Dynex Agility Automated ELISA System User manual

Agility®Automated ELISA System
Operator’s Manual
Part Number 91001040
IMPORTANT
Please read carefully before using the System

Revision History
DYNEX Technologies, Inc.
14340 Sullyfield Circle
Chantilly, VA 20151 USA
Dynex Technologies Limited
Unit B2
Yeoman Gate, Yeoman Way
Worthing, West Sussex
BN13 3QZ UK
Manual Version Revision Date:
Revision E For operation with Agility software November 2014
This publication is for the operators of the DYNEX Agility Automated Microplate
Processing System. Due to continuing software improvement, dialog boxes displayed in
this manual may differ from those actually seen in the software screens. Every effort has
been made to ensure the information in this manual is accurate, updated and consistent
with the product it describes. DYNEX reserves the right to make technical improvements to
the system and documentation without prior notice as part of a continuous program of
product development.
The information in this manual is of a proprietary nature. No part of this publication may be
reproduced, stored in a retrieval system, translated, transcribed, or transmitted in any form
or by any means without prior written permission of DYNEX.
DYNEX does not assume liability for the use of this manual. If the system is not used
according to the description in this manual DYNEX does not assume responsibility for any
consequent effects.
This manual supersedes all previous editions and is published by DYNEX Technologies,
Inc.
Questions or comments regarding the content of this manual can be directed to the
address below or to your supplier.
© 2009, Dynex Technologies, Inc.

Table of Contents
Agility System Operator’s Manual 3
Table of Contents
Table of Contents..................................................................................................................................3
About This Manual................................................................................................................................7
Chapter 1 Overview...........................................................................................................................9
1.1 Introduction .........................................................................................................9
1.2 SmartKitTM .........................................................................................................10
1.3 Sample Rack.....................................................................................................11
1.4 Microplates........................................................................................................11
1.5 Consumable Supplies.......................................................................................12
1.6 Waste................................................................................................................15
1.7 Setting up for LIS-Link.......................................................................................15
Chapter 2 Safety..............................................................................................................................21
2.1 Warning Labels .................................................................................................21
2.2 Warnings and Safety Precautions.....................................................................22
Chapter 3 System Design...............................................................................................................25
3.1 Overview ...........................................................................................................25
3.2 Workspaces ......................................................................................................25
3.2.1 Lower Workspace ................................................................................25
3.2.2 Upper (Reagent) Workspace ...............................................................26
3.3 Transport Arm ...................................................................................................27
3.4 Sample Pipettor Arm.........................................................................................28
3.4.1Overview ..............................................................................................28
3.4.2 Tip Detection........................................................................................29
3.4.3 Liquid Level Detection..........................................................................29
3.5 Reagent Pipettor Arm........................................................................................30
3.5.1Overview ..............................................................................................30
3.5.2 Reagent Dilution...................................................................................32
3.5.3 Reagent Mixing ....................................................................................32
3.6 Sample Loading Module ...................................................................................33
3.7 Consumable Drawers........................................................................................34
3.8 Microplate Washer............................................................................................35
3.9 Microplate Reader.............................................................................................39
3.10 Temperature Incubators....................................................................................40
3.10.1 Ambient Incubators ..............................................................................40
3.10.2 Elevated Temperature Incubators........................................................40
3.11 Front Doors .......................................................................................................41
Chapter 4 Operating the Agility System.......................................................................................43
4.1 Overview ...........................................................................................................43
4.2 Powering up the Instrument..............................................................................45
4.3 The Home Screen and the Instrument Self Test Procedure.............................46
4.4 Filter Setup........................................................................................................47
4.5 System Dashboard............................................................................................48
4.6 Preparing the System for Operation .................................................................49
4.6.1 Empty Waste Liquids and Used Tip Containers ..................................49
4.6.2 Start-of-Day Assays .............................................................................50
4.7 Loading Samples and Consumables ................................................................54
4.7.1 Loading Samples .................................................................................54

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4 Agility System Operator’s Manual
4.7.2 Load Consumables..............................................................................63
4.7.3 Load SmartKits.....................................................................................65
4.7.4 Load Reagent Tip Racks .....................................................................66
4.7.5 Load Microplates..................................................................................66
4.8 Performing an Assay.........................................................................................67
4.9 Viewing Data.....................................................................................................75
4.10 Aborting Plates/Stopping the System/Shutting the System Down....................78
4.10.1 Aborting Plates/Stopping the System ..................................................78
4.10.2 System Shutdown................................................................................80
Chapter 5 Maintenance and Troubleshooting..............................................................................83
5.1 Routine Maintenance Procedures ....................................................................83
5.2 Cleaning and Decontamination.........................................................................85
5.2.1 Cleaning the System............................................................................85
5.2.2 Decontaminating the System:.............................................................86
5.2.3 Components.........................................................................................86
5.3 Replacing the Lamp Assembly and Filters .......................................................88
5.3.1 Accessing the Lamp and Filters...........................................................88
5.3.2 Replacing the Lamp.............................................................................89
5.3.3 Replacing the Filter..............................................................................91
5.4 Replacing Tubing..............................................................................................92
5.4.1 Removal of the Fluidics Panel Assembly.............................................93
5.5 Replacing Tubing on the Fluidics Panel ...........................................................95
Chapter 6 The Graphical User Interface .......................................................................................97
6.1 Introduction .......................................................................................................97
6.2 The Administrator Screen .................................................................................97
6.3 The Home Screen.............................................................................................99
6.4 The Dashboard ...............................................................................................103
6.5 Worklist ...........................................................................................................106
6.6 The Timeline ...................................................................................................108
6.6.1 Overview of the Timeline ...................................................................108
6.6.2 Icons on the Timeline Screen ............................................................110
6.6.2.1 Samples Rack Status Screen.............................................111
6.6.2.2 SmartKit Screen..................................................................112
6.6.2.3 Plate Status Screen............................................................113
6.6.2.4 Consumables Status Screen ..............................................114
6.6.2.5 Incubator Screen.................................................................115
6.6.2.6 Wash Bottle Status Screen.................................................116
6.7 The Timeline Screen and Status Screens ......................................................117
6.7.1 The Timeline Screen..........................................................................117
6.9 Results............................................................................................................119
6.9.1 Result Lot Table.................................................................................122
6.9.2 OD Results Table...............................................................................123
6.9.3 Threshold Table.................................................................................124
6.9.4 Ratio Table.........................................................................................125
6.9.5 Curve Fit Table...................................................................................126
6.9.6 Curve Graph.......................................................................................127
6.9.7 Spreadsheet.......................................................................................128
6.10 Pause/Stop/Abort............................................................................................129
6.11 Utilities Screens ..............................................................................................131
Chapter 7 Error Handling .............................................................................................................143
7.1 Introduction .....................................................................................................143

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Agility System Operator’s Manual 5
Appendix A Specifications..............................................................................................................145
A.1System Specifications.....................................................................................145
A.2 Sample Pipetting Specifications......................................................................145
A.3 Reagent Pipetting Specifications ....................................................................145
A.4 Reader Specifications.....................................................................................146
A.5Washer Specifications.....................................................................................146
A.6 Incubator Specifications..................................................................................146
A.7 Regulatory Compliance...................................................................................147
A.8System Dimensions ........................................................................................147
A.9 Power Requirements.......................................................................................147
Appendix B Consumables and Spare Parts ..................................................................................149
Limited Warranty...............................................................................................................................151
Warranty and Special Provisions....................................................................151
Index 153
DYNEX Technologies Contact Information...................................................................155

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About this Manual
Agility System Operator’s Manual 7
About This Manual
This manual is designed to provide information about operating and maintaining the Agility
Automated ELISA Processing System and includes the following information:
Introduction (Chapter 1) -describes the system and discusses the overall method of
operation.
Safety (Chapter 2) -discusses the safety considerations involved in the operation of the
system.
System Design (Chapter 3) - discusses the various components of the system from an
operational point of view.
Analyzing Samples (Chapter 4) - discusses the steps involved in loading samples,
reagents, and consumables, generating a worklist and obtaining analytical results.
Maintenance and Troubleshooting (Chapter 5) - includes a list of activities that should
be performed on a periodic basic to ensure optimum operation and explains what to do
when there is a problem.
Details of the User Interaction Scheme (Chapter 6) - provides a detailed discussion of
the user interaction scheme for the Agility Automated ELISA Processing System.
System Specifications (Appendix A) - lists the formal specifications for the system
Disposables and Spare Parts (Appendix B) - a list of commonly used components to
support the system.

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8 Agility System Operator’s Manual
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Chapter 1 Overview
Agility System Operator’s Manual 9
Chapter 1Overview
1.1 Introduction
The Agility Automated ELISA Processing System (Figure 1-1) is a flexible, high capacity
system to perform a broad range of automated ELISA assays. The operator simply inserts
packaged SmartKitsTM that contain all of the reagents, standards and related fluids as well as
assay information (Section 1.2) that are required for the assay into the ports on the front panel.
Similarly, the operator places samples (Section 1.3), microplates (Section 1.4) and disposables
such as pipette tips and mixing wells (Section 1.5) into compartments that are accessible from
the front of the system. A straightforward worklist (Section 1.6) on the built in touch screen
interface is used to indicate the desired operation of the system to analyze the samples. If
desired, multiple assays can be performed on a given sample.
Figure 1-1: The Agility Automated ELISA Processing System
In normal operation, all materials are inserted into the system and waste is removed via the
ports shown in Figure 1-1. The status of each port is indicated by a multi-colored LED (see
Section 4 for detailed information).
This chapter introduces the various components that are placed in the system for routine
operation. The internal design of the system includes a sample pipetting arm, a sample
loading module, a transport arm to move items around the system, a reagent pipetting arm,
two workspaces, a microplate heater, a microplate washer, cameras and an absorbance reader
that are all described in detail in Chapter 3. A detailed discussion of preparing the system for
operation and generating a worklist is presented in Chapter 4.

Chapter 1 Overview
10 Agility System Operator’s Manual
1.2 SmartKitTM
The heart of the Agility Automated ELISA Processing System is the SmartKit™, which is a
reagent pack that is designed to hold bottles that contain the fluids that are required to perform
the assay. A SmartKit™includes a two-dimensional barcode label that includes the details of
the assay, data reduction and reporting as well as lot information, usage volumes and pack
layout.
Typically, a complete SmartKit™is provided by a supplier of ELISA assay kits and is simply
placed into the Agility Automated ELISA Processing System. As an alternative, a generic
pack design can be used to hold standard fluid containers that the laboratory user fills from
the bottles of a manufacturers test kit. The pack is fitted into a reagent pack holder to be
loaded on the system through the reagent pack load position. A typical SmartKit™and
reagent pack holder is shown in Figure 1-2.
Figure 1-2: A SmartKit and Reagent Pack Holder
The SmartKitTM pack and pack holder are loaded on the system and the label is read with a
transport arm camera, the transport arm also grips and moves the SmartKitTM around the
system workspace locations with the transport arm where required.

Chapter 1 Overview
Agility System Operator’s Manual 11
1.3 Sample Rack
Samples are placed in a sample rack which is loaded into the system via a sample rack loader
(Figure 1-3) which houses a barcode reader and sensors for tube detection and tube size
detection. 10 sample tube racks which each hold 20 sample tubes are provided; each rack
holds sample tubes with physical dimensions of External Diameter 10-17mm, Internal
Diameter 8-14mm, Height 40-100mm. The system is capable of reading standard laboratory
sample barcode labels and identifying the position of each tube.
Figure 1-3: Sample Loader
1.4 Microplates
A microplate is inserted into a microplate holder (Figure 1-4) that is used to hold and aid
transportation of the microplate around the system. The microplate holder is marked with
white arrows on the end that is to be inserted into the loading bays and indicates the correct
orientation of the A1 position of the microplate relative to the holder.
Figure 1-4: Microplate and Holder

Chapter 1 Overview
12 Agility System Operator’s Manual
1.5 Consumable Supplies
Caution. The sample and reagent pipette tips are defined as accessories as only the
DYNEX tips have been found to meet the stated precision and accuracy specifications
Consumable supplies are placed into the system via the five consumable drawers on the right
side of the system. Each drawer has five positions and racks can be placed in any position.
a) Sample Tips - Sample tips are supplied via a Sample Tip Rack (Figure 1-5) which contains
112 sample tips and has a two-dimensional barcode on both narrow ends of the holder.
The barcode is identified by the system transport arm camera as a sample tip rack and
identifies the lot number of the tips; this information is stored in the event log for tracking
and usage reference. The sample tip rack is loaded on to a consumable drawer and may be
loaded in either orientation that fits into any of the four locations on a drawer.
Figure 1-5: Sample Tip Rack
b) Reagent Tip Rack -Reagent tips are supplied in a reagent tip rack which holds 98 tips and
are loaded into a reagent pack holder (Figure 1-6) for use on the system. The reagent tip
rack has a two-dimensional barcode label on either narrow end of the holder in a position
that is visible through the large window of the reagent pack holder when the reagent tip
rack is inserted. The reagent tip rack / reagent pack holder is loaded through a pack
loading bay in the doors with the visible barcode label facing the instrument. Once read,
the pack would be identified as reagent tips and would then move the rack to the reagent
workspace for use. The barcode label also identifies the lot number of the tips.

Chapter 1 Overview
Agility System Operator’s Manual 13
Figure 1-6: Reagent Tip Rack
c) Deep Well Strip Holder - The deep well strip holder (Figure 1-7) holds 12 deep well strips
for the system to perform deep well pre-dilutions of controls and samples. The deep well
strip holder is loaded on to a consumable drawer and may be loaded in either orientation
that fits into any of the four locations on a drawer. The deep well strip holder is refillable
with deep well strips and has a two-dimensional barcode located on one side of the narrow
end of the holder for the camera on the transport arm to identify the consumable as a deep
well strip holder.
Figure 1-7: Deep Well Strips in Holder

Chapter 1 Overview
14 Agility System Operator’s Manual
d) Reagent Mixing Wells and Holder - The reagent mixing holder holds 18 reagent mixing
wells (6 x 3 wells) for the system to perform reagent mixing. Reagent mixing may be
required where a reagent to be dispensed to the plate is made up of two component
reagents that are required to be mixed prior to dispense due to time stability of the mixed
components. The reagent mixing well holder is filled with 18 reagent mixing wells and
loaded on to a consumable drawer. It may be loaded in either orientation that fits into any
of the four locations on a drawer. The reagent mixing well holder is refillable with reagent
mixing wells and has a two-dimensional barcode located on each narrow end of the holder
for the camera on the transport arm to identify the consumable as a deep well strip holder.
Figure 1-8: Reagent Mixing Wells and Holder

Chapter 1 Overview
Agility System Operator’s Manual 15
1.6 Waste
a) Washer Waste Bottle
The system has a 1 X 10 L capacity washer waste bottle for holding aspirated wash
contents from the system washer. The waste bottle content weight is monitored by a weigh
cell to measure the quantity of fluid and trigger user alarm / notification / status of waste
bottle contents.
b) Tip Waste
Used sample tips are ejected to a tip waste reservoir, which is capable of holding a
minimum of 1334 sample tips (12 sample tip racks). The number of ejected tips is
recorded in the tip status and the user is notified if it requires emptying. If the user
removes the box, a prompt is provided to confirm that the tip waste reservoir was emptied
and counter reset.
1.7 Setting up for LIS-Link
LIS-Link is a separate application that may be installed to enable bidirectional communication
with the laboratory’s LIS system. Worklists may be set up automatically according to
downloaded information from the LIS system. And results of processing and analysis can be
sent automatically or through operator efforts to the LIS system after completion. Consult the
LIS-Link manual for operation instructions.
Agility has been configured for serial communication to the LIS and a cable is included with
the accessory kit. It must be set up on site.
Communication port setup for LIS-Link and LIMS Host
USB to Serial converter
Figure 1-9: Serial converter cable
Plug the converter into a USB port.
Three ports are available on the right side of the instrument at the power receptacle area in
the bottom rear as shown in Figure 1-9.

Chapter 1 Overview
16 Agility System Operator’s Manual
Figure 1-10: Power receptacle area
Three more are located in the power switch area in the front on the lower left.
Figure 1-11: Power switch area
Setup of the port
Each port is automatically assigned a name by Windows. However, LIS-Link software
only recognizes port names COM1 to COM9.

Chapter 1 Overview
Agility System Operator’s Manual 17
From the Windows Start button, right click on Computer to bring up Device Manager.
Figure 1-12: Computer configuration
Figure 1-13: Device Manager
Select the Prolific USB-to-Serial Comm Port. If is not named COM1 to COM9, it
must be renamed.
COM8 and COM9 are available for LIS-Link and LIMS HOST.
Renaming a COM port
Right click on Properties.

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Figure 1-14: COM Port Selection
Figure 1-15: COM Port Properties

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Agility System Operator’s Manual 19
Click on Advanced.
Figure 1-16: Advanced Properties
If the COM port name is not assigned COM 1 to COM9, select a proper COM name
from "COM Port Number" list.
All USB hubs must have power management turned off. In Device Manager, select Universal
Serial Bus Controllers (Figure 1-17). Right click and select Properties on every Generic USB
Hub and every USB Root Hub. For each, got to the Power Management tab (Figure 1-18) and
unselect Allow the Computer to Turn off this device to save power.

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20 Agility System Operator’s Manual
Figure 1-17: USB Hub Setup
Figure 1-18: USB Hub Setup