System Overview

System Overview
01-OCT-09 CONFIDENTIAL
The Story of Access
 1967 - Kallestad Diagnostics

 Focused on high quality immunoassay reagents
 Entered instrumentation market in 1987
 1989 - Purchased by Sanofi Diagnostics Pasteur
 Acquired Genetic Systems Corp in 1990
 1997 - Access product line (Chaska site) purchased by
Beckman Instruments
 Hybritech technology becomes available
 Cooperative partnership with BioRad remains
 1997 - Beckman acquires Coulter
 Immunotech joins immunodiagnostics group
22-APR-10 CONFIDENTIAL
The Evolution of the Access Family
UniCel DxI®
800
LXi®
“Classic” Access®
Access® 2
2004
1990 1991 1992

1993 1993 1994 1995 1996 1997 1998 1999 2001
2000 2001
2002 2002
2003 2003
1990
Immuno Platform Strategy
A technology continuum DxC 660i

Access 2 and identical
DxC 600ireagents across
multiple testing platforms guarantees
equivalent patient results
Universal
CTA
DxI 800 DxC 880i

DxI 600
2006 2007 - 2008
What are Reagents?
Individual
calibrators
for PSA
Calibrator
kit
PSA
Reagent Pack
PSA
Calibrator
card
(comes with
calibrator kit)
The Reagent Pack
 The Access Reagent Pack is

a 5 compartment pack with
an elastomeric seal
 Average on board stability
of 28 days
 Reagent usage tracked by
software:
 Pre-run warning for supply
depletion or expiration
 Superior Calibration Curve
stability
Reagent Pack
Well 0 Well 1 Well 2 Well 3 Well 4
Magnetic Miscellaneous Chemicals Alkaline

Particles Phosphatase
Calibrators
Calibrators are tested like samples, except we already know their
concentration
Generic Reagents
 Used for all assays (not assay-specific)
 Located on fluidics module to the left of the system
Substrate Wash Buffer
Substrate
 Added to all reaction vessels
 Reacts with a chemical from the

reagent pack to produce light
 Light is measured by the luminometer
Wash Buffer
 Multiple Uses
 Rinses away unwanted reaction components
 Cleans system
Good Instrument Maintenance
Instrument Maintenance
Weekly Probe Clean Daily Probe Wash
Preventive Maintenance (6
Weekly System Check
months)
Access Process Flow
Supplies loaded
Samples loaded
Pipettor transfers
fluids to reaction
vessel
Vessel incubates
Vessel is washed
Vessel incubates
and is read
Vessel is sent to
waste
Modular Instrument
 Processing Functions
 Carousel Module
 Main Pipettor Module
 Analytical Module
 Fluidics Module
 Control Functions
 Electronics Module
 Software Module
 Interface Functions
 Base Plate Module
 Peripheral Module
Modular Components
Carousel Module
Reagent Carousel
Internal bar code reader
Tube detector
Sample carousel
Carousel Module
 On Board capacity of 24
Reagent Packs
 Reagent packs are
cooled to 2-10°C
 6 Sample Racks/Trays
of 10 samples each with
continuous load and
continuous STAT load
Carousel Module
 The carousel holds 6

sample racks/trays -
The Sample Rack/Tray 10 samples each
 Primary bar coded
tubes loaded through
host query or
broadcast download
 Continuous Load
 Continuous STAT
access
Main Pipettor Module
Pipettor gantry
Ultrasonic transducer
Primary probe
Main Pipettor Module
 Titanium Primary
Pipettor with multi-
tasking capabilities
 Aspirate, Dispense,
Level Sense, and Mix
 Ultrasonic mixing of
Paramagnetic
Particles and
Reactants
Analytical Module
Wash arm
Luminometer
Wash carousel
Shuttle
Waste chute
Rake
Incubator belt RV storage area
Analytical Module
Immunoincubation
 Asynchronous
Incubator Belt:
 Accommodates
multiple assay
formats with no
interruption to
workflow
 Facilitates a smooth
flow of routine and
STAT samples
Analytical Module
Wash/Read
 Paramagnetic
Particle Separation
 3 Washes prior to
substrate addition
 Continuous Glow
Chemiluminescence
Analytical Module
 Wash arm
Dispense probes
 3 dispense probes
 3 aspirate probes
 Substrate probe
 Wash carousel
 Moves RVs through wash
process, substrate incubation
and signal reading
Aspirate probes
Substrate probe
Fluidics Module
Precision pump
Vacuum pump Vacuum jar
Precision valve
Wash valve
Wash pump
Wash tower
Peristaltic pump Substrate pump

Substrate heater
Electronics Module
Power supply
Card cage
Hard disc drive
Reset button
Floppy drive
Chassis Base Module
Top cover
Carousel door
Front panel
Supply cover
Base panel
Peripherals
 Access  Access 2
 Monitor  Flat panel touch screen
– Monitor arm – Monitor arm
 Keyboard  Keyboard
 Printer  Printer
 Bar code wand  Bar code wand
plus
 External computer
 Mouse
 Hub
External Bar Code Reader
 Used when configuring

 New lots of calibrator
 Used when loading

 Reagent packs
 Substrate (Access 2 only)
 Optional for racks and patient samples
Access Feature Summary
 Onboard capacity
• 60 samples
• 24 on-board assays/1200 tests
• 3 hours on-board supplies/consumables
 Continuous access
• Liquid reagent, 24 hour refrigeration
• Can load samples and most supplies while
running
• QC - 2 levels, once/day
Access Feature Summary (cont’)
 Clot detection (on Access 2)

 Throughput
 100 tests/hour (1-step assays)
 50 tests/hour (2-step assays)
 Same Reagents for
 Access/Access2
 LXi
 DxI
Access 2 WorkGroups
CLIENT SYSTEMS
 Access 2 Workgroups
 Up to four systems can
be networked together
SERVER SYSTEM
Server/Client Communication*
Server PC
DB
 Server PC supports
HD its AU and all clients
Server AU
UI by providing a
UI location for the DB
 Communication flows
UI between AU and DB
Client AU HD through UI
Client PC
*Note this is not how the cabling is set up
Access 2 Glossary
 NT (Microsoft Windows Operating System)
XP (for new systems as of Feb 20100
 RTOS (OS9000 Real Time Operating System)
 UI (user interface)
 AU (analytical unit)
 Access 2 instrument without PC and monitor
 HD with OS9000 RTOS
 Has no UI or database
 PC (console)
 Access 2 PC
 Has UI (and may have database if a server)
Access 2 Glossary
(continued)
 Ethernet card
 Network PCB in Access 2 (NIC)
 Hub
 Multi-port connection box for Ethernet (10Base-T)
 Crossover cable (single system cable)
 Used in older systems to connect PC to AU for single system
configuration (yellow cable), and troubleshooting
 Network cable
 Used to connect PC and AU to Hub (blue = 14 feet, gray = 50
feet)
– Required for workgroup
– Provided, and required for new single system installs,
eliminating need to have PC powered on before AU
System
Status
ACCESS 2 MAIN MENU Buttons
Status
Mode
Help
Completion time clock on all screens Supplies Required

when in Running and Paused modes
(includes utility assay) Work Pending
System clock
Status
on all screens
Line
401422
Interlock Switch
 Location
 Under front panel hinge on
right upper corner of system
 Engaged by flag on hinge
when panel is closed
 Function
 Cuts off power to pipettor
gantry when front panel is
opened
 Purpose of cover
 Safety
 Keeps out room light
 Keeps instrument interior free from dust
Lab Exercise
“Getting Started”
 Objectives
 Use safe practices, including the use of PPE
(personal protective equipment) and the
interlock switch
 Observe an assay being processed through
the system with all the covers open

System Overview

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System Overview

 1967 - Kallestad Diagnostics

1990 1991 1992

A technology continuum DxC 660i

DxI 800 DxC 880i

 The Access Reagent Pack is

Magnetic Miscellaneous Chemicals Alkaline

Substrate Wash Buffer

 Added to all reaction vessels

 Reacts with a chemical from the

 Light is measured by the luminometer

Weekly Probe Clean Daily Probe Wash

Internal bar code reader

 The carousel holds 6

Incubator belt RV storage area

Vacuum pump Vacuum jar

Peristaltic pump Substrate pump

Hard disc drive

 Used when configuring

 Used when loading

 Clot detection (on Access 2)

 RTOS (OS9000 Real Time Operating System)

Completion time clock on all screens Supplies Required

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