Marketing & Sales Guide

HumaCLIA 150 System

Executive Product Market /

Summary Information Positioning

Objection
Handling / Supporting
Competition
Key Selling Material
Arguments

CONFIDENTIAL Vers. 03 / 2022-04 © 2022 HUMAN

Executive Summary
Product Introduction

▪ HumaCLIA 150 is a fully-automated random-access chemiluminescence immunoassay (CLIA) analyzer used for IVD-
applications in small to medium throughout medical diagnostic or university laboratories.

▪ HumaCLIA 150 is HUMAN`s response to the market trend that moves away from the less standardized batch-mode
ELISA-plate technology towards a fully-automated random-access immunoassay (IA) system providing higher
flexibility, especially, with smaller sample series.

▪ HumaCLIA 150 uses coated magnetic microparticles as „solid-phase“. The reactions are based on acridinium ester
(AE) for direct chemiluminescence, like Siemens‘ ADVIA systems and Abbott‘s Architect instruments, to increase
performance and reliability of commonly used clinical assays. This is expressed in the assays robustness and
reproducibility of results.

▪ HumaCLIA 150 allows the use of serum and plasma samples with assays for thyroid, fertility hormones, tumor and
cardiac markers, as well as bone metabolism, among many others to choose from.

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Executive Summary
Market

▪ There still is a trend in the emerging markets to switch from ELISA microplate technology to fully-automated random-
access immunoassay (IA) systems.

▪ The fully-automated IA-system market is a very well served market with many big companies offering IA-systems for
the past one to two decades.

▪ The reagent portfolio being offered by the various companies is very similar and covers diagnostic parameters, like
thyroid function testing, fertility hormones, tumor markers, cardiac markers, TORCH or other infectious disease
parameters.

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Executive Summary
Positioning and targeted customers

Market segment Customer segment

1. Hospital labs (private / public) ▪ Labs testing for: Thyroid function, Fertility hormones,
2. Private labs / Reference labs (small / larger) Tumour markers, Cancer, and more
3. University labs ▪ Small to medium sample volume labs
4. Specialty labs • 15 – 100 samples/day
• 45 – 600 tests/ day
• 10.000 - 150.000 tests/ year

Target customer
1. Switch ELISA users
a. Non-HUMAN ELISA users
b. Existing ELISA-customers
wishing to move to an IA-system
2. Switch from competitive IA-system
3. New labs opening up
4. Back-up system

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Executive Summary
Key Selling Arguments

▪ Simplified operation with random-access capability

HumaCLIA 150 is the perfect random-access immunoassay (IA) solution to be offered as an alternative to ELISA or to
other small to medium throughput IA-analyzers, capable of running 15 - 100 samples/day or 45 - 600 tests/day,
allowing for quick and easy refilling of cuvettes in bulk format and offering ready-to-use reagents and calibrators in the
same kit for simplified logistics.

▪ Modern, intuitive user interface

For all small to medium volume labs, currently, running ELISA microplates or other fully-automated immunoassay (IA)
systems, HumaCLIA 150 is the ideal IA-analyzer, allowing its use through an intuitive user interface ensuring fast
access to all important functions, offering full result traceability with just one click, and allowing for maximum ease of
operation through the use of a touch screen.

▪ Economical, customer-focused reagent concept

The system allows the use of a multi-analyte-control for streamlined logistics and supporting an improved workflow
efficiency in the lab. The customer-focused reagent kit sizes with 2x50 tests allow for maximum flexibility and are ideal
also for low-throughput parameters.

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Executive Summary
Pricing Strategy

▪ A calculation tool including a total operational cost per year to the distributor and to the end-user for reagent rental is
being provided with the launch binder to facilitate the

▪ Most analyzers will be installed on a reagent rental basis in the field.

▪ The reagent prices will need to be adapted country by country. Some assay groups are more cost-effective in the
market, like thyroid tests compared to tumor markers. Some companies offer their assays at fairly low prices basing
their sales strategy on kit volume. In other countries the same competitor company may price the parameters much
higher, depending on the reimbursement , expenditure per capita and competitive landscape, in any given country.
Specialty assays, like Vitamin D and AMH will be more interesting from a pricing-point-of view for sales, compared to
the bread-and-butter-assays, like thyroid or hormones. The more costly specialty assays will also facilitate the
calculation of instrument placements through reagent rental.

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Product Information

Intended use

Product overview

Acridinium ester technology

Benefits of main aspects

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CONFIDENTIAL
HumaCLIA 150 system
Intended use

▪ The instrument HumaCLIA 150 is a fully-automated random-

access chemiluminescence immunoassay (CLIA) system used for
IVD-applications in medical, biology, research and quality control
laboratories.

▪ Tests run on HumaCLIA 150 are used for both, quantitative or

qualitative, determination of various analyte concentrations found
in human plasma or serum samples.

▪ Assays run on HumaCLIA 150, among others, cover thyroid

function tests, fertility hormones, tumor marker, cardiac
parameters, or specialty assays like Vitamin D.

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HumaCLIA 150 system
Components

HumaCLIA 150 instrument Reaction vessels Wash buffer Trigger

Random-access 2 x 1000 pcs reaction vessels 4 x 1000 ml of wash buffer 4 x 220 ml trigger solution for
CLIA instrument including UPS, in a bag concentrate for the washing CLIA reaction
external PC and touch-screen during the CLIA process

Pre-Trigger Reagent kit incl. calibrator Control kit Diluent kit

4 x 220 ml Parameter specific Parameter specific or Only very few assays could
pre-trigger solution 2 x 50 tests / kit multi-control kit require sample dilution
for CLIA reaction including calibrator with different levels

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CONFIDENTIAL
HumaCLIA 150 system
Components

* Picture shows optional printer

* UPS not shown on the picture

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 HumaCLIA 150 system
Technical specifications

71 cm Type Benchtop
Mode Random-access with continuous loading
Technology Acridinium ester
40-150 tests/h (assay mix dep.)
Throughput 80 tests/h on average
(mixed routine parameters)

12 min. (e.g. Troponin I)

Time-to-result
up to 56 min. (e.g. Folate)

Reagent positions 20, cooled

Sample positions 50 (5 positions x10 racks)/ STAT
Reaction vessels Single use in bulk format

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HumaCLIA 150 system
Instrument introduction Reaction carousel (Magnetic separation)
Reaction vessel gripper

Reaction vessel loading area

(1000 cuvettes)
Sample/ Reagent probe
LED alarm for consumables
Incubation area
Optical System Reagent carousel
(20 cooled positions)

Sample/ STAT racks

(10 x 5 positions)

Solid waste

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HumaCLIA 150 system
Consumable and waste management

Internal
Solid waste 2L wash buffer tank

Pre-trigger & Trigger solutions

10L waste tank External
10L wash buffer tank

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HumaCLIA 150 system
4h walk-away time through adequate onboard capacity

20 cooled reagents onboard 50 sample positions with STAT 1000 bulk reaction cuvettes

▪ Keep reagents onboard, ▪ Flexible sample ▪ Convenient,

reduce hands-on management fast and easy refill

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HumaCLIA 150 system
Intuitive Graphical User Interface (GUI) in HUMAN style

Workflow-oriented menu Touch screen Full result-traceability

requiring little training only. allowing for easy operation. for peace of mind.

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HumaCLIA 150 system reagents and controls
Specifications

Reagent/Calibrator kit composition Immunoassay Multi Control kit composition

▪ 2 Reagent cartridges x 50 tests/ kit (100 tests/kit) ▪ One control for multiple analytes
▪ Dedicated liquid, ready-to-use calibrators ▪ 2 levels x 2 vials
(color-coded; max. 4 levels) included in the reagent kit ▪ Lyophilized
▪ Master-calibration curve & lot-traceability (2D-barcode) ▪ Target value sheet
▪ Calibrator target value sheet ▪ IFU
▪ IFU

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HumaCLIA SR
Reagents with calibrators

Magnetic particles Additional assay-dependent reagents

(e.g. lysis buffer or diluent)

Calibrator
▪ master curve Reagent lot and [Link]
▪ lot for traceability for traceability
▪ target values

Calibrator levels Conjugate (AE)

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HumaCLIA 150 system reagents & controls
Features and benefits

Customer-focused kit sizes - 2 cartridges with 50 tests each

▪ Ensuring maximum flexibility with small sample size / low test volume parameters
▪ with little to no reagent waste

Liquid, ready-to-use reagents and calibrators

▪ allowing for an immediate convenient easy use without waiting time

Multi-analyte control (2 levels/ kit)

▪ One control for many different analytes
▪ Reducing complexity of purchasing and daily lab routine management

Dedicated calibrators and respective calibrator barcode included in kit

▪ Reducing logistical management
▪ ensuring reliable results

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HumaCLIA 150 – Benefits of consumables
Wash buffer

Same wash buffer for all parameters

✓ Reducing logistical management
✓ Reducing storage space needed

Buffer concentrate (1:10)

✓ Reducing shipping costs due to less shipping weight and small package

Storage at a wide temperature range (2…35°C)

✓ Flexibility of storage room (fridge or warehouse)

Long stability of 45 days, after dilution

✓ Flexibility of use, long time-span
✓ Cost-effective

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CONFIDENTIAL
HumaCLIA 150 – Benefits of consumables
Pre-trigger and Trigger Solutions

Same solution for all parameters

✓ Reducing logistical management
Pre-trigger solution (2…8°C)
✓ Reducing storage space needed

Ready-to-use solutions
✓ Reducing risk of wrong dilution
✓ No additional hands-on needed Trigger solution (2…30°C)
(Dangerous goods)

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CONFIDENTIAL
HumaCLIA 150 – Benefits of consumables
Cuvettes (Reaction vessels)

Single cuvettes Bulk format

✓ No waste of cuvettes, like with cuvettes-in-a-strip ✓ Convenient, fast and easy re-fill on the fly
✓ Immediate processing of samples,
without sample collection or waiting time

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CONFIDENTIAL
HumaCLIA 150 system
Consumable indicator (LED) to ensure analyzer uptime

Reaction vessels (cuvettes)

Trigger and Pre-trigger solutions

Wash Buffer

Solid Waste

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HumaCLIA 150 - state of the art technology
Acridinium ester (AE) based chemiluminescence technology

▪ Exposure of an acridinium ester label to an

alkaline hydrogen peroxide solution triggers a
flash of light.

▪ Acridinium labeled compounds have 100 times

stronger chemiluminescence intensity
compared to luminol labeled ones

▪ Acridinium esters do not lose the

luminescence efficiency even after binding to
antigen or antibody.

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Advantages of acridinum ester (AE) technology
Good reasons to use AE

High signal-to-noise ratio

▪ allowing for high assay-sensitivity and low-end assay-precision

Small size of AE
▪ for a more efficient indirect binding of AE to the
magnetic beads facilitating the use in a broad range of assay

Labelling versatility
▪ allowing for a comprehensive assay menu

Rapid kinetics with fast light emission

▪ allowing for high throughput

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HumaCLIA 150 system
Benefits of main aspects

Acridinium ester technology Intuitive Graphical User Interface

▪ State-of-the-art method enabling for high ▪ Increasing fast system overview, thereby reducing
assay-sensitivity and low-end assay-precision hands-on time and facilitating lab work-flow

Liquid, ready-to-use 2x50 tests/ kit Visual alarm by LED

▪ No preparation needed and therefore reduced ▪ Ensuring analyzer up-time, thereby reducing risk
hands-on-time and fast start-up of daily routine of potential result delays and no extra reagent/
consumable costs
Calibrator included in reagent kit
▪ Reduced complexity in logistic management and Single reaction vessels in bulk
safety ensuring result quality ▪ Allowing fast and convenient re-fill,
thereby supporting work-flow efficiency
Multi-analyte controls
▪ Reducing logistics, freeing-up storage space,
reducing costs and increasing workflow-efficiency

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Market and positioning

Immunoassay market and HumaCLIA 150

Positioning HumaCLIA 150

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CONFIDENTIAL
HumaCLIA 150 system
Immunassay market
Above-average growth in IVD and significant dominance of CLIA*

Estimated IA market growth: Estimated CLIA IA market growth:

▪ USD 20 to 27 billion (2018 - 2023; CAGR 6.1%) ▪ Over 50% of the IA market is CLIA
vs. average IVD market growth approx. 4% ▪ Growth CLIA ww approx. 6.7%
▪ Reagents: approx. 75% ▪ Growth CLIA in emerging countries approx. 6.5 %- 8.2%

* Markets and Markets™; April 2018; Immunoassay market – Global forecast to 2023

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Driving forces for CLIA technology
Limitations of ELISA vs. particle-based CLIA

ELISA CLIA - ELISA Particle based CLIA

▪ Run samples in batch mode ▪ Run samples in batch mode ▪ Random-access – convenient
(economical CAL & CTR) (economical CAL & CTR) for short sample series
▪ 6-point calibration curve ▪ 6-point calibration curve ▪ Stable calibration curve (28 d)
required with every run required with every run ▪ Automated dilutions needed
▪ Manual dilution ▪ Manual dilution (few dilutions)
▪ Store reagents in fridge after ▪ Store reagents in fridge after ▪ Keep reagents onboard
use use (cooled) after use
▪ Assay time: 1.5h - 3h ▪ Assay time: 1h – 1.5h ▪ Assay time: 9 min -1.5 h

Advantages of particle-based CLIA

 Random-access  More economical  Faster time-to-result

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Special requirements with CLIA business
CLIA is a closed system requesting a professional logistics management and
technical expertise but offering new opportunities

All CLIA analyzers run with reagents from the instrument supplier, only
→ No third party reagents possible
→ Customer is dependent on continuous supply of reagents
→ Efficient and professional stock management needed (supplier, distributor, end-user)

Technical expertise needed is similar to HumaStar 600

→ Training of service and application specialists
→ Stock management of spare parts

Resulting in „secured, continuous and profitable business“

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CONFIDENTIAL
HumaCLIA 150 system
Pillars of system business

Secured, continuous,
profitable business

Training Reagent Stock

Spare part stock ▪ Distributor

management ▪ Customer

Customer support (CS)

Supply Chain Logistics
Technical Service (TS)

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CONFIDENTIAL
Market landscape
HumaCLIA 150 is positioned in a highly competitive market segment

VIDAS/VIDAS 3 iSYS LIASON XL Architect i2000SR

Architect i1000SR (Diasorin) (Abbott)
(bioMérieux) (ids) Maglumi 800 Maglumi 1000
(Abbott)
(Snibe) (Snibe)

LIASON CL-900ii
miniVidas
AIA-900 CL-1000i (Diasorin) (Mindray) AIA-2000
(bioMérieux)
(TOSOH) (Mindray) (TOSOH)

LIASON XS cobas e 411 Access 2 ADVIA Centaur CP

Pathfast AIA-360 AIA-600 IMMULITE 1000
(Diasorin) (Roche) (Beckman Coulter) Cobas e 601 (Siemens)
(Mitsubishi) (TOSOH) (TOSOH) (Siemens)
(Roche)

30 -80 tests/h 80 -150 tests/h 150 -200 tests/h

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CONFIDENTIAL
HUMAN’s next automation
Solution for mid throughput labs

Clinical
ELISA CLIA Diabetes Hemostasis Hematology
Chemistry

Elysis Quattro

up to 150 tests/h

Elysis Duo HumaCLIA 150 HumaStar 600 HumaNex A1c HumaClot Pro HumaCount 5 L

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HumaCLIA 150 system
Is / Is Not
Is Is not

Small to medium sample volume labs Very low throughput labs

▪ 15 - 100 samples/day ▪ < 30 tests/day
▪ 45 - 600 tests/day ▪ < 50 test per parameter/month
▪ 10.000 - 150.000 test/year
High throughput labs
▪ > 600 tests/day

Labs requiring: Labs requiring:

▪ Thyroid function tests ▪ CLIA Infectious Diseases
▪ Fertility hormone assays (after Launch)
▪ Tumor markers (after Launch)
▪ Specialty assays (after Launch)
▪ Cardiac marker (after Launch)

Alternative to ELISA Cannibalize existing secure ELISA business

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CONFIDENTIAL
HumaCLIA 150 system
Positioning statements & key selling arguments

▪ Simplified operation with random-access capability

HumaCLIA 150 is the perfect random-access immunoassay (IA) solution to be offered as an alternative to ELISA or
to other small to medium throughput IA-analyzers, capable of running 15 - 100 samples/day or 45 - 600 tests/day,
allowing for quick and easy refilling of cuvettes in bulk format and offering ready-to-use reagents and calibrators in
the same kit for simplified logistics.

▪ Modern, intuitive user interface

For all small to medium volume labs, currently, running ELISA microplates or other fully-automated immunoassay
(IA) systems, HumaCLIA 150 is the ideal IA-analyzer, allowing its use through an intuitive user interface ensuring
fast access to all important functions, offering full result traceability with just one click, and allowing for maximum
ease of operation through the use of a touch screen.

▪ Economical, customer-focused reagent concept

The system allows the use of a multi-analyte-control for streamlined logistics and supporting an improved workflow
efficiency in the lab. The customer-focused reagent kit sizes with 2x50 tests allow for maximum flexibility and are
ideal also for low-throughput parameters.

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CONFIDENTIAL
 HumaCLIA 150 system
Market segment / customer segment / target customer

Market segment: Hospital labs (private / public) | Private and reference labs | University and specialty labs

Example very low volume customer

Customer segment: Small to medium volume labs Parameter group Assay # tests/day
▪ 15 – 100 samples/day
TSH 10
▪ 45 – 600 tests/day Thyroid fT3 7
▪ 10.000 - 150.000 tests/year fT4 7

PSA 5
Labs testing for: HCG 2
Tumor marker
Thyroid function, Fertility hormones, Testosterone 5
Prolactin 4
Tumor markers, Cardiac,
Estradiol 4
Infectious diseases => anti-TP (Syphilis) FSH 4
Hormones
LH 4
Progesterone 2
Target customer: ▪ Switch ELISA users SUM 50
a) Non-HUMAN ELISA users
b) Existing customers wishing to move to an IA-system

!
Use reagent kit within 2 months
▪ Switch competitive IA-systems 50 tests/month = 1 reagent cartridge
Onboard reagent stability = 28 days/cartridge
▪ New labs opening up
▪ Back-up system

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CONFIDENTIAL
Competition

Competitive particle-based immunoassay (IA) systems

Competitive instrument comparison

HumaCLIA SR Assay portfolio and specifications

Competitive comparison: reagents, calibrators, controls

Method comparison

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CONFIDENTIAL
 Competitive particle based IA-systems
HumaCLIA 150 fits well into the competitive landscape

Siemens
HUMAN DiaSorin Snibe ids Mindray Abbott
Healthcare

Architect
Instrument (Name) HumaCLIA 150 Liaison Maglumi 800 iSYS CL-1000i Immulite 1000
i1000 SR

Throughput max. t/h 150 180 180 120 120 120 100

Type of instrument Bench Top Bench Top Bench Top Bench Top Bench Top Bench Top Floor standing

Continuous loading
Yes Yes Yes Batch / Yes/ Yes Yes Yes Yes
cuvettes / sample / reagent

Reagent positions 20 15 9 15 25 12 25

Sample positions 50 144 40 120 60 Continuous 65

Bulk 720 240 960 176 Test unit Bulk

Reaction cuvettes
(1000) (120strips) (40strips) box (2 x 88) (12) (300)

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CONFIDENTIAL
 Competitive particle based IA-systems
HumaCLIA 150 fits well into the competitive landscape

HUMAN B/C TOSOH Roche BioMérieux Werfen

Instrument (Name) HumaCLIA 150 Access 2 AIA-900 cobas e411 VIDAS BIO-FLASH

Throughput max. t/h 150 100 90 86 80 64

Type of instrument Bench Top Bench Top Bench Top Bench Top Bench Top Bench Top

Continuous loading
Yes TBC / Yes / batch Yes / Yes / batch Yes Batch TBC/ Yes / batch
cuvettes / sample / reagent

Reagent positions 20 24 12 18 30 20

Sample positions 50 60 40 30 30 30

Bulk 30
Reaction cuvettes TBC Unit dose test cup TBC 1400
(1000) (tips)

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Competitor comparison: Detection technologies
HumaCLIA 150 is based on the highly advanced AE detection technology
Other
Acridinium ester (AE) Alkaline phosphatase (ALP) Electro-CL (ECL) Fluorescence (FIA)
(ABEI*, Isoluminol, … )
Chemical-based Enzyme-based Electro-chemical-based Enzyme-based
Enzyme-based

HumaCLIA 150 Access 2 cobas e411 AIA-900 / TOSOH Maglumi 800 / Snibe
HUMAN Beckman Coulter Roche * Methylumbelliferyl-phosphat * N-(4-Aminobutyl)-N-ethylisoluminol

Liaison
Architect i1000SR IMMULITE 1000 Vidas DiaSorin
Abbott Siemens bioMérieux * N-(4-Aminobutyl)-N-ethylisoluminol

Lumipulse
Centaur CP CL-1000i G600II iSYS
Siemens Mindray Fujirebeio ids

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CONFIDENTIAL
Acridinium Ester (AE) detection technology
Good reasons to use AE

▪ High signal-to-noise ratio

allowing for high assay-sensitivity and low-end assay-precision

▪ Labelling versatility
allowing for a comprehensive assay menu

▪ Small size of AE
for a more efficient indirect binding of AE to the magnetic beads (onto antibodies or antigens in the conjugate)
facilitating the use in a broad range of assays

▪ Rapid kinetics with fast light emission

allowing for high throughput

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CONFIDENTIAL
Competitor comparison: Instrument throughput
HumaCLIA 150 max. throughput is at the upper end within its like

≤90 tests/hour 100 tests/hour 120 tests/hour 150 tests/hour 180 tests/hour

cobas e411 Architect i1000SR IMMULITE 1000 HumaCLIA 150 Liaison

Roche Abbott Siemens HUMAN DiaSorin

AIA-900 Access 2 CL-1000i Maglumi 800

TOSOH Beckman Coulter Mindray Snibe

Vidas iSYS Centaur CP

bioMérieux ids Siemens

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Competitor comparison: Reaction vessels
HumaCLIA 150 offers convenient bulk cuvettes for fast and easy re-fill
Single cuvettes in Complex cup
Cuvette box Strips Reagent test unit
bulk system

HumaCLIA 150 cobas e411 Access 2 Maglumi 800 Liaison AIA-900

HUMAN Roche Beckman Coulter Snibe DiaSorin TOSOH

Architect i1000SR iSYS Vidas IMMULITE 1000

Abbott ids bioMérieux Siemens

Centaur CP CL-1000i LUMIPULSE G600II

Siemens Mindray Fujirebeio

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Competitor comparison: Onboard capacities
HumaCLIA 150 onboard capacities are well equilibrated to
allow for a walk-away-time of up to 4 h

200
180
160
140
120
100
80
60
40
20
0
HumaCLIA 150 Maglumi 800 CL-1000i Architect cobas e411
(HUMAN) (Snibe) (Mindray) i1000SR (Roche)
(Abbott)
Onboard reagent positions 20 9 25 25 18
Onboard sample positions 50 40 60 65 75
Cuvette capacity onboard 100 24 17 36 18
Instrument throughput 150 180 120 100 86

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Competitor comparison: Analyzer Part I
Feature

Instrument HumaCLIA 150 Architect i1000SR Access 2 Liaison

Type Bench top Floor standing Bench top Bench top

Operational mode Random-access Random-access Random-access Random-access

Directly coated magnetic particles

Acridinium ester Acridinium ester Alkaline phosphatase
Detection technology (AE) (ALP)
(solid phase) & an isoluminol
(AE)
derivative (conjugate)

Throughput max. test/h 150 100 100 180

STAT Yes Yes Yes Yes

Continuous loading Yes Yes Yes Yes

Integrated computer No Yes Yes Yes

Reagent positions 20 25 24 15

Reagent cooling 2…8°C Yes Yes Yes

Disposable tips extra costs No Yes No Yes

Barcode reagent Yes Yes Yes RFID

Sample positions 50 65 60 144 for samples & reagents

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Competitor comparison: Analyzer Part I
Feature

Instrument HumaCLIA 150 Architect i1000SR Access 2 Liaison

Barcode reader (sample) Internal & external Yes Yes Internal

Auto-dilution Yes, customizable Yes No Autodilute high titier sample

Auto-rerun Yes Yes Yes Yes

Time-to-first-result 18 – 55 min 28, 35 or 43 min Assay specific 17 min

Extra water supply No Yes No No

1000 294 720

Reaction cuvette capacity 360
(Single in bulk format of 1000/bag) (3 cartridges x 98 reaction vessels) (6 cuvettes/strip x 120 strips)
Yes
HW-sensor:
Level detection consumables Wash buffer & liquid waste, Cuvettes Yes No No
SW-calculation:
Trigger/Pre-Trigger, Solid waste

Level detection
Yes Yes Yes Yes, Workaround for cups
(sample & reagent)

Bubble detection No Yes No No

Clot detection Yes Yes Yes Yes

Noise level < 60 db running / < 55 db standby < 62 db < 70 db TBC

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Competitor comparison: Analyzer Part II
Feature

Instrument HumaCLIA 150 Maglumi 800 Cobas e 411 Immulite 1000

Type Bench top Bench Top Bench Top Bench Top

Operational mode Random-access Random Access Random Access Random Access

Acridinium ester Electro-

Detection technology ABEI Alkaline phosphatase (ALP)
(AE) chemiluminescence (ECL)

Throughput max. test/h 150 180 86 120

STAT Yes Yes Yes Yes

Continuous loading
Yes Yes Yes Yes
sample/reagent

Integrated computer o No Yes Yes

Reagent positions 20 9 18 12

Reagent cooling 2…8°C Yes 20 °C No

Disposable tips extra costs No No Yes No

Barcode reagent Yes RFID 2D-Barcode Yes

Sample positions 30 sample disc-based

50 40 na
75 samples rack-based

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Competitor comparison: Analyzer Part II
Feature

Instrument HumaCLIA 150 Maglumi 800 Cobas e 411 Immulite 1000

Barcode reader (sample) Internal & external Yes 1D-Barcode Handheld

Auto-dilute for high

Auto-dilution Yes, customizable
concentrated samples
Yes No

Auto-rerun Yes Manual No

Time-to-first-result 18 – 55 min 17 min 18 min 42 or 72 min

Extra water supply No No Yes No

1000 240 180 n.a.

Reaction cuvette capacity 6 cuvettes/strip x 40 strips 6 box of 30 cuvettes Reagent unit serves as reaction vessel
Single in bulk format of 1000/bag
Yes
HW-sensor:
Level detection
Wash buffer & liquid waste, Cuvettes Yes Yes Yes
consumables SW-calculation:
Trigger/Pre-Trigger, Solid waste

Level detection
Yes Yes (reagents, only) Yes Yes
(sample & reagent)

Bubble detection No No No No

Clot detection Yes Yes Yes No

Noise level < 60 db running / < 55 db standby TBC < 63 db running / < 60 db standby TBC

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Competitor comparison: Analyzer Part III
Feature

Instrument HumaCLIA 150 AIA-900 iSYS CL-1000i

Type Bench top Bench top Bench top Bench top

Operational mode Continuous random-access Continuous random-access Random-access Random-access

Acridinium ester Fluorescent SUB Luminometer (300 – 500 nm)

Detection technology Alkaline phosphates (ALP)
(AE) (Methylumbelliferyl-phosphat) Spectrometer with LED

Throughput max. test/h 150 90 120 120

STAT Yes Yes Yes Yes

Continuous loading Yes

Yes Yes
sample/reagent (samples)

Integrated computer No No

Reagent positions 20 180 tests only 15 25

Reagent cooling 2…8°C na 12…15°C 2…8°C

Disposable tips extra costs No Yes

Barcode reagent Yes Yes

Sample positions 50 100 (10 racks) 120 60

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Competitor comparison: Analyzer Part III
Feature

Instrument HumaCLIA 150 AIA-900 iSYS CL-1000i

Barcode reader (sample) Internal & external Handheld Yes

Auto-dilution Yes, customizable Yes Yes

Auto-rerun Yes TBC

Time-to-first-result 18 – 55 min 20 min 25 min (assay dependent)

Extra water supply No No

1000 n.a. 960 176

Reaction cuvette capacity Reagent unit serves as reaction vessel
Single in bulk format of 1000/bag Single use, 960 cuvettes/box Cuvette box
Yes
HW-sensor:
Level detection Yes Yes
Wash buffer & liquid waste, Cuvettes
consumables (samples only) (cuvettes)
SW-calculation:
Trigger/Pre-Trigger, Solid waste

Level detection
Yes Yes
(sample & reagent)

Bubble detection No Yes no

Clot detection Yes Yes No

Noise level < 60 db running / < 55 db standby

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Competitor comparison: Analyzer Part IV
Feature

Instrument HumaCLIA 150 VIDAS CL-900i

Type Bench top Bench top Bench top

Random-access
Operational mode Continuous random-access Batch analyzer

Acridinium ester ELFA-Technology

Detection technology Alkaline phosphates (ALP)
(AE) Enzyme Linked Fluorescent Assay

Throughput max. test/h 150 80 180

STAT Yes No Yes

Yes
Continuous loading
Yes No (samples, reagents,
sample/reagent consumables)

Integrated computer No No No

Reagent positions 20 30 (5 bays x 6 strips) 15

Reagent cooling 2…8°C No 2…8°C

Disposable tips No Yes No

Barcode reagent Yes Yes Yes

Sample positions 50 30 (5 bays x 6 strips) 60

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CONFIDENTIAL
Competitor comparison: Analyzer Part IV
Feature

Instrument HumaCLIA 150 VIDAS CL-900i

Barcode reader (sample) Internal & external External Yes

Auto-dilution Yes, customizable

Auto-rerun Yes No

Time-to-first-result 18 – 55 min up to 120 min

Extra water supply No No

1000
Reaction cuvette capacity n.a. (Single use, cuvettes in box)
(Single in bulk format of 1000/bag)
Yes
HW-sensor:
Level detection
Wash buffer & liquid waste, Cuvettes n.a.
consumables SW-calculation:
Trigger/Pre-Trigger, Solid waste

Level detection
Yes
(sample & reagent)

Bubble detection No

Clot detection Yes

Noise level < 60 db running / < 55 db standby

Page 51 | © 2019 Human |

CONFIDENTIAL
HumaCLIA SR
HumaCLIA 150 assay portfolio
What does „SR“ stand for?
▪ SR = System Reagents
▪ HumaCLIA SR = Reagents fitting on HumaCLIA 150

Covering routine and specialty assays

CE-mark as of 07/2020
Thyroid TSH, FT3, FT4, T3, T4, Anti-TG, Anti-TPO, TG Available
Available soon
AMH, Total-HCG (α+ß), FSH, LH, PRG, PRL, TES, Planned
Fertility hormones
Estradiol (E2), DHEA-S, ACTH, C-Peptid

Tumor Marker AFP, CEA, CA 125, CA 15-3, CA 19-9, tPSA, fPSA

Cardiac Marker CK-MB, Myoglobulin, BNP, Troponin I

Infectious Diseases Anti-TP (Syphilis)

Bone Marker PTH, Vitamin D total

Inflammation Procalcitonin
Page 52 | © 2019 Human |
HumaCLIA SR assays
Thyroid and Fertility hormones

Thyroid Fertility Hormones

Sample Calibration Reaction Time Sample Calibration Reaction Time
Assay Units Assay Units
volume (µl) Points (mins) volume (µl) Points (mins)
FT3 pg/ml 25 4 38 Progesterone ng/ml 55 4 38
FT4 pg/ml 15 4 38 Testosterone ng/ml 55 4 38
T3 ng/ml 55 4 38 LH mIU/ml 25 3 27
T4 ng/ml 15 4 38 Prolactin ng/ml 15 3 17
TSH μIU/ml 105 3 37 FSH mIU/ml 35 3 27
Anti-TPO IU/ml 10 3 35 E2 pg/ml 25 4 28
Tg ng/ml 55 3 27 HCG mIU/ml 10 3 17
Anti-Tg IU/ml 10 3 35 AMH ng/ml 55 3 20
DHEA-S ng/ml 10 4 12
ACTH pg/ml 55 3 17
C-Peptide ng/ml 15 3 17

Page 53 | © 2019 Human |

CONFIDENTIAL
HumaCLIA SR assays
Tumor Markers, Bone Markers and Infectious Diseases

Tumor Markers Bone Markers

Sample Calibration Reaction Time Sample Calibration Reaction Time
Assay Units Assay Units
volume (µl) Points (mins) volume (µl) Points (mins)
AFP ng/ml 15 3 15 PTH pg/ml 105 3 48
CEA ng/ml 15 3 17 25-OH Vit D ng/ml 55 4 44
CA 125 U/ml 10 3 12
CA 15-3 U/ml 10 3 15
Infectious Diseases
CA 19-9 U/ml 10 3 12
Sample Calibration Reaction Time
Free PSA ng/ml 15 3 17 Assay Units
volume (µl) Points (mins)
Total PSA ng/ml 15 3 17 Anti-TP COI 35 2 34

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CONFIDENTIAL
HumaCLIA SR
Calibrators traced back to the following international reference material

Assay Int. reference preparation Assay Int. reference preparation

TSH WHO 81/565 (3) PSA WHO 96/670

fT3 Not a fPSA WHO 96/668
T3 na
fT4 na
T4 na
HCG WHO 07/364 (5)
Prolactin WHO 84/500 (3)
FSH WHO 92/510
LH WHO 80/552 (2)
AFP WHO 72/225
CEA WHO 73/601

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CONFIDENTIAL
HumaCLIA SR vs Reference preparation
Excellent correlation to expected dilution values of the TSH
IRP WHO 81/565

HumaCLIA TSH vs. TSH WHO 3rd IS 81/565

Range 0.45 - 57.50 WHO µIU/ml
80
y = 1.1143x - 0.7234
70
r = 0.9983
HumaCLIA TSH [µIU/ml]

60 Recovery = 105%
50
Correlation coefficient = 0.9983
40
Recovery = 105%
30

20

10

0
0 10 20 30 40 50 60 70 80
TSH WHO 81/565 [µIU/ml]

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CONFIDENTIAL
HumaCLIA 150
Convenient presentation of HumaCLIA SR & competitor comparison

Company

HumaCLIA Architect
Analyzer Access 2 Liaison Maglumi 800 cobas e 411 Immulite 1000 AIA-900 iSYS CL-1000i VIDAS
150 i1000SR

Reagent 100
Smallest kit sizes 2 x 50 100 50 100 50 100 200 (5 trays x 20 50 60
(tests/ kit) test cups)

Calibrator
Yes no Yes Yes Yes no Yes no Yes Yes
included in kit

Calibrator levels
4 6 6 2 4 2 1
(fT4)

Reagent Ready
Liquid Liquid Liquid Liquid Liquid Liquid
format for use

Calibrator format Liquid Liquid Liquid Liquid Lyophilized Liquid

Page 57 | © 2019 Human |

CONFIDENTIAL
HumaCLIA 150
HumaCLIA SR fT4 stability vs. competitor fT4

Company

HumaCLIA Architect
Analyzer Access 2 Liaison Maglumi 800 cobas e 411 Immulite 1000 AIA-900 iSYS CL-1000i VIDAS
150 i1000SR

na Not
Reagent onboard
28 days 30 days 2 months (4 weeks 28 days na 10 days applicable
stability
in fridge) (strip)

Calibrator stability
up to kit -20°C 4 weeks up to kit
after opening 28 days 8 weeks 30 days 1 day
expiry thaw ≤5x in fridge expiry

•7 days/strip 90 days
Calibration curve 28 days/ lot
28 days/lot Same lot 28 days/lot •New strip 2 weeks (most 14 days/lot
stability 7 days/ kit
•New starter assays)

Page 58 | © 2019 Human |

CONFIDENTIAL
HumaCLIA SR control - Competitor comparison
Convenient Multi-analyte control with HumaCLIA 150

Company

HumaCLIA Architect
Analyzer Access 2 Liaison Maglumi 800 Cobas e 411 Immulite 1000 AIA-900 iSYS CL-1000i VIDAS
150 i1000SR

Multi- Multi- Multi-

Control type fT4 fT4 fT4
analyte analyte analyte

Control format Lyophilized Liquid Lyophilized Liquid Lyophilized Liquid

Control levels
2 3 3 1 4 3 1
(fT4)

Control stability up to kit up to kit

10 days 7 days 4 weeks ?
after opening expiry expiry

Control stability of
1 month no no no no no
frozen aliquots

Page 59 | © 2019 Human |

CONFIDENTIAL
HumaCLIA SR control - Competitor comparison
HumaCLIA assays require comparable sample volumes to other systems

Company

Sample volume/ HumaCLIA Architect

Access 2 Liaison Maglumi 800 Cobas e 411 Immulite 1000 AIA-900 iSYS CL-1000i VIDAS
test (µl) 150 i1000SR

Cup 50 µl
Dead volume 50 300 150
Tube 8mm
Not
TSH 105 150 110 100 50 200 100 200
available

Not
fT3 30 45 125 40 15 50 100
available

Not
fT4 20 25 30 40 15 25 100
available

Not
T3 80 25 55 50 30 25 100
available

Not
T4 20 25 30 40 15 15 200
available
Not
FSH 50 25 25 40 40 100 200
available

Page 60 | © 2019 Human |

CONFIDENTIAL
Method Comparison

HumaCLIA 150 vs. cobas e 411 (Roche)

HumaCLIA 150 vs. Maglumi 800 (Snibe)

HumaCLIA 150 vs. Architect i1000SR (Abbott)

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CONFIDENTIAL
HumaCLIA 150 Method Comparison
TSH - HumaCLIA 150 vs. Roche cobas e411

80 8
N: 111 (0.0-74.7 µIU/ml)
IRP WHO 81/565
70 Slope: 1.019 (0.90-1.10) 7

HumaCLIA150 TSH (µIU/ml) NR 0.30-5.00

Intercept: 0.0906 (<0.30)
R: 0.9946 (≥ 0.95)
60 6
HumaCLIA150 TSH (µIU/ml)

MDP 2
50 5

40 4
Very good Correlation to
Roche cobas e411
30 3

20 2

10 1
NR: Normal Range
MDP 1 MDP: Medical Decision Point
0 0
0 10 20 30 40 50 60 70 80 0 1 2 3 4 5 6 7 8
Roche cobasTSH (µIU/ml) Roche cobasTSH (µIU/ml) NR 0.27-4.20

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CONFIDENTIAL
HumaCLIA 150 Method Comparison
Inter-System Deviations (Bio-Rad Controls) - Roche
TSH (µIU/ml) - Roche (Normal Range 0.27 - 4.20 µIU/ml)
Level 1 Level 2 Level 3
System System System
(0.52) (6.18) (37.5)
Mindray CL -47% Mindray CL -40% Mindray CL -34%
Abbott Architect i -28% Abbott Architect i -26% Abbott Architect i -27%
Siemens Dimension Vista -28% Siemens Advia Centaur -23% Siemens Advia Centaur -23%
Siemens Advia Centaur -28% Beckman Coulter Access -16% Beckman Coulter UniCel Dxl -16%
Beckman Coulter Access -27% Beckman Coulter UniCel Dxl -16% Beckman Coulter Access -14%
Beckman Coulter UniCel Dxl -25% Siemens Dimension Vista -15% Siemens Immulite 1000 -10%
TOSOH AIA Systems -23% Diasorin Liaison -13% TOSOH AIA Systems -10%
Biomerieux Vidas -19% TOSOH AIA Systems -11% Siemens Dimension Vista -7%
Siemens Dimension -18% Siemens Dimension -9% Diasorin Liaison -5%
Snibe Maglumi -11% Snibe Maglumi -9% Siemens Dimension -4%
Siemens Immulite 1000 -10% Siemens Immulite 1000 -7% HumaCLIA150 -2%
Diasorin Liaison -6% HumaCLIA150 -2% Biomerieux Vidas -1%
Roche Elecsys 0% Roche Elecsys 0% Roche Elecsys 0%
HumaCLIA150 25% Biomerieux Vidas 0% Snibe Maglumi 0%

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CONFIDENTIAL
HumaCLIA 150 Method Comparison
fT3 - HumaCLIA 150 vs. Roche cobas e411

40 8
N: 100 (0.94-24.30 pg/ml) No international WHO
Slope : 0.9831 (0.90-1.10) 7 standard available.
Intercept: 0.258 (<2.30)

HumaCLIA 150 fT3 (pg/ml) NR 2.3-4.2

R: 0.9772 (≥ 0.95)
HumaCLIA 150 fT3 (pg/ml)

30 6

20 4 MDP 2
Very good correlation to
Roche cobas e411
3
MDP 1

10 2

1
NR: Normal Range
MDP: Medical Decision Point
0 0
0 10 20 30 40 0 1 2 3 4 5 6 7 8
Roche cobas fT3 (pg/ml) Roche cobas fT3 (pg/ml) NR 2.0-4.4

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CONFIDENTIAL
HumaCLIA 150 Method Comparison
T3 - HumaCLIA 150 vs. Roche cobas e411

6 2,5
N : 100 (0.42-5.41 ng/ml)
Slope: 1.10 (0.90-1.10)
No international WHO
Intercept: -0.087 (<0.60) standard available.
5
R: 0.983 (≥ 0.95) 2

HumaCLIA 150 T3 (ng/ml) NR 0.60-1.80

MDP 2
HumaCLIA 150 T3 (ng/ml)

1,5

3
Very good correlation to
1 Roche cobas e411
MDP 1
2

0,5
1
NR: Normal Range
MDP: Medical Decision Point
0 0
0 1 2 3 4 5 6 0 0,5 1 1,5 2 2,5
Roche cobas T3 (ng/ml) Roche cobas T3 (ng/ml) NR 0.80-2.0

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CONFIDENTIAL
HumaCLIA 150 Method Comparison
AMH - HumaCLIA 150 vs. Roche cobas e411
HumaCLIA 150 (ng/ml)

Diagnostic of AMH (Anti-Mullerian Hormone)

AMH is a reliable marker for prediction of response to
controlled ovarian stimulation and can therefore add
prognostic information to the counseling and planning
process for infertile couples seeking treatment.

Very good correlation to

Roche cobas e411

Normal Range depending on sex and age

Page 66 | © 2019 Human |

CONFIDENTIAL
HumaCLIA 150 Method Comparison
TSH - HumaCLIA 150 vs. Maglumi 800 (Snibe)
External user-evaluation Georgia
IRP WHO 81/565

Very good correlation to

Maglumi 800 (Snibe)

Page 67 | © 2019 Human |

CONFIDENTIAL
HumaCLIA 150 Method Comparison
Inter-System Deviations (Bio-Rad Controls) - Snibe

TSH (µIU/ml) - Snibe

System Level 1 System Level 2 System Level 3
Mindray CL -41% Mindray CL -34% Mindray CL -34%
Abbott Architect i -19% Abbott Architect i -19% Abbott Architect i -27%
Siemens Dimension Vista -19% Siemens Advia Centaur -15% Siemens Advia Centaur -23%
Siemens Advia Centaur -19% Beckman Coulter Access -8% Beckman Coulter UniCel Dxl -16%
Beckman Coulter Access -18% Beckman Coulter UniCel Dxl -7% Beckman Coulter Access -14%
Beckman Coulter UniCel Dxl -16% Siemens Dimension Vista -6% Siemens Immulite 1000 -11%
TOSOH AIA Systems -14% Diasorin Liaison -5% TOSOH AIA Systems -10%
Biomerieux Vidas -10% TOSOH AIA Systems -3% Siemens Dimension Vista -7%
Siemens Dimension -9% Siemens Dimension 0% Diasorin Liaison -5%
Snibe Maglumi 0% Snibe Maglumi 0% Siemens Dimension -4%
Siemens Immulite 1000 1% Siemens Immulite 1000 2% HumaCLIA150 -2%
Diasorin Liaison 5% HumaCLIA150 8% Biomerieux Vidas -2%
Roche Elecsys 12% Roche Elecsys 10% Roche Elecsys 0%
HumaCLIA150 40% Biomerieux Vidas 10% Snibe Maglumi 0%

Page 68 | © 2019 Human |

CONFIDENTIAL
HumaCLIA 150 Method Comparison
T3 - HumaCLIA 150 vs. Maglumi 800 (Snibe)
External user-evaluation Georgia

Page 69 | © 2019 Human |

CONFIDENTIAL
HumaCLIA 150 Method Comparison
fT3 - HumaCLIA 150 vs. Maglumi 800 (Snibe)
External user-evaluation Georgia

No international reference
material available.

Very good correlation to

Maglumi 800 (Snibe)

Page 70 | © 2019 Human |

CONFIDENTIAL
HumaCLIA 150 Method Comparison
TSH - HumaCLIA 150 vs. Architect i1000SR (Abbott)

60 6
n = 99 (0.02-52.15 µIU/ml)
y = 1.306*x + 0.063
r = 0.983
50 5

HumaCLIA150 TSH (µIU/ml)

HumaCLIA150 TSH (µIU/ml)

40 4

RR = 0.30 - 5.0 µIU/ml

RR = 0.30 - 5.0 µIU/ml

30 3

20 2

10 1 Very good correlation to

Architect i1000SR

0 0
0 10 20 30 40 50 60 0 1 2 3 4 5 6
Architect TSH (µIU/ml) Architect TSH (µIU/ml)
RR = 0.35 - 4.94 µIU/ml RR = 0.35 - 4.94 µIU/ml

Page 71 | © 2019 Human |

HumaCLIA 150 vs. Abbott Architect
Bio-Rad Target Values TSH - Abbott Architect

Page 72 | © 2019 Human |

HumaCLIA 150 Method Comparison
FSH - HumaCLIA 150 vs. Architect i1000SR (Abbott)

180 12
n = 82 (0.20-143.68 mIU/ml)
160 y = 1.128*x + 0.293

RR Women Follicular Phase 2.5 - 10.2 mIU/ml

RR Women Follicular Phase 2.5 - 10.2 mIU/ml

r = 0.994 10

HumaCLIA150 FSH (mIU/ml)

HumaCLIA150 FSH (mIU/ml)

140

120 8

100
6
80

60 4

40
2 Very good correlation to
20 Architect i1000SR
0 0
0 20 40 60 80 100 120 140 160 180 0 2 4 6 8 10 12
Architect FSH (mIU/ml) Architect FSH (mIU/ml)
RR Women Follicular Phase 3.03 - 8.08 mIU/ml RR Women Follicular Phase 3.03 - 8.08 mIU/ml

Page 73 | © 2019 Human |

HumaCLIA 150 vs. Abbott Architect
Bio-Rad Target Values FSH - Abbott Architect

Page 74 | © 2019 Human |

HumaCLIA 150 Method Comparison
T-PSA - HumaCLIA 150 vs. Architect i1000SR (Abbott)

100 10
n = 100 (0.01-91.77 ng/ml)
90 y = 1.072*x + 0.071
r = 0.993
80 8

HumaCLIA150 t-PSA (ng/ml)

HumaCLIA150 t-PSA (ng/ml)

70

60 6

RR ≤ 4.0 ng/ml
RR ≤ 4.0 ng/ml

50

40 4

30

20 2
Very good correlation to
10 Architect i1000SR
0 0
0 10 20 30 40 50 60 70 80 90 100 0 2 4 6 8 10
Architect t-PSA (ng/ml) Architect t-PSA (ng/ml)
RR ≤ 4.0 ng/ml RR ≤ 4.0 ng/ml

Page 75 | © 2019 Human |

Objection Handling / Keyselling Aurguments

SWOT analysis and objection handling

HumaCLIA 150 key selling points vs. competitors

Page 76 | © 2019 Human |

CONFIDENTIAL
HumaCLIA 150 system
SWOT analysis & How to deal with the identified aspects
STRENGHTS WEAKNESSES

▪ Intuitive GUI with excellent overview on “Main screen” ▪ Unknown HumaCLIA 150 to market
=> easy use with short training period => early adoptors needed (Key Opinion Leaders)
▪ Availability of method comparison data => 1st country installations with on-site support from
=> good to excellent correlation with Roche & Snibe Wiesbaden TS/CS

▪ Excellent local, fast reacting service & support through ▪ Limited reagent portfolio at time of launch
HUMAN‘s distribution network => identification of correct labs
=> more assays in the pipeline

OPPORTUNITIES THREATS

▪ Growing CLIA market ▪ Competitors offer refurbished analyzers

=> state-of-the-art instrument (AE technology) => Identify best pricing strategy in every country
▪ Brand new analyzer ▪ Original supplier selling in our regions
=> door opener for new discussions => Collect competitor invoices for HUMAN’s
▪ Large, world-wide ELISA customer base price negotiations.
=> large customer base to switch

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CONFIDENTIAL
HumaCLIA 150 system
Objection handling

HUMAN is not known in the area of HumaCLIA 150 is a new system

CLIA immunoassay system
• CE-marked analyzer
business.
• CE-marked reagents
How to handle it

• External User Evaluation (Georgia & Saudi Arabia)

• Identify early adopters
• Create reference labs

Limited reagent portfolio, at the time HumaCLIA 150’s assay range is increasing continuously
of launch. • Most customers only run “bread and butter” assays.
• Select the correct labs for your HumaCLIA 150 offer by comparing the labs’ parameter
requirements with the current HumaCLIA 150 assay portfolio
• Key-opinion leader
Objection Handling• More assays are in the pipeline
• Takes time to CE-mark assays, which is an indication to lot-to-lot quality

Page 78 | © 2019 Human |

CONFIDENTIAL
How to challenge
ELISA

Less cost effective

ELISA often is less cost effective with smaller assay series
=> Require reagent and wells to run a calibration curve
▪ with every run
▪ 6 calibrators
▪ in duplicates
=> Require reagent and wells to run controls
▪ multiple controls
▪ with every run More hands on
▪ at the start and at the end of the sample series ELISA requires more hands on
=> ELISA is run in batch not in random-access => Little time for more important tasks
.
.

Page 79 | © 2019 Human |

CONFIDENTIAL
 ELISA (non-HUMAN / HUMAN) - 1
Limitation of Feature of Benefit with Value to Customer with
ELISA HumaCLIA 150 HumaCLIA 150 HumaCLIA 150
Batch run Random-access • Faster time-to-result • Good lab reputation providing
• Higher flexibility with smaller assay excellent and reliable service to
series physicians (faster result reporting)
• Less overtime • Lower labor costs
• Easier routine
Limited measuring range Broad measuring range & higher • Exact quantification on the first “go” • Lower total cost of ownership
sensitivity with many assays. • No further dilution needed • Interesting workplace
• Less hands on due to auto-dilution (keep well trained med tech’s)
feature • Good lab reputation providing
• Faster result reporting excellent and reliable service to
• No additional run needed (reagent, physicians (faster result reporting)
sample , cuvette, wash, sub, time)
Manual dilution Auto-dilution • Less hands-on time • Pay Med Techs for higher value
• Free-up time for more important tasks
tasks • Good lab reputation providing
• Reduced risk of error excellent and reliable service to
physicians (correct result reporting)
Manual reagent position allocation Positive reagent vial identification • Less hands-on • Pay Med Techs for higher value
• Free-up time for more important tasks
tasks • Reduced costs (fewer repetitions
• Reduced risk of errors after error)

Page 80 | © 2019 Human |

CONFIDENTIAL
 ELISA (non-HUMAN / HUMAN) - 2
Limitation of Feature of Benefit with Value to Customer with
ELISA HumaCLIA 150 HumaCLIA 150 HumaCLIA 150
> 2 calibrators 2-point calibration master curve • Less reagent and cuvette • Lower total cost of ownership
(up to 6 CAL vials) consumption
• Less hands-on
Run-specific calibration curve Longer stability of calibration curve • Less reagent and cuvette • Lower total cost of ownership
• 7-21 days with same kit consumption • Interesting workplace
• 28 - 42 days with same lot • Less hands-on (keep well trained med tech’s)
• More cost-effective with smaller • Good lab reputation providing
assay series excellent and reliable service to
• Random-access (no batch run) physicians (faster result reporting)
• Higher flexibility with smaller assay
series

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CONFIDENTIAL
How to challenge
Architect i1000SR (Abbott)

Separate calibrator kits • Requires more purchasing logistics & extra coordination in the lab

Cuvette waste • Initialization followed by extensive cuvette waste after analyzer stop

GUI • Less intuitive than HumaCLIA 150

• HumaCLIA 150 allows the end-user to run a performance check after
No system check by end-user possible
maintenance
Waiting time • (15 min) during maintenance, until touch screen is accessible, again
• No larger wash container can be connected externally like with HumaCLIA
Wash container only inside
150
• Potential reagent waste
Min. 100 tests/cartridge
• Potential waste costs
Start-up time • Longer than with HumaCLIA 150

Page 82 | © 2019 Human |

CONFIDENTIAL
 Architect 1000 (Abbott)
Limitation of Feature of Benefit with Value to Customer with
Architect 1000 HumaCLIA 150 HumaCLIA 150 HumaCLIA 150
Cuvette waste • Less cuvettes needed • Lower total cost of ownership
Every instr. stop results in an instr. • Less hands-on time • Interesting workplace
Instrument stop w/o cuvette waste
initialization with extensive cuvette • Free-up time for more important (keep well trained med tech’s)
waste tasks • Save costs for technician’s overtime
• Less logistics needed by lab and
purchasing department
• Less storage space needed in the • Attractive working place for
Separate calibrator kits Calibrator included in reagent kit
fridge technicians
• Dedicated calibrators ensuring result
quality
• Lower tests/reagent cartridge
Smallest kit size 1x100 tests/kit Smallest offer 2x50 tests/kit • Lower total cost of ownership
resulting in reduced reagent waste
• No waiting time, but continuous
• Save costs for technician’s overtime
Touch-screen freeze during Touch-screen is accessible during working with analyzer (parallel
• Interesting workplace
maintenance (approx. 15min) maintenance accessibility to result or reagent
(keep well trained med tech’s)
management screen)
Additional larger external wash • Attractive working place for
Wash container inside only • Increase in workflow efficiency
container connectable technicians
• Increase in workflow efficiency • Technicians available for daily routine
Less intuitive GUI More intuitive user interface
• Less training needed instead of wasting time for training.
• More sample results/ reagent
Up to 6 calibrator levels 2 – 4 calibrator levels • Use less reagent for calibration
• Make cost effective use of reagents

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CONFIDENTIAL
How to challenge
cobas e411 (Roche)

Separate calibrator kits Requires more purchasing logistics & extra coordination in the lab
=> Increased total cost of ownership
Various system reagents
=> Additional ordering & storage logistics needed
ECL Measuring cells exchange Additional operating costs / costly once per year
=> Less flexibility
Smallest cartridge size 100 tests
=> Increased total cost of ownership

Page 84 | © 2019 Human |

CONFIDENTIAL
 cobas e411 (Roche)
Limitation of Feature of Benefit with Value to Customer with
Cobas e411 HumaCLIA 150 HumaCLIA 150 HumaCLIA 150
Many system reagents Few system reagents • Less coordination of system • Lower total cost of ownership
ProCell Conditioning of the Electrode & • Wash Buffer reagents (ordering & storage & • Interesting workplace
Washing of the streptavidin-coated microbeads • Trigger/ Pre-Trigger during analyzer operation) (keep well trained med tech’s)
CleanCell Cleaning of tubing system & of the
measuring cell after every measurement
• Easier instrument use
Sysclean Sodium Hypochlorite Solution • Reduced hidden costs
(NaClO) used for cleaning of the measuring cell (e411 additional EUR 1,- to 4,-
(every two weeks) consumable costs per test)
Syswash Increasing rinsing efficiency
between pipetting steps. Preventing Bacterial
growth. 1+100 dist. Water

ECL Measuring cells No “ECL Measuring cell” • No additional operating costs • Lower total cost of ownership
Replacement due to wear and tear involved to exchange any ECL
happening with Measuring cell
electrochemiluminescence technology • Less instrument down time

Smallest kit size 1x100 tests/kit Smallest offer 2x50 tests/kit • Lower tests/reagent cartridge • Lower total cost of ownership
resulting in reduced reagent waste
Separate calibrator kits Calibrator included in reagent kit • Less logistics needed by lab and • Attractive working place for
purchasing department technicians
• Less storage space needed in the • Keep staff
fridge
• Dedicated calibrators ensuring result
quality

Page 85 | © 2019 Human |

CONFIDENTIAL
How to challenge
Maglumi 800 (Snibe)

• Wait for 30 mins before use (equilibrate at room temp & shake)
Reagent preparation
• Strip is recommended to be stored in fridge if used after 12 hours
Not all kits are CE-marked • Alternative instrument needed for anti-TP (Syph)

Reagent positions • Limited to 9 positions

• No multi-control
Control
• 1 Level only
Large sample dead volume • 300 µl/test
• 6-cuvettes/ strip
Cuvette waste • Collect 6 samples
• Waste of unused cuvettes
• Not available with 2° tubes
Liquid level detection (samples)
• Conductivity workaround: Eppendorf vial in tube with water
Run sample in duplicates • All or no sample => inconvenient
Page 86 | © 2019 Human |
CONFIDENTIAL
 Maglumi 800 (SNIBE) – Part 1
Limitation of Feature of Benefit with Value to Customer with
Maglumi 800 HumaCLIA 150 HumaCLIA 150 HumaCLIA 150
Reagent preparation (30min) Immediate use after • Less hands-on time • Attractive working place for
• no 30 minutes resuspension of • Free-up time for more important technicians
microbeads needed and no tasks • Keep staff
equilibration to room temperature • Efficient daily workflow 24/7
• Invertion of reagent cartridge only • Happy technicians
6-cuvette-strip Single cuvettes • No cuvette waste • Lower total cost of ownership
Cuvette waste, due to: w/o batch mode, but random-access • True random-access processing of • Good lab reputation providing
➢ Sample racks handled in batch- samples excellent and reliable service to
mode by instrument: rack loading • Flexibility in loading samples physicians (fast result reply
time dependent • Faster time-to-result for multiple appreciated by physicians)
➢ Samples assigned to incubation time sample test requests (1-step & 2-
strips step assays in combination)
No 24/7 reagents onboard Reagents can be kept onboard 2…8°C • Less hands-on time • Attractive working place for
(Strips are recommended to be stored • Save time for more important tasks technicians
in fridge if used after 12 hrs) • Efficient daily workflow 24/7 • Keep staff

Liquid level detection Sample liquid level detection • Less hands-on • Attractive working place for
Sample cups • High-sensitivity capacity based • Free-up time for more important technicians
• No work-around required with cup in tasks • Keep staff
water-tube • Increased work-flow efficiency • Lab providing timely results and
• No alarms good service to requesting doctors
• Ensure results on time

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 Maglumi 800 (SNIBE) – Part 2
Limitation of Feature of Benefit with Value to Customer with
Maglumi 800 HumaCLIA 150 HumaCLIA 150 HumaCLIA 150
Large sample dead volume Usual dead volume of • Run more samples out of one tube • No discussion with requesting doctors
(300 µl) • 50µl with cups • No extra draw needed about need of second blood draws
• 8mm extra volume in 1° tubes • Run all samples requested in one go out • Be a lab of choice to requesting doctors
of one blood draw
Duplicate result requests Individual sample request for • No waste of reagents • Lower cost of ownership
(all or no sample) duplicate results • Easy flexible handling
One control level per Multi-analyte control • More than one level should be run • Ensure high-quality results
parameter • 2 levels according to GLP • Peace of mind
• Covering many parameters • No external controls need to be • Lower cost of ownership
purchased • Attractive working place for technicians
• Less logistics needed by lab and • Keep staff
purchasing department
• Less storage space needed in the fridge
WASH & SUB Wash & Trigger & Pre-Trigger • Continuous running of analyzer • Lower total cost of ownership
w/o “empty bottle” error message Level check with • No waste of Sample & RGT (with sudden • Good lab reputation providing excellent
• visual alarm stop of analyzer) and reliable service to physicians
• error messages • Reliable time-to-result (providing timely results)
• Interesting workplace
(keep well trained med tech’s)
Time-to-result display Result-specific time-to-result • Med Tech’s can concentrate on other • Good lab reputation providing excellent
(one time for end of all) display tasks and reliable service to physicians
• No batch-mode effect (providing timely results)
• Correct time-to-result communication to • Interesting workplace
physicians (keep well trained med tech’s)
• Reliable walk-away time
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 Maglumi 800 (SNIBE) – Part 3
Limitation of Feature of Benefit with Value to Customer with
Maglumi 800 HumaCLIA 150 HumaCLIA 150 HumaCLIA 150
Reagent positions: 9 20 reagent positions • No batch run needed • Happy staff
• Multiple cartridges of the same • Fast results in one go. • Be a lab of choice for med techs
parameter & different lots • No overtime hours • Keep staff. No need for continuous
• Cooled • Increased user flexibility recruitment.
• One fill of reagents per day
Onboard capability: up to 40 50 sample positions • Increased user flexibility • Happy staff
samples • 5 positions x 10 racks • Be a lab of choice for med techs
• Mix of 1° and 2° tubes & cups • Easy flexible handling • Keep staff. No need for continuous
• 50 STAT optionally recruitment.

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How to challenge
Access 2 (Beckman Coulter)

• Max 294 (3 cartridges x 98 cuvettes)

Loading of cuvettes inconvenient
requires removal of empty cartridge spines
Calibrator levels • Up to 7/ assay

Larger sample volume • Up to 250 µl

Long analysis time • 30 – 75 min

No onboard dilution capability • Risk of wrong dilution or result reporting

Wash buffer (no concentrate) • Causes higher storage & transportation costs

No controls provided by supplier • End-user is required to purchase 3rd party controls

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 Access 2 (Beckmann Coulter)
Limitation of Feature of Benefit with Value to Customer with
Access 2 HumaCLIA 150 HumaCLIA 150 HumaCLIA 150
Wash Buffer bottle (2L) Wash Buffer concentrate • Less storage room needed • Lower total cost of ownership
(no concentrate; box of 4 x 1,950 ml) (4x 1L for 40L; 1+9) • Lower cost through cheaper
transportation
No onboard dilution capability • Sample pre-dilution • Less hands-on • Lower total cost of ownership
• Auto-dilution • Free-up time for more important • Less tel-calls with doctors
tasks
• Longer walk-away time
• Reduce potential errors
Long analysis time 12 - 44 min • Lab can provide results faster to • Keep happy doctors
30 - 75 min doctor’s office • Interesting workplace
• Med Tech can finish work earlier (keep well trained med tech’s)
• Save costs for technician’s overtime
Larger sample volume • 5 – 50 µl/test • More tests of same blood draw tube • More tests can be offered to
up to 250 µl/ test • Few 100 µl/test • Aliquoting facilitated requestor without increasing # of
draws
• Interesting employer due to happier
+8µL system volume patients
Calibrator levels 2 – 4 calibrator levels • Use less reagent for calibration • More sample results/ reagent
Up to 7 • Make cost effective use of reagents

No controls provided by supplier Controls provided • No need to purchase 3rd party • Peace of mind
control material • Good choice – all you need out of
• No discussions about bad reagent or one hand (supplier)
control quality
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How to challenge
AIA-900 (TOSOH)

No a-TP (Syphilis) assay • Lab requires an additional analyzer

Single reagent cup/ test, disposable reagent
• Thereby producing a lot of plastic and aluminum foil waste per test
tips and disposable sample tips
Max. 5 tests/ patient only • HumaCLIA is not limited to the tests per patient.

Max. 90 tests/ hour • Much lower throughput than HumaCLIA 150

Intensive manual work • With loading of up to 5 test cups behind each patient sample

Large sample volume • up to 150 µl/test

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 AIA-900 (TOSOH)
Limitation of Feature of Benefit with Value to Customer with
AIA-900 HumaCLIA 150 HumaCLIA 150 HumaCLIA 150
Large sample volume • Most 10 – 55 µl/test • More tests of same blood draw tube • More tests can be offered to
up to 150 µl/test • Some 15 – 55 µl/test • Aliquoting facilitated requestor without increasing # of
• TSH 100 µl draws
• Interesting employer due to happier
patients
Intensive manual work Reagent cartridges for 50 tests • Less hands on. • Interesting workplace
(loading of up to 5 test cups behind • Free-up time for more important (keep well trained med tech’s)
each patient sample) tasks

Throughput 90 tests/hour Up to 150 tests/hour • Higher flexibility • Provide results faster

• Less hands-on

No anti-TP (Syphilis) Soon available • No additional analyzer needed • Save money for another instrument
• a-TP (Syphilis) • No need for Med Tech to be trained • Make best of use of Med Tech’s time
on another analyzer (1 vs. 2 analyzers to look after)

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 How to challenge
AIA-360 (TOSOH)

No a-TP (Syphilis) assay • Lab requires an additional analyzer

Single reagent cup/ test, disposable reagent tips • Thereby producing a lot of plastic and aluminum foil waste per test
and disposable sample tips
Max. 4 tests/ patient sample only • HumaCLIA is not limited to the tests per patient.

Max. 36 tests/ hour • Much lower throughput than HumaCLIA 150; not the same customer segment.

Max. 25 sample positions • Much lower capacity than HumaCLIA 150 with 50 sample positions.
(tubes and/or cups)
Min. sample volume of 500µL/tube or 100µL/cups • Larger sample volumes needed with AIA-360, allowing fewer tests per sample.

Intensive manual work • Sample loading only one by one on the sample carousel in the instrument. Instead
(1 cup/test) HumaCLIA 150 uses racks of 5 positions and direct frontal placement of sample racks.
• Test reagent cups need to be loaded one after the other. Instead with HumaCLIA 150 50
tests/cartridge are being loaded, at once.
Large sample volume • up to 150 µl/test, allowing fewer tests per sample.

Time consuming calibration • 6 levels run in triplicates (18 reagent cups). No automated barcode reading, all manual
exchange. No positive sample or reagent position identification. Traceability by manual
notes on copy of thermal-paper print-out. Manual discarding of used test cups.
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 AIA-360 (TOSOH)

Limitation of Feature of Benefit with Value to Customer with

AIA-900 HumaCLIA 150 HumaCLIA 150 HumaCLIA 150
Large sample volume • Most 10 – 55 µl/test • More tests of same blood draw tube • More tests can be offered to
up to 150 µl/test • Some 15 – 55 µl/test • Aliquoting facilitated requestor without increasing # of
• TSH 100 µl draws
• Interesting employer due to happier
patients
Intensive manual work Reagent cartridges for 50 tests • Less hands on. • Interesting workplace
(loading of up to 4 test cups behind • Free-up time for more important (keep well trained med tech’s)
each patient sample) tasks

Throughput 36 tests/hour Up to 150 tests/hour • Higher flexibility • Provide results faster

• Less hands-on

No anti-TP (Syphilis) Soon available • No additional analyzer needed • Save money for another instrument
• a-TP (Syphilis) • No need for Med Tech to be trained • Make best of use of Med Tech’s time
on another analyzer (1 vs. 2 analyzers to look after)

Small touch screen with blue writing Colorful touch screen • Higher flexibility • Interesting workplace
• Perfect menu overview • Less hands-on (keep well trained med tech’s)
• Flat hierarchie • New attractive technology • Appealing new technology
• Easy, fast & flexible menu jumps
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How to challenge
CL-1000i (Mindray)

Outdated detection technology alkaline

• No state-of-the-art reagents, like “old” Immulite (Siemens/DPC)
phosphatase (ALP)
• 176 cuvettes/ box
Limited cuvettes on board
• Short walk-away time
Reagent positions • Limited to 9 positions
Not all kits are CE-marked
• Alternative needed: Other IA-System or ELISA
(e.g. a-TP Syphilis)

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 CL-1000i (MINDRAY)

Limitation of Feature of Benefit with Value to Customer with

CL-1000i HumaCLIA 150 HumaCLIA 150 HumaCLIA 150
Not the latest state of the art State-of-the-art technology with • Use of high-sensitivity assays • Peace of mind
detection technology Acridinium ester (like Centaur or • Use of low-end assay-precision • Provide good service to requesting
(Alkaline phosphatase) Architect) => thereby obtaining result values doctors
instead of just above/below values

Few cuvettes only 1000 cuvettes • Long walk-away time (4 h) • Interesting workplace
(176 cuvettes/ box) • Less hands-on time. (keep well trained med tech’s)
• Save time for more important tasks

Low number of reagent positions (9) 50 cooled reagent positions • Higher flexibility • Provide results faster
• Less hands-on

No anti-TP (Syphilis) Soon available • No additional analyzer needed • Save money for another instrument
• a-TP (Syphilis) • No need for Med Tech to be trained • Make best of use of Med Tech’s time
on another analyzer (1 vs. 2 analyzers to look after)

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How to challenge
CL-900i (Mindray)

Outdated detection technology alkaline

• No state of the art reagents, like “old” Immulite (Siemens/DPC)
phosphatase (ALP)
• 88 cuvettes /box x 2 (176 cuvettes/run)
Limited cuvettes on board
• Shorter walk-away time
• Limited to 15 positions
Reagent positions
• Increased hands-on time

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 CL-900i (MINDRAY)

Limitation of Feature of Benefit with Value to Customer with

CL-900i HumaCLIA 150 HumaCLIA 150 HumaCLIA 150
Not the latest state of the art State-of-the-art technology with • Use of high-sensitivity assays • Peace of mind
detection technology Acridinium ester (like new Centaur and • Use of low-end assay-precision • Provide good service to requesting
Alkaline phosphatase, like old Architect) => thereby obtaining result values doctors
IMMULITE systems • High signal-to-noise ratio instead of just above/below values
• Small size of AE • Obtain results fast
• Rapid kinetics with fast light-
emission
Few cuvettes 1000 cuvettes • Long walk-away time (4 h) • Interesting workplace
88 cuvettes/box x 2 (defined by wash buffer) (keep well trained med tech’s)
= 176 cuvettes/run • Less hands-on time.
• Save time for more important tasks
Lower number of reagent positions 20 reagent positions • No batch run needed • Happy staff
15 positions • Multiple cartridges of the same • Fast results in one go. • Be a lab of choice for med techs
parameter & different lots • No overtime hours • Keep staff. No need for continuous
• Cooled • Increased user flexibility recruitment.
• One fill of reagents per day
Small solid waste container Cuvette capacity of up to 500 cuvettes • Long walk-away time of 4 hours • Interesting workplace (happy med
Capacity 200 cuvettes; of waste container (defined by wash buffer) tech’s)
under-designed for 180 tests/hour • Less hands-on time • keep well trained med tech’s
• Save time for more important tasks • No need for continuous staff
recruitment.

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How to challenge
IMMULITE 1000 (Siemens)

Old system (from DPC) • Not very attractive

• Some parameters with smallest kit size of 200 tests
Kit size
(LH, Prolactin, anti-TP/Syphilis, …)
Each sample cup can have up to five test
• Limitations of tests per sample
units behind it
No controls provided by supplier • End-use is required to purchase 3rd party controls

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 Immulite 1000 (Siemens)
Limitation of Feature of Benefit with Value to Customer with
Immulite 1000 HumaCLIA 150 HumaCLIA 150 HumaCLIA 150
Not the latest state of the art State-of-the-art technology with • Use of high-sensitivity assays • Peace of mind
detection technology Acridinium ester (like Centaur or • Use of low-end assay-precision • Provide good service to requesting
(Alkaline phosphatase) Architect) => thereby obtaining result values doctors
instead of just above/below values
Kit size some parameter ≥200 test/kit 2x50 tests/ kit • Reduced risk of reagent waste • Lower cost of ownership
(LH, Prolactin, anti-TP/Syphilis)

Indirect tube sampling Direct automated sampling from • Less manual work • Free up time for more important
primary tubes (or secondary tubes) • Make use of full primary tube draw tasks
volume in one go
Each sample cup can have up to 5 # tests/sample is not limited to 5 • Less hands on • Free up time for more important
test units behind it • Longer walk-away time tasks

Reagent test cups Reagent cartridge • Less hands on • Free up time for more important
(1 test) (min. 50 tests) • Longer walk-away time tasks
• Reduced waste • Pay Med Techs for more valuable
work
• Lower total cost of ownership
• Good lab reputation (working
ecologically)
No controls provided by supplier Controls provided • No need to purchase 3rd party
control material

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How to challenge
iSYS (ids)

Mainly specialty assays,

• Additional analyzer required to run thyroid, cancer, tumour marker, etc
but little to no routine tests
Large sample volume • Up to 300 µl/test
• Loading of reagent cartridge into the reagent tray at least 40 minutes
Long waiting time before first run
prior to starting the assay
Reagent onboard stability • 14 days only

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How to challenge
Liaison (DiaSorin)

No instrument cover • Debris easily falls into the reactions, potentially causing wrong results
• 6-cuvettes/ strip
Cuvette waste • Collect 6 samples
• Waste of unused cuvettes

Multiple error messages hamper

daily routine

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How to challenge
LUMIPULSE G600II (Fujirebio)

Constant 60 tests/hr • Lowest throughput of all main competitors

All assays 35 min time-to-result • Shortest time for emergency cardiac parameter is 35 minutes

33 samples onboard • Primary tubes only

Up to 112 tests onboard • Average of 3 tests/ sample, only

Disposable sample tips (in Box) • Additional running costs

Manual external barcode reader for samples • Increased hands on

Reagent strips • 1 strip = 1 test

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 LUMIPULSE G600II (Fujirebio) - 1
Limitation of Feature of Benefit with Value to Customer with
LUMIPULSE G600II HumaCLIA 150 HumaCLIA 150 HumaCLIA 150
Constant 60 tests/h Average 80 tests/h in routine • Obtain more patient results • Better service to doctors
up to 150 tests/h • Finish work earlier • Save costs for technician’s overtime
(no overtime) • Increased flexibility
• Interesting workplace
(keep well trained med tech’s)
All assays 35 min time-to-result Cardiac assays take only 12 min, like • Faster time-to-result • Provide emergency results faster
Troponin I or CK-MB • Be more competitive

33 samples onboard 50 samples onboard capacity • Longer walk-away time • Better service to doctors
• Work gets done faster • Save costs for technician’s overtime
• Interesting workplace
(keep well trained med tech’s)
Primary sample tubes, only 1° or 2° sample tubes or sample cups • Increased flexibility • Better service to doctors
or Eppendorf cups • Run aliquots • Peace of mind

Disposable sample tips (in box) 45 min • Lab can provide results faster to • Keep happy doctors
doctor’s office • Interesting workplace
• Med Tech can finish work earlier (keep well trained med tech’s)
• Save costs for technician’s overtime
Manual external barcode reader for Internal sample barcode reader • Less hands on time • Lower cost of ownership
samples • Faster introduction of samples • Free up time for more important
tasks
• Interesting workplace
(keep well trained med tech’s)

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 LUMIPULSE G600II (Fujirebio) - 2
Limitation of Feature of Benefit with Value to Customer with
LUMIPULSE G600II HumaCLIA 150 HumaCLIA 150 HumaCLIA 150
Reagent strip = one test 1 reagent cartridges offers 50 tests • Longer walk away time • Increased workflow efficiency
onboard • Higher flexibility • Interesting workplace
• Larger throughput (keep well trained med tech’s)
• Save costs for technician’s overtime
• Better service to doctors

Up to 112 tests onboard 1000 tests onboard • Longer walk away time • Increased workflow efficiency
Average 3 tests/ sample (20 cartridges x 50 tests) • Higher flexibility • Interesting workplace
• Larger throughput (keep well trained med tech’s)
• Save costs for technician’s overtime
• Better service to doctors

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How to challenge
Vidas (bioMérieux)

Batch mode
• Increased total cost of ownership
(multiple assay testing)
Reagent strips • More hands-on
(1 strip/ patient/ test) • Costly
Strips / calibration • Increased costs per result

Large sample volume • Up to 300 µl/test

Long analysis time • Up to 120 min

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 VIDAS (bioMérieux)
Limitation of Feature of Benefit with Value to Customer with
VIDAS HumaCLIA 150 HumaCLIA 150 HumaCLIA 150
Batch mode/ multiple assay testing Random-access • Easy to use when a large number of • Increased flexibility
samples has to be tested

Reagent strips Reagent cartridges • Less hands on • Free up time for more important
(1 patient/1 strip) • Longer walk-away time tasks
• Less plastic waste • Pay Med Techs for more valuable
work
• Good lab reputation (working
ecologically)
Large sample volume • 10 – 50 µl/test • More tests of same blood draw tube • More tests can be offered to
up to 300 µl/test • 100 µl with a-TP (Syphilis), HIV, • Aliquoting facilitated requestor without increasing # of
HBsAg draws
• Interesting employer due to happier
patients
Long analysis time 45 min • Lab can provide results faster to • Keep happy doctors
up to 120 min doctor’s office • Interesting workplace
• Med Tech can finish work earlier (keep well trained med tech’s)
• Save costs for technician’s overtime
Use strips for calibration Use less expensive reagent • More costly • Lower cost of ownership

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Supporting Material

Testimonials

Frequently asked questions

Customer Presentation

Calculation Tool

Documentation and other tools

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HumaCLIA 150 user evaluation Georgia
Usability testing and comparison to Maglumi 800

LTD VISTAMEDI
Tbilisi, Georgia

Laboratory profile
• Private organization in healthcare sector
• Working 24/7
• About 1.300 tests per day
• About 400 samples per day
• Samples from other clinics & directly from patients, on-call service
• External quality control – RfB, RIQAS, HumEQAS, VITAL-EQA

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HumaCLIA 150 user evaluation Georgia
Voice of customer - comparison to Maglumi 800

Top 3 advantages of HumaCLIA 150 system

Reagents are truly ready-to-use

No time needed for micro-bead preparation.
→ Benefit: - Faster time to start

Single reaction cuvettes in bulk-format

No waiting time or waste of reaction vessels in a cuvette-strip
→ Benefit: - Less waste - More cost-effective - Continuous sample loading - Easy and fast refill

Individual sample request for duplicate results

Increased flexibility in the lab
→ Benefit: - No waste of reagents - Lower cost of ownership

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HumaCLIA 150 user evaluation Saudi Arabia
Usability testing and comparison to cobas

Bio-House Medical Lab

Rhiyad, Saudi Arabia

Laboratory profile
• Private organization in healthcare sector
• Working 24/7
• About 1.300 tests per day
• External quality control – RIQAS
• Bio-House [Link] under qualification of CBAHI
(Saudi Central Board for Accreditation of Healthcare Institutions)

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HumaCLIA 150 user evaluation Saudi Arabia
Voice of customer - comparison to cobas

Top 3 advantages of HumaCLIA 150 system

User interface easy to handle

No time-consuming training requirement
→ Benefit: - Fast time-to-operation - Little interruption of routine work - Happy lab staff

Visible alarm (LED) for consumables

No sudden interruption or down time of analyzer
→ Benefit: - Fluent and effective work-flow - No waste of sample, reagents, cuvettes and lab technicians’ time

Ready-to-use calibrator included in reagent kit

Allowing for immediate start of routine
→ Benefit: - Reduced logistical efforts - No preparation step

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HumaCLIA 150 system
Frequently Asked Questions
Is HumaCLIA 150 a random-access system?
Yes, HumaCLIA 150 is a random-access system

Why is the instrument name “150”?

It is possible to run 150 tests per hour at maximum.

How many assays can be run at the same time?

There are 20 reagent positions. Therefore 20 types of assays can be run at the same time.

How many STAT positions does the system offer?

All of the 50 sample positions (5 racks with 10 positions each) can be used as STAT. STAT samples can be flexibly defined. One way is to use
the barcode and colour-defined STAT racks. Alternatively, a sample shown to the instrument in a normal sample rack, can be defined in the
software interface as STAT.

What is the onboard stability of the reagents?

Onboard reagent stability is 28 days/cartridge; i.e. 56 days/kit.

How are the calibrators being offered?

The calibrators come within the reagent kit.

How long is the onboard stability of the calibrators?

Onboard calibrator stability is 28 days. Multiple calibrations with the same vials are possible.

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HumaCLIA 150 system
Frequently Asked Questions
For how long are the calibration curves valid?
The calibration curve is valid for 28 days
▪ for the same kit
▪ for the same reagent lot
▪ as long as the controls are within range

What is the pack size of the “Immunoassay Multi Analyte” control?

The Immunoassay Multi Analyte control contains 2 levels. Every level is offered in 2 vials with 3ml.
▪ Level 1: 2*3ml
▪ Level 2: 2*3ml

Does HumaCLIA 150 offer sample level detection?

Yes, HumaCLIA 150 does have onboard sample level detection. It is using a high-sensitive, precise capacity measurement for the level
detection in both, primary and secondary tubes. The HumaCLIA 150 conductivity level detection works without work-around.
With Maglumi (SNIBE), for example, a work-around is required, because the conductivity is not sensitive enough.
The work-around involves the placement of the sample cup into a tube filled with water in order to allow conductivity for liquid level sensing.

Does the instrument offer reagent level detection?

Yes, HumaCLIA 150 does have onboard reagent level detection.
The reagent volume is adjusted by recalculation, immediately after reagent pipetting.
The Maglumi instrument (SNIBE), on the other hand, calculates the remaining tests, just before pipetting.
This potentially results in a reagent missing failure message
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HumaCLIA 150 system
Frequently Asked Questions
How large is the sample dead volume?
1° tubes, require 8 mm filling level extra.
2° tubes, like Eppendorf cups require at least 50 µl extra volume.

How many tests can be performed with the Trigger solution?

The number of tests that can be performed with one bottle of Trigger (220 ml) is at minimum 800 tests/bottle.

What is the required volume of Trigger or Pre-trigger per test?

Pre-trigger solution 100 µl/test.
Trigger solution 200 µl/test

What are the onboard stabilities of the Trigger and of the Pre-trigger solutions?
The onboard stability of both, the pre-trigger and of the trigger solution, is 28 days, each.

Does the instrument stop and remember the work-list after the PC suddenly fails (crashes)?
If the PC crashes, the instrument will stop after some minutes and the work-list is gone, because the intelligence is on the PC and
not on the instrument.

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HumaCLIA 150 system
Frequently Asked Questions
When does the instrument perform a photometer check?
The instrument is checking the photometer mechanically during the start-up. It is checking whether the shutter that prevents light from entering
the detection chamber containing the photo-multiplyer, is closing properly, before result detection.
However, the photometer check, itself, is being performed during the service maintenance by the end-user, every 3 months. The check starts
automatically after request on the user interface. All it requires is distilled water provided as sample and in an empty reagent cartridge. The lab
can individually decide to perform the check prior to the usual 3 months.
No additional liquid solution is needed to be purchased.

After how many measurements do I need to exchange the photomultiplier (PMT) detection unit?
Under normal conditions, it is not expected to exchange the photomultiplier. There are no additional maintenance costs, in this respect.

Are there any sample handling steps, like e.g. sample dilution, required to be performed manually?
No, all reagents are onboard, also the dilution buffer.

Which parameters can be diluted?

An individual diluent is offered with HCG. However, in general, samples can be diluted with all assay parameters;
except with competitive assays, like fT3 or fT4.

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HumaCLIA 150 system
Documentation and other tools

User Manual HumaCLIA 150

Specifications HumaCLIA 150

Calculation Tool

Flyer HumaCLIA 150 System

Assay Sheet HumaCLIA SR

Product Information Card

Customer Presentation

Product Presentation Video

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CONFIDENTIAL