigorously studied; however, the
The spreading layer filters out the potentially
prevalence of MGUS, the most common cause of paraproteinemia, is approximately 3-4%
interfering paraproteins.
in individuals > 50 years old and 6-8% for those individuals >80 years old.1 Paraproteins
present in serum can interfere in a variety of ways with a number of laboratory assays,
leading to a range of incorrect laboratory results.

* Prevalence of Monoclonal Gammopathy of Undetermined Significance: A Systematic Review - Rishi K. Wadhera, MPhil, and S. Vincent Rajkumar, MD - Mayo Clin Proc. • October 2010;85(10):933-942 • doi:10.4065/mcp.2010.0337 • https://www.mayoclinicproceedings.org/

8 | OrthoClinicalDiagnostics.com Because Every Test Is A Life™ | 9

 The Diagnostic Journey

Systems & Technology The Challenge

The VITROS® Solution: Minimising the potential for system error
and delays that can negatively impact
System design and built-in technologies eliminate the need for
FPY.*
interventions, driving First Pass Yield* to 96%, which is 12% higher
than the average non-VITROS® systems.

FIRST PASS YIELD (% tubes with no intervention)
NON-VITROS® SYSTEMS
Examples of typical interventions VITROS® Solution The Laboratory
VITROS® SYSTEMS
Impact
Visually inspect samples, add comments, re-run VITROS® MicroSlide spreading layer filters out proteins
samples due to endogenous interferences. and lipids when appropriate, which minimises endogenous The right result, first time
interferences.
Optimum first pass yield benefits
VITROS® MicroSensor technology flags assay specific
laboratory and patient alike, ensuring
HIL on each sample.
earliest diagnosis and treatment.

LEAN ANALYTICAL WORKFLOW

Ideally 100% of sample tubes should pass through this
process the first time Re-run atypical samples for electrolytes due to lack of VITROS® Direct Potentiometry is NOT impacted by
confidence in results with indirect potentiometry. dilution, proteins, lipids. Built-in savings,
Pre-Analytical Analytical Post- Analytical not hidden costs

Built-in savings as fewer reagents are

Re-run samples due to lack of confidence in e.g. volume VITROS® Intellicheck is an analytical control process for wasted on re-runs.
dispensing, temperature control, ... each test designed to significantly reduce analytical errors

INTERVENTIONS

Deliver Re-run samples due to bubbles VITROS® SMART Metering pressure level sensing More patients results from
Potential or clots. technology detects bubbles/clots.
for errors
Bar code precious staff time
adjustment
Rack/Centrifuge
Greater efficiency in staff utilisation
Endogenous Pour offs
interferences with minimal time spent managing
Re-run samples due to carryover risks. VITROS® Single-use tips eliminates risk of carryover for
On analyser re-runs.
sample and reagent dispensing eliminate carryover.
Clots Manual dilutions
Review exceptions
Repeat testing
Re-run samples due to erroneous results caused by bad VITROS® Analysers don’t need water. Just a PLUG!
Release results
water quality.

Archive

STANDARD FLOW

* First Pass Yield (FPY) is a manufacturing metric which measures the effectiveness of a process and the elimination of waste from that process. See final page for data source information

10 | OrthoClinicalDiagnostics.com Because Every Test Is A Life™ | 11

 The Diagnostic Journey

Laboratory Operations The Challenge

The VITROS® Solution: Ensuring continuous reliability and
achieving maximum system uptime.
Our award-winning Ortho Care™ service ensures your team is
trained, and your laboratory is installed and ready to go from day
one. Through the power of our technology, we act as your eyes and
ears to keep your lab running smoothly, every minute of every day.
Get more of the uptime you pay for. The Laboratory
VITROS® Analysers require significantly less daily maintenance
and their reduced calibration frequency allows for best in class
Impact
analyser uptime.
Smart Service Merged Reality e-Connectivity® The right result, first time
Analyser downtime: Minutes per system, per day
With first-in-class technology, Enables Ortho to “touch” your Ortho Clinical Diagnostics Increased number of samples which
analyser without coming on site. Non-VITROS ® get the right result first time as analyser
the Smart Service app arms our e-Connectivity® Technology
downtime is kept to a minimum.
Ortho Care teams with analyser Technical solution specialists and Interactive system VITROS® Systems
intelligence in the palm of their field engineers can show a Management feature provides
hand. Ortho Field Engineers have resolution, eliminating the need a real-time and secure
Maintenance Built-in savings,
the information they need to for an on-site visit. two-way interactive
not hidden costs
quickly and completely resolve connection between our Calibrations / Quality Control
issues, giving you faster VITROS® portfolio and Ortho Service Downtime
Less reagents wasted on non-value
resolution and improved Care™ Services. added calibrations.

reliability. VITROS® Systems are on average available 90 minutes more per

day for analysing patient results compared to Non-VITROS®.

Proactive and Predictive alerts through e-Connectivity® can minimise downtime Number of calibrations p.a.
For a typical lab of ≈ 1 million tests p.a.

Without e-Connectivity® Technology

5,000 Expected
Unscheduled Call Field
Break Travel Plan
Downtime Centre Diagnose 4,000 Actual
3,000
With e-Connectivity® Technology
2,000
Scheduled
Predict Schedule Fix
Downtime 1,000

0
DOWNTIME
Non-VITROS® Systems VITROS® Systems

Lot specific calibration frequency typically means

every 6 months with VITROS® MicroSlide technology.
See final page for data source information.

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 The Diagnostic Journey

Laboratory Management The Challenge

The VITROS® Solutions: Delivering greater productivity when faced with
ever increasing workloads.
Innovating to meet the challenges of today and tomorrow is what we
do. It’s why we are one of the most progressive IVD companies in the
world, and why we champion collaboration with our partners to ensure
ultimate flexibility. Optimising your Lab year after year. The Laboratory
It’s this combination that has led to us developing a breakthrough in Working with other industry leaders - Thermo Fisher Scientific Impact
portfolio solutions. Automated, optimised and high performance and Data Innovations - we have designed our VITROS®
solutions that increase throughput without compromising on accuracy Automation Solutions, a platform with no water or drainage
The right result, first time
or quality. which delivers the capacity and flexibility that puts you totally in
Our ValuMetrix™ consulting service can benchmark performance and control of your day-to-day operations. Built-in savings through a minimal need
for resources (reagents and staff) to
design the most efficient lab possible. Then throughout the relationship operate the analysers.
we continuously assess how to further optimise productivity.
SCALABLE SMART
Grow at your own pace Seamless connection between VITROS® Built-in savings,
without having to completely Analysers and automation to review systems’ not hidden costs
ValuMetrix® Equation for Success redesign your lab status and adapt workflows accordingly
Apply the full benefits of Lean
processes to your entire lab to drive
Optimum improved services to clinicians and
People Product Process Performance patients.

 Increased  High-quality  Layout based on  Labour optimisation

percentage of value- analyser and test Lean principles More patients results from
 Enhanced service
added activity methodologies and post-analytic precious staff time
levels
processes
 Ergonomically +  Minimal system + =
 Cost containment TRACEABLE FLEXIBLE OPEN In order to save precious staff time,
correct design maintenance  Workstation design handling repetitive tasks, ensuring
Full traceability, from Configure your hardware, Connect the systems
 Staff engaged  Optimal process workloads flow.
sample reception at ES software and algorithm to you need to create
in continuous flow to and through Flex to sample disposal adapt to your needs and an automated
improvement testing systems at the Cold Storage processes streamlined workflow

Auto-verification drives efficiency

Could you have predicted today’s needs
10 years ago? In a changing world, you At Marion General Hospital Data Innovations Middleware in
need the ability to evolve. 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.

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 The VITROS® Solution

VITROS® Solutions Portfolio

Chemistry Integrated

Compact chemistry systems designed to allow you to optimise use of space. Our integrated platforms are designed to help you efficiently consolidate
critical testing to deliver quality and timely results.

VITROS® XT 3400 System VITROS® 5600 System

VITROS® 4600 System VITROS® XT 7600 System

Immunodiagnostics Automation Solutions

Fully automated immunoassay platform for your routine and specialty testing with Flexible design concepts, which enables modules to be placed within existing
a comprehensive menu. infrastructure, avoiding lengthy and costly building work.

VITROS® 3600 System

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 The VITROS® Solution

VITROS® Assay Menu

VITROS® ECi/ECiQ Immunodiagnostic Systems VITROS® ECi/ECiQ Immunodiagnostic Systems VITROS® ECi/ECiQ Immunodiagnostic Systems VITROS® ECi/ECiQ Immunodiagnostic Systems VITROS® ECi/ECiQ Immunodiagnostic Systems

VITROS® 3600 Immunodiagnostic System VITROS® 3600 Immunodiagnostic System VITROS® 3600 Immunodiagnostic System VITROS® 3600 Immunodiagnostic System VITROS® 3600 Immunodiagnostic System

VITROS® XT 3400 Chemistry System VITROS® XT 3400 Chemistry System VITROS® XT 3400 Chemistry System VITROS® XT 3400 Chemistry System VITROS® XT 3400 Chemistry System
The VITROS® XT MicroSlides* combine two
VITROS® 4600/5,1 FS Chemistry Systems VITROS® 4600/5,1 FS Chemistry Systems VITROS® 4600/5,1 FS Chemistry Systems VITROS® 4600/5,1 FS Chemistry Systems VITROS® 4600/5,1 FS Chemistry Systems thin film reagents onto the same slide. These

VITROS® 5600 Integrated System
VITROS XT 7600 Integrated System
®
VITROS® 5600 Integrated System
VITROS XT 7600 Integrated System
®
VITROS® 5600 Integrated System
VITROS XT 7600 Integrated System
®
VITROS® 5600 Integrated System
VITROS XT 7600 Integrated System
®
VITROS® 5600 Integrated System assays can be run on the new VITROS® XT
Systems*.
VITROS XT 7600 Integrated System
®

CARDIAC HBs Ag ES + + + + Vancomycin + + + Chloride + + + + SEPSIS XT VITROS® VITROS®

Apolipoprotein A1 + + + HIV Combo + + + + RESPIRATORY Creatinine + + + + Procalcitonin (PCT) + + + + MicroSlides XT 7600 XT 3400

Apolipoprotein B + + + Rubella IgG + + + + Carbon Dioxide + + + + Cystatin C*5 + + + THYROID/METABOLIC

ALTV & AST + +
Cholesterol + + + + Rubella IgM + + + + Chloride + + + + Glucose + + + + Cortisol + + + +
CKMB + + + + SARS-CoV-2 Antigen + + + (+) Potassium + + + + Microalbumin + + + Free T3 + + + +
UREA & CREA + +
CKMB Mass + + + + T. Cruzi + + + + Sodium + + + + Phosphorus + + + + Free T4 + + + +
Direct HDL + + + + Toxoplasma IgG + + + + SKELETAL/BONE Potassium + + + + Intact PTH + + + +
TRIG & CHOL + +
Direct LDL + + + Toxoplasma IgM + + + + ALKP + + + + NephroCheck® + + + Lactate + + + +
Homocysteine + + + Syphilis + + + + Calcium + + + + Sodium + + + + T3 Uptake + + + +
TBIL & ALKP + +
hsCRP + + + ONCOLOGY Intact PTH + + + + Urea + + + + Total T3 + + + +
LDH + + + + AFP + + + + NTx + + + + Uric Acid + + + + Total T4 + + + +
GLUC & CA + +
Lipoprotein(a)*5 + + + Beta 2 microglobulin1 + + + Phosphorus + + + + Urine Protein + + + + TSH + + + +
Myoglobin + + + + CA 125 IITM + + + + Vitamin D + + + + HEPATIC DIABETES
ALB & TP + +
NT-proBNP + + + + CA 15-3TM + + + + PANCREATIC AAT + + + Beta-Hydroxybutyrate*4 + + +
Total CK + + + + CA 19-9TM + + + + Amylase + + + + Albumin + + + + Creatinine + + + +
Triglycerides + + + + CEA + + + + Lipase + + + + ALKP + + + + Glucose + + + + * The VITROS® XT Systems and XT Microslides are not available
for sale in all countries.
hs Troponin I + + + + IgA + + + NUTRITIONAL ASSESSMENT Alpha-2 Macroglobulin*1 + + + Glycated Serum Protein*5 + + +
DRUGS OF ABUSE (URINE) IgG + + + Albumin (turbidimetric)1 + + + ALT + + + + HbA1c + + +
Amphetamines + + + IgM + + + Direct TIBC + + + Ammonia + + + + Insulin + + + +
Barbiturates + + + Kappa Free Light Chain*5 + + + Ferritin + + + + AST + + + + Microalbumin + + +
Benzodiazepines + + + Lamda Free Light Chain*5 + + + Folate + + + + BuBc + + + + C-Peptide + + + +
Buprenorphine*2 + + + Free PSA + + + + Iron + + + + Ceruloplasmin*1 + + + Urea + + + +
+ = Available
Cocaine Metabolites + + + Total PSA II + + + + Prealbumin + + + Cholinesterase + + + + REPRODUCTIVE
(+) = Availability expected
DRI Ecstasy*
® 2
+ + + TOXICOLOGY Total Protein + + + + GGT + + + + Estradiol + + + +
D = In development/currently not available
Ethyl Glucuronide*2 + + + Acetaminophen + + + + Transferrin + + + IgA + + + FSH + + + + R = Requires resubmission to be run on the
Heroin Metabolite*2 + + + Alcohol + + + + Vitamin B12 + + + + IgG + + + LH + + + + VITROS® XT 7600
Methadone + + + Cholinesterase + + + + ANEMIA IgM + + + Progesterone + + + +
Methadone Metabolite*2 + + + Salicylate + + + + Direct TIBC + + + Prealbumin + + + Prolactin + + + +
* MicroTip Partnership Assay (MPA); Reagents and
Opiate + + + PRENATAL Ferritin + + + + Total Bilirubin + + + + Testosterone + + + +
validated applications available directly from Ortho
DRI Oxycodone*
® 2
+ + + CMV IgG + + + + Folate + + + + SPINAL Total ß-hCG + + + +
Clinical Diagnostics; Product availability subject to
PCP + + + CMV IgM + + + + Iron + + + + Glucose (csf) + + + + IMMUNOSUPPRESSANT DRUGS
third party’s or their agent’s capability to support the
THC + + + Rubella IgG + + + + TIBC + Total Protein (csf) + + + + Cedia® Cyclosporine*2 + + + laboratories.
Tricyclics (serum)*2 + + + Rubella IgM + + + + Transferrin + + + LIPIDS QMS® Everolimus*2 + + +
Supplier information:
Propoxyphene*2 + + + Toxoplasma IgG + + + + Vitamin B12 + + + + Apolipoprotein A1 + + + Cedia® Mycophenolic Acid*2 + + +
1. DiAgam
INFECTIOUS DISEASE Toxoplasma IgM + + + + GENERAL CHEMISTRY Apolipoprotein B + + + QMS Tacrolimus*
® 2
+ + +
2. Thermo Fisher Scientific Inc
Anti-HIV 1+2 + + + + Total ß-hCG + + + + Amylase + + + + Cholesterol + + + + COAGULATION AND FIBRINOLYSIS 3. Siemens Healthcare
Anti-HCV + + + + THERAPEUTIC DRUG MONITORING Calcium + + + + Direct HDL + + + + Antithrombin III*1 + + + 4. Stanbio Laboratory
Anti-HBc + + + + QMS® Amikacin*2 + + + Glucose + + + + Direct LDL + + + Fibrinogen*1 + + + 5. Diazyme Laboratories, Inc
Anti-HBc IgM + + + + Caffeine + + + Lactate + + + + Triglycerides + + + + D-Dimer*5 + + + 6. ARK Diagnostics, Inc
Anti-HBe + + + + Carbamazepine + + + + LDH + + + + INFLAMMATORY
Anti-HBs + + + + Digitoxin*2 + + + Lipase + + + + Alpha-1 Acid glycoprotein*1 + + +
CA 125 II™, CA 15-3™ and CA 19-9™ are trademarks
Anti-HAV IgM + + + + Digoxin + + + + Magnesium + + + + ASO + + +
of Fujirebio Diagnostics Inc.
Anti-HAV Total + + + + Gentamicin + + + Phosphorus + + + + C3 + + +
Anti-HTLV I/II + + + + Lithium + + + + Total CK + + + + C4 + + + CEDIA®, DRI® and QMS® are registered trademarks
Anti-SARS-CoV-2 Total + + + + Methotrexate*6 + + + Urea + + + + CRP + + + + of Thermo Fisher Scientific and its subsidiaries.

Anti-SARS-CoV-2 IgG + + + + Emit® 2000 Phenobarbital*3 R + + Uric Acid + + + + HPT + + + HIV and Hepatitis co-developed with Grifols.
CMV IgG + + + + Phenytoin + + + + RENAL IgA + + +
Product availability is subject to fulfillment of regu-
CMV IgM + + + + Theophylline + + + + Albumin + + + + IgG + + +
latory requirements in each market.
HBeAg + + + + Tobramycin + + + Calcium + + + + IgM + + +
HBs Ag ES Confirmatory + + + + Valproic Acid + + + Carbon Dioxide + + + + IL-6 + + + +
RF + + +

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 The VITROS® Solution

VITROS® Ecological Solutions

VITROS® Waterless Technology

VITROS® Technologies helping to lower the laboratory’s eco footprint.

Saving Water since 1978

Provides flexibility Eliminates risks associated with

to configure or expand the lab over time complex water purification systems

Emergency preparedness No costs involved for purification systems

NO NEED FOR WATER
“Where you need it, when you need it” and plumbing infrastructures

Removes water as a potential

Stay ahead of ecology-driven
source of poor quality results
regulations and charges

20 | OrthoClinicalDiagnostics.com Because Every Test Is A Life™ | 21

 Summary

Ortho VITROS® Solutions

Contributes to Improve Patient Care
Five Key Benefits
Our portfolio solutions is ready to transform your lab’s entire ecosystem, to
future proof it and to improve the quality of care you provide to patients.

1. A market leading first pass yield of 96%, in combination with a market

leading 95% reagent efficiency. Offers the best in test quality and the best
in minimising interferences effecting your lab.

2. Advanced automation with auto-verification delivers worry-free results

around the clock, saving hundreds of manual skilled labour hours per year.

3. Our innovative waterless technology powers our clinical testing solutions

since 1978. Our VITROS® Systems do not require water or drains to operate,
helping our customers reduce their environmental footprint.

Each VITROS® System alone saves hospitals 170,000L of purified water a

year per analyser, enough for a family of 4 to survive on for 20 years.*

4. Our predictive technologies “e-Connectivity” increases analyser uptime,

improves reliability and optimize system performance.

5. Ortho Care™, our holistic support programme provides real-time,

personalised service and support to ensure labs are running efficiently so
you can consistently deliver excellent patient care.

* See final page for data source information.

First Pass Yield (FPY) is a manufacturing metric which measures the effectiveness of a process and the elimination of waste from that process.

22 | OrthoClinicalDiagnostics.com Because Every Test Is A Life™ | 23

 For more information, please contact your
Ortho Clinical Diagnostics representative or visit

OrthoClinicalDiagnostics.com

Source of data:

VITROS® vs non-VITROS® comparative data in this document are sourced from ORTHO VALUATOR℠data from
more than 120 on-site studies in multiple countries, commissioned by Ortho Clinical Diagnostics.

Data were gathered utilizing Six Sigma standardised 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
performed, a third party (EAC) Enterprise Analysis Corporation verified the methodology used for
comparisons. An attestation letter from EAC is available (CL10647).

Techniques used for gathering data: Interviewing lab personnel, Data compiling and recording, Direct
observation & Manufacturer labelling. Please consult your Ortho Clinical Diagnostics sales representative for
the optimal VITROS® System solution to accommodate your specific needs. Product availability is subject to
local regulatory and support requirements. All trademarks are the property of their respective owners.

© Ortho Clinical Diagnostics 2021. “Because Every Test Is A Life” is a trademark of Ortho Clinical Diagnostics.
Last update: July 2021. PR-10335

Ortho Clinical Diagnostics is a global leader of in vitro diagnostics dedicated to improving and saving lives through innovative
laboratory testing and blood-typing solutions. We never stop innovating to offer streamlined, sustainable laboratory solutions
that deliver fast, accurate, reliable test results to support exceptional patient care. OrthoClinicalDiagnostics.com