Qiagen QIAcuity 911000 User manual

Sample to Insight__
June 2022
QIAcuity®
User Manual
911000, 911020, 911040, 911050
QIAGEN GmbH
QIAGEN Strasse 1, 40724 Hilden
, GERMANY

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Contents
Introduction .......................................................................................................................7
About this user manual .............................................................................................7
Intended use of the QIAcuity......................................................................................8
Requirements for QIAcuity users...............................................................................10
Safety Information ............................................................................................................11
Proper use.............................................................................................................11
Electrical safety......................................................................................................13
Environment...........................................................................................................14
Biological safety ....................................................................................................14
Chemicals .............................................................................................................15
Maintenance safety ................................................................................................16
Radiation safety .....................................................................................................16
Symbols on the QIAcuity.........................................................................................17
General Description..........................................................................................................18
QIAcuity principle ..................................................................................................18
External features of QIAcuity ...................................................................................20
Thermal cycler .......................................................................................................23
Optical system.......................................................................................................24
Installation Procedure........................................................................................................25
Installation of AC power cord ..................................................................................27
Unpacking the QIAcuity..........................................................................................28
Packing the QIAcuity ..............................................................................................28
Installing the QIAcuity.............................................................................................29
Upgrading QIAcuity Software Suite to new version ....................................................38
Uninstalling the QIAcuity Software Suite ...................................................................46
Updating the instrument software .............................................................................49
Establishing a connection between the QIAcuity instrument and the QIAcuity Software
Suite.....................................................................................................................51
Getting started with the QIAcuity .............................................................................65

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Operating the QIAcuity Instrument......................................................................................71
Operating the QIAcuity Software Suite ...............................................................................93
Getting started.......................................................................................................93
Concepts of the QIAcuity Software Suite...................................................................95
Audit trail............................................................................................................134
Setting up an experiment ......................................................................................145
Defining General Data..........................................................................................148
Setting up templates .............................................................................................168
Analysis..............................................................................................................172
Reports ...............................................................................................................244
Sign report ..........................................................................................................248
Archive ...............................................................................................................251
Re-analysis of plates after QIAcuity Software Suite version upgrade ...........................254
Volume Precision Factor (VPF)................................................................................255
Operating Plates ............................................................................................................258
QIAcuity Nanoplate 26K 24-well...........................................................................259
QIAcuity Nanoplate 26K 8-well.............................................................................259
QIAcuity Nanoplate 8.5K 24-well..........................................................................259
QIAcuity Nanoplate 8.5K 96-well..........................................................................260
Maintenance Procedures .................................................................................................263
Cleaning agents...................................................................................................263
Servicing.............................................................................................................266
Regular maintenance procedure of QIAcuity ...........................................................267
Periodic maintenance ...........................................................................................267
Decontaminating the QIAcuity ...............................................................................269
Regular maintenance procedure for QIAcuity Instrument Software..............................269
Regular maintenance procedure for QIAcuity Software Suite .....................................271
Troubleshooting..............................................................................................................272
General information .............................................................................................272
Contacting QIAGEN Technical Services..................................................................272
Performing a self-check on the QIAcuity instrument...................................................272

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Creating a support package with the QIAcuity instrument software ............................273
Creating a support package with the QIAcuity Software Suite ...................................277
Troubleshooting the instrument and software............................................................279
Accessing the system status and clearing errors .......................................................282
Glossary........................................................................................................................284
Appendix A – Technical Data ..........................................................................................285
Operating conditions............................................................................................285
Transport conditions .............................................................................................286
Storage conditions ...............................................................................................286
Mechanical data and hardware features.................................................................286
Declaration of conformity ......................................................................................289
Waste Electrical and Electronic Equipment (WEEE) ..................................................289
California Proposition 65......................................................................................290
Liability Clause ....................................................................................................290
Declaration list of China RoHS (SJT 11364-2014)....................................................290
Appendix B – QIAcuity Accessories..................................................................................292
Ordering information............................................................................................292
Appendix C – Informations de sécurité..............................................................................295
Utilisation appropriée ...........................................................................................295
Sécurité électrique................................................................................................297
Environnement .....................................................................................................298
Sécurité biologique ..............................................................................................298
Produits chimiques................................................................................................300
Sécurité de maintenance.......................................................................................300
Sécurité contre les rayonnements............................................................................301
Symboles sur le QIAcuity ......................................................................................301
Appendix D – Sicherheitshinweise....................................................................................302
Sachgemäße Handhabung....................................................................................302
Schutz vor Stromschlag.........................................................................................304
Umgebung ..........................................................................................................305
Biologische Sicherheit...........................................................................................306

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Chemikalien ........................................................................................................307
Wartungssicherheit...............................................................................................307
Strahlensicherheit.................................................................................................308
Symbole auf dem QIAcuity....................................................................................308
Appendix E – User management permissions.....................................................................309
Document Revision History...............................................................................................312

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Introduction
Thank you for choosing QIAcuity. We are confident it will become an integral part of your
laboratory. Before using QIAcuity, it is essential that you read this user manual carefully and pay
attention to the safety information. The instructions and safety information in the user manual must
be followed to ensure safe operation of the instrument and to maintain the instrument in a safe
condition.
About this user manual
This user manual provides information about QIAcuity in the following sections:
1. Introduction
2. Safety Information
3. General Description
4. Installation Procedures
5. Operating Procedures
6. Maintenance Procedures
7. Troubleshooting
8. Glossary
9. Appendix A – Technical Data
10. Appendix B – QIAcuity Accessories
11. Appendix C – Consignes de sécurité (Safety Information in French)
12. Appendix D – Sicherheitshinwiese (Safety Information in German)
13. Appendix E – User management permissions
14. Document Revision History
Technical assistance
At QIAGEN®, we pride ourselves on the quality and availability of our technical support. Our
Technical Services Departments are staffed by experienced scientists with extensive practical and
theoretical expertise in molecular biology and the use of QIAGEN products. If you have any
questions or experience any difficulties regarding the QIAcuity or QIAGEN products in general, do
not hesitate to contact us.

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QIAGEN customers are a major source of information regarding advanced or specialized uses of
our products. This information is helpful to other scientists as well as to the researchers at QIAGEN.
We therefore encourage you to contact us if you have any suggestions about product performance
or new applications and techniques.
For technical assistance and more information, please see our Technical Support Center at
www.qiagen.com/support/technical-support or call one of the QIAGEN Technical Service
Departments or local distributors (see back cover or visit www.qiagen.com).
Policy statement
It is the policy of QIAGEN to improve products as new techniques and components become
available. QIAGEN reserves the right to change specifications at any time.
To produce useful and appropriate documentation, we appreciate your comments about this user
manual. Please contact QIAGEN Technical Services.
Intended use of the QIAcuity
QIAcuity systems are designed to determine absolute amounts of target DNA in a sample by using
a digital PCR (dPCR) approach.
Digital PCR uses the procedure of end-point PCR, but splits the PCR reaction in many single partitions
in which the template is randomly distributed across all available partitions. After PCR, the target
molecule is detected by measuring the fluorescence – either of sequence specific DNA probes or of
intercalating dyes – in all positive partitions. As the template is distributed randomly, Poisson
statistics can be used to calculate the amount of target DNA per positive partition. The total amount
of target DNA in all partitions of a well is then calculated by multiplying the amount of target DNA
per partition with the number of positive partitions. Calculation of target concentration is determined
by referring back to the volume in all analyzable partitions, i.e., partitions which were filled with
reactions mix. The total number of filled partitions is identified by a fluorescent dye, present in the
reaction mix itself. Absolute quantification by dPCR eliminates the need of standard curves to
determine amounts of target DNA in a given sample.
Aside from absolute quantification, the QIAcuity software provides analysis modules for mutation
detection, genome editing analysis, copy number variation (CNV), and gene expression analysis.

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QIAcuity systems are intended to be used only in combination with QIAGEN kits indicated for use
with the QIAcuity systems such as QIAcuity Nanoplates and QIAcuity PCR Reagents for the
applications described in the kit handbooks.
If QIAcuity is used with products other than QIAGEN kits or QIAGEN assays designed for dPCR, it
is the user’s responsibility to validate the performance of such product combination for any
particular application.
The QIAcuity system is intended for use by professional users trained in molecular biological
techniques and the operation of the QIAcuity system.
The QIAcuity system is intended for molecular biology applications. This product is not intended for
the diagnosis, prevention, or treatment of a disease.

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Requirements for QIAcuity users
This table covers the general level of competence and training necessary for transportation,
installation, use, maintenance, and servicing of the QIAcuity systems.
Table 1. Requirements for QIAcuity users
Task Personnel Training and experience
Delivery No special requirements No special requirements
Installation Laboratory technicians or equivalent Appropriately trained or experienced
personnel familiar with use of
computers and automation in general
Routine use (running protocols) Laboratory technicians or equivalent Appropriately trained or experienced
personnel familiar with use of
computers and automation in general
Assay design and validation Scientist or equivalent Appropriately trained or experienced
personnel familiar with molecular
biological techniques
Dust filter replacement Laboratory technicians or equivalent Appropriately trained or experienced
personnel familiar with use of
computers and automation in general
Preventive maintenance QIAGEN service personnel or service
technicians of an authorized agent
Trained and authorized by QIAGEN
Servicing QIAGEN service personnel or service
technicians of an authorized agent
Trained and authorized by QIAGEN

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Safety Information
Before using the QIAcuity, it is essential that you read this user manual carefully and pay attention
to the safety information. The instructions and safety information in the user manual must be followed
to ensure safe operation of the instrument and to maintain the instrument in a safe condition.
Note: Translations of the Safety Information in French and German are available in in Appendix C
– Informations de sécurité and Appendix D – Sicherheitshinweise.
The following types of safety information appear in this manual.
WARNING
The term WARNING is used to inform you about situations that could result in
personal injury to you or other persons.
Details about these circumstances are given in a box like this one.
CAUTION
The term CAUTION is used to inform you about situations that could result in
damage to the instrument or other equipment.
Details about these circumstances are given in a box like this one.
The advice given in this manual is intended to supplement, not supersede, the normal safety
requirements prevailing in the user’s country.
Proper use
WARNING Risk of personal injury and material damage [W1]
Improper use of the QIAcuity may cause personal injuries or damage to the
instrument. The QIAcuity must only be operated by qualified personnel who
have been appropriately trained.
Servicing of the QIAcuity must only be performed by a QIAGEN Field Service
specialist.
Perform the maintenance as described in the Maintenance Procedures section. QIAGEN charges
for repairs that are required due to incorrect maintenance.

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WARNING Risk of personal injury and material damage [W2]
The QIAcuity is too heavy to be lifted by one person. To avoid personal injury
or damage to the instrument, do not lift the instrument alone. The bottom plane
shall be used for lifting. Do not lift at the touchscreen.
WARNING
Risk of personal injury and material damage [W3]
Do not attempt to move the QIAcuity during operation.
CAUTION
Damage to the instrument [C1]
Avoid spilling water or chemicals onto the QIAcuity. Damage caused by water
or chemical spillage will void your warranty.
In case of emergency, power OFF the QIAcuity at the power switch located in the back of the
instrument and unplug the power cord from the power outlet.
CAUTION Damage to the instrument [C2]
Only use QIAcuity-specific consumables with the QIAcuity. Do not use the
plates without applied top-seals. Damage caused by use of other consumables
will void your warranty.
CAUTION
Damage to the instrument [C3]
Do not drop objects into the instrument when the plate tray is ejected.
WARNING
Risk of explosion [W4]
The QIAcuity is intended for use with reagents and substances supplied with
QIAGEN kits or others that are outlined in respective Information for Use. Use
of other reagents and substances may lead to fire or explosion.
CAUTION Damage to the instrument [C4]
Do not stack instruments and do not place items on top of the QIAcuity.
CAUTION
Damage to the instrument [C5]
Do not lean against the touchscreen when it is pulled out.

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Electrical safety
Note: Disconnect the line power cord from the power outlet before servicing.
WARNING
Electrical hazard [W5]
Any interruption of the protective conductor (earth/ground lead) inside or
outside the instrument or disconnection of the protective conductor terminal is
likely to make the instrument dangerous.
Intentional interruption is prohibited.
Lethal voltages inside the instrument
When the instrument is connected to line power, terminals may be live and
opening covers or removing parts is likely to expose live parts.
WARNING
Damage to electronics [W6]
Before powering ON the instrument, make sure that the correct supply voltage
is used.
Use of incorrect supply voltage may damage the electronics.
To check the recommended supply voltage, refer to the specifications
indicated in the type plate of the instrument.
WARNING
Risk of electric shock [W7]
Do not open any panels on the QIAcuity.
Risk of personal injury and material damage
Only perform maintenance that is specifically described in this user manual.
To ensure satisfactory and safe operation of the QIAcuity, follow these guidelines:
The line power cord must be connected to a line power outlet that has a protective conductor
(earth/ground).
Do not adjust or replace internal parts of the instrument.
Do not operate the instrument with any covers or parts removed.
If liquid has spilled inside the instrument, power OFF the instrument, disconnect it from the
power outlet, and contact QIAGEN Technical Services.
If the instrument becomes electrically unsafe, prevent other personnel from operating it, and contact
QIAGEN Technical Services.

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The instrument may be electrically unsafe when:
It or the line power cord appears to be damaged.
It has been stored under unfavorable conditions for a prolonged period.
It has been subjected to severe transport stresses.
Liquids come in contact directly with electrical components of the QIAcuity.
Environment
Operating conditions
WARNING Explosive atmosphere [W8]
The QIAcuity is not designed for use in an explosive atmosphere.
CAUTION
Damage to the instrument [C6]
Direct sunlight may bleach parts of the instrument and cause damage to plastic
parts.
The QIAcuity must be located out of direct sunlight.
CAUTION
Risk of overheating [C7]
To ensure proper ventilation, maintain a minimum clearance of 10 cm at the
sides and rear of the QIAcuity.
Slits and openings that ensure the ventilation of the QIAcuity must not be
covered.
Biological safety
Specimens and reagents containing materials from humans should be treated as potentially
infectious. Use safe laboratory procedures as outlined in publications such as Biosafety in
Microbiological and Biomedical Laboratories, HHS (www.cdc.gov/labs/BMBL.html).

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Samples
Samples may contain infectious agents. You should be aware of the health hazard presented by
such agents and should use, store, and dispose of such samples according to the required safety
regulations.
WARNING
Samples containing infectious agents [W9]
Some samples used with this instrument may contain infectious agents. Handle
such samples with the greatest of care and in accordance with the required
safety regulations.
Always wear safety glasses, 2 pairs of gloves, and a lab coat.
The responsible body (e.g., laboratory manager) must take the necessary
precautions to ensure that the surrounding workplace is safe, and that the
instrument operators are suitably trained and not exposed to hazardous levels
of infectious agents as defined in the applicable Material Safety Data Sheets
(MSDSs) or OSHA*, ACGIH†, or COSHH‡documents.
Venting for fumes and disposal of wastes must be in accordance with all
national, state, and local health and safety regulations and laws.
Chemicals
WARNING Hazardous chemicals [W10]
Some chemicals used with this instrument may be hazardous or may become
hazardous after completion of the protocol run.
Always wear safety glasses, gloves, and a lab coat.
The responsible body (e.g., laboratory manager) must take the necessary
precautions to ensure that the surrounding workplace is safe and that the
instrument operators are not exposed to hazardous levels of toxic substances
(chemical or biological) as defined in the applicable Safety Data Sheets (SDSs)
or OSHA,* ACGIH†, or COSHH‡documents.
Venting for fumes and disposal of wastes must be in accordance with all
national, state, and local health and safety regulations and laws.
* OSHA : Occupational Safety and Health Administration (United States of America).
† ACGIH : American Conference of Government Industrial Hygienists (United States of America).
‡ COSHH : Control of Substances Hazardous to Health (United Kingdom).

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Maintenance safety
WARNING/
CAUTION
Risk of personal injury and material damage [W11]
Only perform maintenance that is specifically described in this user manual.
WARNING
Risk of fire [W12]
Do not allow cleaning fluid or decontamination agents to come into contact
with the electrical parts of the QIAcuity.
CAUTION
Damage to the instrument [C8]
Do not use bleach, solvents, or reagents containing acids, alkalis, or abrasives
to clean the QIAcuity.
CAUTION
Damage to the instrument [C9]
Do not use spray bottles containing alcohol or disinfectant to clean surfaces of
the QIAcuity.
Radiation safety
WARNING
Risk of personal injury [W13]
Hazard Level 2 laser light: Do not stare into the light beam when using
handheld bar code scanner.

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Symbols on the QIAcuity
Symbol Location Description
Type plate on the back of the
instrument
CE mark for European Conformity
Type plate at the back of the
instrument
CSA listing mark for Canada and the
USA
Type plate on the back of the
instrument
RCM mark for Australia and New
Zealand
Type plate on the back of the
instrument
RoHS mark for China (the restriction of
the use of certain hazardous
substances in electrical and electronic
equipment)
Type plate on the back of the
instrument
Waste Electrical and Electronic
Equipment (WEEE) mark for Europe
Type plate on the back of the
instrument
Legal manufacturer
Type plate on the back of the
instrument
Consult instructions for use
Type plate on the back of the
instrument
See chapter Safety Information for risks
Type plate on the back of the
instrument
Date of manufacture
On the drawer Biological hazard – some samples
used with this instrument may contain
infectious agents and must be handled
with gloves.

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General Description
The QIAcuity performs a fully automated processing of the QIAcuity Nanoplates, including all
necessary steps of plate priming, sealing of partitions, thermocycling, and image analysis.
Depending on the plate type, up to 8, 24, or 96 samples per plate can be analyzed. For high
sensitivity applications, the QIAcuity Nanoplate 26K 8- or 24-well is available. The number of in
parallel processable plates depends on the instrument configuration (One, Four, Eight). The
QIAcuity controls all integrated modules, including a robotic gripper for plate handling, a
partitioning module, a PCR thermocycler, and a fluorescence imaging module.
Setting up experiments and the analysis of results is done in the stand-alone QIAcuity Software
Suite. The Software Suite and instrument software are able to communicate with each other over a
direct or a network connection. If the Software Suite is not available in the instrument, setting up an
experiment only in the instrument is also possible.
QIAcuity principle
The QIAcuity is designed as a walk-away instrument that integrates and automates all plate
processing steps. Only the plate preparation must be done manually before starting the run. This
includes the pipetting of the target reagents and master mix in the input wells of the plate and the
closing of the wells with the top-seal. If this preparation is done and the experiment is set up, the
plate must be placed in a free plate slot of the instrument tray. By reading the barcode of the plate,
the instrument links the plate to the experiment previously defined in the software and after pressing
the play button, all further steps are performed fully automated by the instrument.
The following process steps are done sequentially:
Partitioning: In the first module, the microchannels and partitions of the plate are filled with the input
volume of the wells. This is done by plunging the pins in the elastic top-seal and the input wells. This
creates a peristaltic pressure that pumps the input well liquid into the microchannels and partitions.
Subsequentially, the connecting channels between the partitions are being closed by a pressure-
controlled rolling process (see images hereafter).

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Scheme of filling and partitioning of a well.
Principle of priming and rolling to allow partitioning of the wells.
Thermocycling: The second step and module is a high-accuracy plate thermocycler that performs
the polymerase chain reaction. The cycling profile can be set in the QIAcuity
Software Suite or the
instrument software. For more details on the thermal cycler specification, see Appendix A –
Technical Data.
Imaging: The final process step is the image acquisition of all wells. The user can select the detection
channels in the experiment setup. The partitions that have a target molecule inside emit fluorescence light
and are brighter than the ones without target (see image hereafter). For more details and specifications
on the imaging system, see section Appendix A – Technical Data.

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Scheme of positive (green) and negative (blue) partitions after imaging.
External features of QIAcuity
Touchscreen
The QIAcuity is controlled using a swivel-mounted touchscreen. To adjust the angle of the
touchscreen, pull gently at the bottom edge. The touchscreen enables the user to see an overview
of all plate slots and the corresponding process steps and remaining times. Additionally, it can be
used to extend the plate tray, start/stop plate runs, set up experiments, etc. For all functions and
instructions of the instrument software, see Operating the QIAcuity
Instrument.
Pulled out touchscreen.