QIAGEN QIAstat-Dx User Manual
Sample to Insight__
691223
QIAGEN GmbH, QIAGEN Strasse 1, D
R
September 2020
QIAstat-Dx® Respiratory
SARS-CoV-2 Panel
Instructions for Use
(Handbook)
6
Version 1
For
in vitro
Rx Only
4
diagnostic use under Emergency Use Authorization Only
-40724 Hilden
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QIAstat-Dx Respiratory SARS-CoV-2 Panel Instructions for Use (Handbook) 09/2020
Contents
Intended Use .............................................................................................................. 4
Summary and Explanation ........................................................................................... 6
QIAstat-Dx Respiratory SARS-CoV-2 Panel Cartridge Description ............................ 6
Pathogen Information .................................................................................................. 8
Principle of the Procedure .......................................................................................... 10
Description of the process ................................................................................ 10
Sample collection and cartridge loading ........................................................... 11
Sample preparation, nucleic acid amplification and detection ............................. 13
Materials Provided .................................................................................................... 14
Kit contents .................................................................................................... 14
Materials Required but Not Provided........................................................................... 15
Warnings and Precautions ......................................................................................... 16
Safety information .......................................................................................... 16
Reagent Storage and Handling .................................................................................. 19
Specimen Handling, Storage and Preparation .............................................................. 19
Procedure ................................................................................................................ 20
Internal Control .............................................................................................. 20
Protocol: Transport medium liquid samples ........................................................ 21
Viewing results ............................................................................................... 32
Interpretation of Results .............................................................................................. 34
Internal Control interpretation ........................................................................... 34
Pathogen Result interpretation .......................................................................... 34
QIAstat-Dx Respiratory SARS-CoV-2 Panel Instructions for Use (Handbook) 09/2020
3
Quality Control ......................................................................................................... 43
Limitations ................................................................................................................ 44
Conditions of Authorization for the Laboratory ............................................................. 47
Performance Characteristics ....................................................................................... 49
SARS-CoV-2 Target ......................................................................................... 49
Clinical performance ...................................................................................... 49
Analytical performance ................................................................................... 50
Additional Targets included in the QIAstat-Dx SARS-CoV-2 Panel ......................... 53
Clinical performance ...................................................................................... 53
Expected values ............................................................................................. 73
Analytical performance ................................................................................... 80
Appendices............................................................................................................ 111
Appendix A: Installing the Assay Definition File ................................................ 111
Appendix B: Glossary ................................................................................... 113
Appendix C: Disclaimer of warranties ............................................................. 115
Symbols ................................................................................................................. 116
Ordering Information .............................................................................................. 117
Handbook Revision History ...................................................................................... 119
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QIAstat-Dx Respiratory SARS-CoV-2 Panel Instructions for Use (Handbook) 09/2020
Intended Use
The QIAstat-Dx Respiratory SARS-CoV-2 Panel is a multiplexed nucleic acid real-time PCR test
intended for the qualitative detection and differentiation of nucleic acid from multiple
respiratory viral and bacterial organisms, including the SARS-CoV-2 virus, in nasopharyngeal
swabs (NPS) eluted in universal transport media collected from patients suspected of
COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the
Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform
high complexity and moderate complexity tests.
The QIAstat-Dx Respiratory SARS-CoV-2 Panel is intended for the detection and differentiation
of nucleic acid from SARS-CoV-2 and the following organism types and subtypes: Adenovirus,
Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, SARS-CoV-2,
Human Metapneumovirus A+B, Influenza A, Influenza A H1, Influenza A H3, Influenza A
H1N1/pdm09, Influenza B, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus
3, Parainfluenza virus 4, Rhinovirus/Enterovirus, Respiratory Syncytial Virus A+B,
,
pertussis
Chlamydophila pneumoniae
, and
Mycoplasma pneumoniae
.
Bordetella
SARS-CoV-2 RNA and nucleic acids from the other respiratory viral and bacterial organisms
identified by this test are generally detectable in nasopharyngeal swabs (NPS) during the acute
phase of infection. Positive results are indicative of the presence of the identified
microorganism, but do not rule out co-infection with other pathogens not detected by the test,
or lower respiratory tract infection that is not detected by a nasopharyngeal swab. The agent
detected may not be the definite cause of disease.
For SARS-CoV-2 positive specimens; clinical correlation with patient history and other
diagnostic information is necessary to determine patient infection status. Laboratories within
the United States and its territories are required to report all SARS-CoV-2 positive results to the
appropriate public health authorities.
QIAstat-Dx Respiratory SARS-CoV-2 Panel Instructions for Use (Handbook) 09/2020
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Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole
basis for treatment or other patient management decisions. Negative SARS-CoV-2 results must
be combined with clinical observations, patient history, and epidemiological information.
Negative results for other organisms identified by the test may require additional laboratory
testing (eg, bacterial and viral culture, immunofluorescence and radiography) when evaluating
a patient with possible respiratory tract infection.
Testing with the QIAstat Dx Respiratory SARS-CoV-2 Panel is intended for use by qualified and
trained operators who are proficient in performing the tests using the QIAstat Dx Analyzer
System. The QIAstat Dx Respiratory SARS-CoV-2 Panel is only for use under the Food and Drug
Administration’s Emergency Use Authorization.
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QIAstat-Dx Respiratory SARS-CoV-2 Panel Instructions for Use (Handbook) 09/2020
Summary and Explanation
QIAstat-Dx Respiratory SARS-CoV-2 Panel Cartridge Description
The QIAstat-Dx Respiratory SARS-CoV-2 Panel Cartridge is a disposable plastic device that
allows performance of fully automated molecular assays for the detection of respiratory
pathogens. The main features of the QIAstat-Dx Respiratory SARS-CoV-2 Panel Cartridge
include compatibility with nasopharyngeal swab in transport medium (liquid samples),
hermetical containment of the pre-loaded reagents necessary for testing, and true walk-away
operation. All sample preparation and assay testing steps are performed within the cartridge.
All reagents required for the complete execution of a test run are pre-loaded and self-contained in
the QIAstat-Dx Respiratory SARS-CoV-2 Panel Cartridge. The user does not need to come in contact
with and/or manipulate any reagents. During the test, reagents are handled within the cartridge in
the Analytical Module of the QIAstat-Dx Analyzer 1.0 by pneumatically-operated microfluidics and
make no direct contact with the actuators. The QIAstat-Dx Analyzer 1.0 houses air filters for both
incoming and outgoing air, further safeguarding the environment. After testing, the cartridge stays
hermetically closed at all times, greatly enhancing its safe disposal.
Within the cartridge, multiple steps are automatically performed in sequence using pneumatic
pressure to transfer samples and fluids via the transfer chamber to their intended destinations.
QIAstat-Dx Respiratory SARS-CoV-2 Panel Instructions for Use (Handbook) 09/2020
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Swab port
Main port
Traceability bar code
Reaction chambers
After the QIAstat-Dx Respiratory SARS-CoV-2 Panel Cartridge containing the sample is
introduced into the QIAstat-Dx Analyzer 1.0, the following assay steps occur automatically:
Resuspension of Internal Control
Cell lysis using mechanical and/or chemical means
Membrane-based nucleic acid purification
Mixing of the purified nucleic acid with lyophilized master mix reagents
Transfer of defined aliquots of eluate/master mix to different reaction chambers
Performance of multiplex real-time RT-PCR testing within each reaction chamber.
Note: An increase in fluorescence, indicating detection of the target analyte, is detected
directly within each reaction chamber.
Figure 1. Layout of the QIAstat-Dx Respiratory SARS-CoV-2 Panel Cartridge and its features.
Note: The swab port is not used for the QIAstat-Dx Respiratory SARS-CoV-2 Panel assay.
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QIAstat-Dx Respiratory SARS-CoV-2 Panel Instructions for Use (Handbook) 09/2020
Pathogen Information
Acute respiratory infections can be caused by a variety of pathogens, including bacteria and
viruses, and generally present with nearly indistinguishable clinical signs and symptoms. The
rapid and accurate determination of the presence or absence of potential causative agent(s)
helps make timely decisions regarding treatment, hospital admission, infection control, and
return of the patient to work and family. It may also greatly support improved antimicrobial
stewardship and other important public health initiatives.
The QIAstat-Dx Respiratory SARS-CoV-2 Panel Cartridge is a single-use cartridge that includes
all reagents needed for nucleic acid extraction, nucleic acid amplification and detection of
22 bacteria and viruses (or their subtypes), including SARS-CoV-2 that cause respiratory
symptoms. Testing requires a small sample volume and minimal hands-on time, and the results
are available in approximately one hour.
The SARS-CoV-2 target in the QIAstat-Dx Respiratory SARS-CoV-2 Panel has been designed
upon alignment of more than 170 genomic sequences available in public databases from the
SARS-CoV-2, which was identified as the causative agent of the viral pneumonia (COVID-19)
outbreak originated in Wuhan, Hubei, China. The SARS-CoV-2 in this panel targets 2 genes
of the virus genome (Orf1b poly gene (Rdrp gene) and E genes) detected with the same
fluorescence channel. The two gene targets are not differentiated and amplification of either
or both gene targets leads to a fluorescence signal.
Pathogens (and subtypes) that can be detected and identified with the QIAstat-Dx Respiratory
SARS-CoV-2 Panel are listed in Table 1 (next page).
QIAstat-Dx Respiratory SARS-CoV-2 Panel Instructions for Use (Handbook) 09/2020
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Table 1. Pathogens detected by the QIAstat-Dx Respiratory SARS-CoV-2 Panel
Pathogen Classification (genome type)
Influenza A Orthomyxovirus (RNA)
Influenza A, subtype H1N1/2009/pdm09 Orthomyxovirus (RNA)
Influenza A subtype H1 Orthomyxovirus (RNA)
Influenza A subtype H3 Orthomyxovirus (RNA)
Influenza B Orthomyxovirus (RNA)
Coronavirus 229E Coronavirus (RNA)
Coronavirus HKU1 Coronavirus (RNA)
Coronavirus NL63 Coronavirus (RNA)
Coronavirus OC43 Coronavirus (RNA)
SARS-CoV-2 Coronavirus (RNA)
Parainfluenza virus 1 Paramyxovirus (RNA)
Parainfluenza virus 2 Paramyxovirus (RNA)
Parainfluenza virus 3 Paramyxovirus (RNA)
Parainfluenza virus 4 Paramyxovirus (RNA)
Respiratory Syncytial Virus A/B Paramyxovirus (RNA)
Human Metapneumovirus A/B Paramyxovirus (RNA)
Adenovirus Adenovirus (DNA)
Rhinovirus/Enterovirus Picornavirus (RNA)
Mycoplasma pneumoniae
Chlamydophila pneumoniae
Bordetella pertussis
Bacterium (DNA)
Bacterium (DNA)
Bacterium (DNA)
Note: Enterovirus and Rhinovirus are both detected, but not differentiated, with the QIAstat-Dx Respiratory SARS-CoV-2
Panel.
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QIAstat-Dx Respiratory SARS-CoV-2 Panel Instructions for Use (Handbook) 09/2020
Principle of the Procedure
Description of the process
Diagnostic tests with the QIAstat-Dx Respiratory SARS-CoV-2 Panel are performed on the
QIAstat-Dx Analyzer 1.0. All of the sample preparation and analysis steps are performed
automatically by the QIAstat-Dx Analyzer 1.0. Samples are collected and loaded manually
into the QIAstat-Dx Respiratory SARS-CoV-2 Panel Cartridge:
A transfer pipette provided with the test kit is used for dispensing transport medium liquid
sample into the main port (Figure 2).
Figure 2. Dispensing transport medium liquid sample into the main port.
QIAstat-Dx Respiratory SARS-CoV-2 Panel Instructions for Use (Handbook) 09/2020
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Sample collection and cartridge loading
The collection of samples and their subsequent loading into the QIAstat-Dx Respiratory
SARS-CoV-2 Panel Cartridge should be performed by personnel trained in safe handling of
biological samples.
The following steps are involved and must be executed by the user:
1. A nasopharyngeal swab sample is collected.
2. The nasopharyngeal swab is placed into transport medium.
3. The sample information is manually written on or a sample label is affixed to the top of a
QIAstat-Dx Respiratory SARS-CoV-2 Panel Cartridge.
4. Transport medium liquid sample is loaded manually into the QIAstat-Dx Respiratory
SARS-CoV-2 Panel Cartridge.
300 μl of sample is transferred into the main port of the QIAstat-Dx Respiratory
SARS-CoV-2 Panel Cartridge using one of the included transfer pipettes.
Note: When loading transport medium liquid sample, the user performs a visual check of
the sample inspection window (see image below) to confirm that the liquid sample has
been loaded (Figure 3, next page).
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QIAstat-Dx Respiratory SARS-CoV-2 Panel Instructions for Use (Handbook) 09/2020
Figure 3. Sample inspection window (blue arrow).
5. The sample bar code and QIAstat-Dx Respiratory SARS-CoV-2 Panel Cartridge QR code
are scanned in the QIAstat-Dx Analyzer 1.0.
6. The QIAstat-Dx Respiratory SARS-CoV-2 Panel Cartridge is introduced into the QIAstat-Dx
Analyzer 1.0.
7. The test is started on the QIAstat-Dx Analyzer 1.0.
QIAstat-Dx Respiratory SARS-CoV-2 Panel Instructions for Use (Handbook) 09/2020
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Sample preparation, nucleic acid amplification and detection
The extraction, amplification, and detection of nucleic acids in the sample are performed
automatically by the QIAstat-Dx Analyzer 1.0.
1. The liquid sample is homogenized and cells are lysed in the lysis chamber of the QIAstatDx Respiratory SARS-CoV-2 Panel Cartridge, which includes a rotor that turns at high
speed.
2. Nucleic acids are purified from the lysed sample via binding to a silica membrane in the
purification chamber of the QIAstat-Dx Respiratory SARS-CoV-2 Panel Cartridge in the
presence of chaotropic salts and alcohol.
3. The purified nucleic acids are eluted from the membrane in the purification chamber and
are mixed with the lyophilized PCR chemistry in the dried-chemistry chamber of the
QIAstat-Dx Respiratory SARS-CoV-2 Panel Cartridge.
4. The mixture of sample and PCR reagents is dispensed into the QIAstat-Dx Respiratory
SARS-CoV-2 Panel Cartridge PCR chambers, which contain lyophilized, assay-specific
primers and probes.
5. The QIAstat-Dx Analyzer 1.0 creates the optimal temperature profiles to carry out
effective multiplex real-time RT-PCR and performs real-time fluorescence measurements to
generate amplification curves.
6. The QIAstat-Dx Analyzer 1.0 Software interprets the resulting data and process controls
and delivers a test report.
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QIAstat-Dx Respiratory SARS-CoV-2 Panel Instructions for Use (Handbook) 09/2020
Materials Provided
Kit contents
QIAstat-Dx Respiratory SARS-CoV-2 Panel
Catalog no.
Number of tests
QIAstat-Dx Respiratory SARS-CoV-2 Panel Cartridge* 6
Transfer pipettes† 6
* 6 individually packaged cartridges containing all reagents needed for sample preparation and multiplex real-time RT-
PCR, plus Internal Control.
†
6 individually packaged transfer pipettes for dispensing liquid sample into the QIAstat-Dx Respiratory SARS-CoV-2
Panel Cartridge.
691223
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QIAstat-Dx Respiratory SARS-CoV-2 Panel Instructions for Use (Handbook) 09/2020
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Materials Required but Not Provided
The QIAstat-Dx Respiratory SARS-CoV-2 Panel is designed for use with the QIAstat-Dx Analyzer
1.0. Before beginning a test, make sure the following are available:
QIAstat-Dx Analyzer 1.0 (at least one Operational Module and one Analytical Module)
with software version 1.2 or higher
QIAstat-Dx Analyzer 1.0 User Manual
QIAstat-Dx latest Assay Definition File software for Respiratory SARS-CoV-2 Panel
installed on the Operational Module
(for use with software version 1.2 or higher)
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QIAstat-Dx Respiratory SARS-CoV-2 Panel Instructions for Use (Handbook) 09/2020
Warnings and Precautions
For
in vitro
diagnostic use under Emergency Use Authorization only.
The QIAstat-Dx Respiratory SARS-CoV-2 Panel is to be used by laboratory professionals trained
in the use of QIAstat-Dx Analyzer 1.0.
This device is restricted to sale by or on the order of a physician, or to a clinical laboratory;
its use is restricted to, by, or on the order of a physician.
Pertussis is a nationally notifiable infectious disease in the U.S. If
detected, notify state and/or local health departments.
Laboratories are required to report all positive SARS-CoV-2 results to the appropriate public
health authorities.
Bordetella pertussis
is
Safety information
When working with chemicals, always wear a suitable lab coat, disposable gloves, and
protective goggles. For more information, consult the appropriate safety data sheets (SDSs).
These are available online in PDF format at www.qiagen.com/safety where you can find, view
and print the SDS for each QIAGEN kit and kit component.
Always wear appropriate personal protective equipment, including but not limited to
disposable powder-free gloves, a lab coat, and protective eyewear. Protect skin, eyes, and
mucus membranes. Change gloves often when handling samples.
QIAstat-Dx Respiratory SARS-CoV-2 Panel Instructions for Use (Handbook) 09/2020
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Handle all samples, used cartridges and transfer pipettes as if they are capable of transmitting
infectious agents. Always observe safety precautions as outlined in relevant guidelines, such
®
(CLSI)
as the Clinical and Laboratory Standards Institute
from Occupationally Acquired Infections; Approved Guideline
Protection of Laboratory Workers
(M29), or other appropriate
documents provided by:
OSHA
ACGIH
®
: Occupational Safety and Health Administration (United States of America)
®
: American Conference of Government Industrial Hygienists (United States of
America)
COSHH: Control of Substances Hazardous to Health (United Kingdom)
Follow your institution’s safety procedures for handling biological samples. Dispose of
samples, QIAstat-Dx Respiratory SARS-CoV-2 Panel Cartridges, and transfer pipettes
according to the appropriate regulations.
The QIAstat-Dx Respiratory SARS-CoV-2 Panel Cartridge is a closed, single-use device that contains
all reagents needed for sample preparation and multiplex real-time RT-PCR within the QIAstat-Dx
Analyzer 1.0. Do not use a QIAstat-Dx Respiratory SARS-CoV-2 Panel Cartridge that is past its
expiration date, appears damaged, or leaks fluid. Dispose of used or damaged cartridges in
accordance with all national, state, and local health and safety regulations and laws.
Observe standard laboratory procedures for keeping the working area clean and
contamination-free. Guidelines are outlined in publications such as the
Microbiological and Biomedical Laboratories
from the Centers for Disease Control and
Biosafety in
Prevention and the National Institutes of Health (https://www.cdc.gov/labs/BMBL.html).
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QIAstat-Dx Respiratory SARS-CoV-2 Panel Instructions for Use (Handbook) 09/2020
Highly flammable liquid and vapour. Harmful if swallowed or if
ory tract. Keep away from
dust/fume/gas/mist/vapours/spray. Wear protective
gloves/protective clothing/eye protection/face protection. Wear
Continue rinsing. IF exposed or concerned: Immediately call a
and keep comfortable for breathing.
The following hazard and precautionary statements apply to components of the QIAstat-Dx
Respiratory SARS-CoV-2 Panel.
QIAstat-Dx Respiratory SARS-CoV-2 Panel Cartridge
Contains: ethanol; guanidine hydrochloride; guanidine thiocyanate;
isopropanol; proteinase K; t-Octylphenoxypolyethoxyethanol. Danger!
inhaled. May be harmful in contact with skin. Causes severe skin burns
and eye damage. May cause allergy or asthma symptoms or breathing
difficulties if inhaled. May cause drowsiness or dizziness. Harmful to
aquatic life with long lasting effects. Contact with acids liberates very
toxic gas. Corrosive to the respirat
heat/sparks/open flames/hot surfaces. No smoking. Avoid breathing
respiratory protection. IF IN EYES: Rinse cautiously with water for
several minutes. Remove contact lenses, if present and easy to do.
POISON CENTER or doctor/ physician. Remove person to fresh air
QIAstat-Dx Respiratory SARS-CoV-2 Panel Instructions for Use (Handbook) 09/2020
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Reagent Storage and Handling
Store the QIAstat-Dx Respiratory SARS-CoV-2 Panel Cartridges in a dry, clean storage space
at room temperature (15–25°C). Do not remove the QIAstat-Dx Respiratory SARS-CoV-2 Panel
Cartridges or the transfer pipettes from their individual packaging until actual use. Under these
conditions, QIAstat-Dx Respiratory SARS-CoV-2 Panel Cartridges can be stored until the
expiration date printed on the individual packaging. The expiration date is also included in
the QIAstat-Dx Respiratory SARS-CoV-2 Panel Cartridge bar code and is read by the
QIAstat-Dx Analyzer 1.0 when the cartridge is inserted into the instrument to run a test.
Specimen Handling, Storage and Preparation
Nasopharyngeal samples should be collected and handled according to the manufacturer’s
recommended procedures.
Recommended storage conditions for NPS (nasopharyngeal swab) resuspended in UTM
specimens are listed below:
Room temperature up to 4 hours at 15–25°C
Refrigerated up to 3 days at 2–8°C
Frozen up to 30 days at –15 to –25°C
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QIAstat-Dx Respiratory SARS-CoV-2 Panel Instructions for Use (Handbook) 09/2020
Procedure
Internal Control
The QIAstat-Dx Respiratory SARS-CoV-2 Panel Cartridge includes a full process Internal Control
which is titered MS2 bacteriophage. The MS2 bacteriophage is a single-stranded RNA virus
that is included in the cartridge in dried form and is rehydrated upon sample loading. This
Internal Control material verifies all steps of the analysis process, including sample
resuspension/homogenization, lysis, nucleic acid purification, reverse transcription and PCR.
A positive signal for the Internal Control indicates that all processing steps performed by the
QIAstat-Dx Respiratory SARS-CoV-2 Panel Cartridge were successful.
A negative signal of the Internal Control does not negate any positive results for detected and
identified targets, but it does invalidate all negative results in the analysis. Therefore, the test
should be repeated if the Internal Control signal is negative.
QIAstat-Dx Respiratory SARS-CoV-2 Panel Instructions for Use (Handbook) 09/2020
21
Protocol: Transport medium liquid samples
Sample collection, transport and storage
Collect nasopharyngeal swab samples according to the swab manufacturer’s recommended
procedures and place the swab into Universal Transport Medium.
Loading a sample into the QIAstat-Dx Respiratory SARS-CoV-2 Panel Cartridge
1. Open the package of a QIAstat-Dx Respiratory SARS-CoV-2 Panel Cartridge using the
tear notches on the sides of the packaging (Figure 4).
IMPORTANT: After the package is open, sample should be introduced inside the
QIAstat-Dx Respiratory SARS-CoV-2 Panel Cartridge and loaded into the QIAstat-Dx
Analyzer 1.0 within 120 minutes.
Figure 4. Opening the QIAstat-Dx Respiratory SARS-CoV-2 Panel Cartridge.
2. Remove the QIAstat-Dx Respiratory SARS-CoV-2 Panel Cartridge from the packaging and
position it so that the QR code on the label faces you.
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QIAstat-Dx Respiratory SARS-CoV-2 Panel Instructions for Use (Handbook) 09/2020
3. Manually write the sample information or place a sample information label on the top of
the QIAstat-Dx Respiratory SARS-CoV-2 Panel Cartridge. Make sure that the label is
properly positioned and does not block the lid opening (Figure 5).
Figure 5. Sample information placement on top of QIAstat-Dx Respiratory SARS-CoV-2 Panel Cartridge.
4. Open the sample lid of the main port on the front of the QIAstat-Dx Respiratory
SARS-CoV-2 Panel Cartridge (Figure 6).
Figure 6. Opening the sample lid of main port.
QIAstat-Dx Respiratory SARS-CoV-2 Panel Instructions for Use (Handbook) 09/2020
23
5. Open the tube with the sample to be tested. Use the supplied transfer pipette to draw up
fluid to the third fill line on the pipette (i.e., 300 μl) (Figure 7).
®
IMPORTANT: Take care to avoid drawing air into the pipette. If Copan
UTM®, Universal
Transport Medium is used as transport medium take care not to aspirate any of the beads
present in the tube. If air or beads are drawn into the pipette, carefully expel the sample
fluid in the pipette back into the sample tube and draw up fluid again.
Figure 7. Drawing up sample into the supplied transfer pipette.
6. Carefully transfer 300 μl of sample volume into the main port of the QIAstat-Dx
Respiratory SARS-CoV-2 Panel Cartridge using the supplied single-use transfer pipette
(Figure 8, next page).
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QIAstat-Dx Respiratory SARS-CoV-2 Panel Instructions for Use (Handbook) 09/2020
Figure 8. Transferring sample to main port of QIAstat-Dx Respiratory SARS-CoV-2 Panel Cartridge.
7. Firmly close the sample lid of the main port until it clicks (Figure 9).
Figure 9. Closing the sample lid of the main port.
QIAstat-Dx Respiratory SARS-CoV-2 Panel Instructions for Use (Handbook) 09/2020
25
8. Visually confirm that the sample has been loaded by checking the sample inspection
window of the QIAstat-Dx Respiratory SARS-CoV-2 Panel Cartridge (Figure 10).
IMPORTANT: After the sample is placed inside the QIAstat-Dx Respiratory SARS-CoV-2
Panel Cartridge, the cartridge must be loaded into the QIAstat-Dx Analyzer 1.0 within
90 minutes.
Figure 10. Sample inspection window (blue arrow).
Starting the QIAstat-Dx Analyzer 1.0
9. Power ON the QIAstat-Dx Analyzer 1.0 using the On/Off button on the front of the
instrument.
Note: The power switch on the back of the Analytical Module must be set in the “I”
position. The QIAstat-Dx Analyzer 1.0 status indicators will turn blue.
10. Wait until the Main screen appears and the QIAstat-Dx Analyzer 1.0 status indicators
turn green and stop blinking.
11. Log in to the QIAstat-Dx Analyzer 1.0 by entering the user name and password.
Note: The Login screen will appear if User Access Control is activated. If the User Access Control
is disabled, no user name/password will be required and the Main screen will appear.
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QIAstat-Dx Respiratory SARS-CoV-2 Panel Instructions for Use (Handbook) 09/2020
12. If the Assay Definition File software has not been installed on the QIAstat-Dx
Analyzer 1.0, follow the installation instructions prior to running the test (see “Appendix
A: Installing the Assay Definition File”, page 111, for additional information).
Running a test
13. Press the Run Test button in the top right corner of the touchscreen of the QIAstat-Dx
Analyzer 1.0.
14. When prompted, scan the sample ID bar code on the UTM tube containing the sample,
or scan the specimen information bar code located on the top of the QIAstat-Dx
Respiratory SARS-CoV-2 Panel Cartridge (see step 3) using the integrated front bar code
reader of the QIAstat-Dx Analyzer 1.0 (Figure 11).
Note: It is also possible to enter the sample ID using the virtual keyboard of the
touchscreen by selecting the Sample ID field.
Note: Depending on the chosen system configuration, entering the patient ID may also
be required at this point.
Note: Instructions from the QIAstat-Dx Analyzer 1.0 appear in the Instructions Bar at the
bottom of the touchscreen.
Figure 11. Scanning sample ID bar code.
QIAstat-Dx Respiratory SARS-CoV-2 Panel Instructions for Use (Handbook) 09/2020
27
15. When prompted, scan the bar code of the QIAstat-Dx Respiratory SARS-CoV-2 Panel
Cartridge to be used (Figure 12). The QIAstat-Dx Analyzer 1.0 automatically recognizes
the assay to be run based on the cartridge bar code.
Note: The QIAstat-Dx Analyzer 1.0 will not accept QIAstat-Dx Respiratory SARS-CoV-2 Panel
Cartridges with lapsed expiration dates, previously used cartridges, or cartridges for assays
that have not been installed on the unit. An error message will be shown in these cases and
the QIAstat-Dx Respiratory SARS-CoV-2 Panel Cartridge will be rejected. Refer to the
QIAstat-Dx Analyzer 1.0 User Manual
for further details on how to install assays.
Figure 12. Scanning QIAstat-Dx Respiratory SARS-CoV-2 Panel Cartridge bar code.
16. The Confirm screen will appear. Review the entered data and make any necessary
changes by selecting the relevant fields on the touchscreen and editing the information.
17. Press Confirm when all the displayed data are correct. If needed, select the appropriate
field to edit its content, or press Cancel to cancel the test (Figure 13, next page).
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QIAstat-Dx Respiratory SARS-CoV-2 Panel Instructions for Use (Handbook) 09/2020
Figure 13. Confirming data entry.
18. Make sure that both sample lids of the swab port and main port of the QIAstat-Dx
Respiratory SARS-CoV-2 Panel Cartridge are firmly closed. When the cartridge entrance
port on the top of the QIAstat-Dx Analyzer 1.0 automatically opens, insert the QIAstat-Dx
Respiratory SARS-CoV-2 Panel Cartridge with the bar code facing to the left and the
reaction chambers facing down (Figure 14, next page).
Note: There is no need to push the QIAstat-Dx Respiratory SARS-CoV-2 Panel Cartridge
into the QIAstat-Dx Analyzer 1.0. Position it correctly into the cartridge entrance port and
the QIAstat-Dx Analyzer 1.0 will automatically move the cartridge into the Analytical
Module.
QIAstat-Dx Respiratory SARS-CoV-2 Panel Instructions for Use (Handbook) 09/2020
29
Figure 14. Inserting QIAstat-Dx Respiratory SARS-CoV-2 Panel Cartridge into QIAstat-Dx Analyzer 1.0.
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QIAstat-Dx Respiratory SARS-CoV-2 Panel Instructions for Use (Handbook) 09/2020
19. Upon detecting the QIAstat-Dx Respiratory SARS-CoV-2 Panel Cartridge, the QIAstat-Dx
Analyzer 1.0 will automatically close the lid of the cartridge entrance port and start the
test run. No further action from the operator is required to start the run.
Note: The QIAstat-Dx Analyzer 1.0 will not accept a QIAstat-Dx Respiratory SARS-CoV-2
Panel Cartridge other than the one used and scanned during the test setup. If a cartridge
other than the one scanned is inserted, an error will be generated and the cartridge will
be automatically ejected.
Note: Up to this point, it is possible to cancel the test run by pressing the Cancel button in
the bottom right corner of the touchscreen.
Note: Depending on the system configuration, the operator may be required to re-enter
their user password to start the test run.
Note: The lid of the cartridge entrance port will close automatically after 30 seconds if a
QIAstat-Dx Respiratory SARS-CoV-2 Panel Cartridge is not positioned in the port. If this
occurs, repeat the procedure starting with step 17.
20. While the test is running, the remaining run time is displayed on the touchscreen.
21. After the test run is completed, the Eject screen will appear (Figure 15, next page) and
the Module status bar will display the test result as one of the following options:
TEST COMPLETED: The test was completed successfully
TEST FAILED: An error occurred during the test
TEST CANCELED: The user canceled the test
IMPORTANT: If the test fails, refer to the “Troubleshooting” section in the
Analyzer 1.0 User Manual
for possible reasons and instructions on how to proceed.
QIAstat-Dx
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