Optigene Genie HT User manual

IFU_EN_GEN-HT Version 1.01 July2020
User Manual
v1.01
(Instrument Software Version v4.00)

IFU_EN_GEN-HT Version 1.01 July2020
Unit 5, Blatchford Road
Horsham
West Sussex
RH13 5QR
United Kingdom
Tel: [phone]
Fax: [phone]
www.optigene.co.uk
[email protected]
If you have any feedback or comments about the instrument please email:
feedbac[email protected]
Information in this document is subject to change without notice.
OptiGene Ltd. assumes no responsibility for any errors that may appear in this document. This document is believed
to be complete and accurate at the time of publication.
In no event shall OptiGene Ltd. be liable for incidental, multiple, or consequential damages in connection with or
arising from use of this document.
Genie® HT and its design is a registered trademark of OptiGene Ltd. or its subsidiaries in the UK and other countries.

IFU_EN_GEN-HT Version 1.01 July2020
SAFETY NOTICES ....................................... 3
SUPPORT ................................................ 11
TROUBLESHOOTING AND MAINTENANCE
............................................................... 11
How to obtain support ........................... 11
Supported consumables ........................ 11
BOX CONTENTS ...................................... 12
UNPACKING THE INSTRUMENT .............. 12
SITE PREPARATION ................................. 14
How to set up Genie® HT ....................... 14
Connections ........................................... 15
Opening & Closing the LidS .................... 16
Inserting Tubes ....................................... 16
USER INTERFACE .................................... 18
Genie® HT Welcome Screen .................. 18
Genie® HT Login Screen ......................... 19
Home Screen .......................................... 19
Blocks ..................................................... 20
Enabled/Disabled Blocks ................... 20
Block Status ....................................... 21
Starting a Run .................................... 21
Settings .................................................. 24
User ................................................... 24
Colours ............................................... 24
Graph Options ................................... 25
Tests ................................................... 26
Date and Time ................................... 26
Screenshot ......................................... 26
Video .................................................. 27
Replay ................................................ 27
Install ................................................. 27
Users.................................................. 28
Language ........................................... 29
Report................................................ 29
USB Devices ....................................... 30
Wireless* ........................................... 30
NETWORK CONNECTION* ................. 30
Self-Test ............................................. 30
Copy & Paste ..................................... 31
Profiles ................................................... 33
Profile Screen Overview .................... 33
Active ..................................................... 36
Profile ................................................ 36
Temperature ..................................... 36
Amplification ..................................... 37
Anneal ............................................... 37
Results ............................................... 38
Additional Options ............................ 41
View ....................................................... 43
GENIE RESULT CALLING ......................... 46
Overview ................................................ 46
Result Calling Interface .......................... 47
Target parameters ............................. 48
Regions of interest ............................ 50
Result Definitions .............................. 56
Overall Result .................................... 57
CONNECTING TO EXTERNAL DEVICES .... 61
Pendrive ................................................. 61
Wired Connection .................................. 61
Wireless Connection* ............................ 63
Genie® HT Software updates ................. 64
GENIE® HT TECHNICAL SPECIFICATION . 66
Table of Contents

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SAFETY NOTICES
Please read the following section carefully before
using Genie® HT.
The Genie® HT is specifically designed to run any isothermal amplification method that employs
target detection by fluorescence measurement. Genie® HT will detect all dyes that can be
excited from a blue light source and with an emission between 510 and 560 nm and all dyes
excited by a yellow light source with an emission above 620 nm. Further uses include enzyme
kinetic analysis and protein denaturation analysis using fluorescent dyes.
The equipment supplied has been designed to be completely safe to use. However to avoid any
risk to the safety of the equipment, operator, or anybody in the vicinity of the equipment,
please read this chapter before unpacking and using the instrument. If there is any doubt as to
the correct use of the equipment contact the vendor.
Notices
Using the instrument in a manner not specified by OptiGene may result in
personal injury or damage to the instrument and the protection provided by the
equipment may be impaired.
Always ensure that the surface on which the instrument is placed is level and
stable and will not cause the instrument to topple over. Ensure that the surface
is suitable for the weight and size of the instrument. If the instrument is
dropped it may be damaged.
The instrument should never be lifted by its covers. Always ensure that the base
or sides are used as the lifting point.
Chapter

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The instrument is electrically powered. Please ensure that the correct voltage
settings have been applied before applying power to the instrument. If in doubt
consult a qualified electrician. The instrument has a rating label affixed to the rear.
Please consult this if needed.
Always disconnect the equipment before moving or removing any guards or
covers. Switch off at the mains, remove the mains plug from the wall socket and
remove the cable from the inlet socket on the rear.
While every effort has been made to protect the inside of the instrument
against splashes, the instrument carries no IP rating. If fluids are spilt on the
instrument they may cause damage and cause an electrical hazard.
If a spill occurs, remove power from the instrument. Do not touch the
instrument or any fluid flowing from it while it is connected to the mains supply.
Always follow local health and safety guidelines.
The instrument is not intended for use with flammable substances.
It is not advised to open the lids whilst the instrument is running as it could
cause measurement errors leading to incorrect results.
It is advised to run the ‘Self-Test’ function at the start of every session. This is
located in Settings.
OptiGene Limited recommends that every two years the instrument's
performance is checked for degradation. This can be done by requesting and
purchasing ready-made strips from OptiGene that will perform an amplification
and anneal run on the instrument which can then be assessed to check for
optical or thermal performance issues.
Normal safe local operating standards should be applied at all times. The warnings above are
for guidance only. Please consult the instrument supplier if there is any doubt.

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Disconnection Method
Genie® HT is disconnected by removal of incoming mains power source to the
unit. Following disconnection the unit should be left for a period of at least 5
minutes before any internal assemblies are removed or examined.
When in use the heating block and heated lid are hot, so allow to cool before
touching the surfaces.
Safe removal of fluids from Genie® HT will depend on the chemistry used. This will
also require knowledge of the fluids used in the system to adhere with local health
and safety and COSHH regulations. If in doubt, consult the person responsible for the
equipment in the laboratory.
Cleaning Method
The Genie® HT can be disinfected using the following procedure which can be used as a safety
measure if this equipment is routinely exposed to bio-hazardous materials and it is
recommended that it should be performed prior to moving or shipping the instrument.
1. Remove all strips from the instrument and dispose of appropriately.
2. Wipe all outside surfaces of the Genie® HT with a 10% bleach solution.
3. After 10 minutes wipe all the same surfaces with a 70% ethanol solution.
CAUTION: Do not allow any of the liquid solutions to enter the wells as this can cause damage.

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Explanation of Symbols
In vitro diagnostics
Serial number
Batch code
Catalogue number
Manufacturer Date of Manufacture
Use by date
Consult electronic instructions for use
Store at (temperature range)
Keep away from sunlight
Handle with care
Keep dry
This way up
Biohazard
WEEE: waste electrical and electronic equipment should not be
disposed of in your dustbin or wheelie bin. OptiGene Limited
must be consulted regarding end-of-life disposal.

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Background Information
OptiGene Limited was formed in 2008 to develop and deliver advanced molecular diagnostics
solutions for applications across a range of market sectors, with the primary goal of providing
the highest quality instrumentation and performance-leading reagents to support isothermal
amplification of DNA and RNA. The market pull for this venture came from the growing
demands around the world for field testing, rapid results and point-of-care diagnostics.
OptiGene has developed innovative products that support sensitive and specific detection of
bacteria and viruses, for use in the fields of plant health, food safety, veterinary medicine,
environmental monitoring and human healthcare. Bio-defence and forensics are also key
markets that OptiGene addresses, either directly or through its growing network of
international distributors. The company has exploited its expertise in both instrument design
and enzymology to develop a sophisticated open platform that will support all isothermal
amplification methods that employ target detection by fluorescence measurement. Ultra-
sensitive molecular detection that has previously been constrained to laboratory use by highly-
qualified personnel and taking hours to complete can now be deployed to point of application
and run with very little training, producing results in single minutes. A continuous programme
of development is maintained at OptiGene to satisfy the evolving demands of its customers
and the wider market, in both instrumentation and enzymes and assays.
The Genie® platform
OptiGene Genie® instruments are essentially highly sophisticated temperature-controlled
fluorimeters. They are almost exclusively applied to running molecular diagnostic assays employing
isothermal amplification of DNA and RNA, enabling sensitive detection of bacteria and viruses at
a molecular level by fluorescence measurement. Genie® HT is the flagship high-throughput
instrument; it was released to market in spring 2020, joining Genie® II (released 2011) and
Genie® III instruments, many of which are to be found in a variety of diagnostic settings around
the world. This powerful and extremely flexible platform allows isothermal amplification of
DNA and RNA to take place in a compact device.
All Genie® instruments operate with the OptiGene strip-of-8 reaction tubes (catalogue number
Genie® strips OP-0008-50 [50 strips] and OP-0008-500 [500 strips]). This proprietary consumable
incorporates attached, locking caps which allow for a closed tube assay to prevent cross-
contamination. Enzymes are available in the form of several master mixes that feature combinations
of high-speed operation, inherent RT activity and thermostability, together with separate primers,
specific to the target bacterial or virus RNA/DNA.
Specific instructions for the preparation and use of the Genie® strips are to be found in the
appropriate OptiGene assay Instructions for Use (e.g. COVID-19_RNA RT-LAMP KIT-500_IFU V1.0
10/07/2020 and COVID-19_Direct RT-LAMP KIT-500_IFU V1.0 10/07/2020 for SARS-CoV-2 RNA).
To perform a test, the instrument is switched on and the software allowed to initialise. Dry and
disinfected loaded strips are placed in the instrument’s heater block (Genie® III – single block;

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Genie® II – independent dual blocks; Genie® HT – 1 to 12 independent blocks), and the lid
closed.
An appropriate protocol is selected from the start-up menu on the display (see Chapter 5 for
details) and the run started. The protocol defines the operation sequence of instrument,
setting the heated block temperature vs time profile. Custom profiles can be created by the
user.
The Genie® II, III & HT devices detect amplified product in real-time using fluorescence
measurement. The Genie® platforms automatically run an anneal curve at the end of
amplification, where the reaction is heated to 98°C and slowly cooled and the peak of the
resulting fluorescence detected. This acts as a secondary confirmatory check - ensuring LAMP
amplicons are specific to the particular target. The result is interpreted and reported
automatically from both the amplification and the anneal temperature. Genie® instruments
can generate results according to detected amplification times, anneal peaks and other
features (Result Calling). Due to the varying requirements of differing applications, setting up
the parameters is highly flexible. This is described in detail in Chapter 6.
Genie® HT is of modular design, employing up to 12 autonomous modules, each accepting a
Genie® micro-tube plastic reaction strip of 8 wells. The modules use the core ceramic heated
block technology of the Genie® platform, incorporating integrated optics and photodetectors,
dedicated controller and data acquisition electronics. The user interface is via a 10.1”
projective capacitive touch panel; connectivity is via USB (2 x USB-A and 1 x USB-B ports) and
RJ45 ethernet.
Intended Use
The Genie® HT is specifically designed to run any isothermal amplification method that employs
target detection by fluorescence measurement. Genie® HT will detect all dyes that can be
excited from a blue light source and with an emission between 510 and 560 nm and all dyes
excited by a yellow light source with an emission above 620 nm. Further uses include enzyme
kinetic analysis and protein denaturation analysis using fluorescent dyes. The Genie® HT is
intended to be used in an appropriately equipped facility, e.g. a hospital microbiology
laboratory, or mobile laboratory such as the Hampshire Hospitals NHS Trust “Lab in motion”, or
similar environment, by a trained non-specialist healthcare professional for molecular
diagnostic purposes.
In particular, Genie® HT can perform rapid detection of SARS-CoV-2 virus (COVID-19) within
nasopharyngeal and oropharyngeal swabs, using the CE-IVD registered OptiGene
COVID-19_Direct and COV-19_RNA RT-LAMP kits.
General Precautions for Molecular Diagnostic usage
 Molecular Diagnostic assays are intended for use by professional users only, such as
laboratory or health professionals and technicians, trained in molecular biological
techniques.
 National guidelines on biosafety should be followed in all circumstances.

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 All samples should be handled as if they are infectious, following conventional biosafety
precautions.
 Material Safety Data Sheets (MSDS) for OptiGene reagents are available from OptiGene
Limited. In particular, MSDS for the COVID-19 RT-LAMP kits and COV-19-Direct LAMP kits
are available from the OptiGene Limited website (http://www.optigene.co.uk/human-
diagnostics/)
 Dispose of used strips as contaminated laboratory waste
Storage and Handling
The Genie HT is a heavy instrument and weighs 18kg. Lift from the front and back of the
instrument, never from the lids. Keep the lids closed when not in use to prevent the ingress of
dust or contaminants to the optics.
Handle the instrument and its accessories with care and wear appropriate personal protective
equipment when preparing and handling Genie® strips. See the specific instructions for the
preparation and use of the Genie® strips, supplied with the assay. OptiGene assay Instructions for
Use (e.g. COVID-19_RNA RT-LAMP KIT-500_IFU V1.0 10/07/2020 and COVID-19_Direct RT-LAMP KIT-
500_IFU V1.0 10/07/2020 for SARS-CoV-2 RNA) are supplied with the reagent kits.
Serious Incidents
Any serious incidents encountered during the use if this device must be reported in the first
incidence to OptiGene Ltd.

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Technical Specification
Sample Number 12 x 8 wells
Sample Volume 10 µl to 150 µl
Touchscreen 10.1” High-brightness LCD with multi-touch projective capacitive touch
panel (1280 x 800)
Heater technology Ceramic substrate with resistive coating
Cooling method Forced convection
Temperature sensors High-precision thermistor
Temperature control type Multi-zone independent digital PID
Temperature control range ambient - 100°C
Temperature accuracy ±0.1°C
Temperature uniformity
across block ±0.2°C
Temperature gradient Programmable up to 8°C
Optics source 470 nm & 590nm dual colour LED with high-quality interference filter 40 nm
band pass
Detection optics Photodiodes with high-quality interference filters 510-560 nm band pass &
620 nm long pass
Operating temperature 0°C - 40°C
Storage Temperature 20°C - 70°C
Approvals CE
Dimensions 635mm (L) X 434mm (W) X 153mm (H)
Weight 18kg / 40lbs
Connections
1 x USB ‘B’
2 x USB ‘A’
1 x Power in
1 x RJ45 – Network connection
1 x USB ‘A’ – diagnostic port
Environmental protection IP20
Wireless Connections Bluetooth & WiFi
Power supply Input: 100-240V AC, 50/60Hz
RoHS Compliance
OptiGene Limited declares that, to the best of our knowledge, all electrical and electronic equipment (EEE) sold by the company
are in compliance with Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the
use of certain hazardous substances in electrical and electronic equipment (also known as “RoHS2”).
REACh Statement
OptiGene Limited also declares that no products sold by the company are known to contain any of the substances of very high
concern (SVHC) as intentionally added components with regards to the European Regulation No. 1907/2006 (Registration,
Evaluation, Authorisation & restriction of Chemicals).

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SUPPORT
TROUBLESHOOTING AND MAINTENANCE
HOW TO OBTAIN SUPPORT
For the latest services and support information go to http://www.optigene.co.uk/support.htm
for frequently asked questions, software and firmware downloads, to request Troubleshooting
Assistance, and to report any bugs.
IMPORTANT! When directed to do so, contact OptiGene Ltd. to schedule maintenance
or calibration of a Genie® HT instrument.
OptiGene Limited suggests that every two years the instrument's performance is checked for
degradation. This can be done by requesting ready-made strips from OptiGene that will
perform an amplification and anneal run on the instrument which can then be assessed to
check for optical or thermal performance issues.
SUPPORTED CONSUMABLES
IMPORTANT! Genie® HT uses a proprietary tube strip that maximises optical and
thermal efficiencies. Other tubes and strips will not fit.
IMPORTANT! Forcing non-supported consumables will cause damage to the
instrument and invalidate the warranty.
IMPORTANT! The shape of the tubes is such that they will only fit in one way round.
The locating pins on the block have corresponding holes in the strips.
IMPORTANT! The strips are single use only and have been designed with a locking cap
and should never be opened after a run has ended.
Chapter

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BOX CONTENTS
The following is a list of contents in the box for Genie® HT:
 Genie® HT instrument
 Barcode scanner
 Stylus
 Power lead
 USB connection lead
 USB memory stick containing this manual as a ‘.PDF’ file
UNPACKING THE INSTRUMENT
The Genie HT is a heavy instrument and weighs 18kg. Lift from the front and back of
the instrument out of the box.
NEVER LIFT THE INSTRUMENT FROM THE LIDS
Please retain packaging for future use. If repacking the instrument for transport, make sure to
safely dispose of any used strips in any of the blocks prior to packing.
Allow 10 minutes to unpack and set up the instrument. Choose a location with sufficient space
to be able to see the screen and load strips into the instrument.
1. Cut the tape on the flaps on the box to open the shipping box.
2. Open the flaps and remove the top layer of foam and then lift out the accessories
(shown below). Then lift out the foam layer.
Chapter
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3. Remove the triangular foam piece from on top of the screen. Carefully lift the
instrument from the box lifting from the front and back of the machine. A second
person may be required.
4. Place the instrument on a flat stable surface.

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SITE PREPARATION
HOW TO SET UP GENIE® HT
Genie® HT has been designed to be used in a laboratory. When it is being used, the instrument
should be placed on a level and stable surface and the surfaces surrounding the instrument
must be clear of obstructions at all times.
Care must be taken not to unduly restrict the air at the outlet vents at the sides. Restricting
airflow may impede operation and could affect performance.
Electrical points should be close to the instrument to avoid injury from trailing wires.
It is recommended that the instrument is kept away from sinks and other wet areas when
running.
Chapter
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CONNECTIONS
Genie® HT is ready to use straight out of the box with only a single power connection. It can be
operated standalone and does not require a computer to be connected. Genie® HT can be
connected to multiple peripherals (barcode scanner, printer, USB pendrive) via the front USB A
sockets and connected to a computer via the rear USB B socket or to a network via the rear
RJ45 socket.
Located at the rear is the on/off power switch and power cable connector. Connect the power
cable into the back of the instrument and when the switch is in the on position Genie® HT will
power up and progress through its checks.
DUAL USB (FOR
EXTERNAL DEVICES)
MAINS IEC
HEADPHONES SOCKET
POWER
SWITCH

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OPENING & CLOSING THE LIDS
Gently lift the lids upwards. Close the lids by lowering gently.
Care must be taken to ensure that objects are not obstructing the lids when trying
to close it and under no circumstances should the lids be forced open or closed.
INSERTING TUBES
IMPORTANT! Genie® HT uses a proprietary tube strip that maximises optical and
thermal efficiencies. Other tubes and strips will not fit.
IMPORTANT! The shape of the tubes is such that they will only fit in one way round.
The locating pins on the block have corresponding holes in the strips.
Genie® HT can be shut down using the power button in the bottom left corner. At this point
Genie® HT can be switched off using the switch on the rear.
USB (TO PC) RJ45 TO
NETWORK
USB (DIAGNOSTIC
PORT)

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Note: If this button is pressed during a run, Genie® HT will not enter standby.
When in standby, normal operation can be resumed by pressing anywhere on the screen.

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USER INTERFACE
Genie® HT uses a touchscreen for viewing and inputting data.
Touch the screen gently and press the appropriate keys when required. The touch screen can
be operated while wearing protective gloves or by using the stylus included with the
instrument.
IMPORTANT! Do not use a pen or any other sharp implements to touch the screen.
GENIE® HT WELCOME SCREEN
When switching on, the LED above the screen will be amber in colour. Wait for the light to
change to green, then touch the screen to access the login screen or home screen.
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GENIE® HT LOGIN SCREEN
If users are set up on the instrument and a log in is required, the next screen will be a login
screen. Log in using your user login and password.
HOME SCREEN
The next screen will be the home screen. This gives an overview of the status and temperature
of all of the blocks, and their current position in their runs. The menu to the right gives access
to the soft power switch, starting a run, accessing and viewing old log files, settings and the
data and time.