September 2022

QIAstat-Dx® Meningitis/Encephalitis (ME)

Panel Instructions for Use (Handbook)

Version 1
For in vitro diagnostic use

691611

QIAGEN GmbH, QIAGEN Strasse 1, 40724 Hilden, GERMANY

R3

Sample to Insight
Contents

Intended Use .............................................................................................................. 4

Summary and Explanation ........................................................................................... 6

QIAstat-Dx ME 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 ............................ 12

Materials Provided .................................................................................................... 13

Kit contents .................................................................................................... 13

Materials Required But Not Provided........................................................................... 14

Warnings and Precautions ......................................................................................... 15

Safety information .......................................................................................... 15

Laboratory precautions .................................................................................... 17

Reagent Storage and Handling .................................................................................. 18

Specimen Handling, Storage and Preparation .............................................................. 18

Procedure ................................................................................................................ 19

Internal Control .............................................................................................. 19

Protocol: cerebrospinal fluid samples ................................................................ 19

Interpretation of Results .............................................................................................. 29

Viewing results ............................................................................................... 29

2 QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022

 Viewing amplification curves ........................................................................... 31

Result interpretation ........................................................................................ 40

Internal Control interpretation ........................................................................... 40

Quality Control ......................................................................................................... 41

Limitations ................................................................................................................ 41

Performance Characteristics ....................................................................................... 43

Clinical performance....................................................................................... 43

Analytical performance ................................................................................... 47

Appendix A: Installing the Assay Definition File ............................................................ 72

Appendix B: Glossary ............................................................................................... 74

Appendix C: Disclaimer of warranties ......................................................................... 75

References ............................................................................................................... 76

Symbols ................................................................................................................... 77

Instructions for Use (Handbook) Revision History ........................................................... 79

QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022 3

Intended Use
The QIAstat-Dx Meningitis/Encephalitis (ME) Panel (“QIAstat-Dx ME Panel”) is a qualitative
multiplexed nucleic acid-based in vitro diagnostic test intended for use with the QIAstat-Dx
System. The QIAstat-Dx ME Panel is capable of simultaneous detection and identification of
multiple bacterial, viral, and yeast nucleic acids from cerebrospinal fluid (CSF) specimens
obtained via lumbar puncture from individuals with signs and/or symptoms of meningitis
and/or encephalitis.

The following organisms are identified and differentiated using the QIAstat-Dx ME Panel:
Escherichia coli K1, Haemophilus influenzae, Listeria monocytogenes, Neisseria meningitidis
(encapsulated), Streptococcus agalactiae, Streptococcus pneumoniae, Mycoplasma
pneumoniae, Streptococcus pyogenes, Herpes simplex virus 1, Herpes simplex virus 2, Human
herpes virus 6, Enterovirus, Human parechovirus, Varicella-zoster virus and Cryptococcus
neoformans/gattii*.

The QIAstat-Dx ME Panel is indicated as an aid in the diagnosis of specific agents of meningitis
and/or encephalitis and results must be used in conjunction with other clinical,
epidemiological, and laboratory data. Results from the QIAstat-Dx ME Panel are not intended
to be used as the sole basis for diagnosis, treatment, or other patient management decisions.
Positive results do not rule out co-infection with organisms not included in the QIAstat-Dx ME
Panel. The agent or agents detected may not be the definite cause of the disease. Negative
results do not preclude central nervous system (CNS) infection.

Not all agents of CNS infection are detected by this test, and sensitivity in clinical use may
differ from that described in the package insert.

* Cryptococcus neoformans and Cryptococcus gattii are not differentiated.

4 QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022

The QIAstat-Dx ME Panel is not intended for testing of specimens collected from indwelling
CNS medical devices.

The QIAstat-Dx ME Panel is intended to be used in conjunction with standard of care (e.g.,
culture for organism recovery, serotyping, and antimicrobial susceptibility testing).

The QIAstat-Dx ME Panel is intended for in vitro diagnostic use by laboratory professionals only.

QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022 5

Summary and Explanation
QIAstat-Dx ME Panel Cartridge description

The QIAstat-Dx ME Panel Cartridge is a disposable plastic device that allows performance of
fully automated molecular assays for the detection and identification of nucleic acids from
multiple agents, directly from CSF samples. The main features of the QIAstat-Dx ME Panel
Cartridge include compatibility with a liquid sample type, 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 ME 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.

After the QIAstat-Dx ME 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 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.

6 QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022

Note: An increase in fluorescence, indicating detection of the target analyte, is detected
directly within each reaction chamber.

Main port
Swab port

Traceability bar code

Figure 1. Layout of the QIAstat-Dx ME Panel Cartridge and its features.

Note: The swab port is not used for the QIAstat-Dx ME Panel assay.

QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022 7

Pathogen Information

Meningitis and encephalitis are potentially devastating conditions and can be associated with
significant morbidity and mortality.(1) Meningitis is defined as inflammation of the meninges,
encephalitis is defined as inflammation of the brain parenchyma, and meningoencephalitis is
defined as inflammation at both locations. All these conditions can be caused by bacteria,
viruses, or fungi, with encephalitis being more commonly associated with a viral etiology.(2)
Clinical presentations are usually nonspecific; as patients often experience headache, altered
mental status, and, in the case of meningitis, nuchal rigidity. Early diagnosis is vital, as
symptoms can appear suddenly and escalate to brain damage, hearing and/or speech loss,
blindness, or even death. As treatment differs depending on the cause of the disease,
identification of a specific causative agent is necessary to adjust treatment accordingly.

The QIAstat-Dx ME Panel Cartridge allows detection of 15 bacterial, viral, and fungal
pathogenic targets that cause signs and/or symptoms of meningitis and/or encephalitis.
Testing requires a small sample volume and minimal hands-on time, and the results are
available in less than 80 minutes.

Pathogens that can be detected and identified with the QIAstat-Dx ME Panel are listed in Table 1.

8 QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022

Table 1. Pathogens detected by the QIAstat-Dx ME Panel

Pathogen Classification (genome type)

Escherichia coli K1 Bacterium (DNA)

Haemophilus influenzae Bacterium (DNA)

Listeria monocytogenes Bacterium (DNA)

Neisseria meningitidis (encapsulated) Bacterium (DNA)

Streptococcus agalactiae Bacterium (DNA)

Streptococcus pneumoniae Bacterium (DNA)

Streptococcus pyogenes Bacterium (DNA)

Mycoplasma pneumoniae Bacterium (DNA)

Herpes simplex virus 1 Herpesvirus (DNA)

Herpes simplex virus 2 Herpesvirus (DNA)

Human herpes virus 6 Herpesvirus (DNA)

Enterovirus Picornavirus (RNA)

Human parechovirus Picornavirus (RNA)

Varicella-zoster virus Herpesvirus (DNA)

Cryptococcus gattii/Cryptococcus neoformans Yeast (DNA)

QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022 9

Principle of the Procedure
Description of the process

Diagnostic tests with the QIAstat-Dx ME 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 ME Panel
Cartridge.

A transfer pipette is used for sample transfer into the main port (Figure 2).

Figure 2. Dispensing sample into the main port.

10 QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022

Sample collection and cartridge loading

The collection of samples and their subsequent loading into the QIAstat-Dx ME 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 Cerebral Spinal Fluid (CSF) sample is collected.

2. The sample information is manually written on or a sample label is affixed to the top of a
QIAstat-Dx ME Panel Cartridge.
3. CSF sample is loaded manually into the QIAstat-Dx ME Panel Cartridge.
200 μl of sample is transferred into the main port of the QIAstat-Dx ME Panel Cartridge
using one of the included transfer pipettes. Use alternative sterile and graduated pipettes
in case all six pipettes provided with the kit have been used.
Note: When loading a CSF 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).

Figure 3. Sample inspection window (blue arrow).

QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022 11

4. The sample bar code and QIAstat-Dx ME Panel Cartridge QR code are scanned in the
QIAstat-Dx Analyzer 1.0.
5. The QIAstat-Dx ME Panel Cartridge is introduced into the QIAstat-Dx Analyzer 1.0.
6. The test is started on the QIAstat-Dx Analyzer 1.0.

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 sample is homogenized, and cells are lysed in the lysis chamber of the QIAstat-Dx
ME 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 ME 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 ME Panel Cartridge.
4. The mixture of sample and PCR reagents is dispensed into the QIAstat-Dx ME 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.

12 QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022

Materials Provided
Kit contents

QIAstat-Dx ME Panel 691611

Catalog no. 6
Number of tests

QIAstat-Dx ME 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 ME Panel Cartridge.

QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022 13

Materials Required But Not Provided
The QIAstat-Dx ME 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 1.4 or higher
 QIAstat-Dx Analyzer 1.0 User Manual (for use with software version 1.4 or higher)
 QIAstat-Dx latest Assay Definition File software for the QIAstat-Dx ME Panel installed in the
Operational Module.

14 QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022

Warnings and Precautions
For in vitro diagnostic use.

The QIAstat-Dx ME Panel is to be used by laboratory professionals trained in the use of

QIAstat-Dx Analyzer 1.0.

Safety information

When working with chemicals, always wear a suitable lab coat, disposable gloves, and
protective goggles. Protect the skin, eyes, and mucus membranes, and change gloves often
when handling samples. 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.

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 as the
Clinical and Laboratory Standards Institute® (CLSI) Protection of Laboratory Workers from
Occupationally Acquired Infections; Approved Guideline (M29), or other appropriate documents.

Follow your institution’s safety procedures for handling biological samples. Dispose of samples,
QIAstat-Dx ME Panel Cartridges, and transfer pipettes according to the appropriate regulations.

The QIAstat-Dx ME 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 ME Panel Cartridge if it 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.

QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022 15

Observe standard laboratory procedures for keeping the working area clean and
contamination-free. Guidelines are outlined in publications such as the Biosafety in
Microbiological and Biomedical Laboratories from the Centers for Disease Control and
Prevention and the National Institutes of Health (www.cdc.gov/od/ohs/biosfty/biosfty.htm).

The following hazard and precautionary statements apply to components of the QIAstat-Dx
ME Panel.

Contains: ethanol; guanidine hydrochloride; guanidine thiocyanate;

isopropanol; proteinase K; t-Octylphenoxypolyethoxyethanol.
Danger! Highly flammable liquid and vapor. Harmful if swallowed
or if 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 respiratory tract. Keep away
from heat/sparks/open flames/hot surfaces. No smoking. Avoid
breathing dust/fume/gas/mist/vapors/spray. Wear protective
gloves/protective clothing/eye protection/face protection. Wear
respiratory protection. IF IN EYES: Rinse cautiously with water for
several minutes. Remove contact lenses, if present and easy to do.
Continue rinsing. IF exposed or concerned: Immediately call a
POISON CENTER or doctor/ physician. Remove person to fresh air
and keep comfortable for breathing.

16 QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022

Laboratory precautions

To guard against possible contamination of the specimen and work area standard laboratory
safety and cleaning procedures should be used, including the following precautions:

 Samples should be processed in a biosafety cabinet or a similar clean surface ensuring the
user’s protection. If a biosafety cabinet is not used, a dead air box (e.g., AirClean PCR
workstation), a splash shield (e.g., Bel-Art Scienceware Splash Shields), or a face shield
should be used when preparing samples.
 A biosafety cabinet that is used for performing CSF pathogen testing (e.g. culture) should
not be used for sample preparation or cartridge loading.
 Prior to processing samples, thoroughly clean the work area using a suitable cleaner such
as freshly prepared 10% bleach or a similar disinfectant. To avoid residue buildup and
potential damage to the specimen or interference from disinfectants, wipe disinfected
surfaces with water.
 Samples and cartridges should be handled one at a time.
 Use clean gloves to remove materials from bulk packaging bags and reseal bulk packaging
bags when not in use.
 Change gloves and clean the work area between each sample.
 Discard used cartridges in an appropriate biohazard container immediately after the run
has been completed.
 Avoid excessive handling of cartridges after test runs.
 Avoid damaging the cartridge.
 Use clean gloves to remove materials from bulk packaging boxes, and close bulk
packaging when not in use.

QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022 17

Reagent Storage and Handling
Store the QIAstat-Dx ME Panel Cartridges in a dry, clean storage space at room temperature
(15–25°C). Do not remove the QIAstat-Dx ME Panel Cartridges or the transfer pipettes from
their individual packaging until actual use. Under these conditions, the QIAstat-Dx ME Panel
Cartridges can be stored until the expiration date printed on the individual packaging. The
expiration date is also included in the QIAstat-Dx ME 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

CSF specimens should be collected and handled according to the recommended procedures.

Recommended storage condition for CSF is room temperature (15–25˚C) up to 12 hours.

18 QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022

Procedure
Internal Control

The QIAstat-Dx ME Panel Cartridge includes a full process Internal Control, which is titered
Schizosaccharomyces pombe, a yeast (fungi) 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 homogenization, lysis of viral and cellular structures (by
means of chemical and mechanical disruption), nucleic acid purification, reverse transcription,
and real-time PCR.

A positive signal for the Internal Control indicates that all processing steps performed by the
QIAstat-Dx ME 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.

Protocol: cerebrospinal fluid samples

Sample collection, transport and storage

The CSF specimen should be collected via lumbar puncture and should not be centrifuged.

Loading a sample into the QIAstat-Dx ME Panel Cartridge

1. Thoroughly clean the work area with freshly prepared 10% bleach (or a suitable
disinfectant) followed by a water rinse.
2. Open the package of a QIAstat-Dx ME Panel Cartridge using the tear notches on the sides
of the packaging (Figure 4).

QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022 19

 IMPORTANT: After the package is opened, sample should be loaded inside the
QIAstat-Dx ME Panel Cartridge and loaded into the QIAstat-Dx Analyzer 1.0 within
120 minutes.

Figure 4. Opening the QIAstat-Dx ME Panel Cartridge.

3. Remove the QIAstat-Dx ME Panel Cartridge from the packaging and position it so that the
bar code on the label faces you.
4. Manually write the sample information or place a sample information label on the top of
the QIAstat-Dx ME Panel Cartridge. Make sure that the label is properly positioned and
does not block the lid opening (Figure 5).

20 QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022

Figure 5. Sample information placement on top of QIAstat-Dx Meningitis/Encephalitis Panel Cartridge.

5. Open the sample lid of the main port on the front of the QIAstat-Dx ME Panel Cartridge
(Figure 6).

Figure 6. Opening the sample lid of main port.

6. Open the tube with the sample to be tested. Use the supplied transfer pipette to draw fluid
up to the second fill line on the pipette (i.e., 200 µL) (Figure 7).
IMPORTANT: Do not draw air into the pipette. If air is drawn into the pipette, carefully
expel the sample fluid in the pipette back into the sample tube and draw up fluid again.

QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022 21

Figure 7. Drawing sample into the supplied transfer pipette.

7. Carefully transfer 200 µl of sample into the main port of the QIAstat-Dx ME Panel Cartridge
using the supplied single-use transfer pipette (Figure 8).

Figure 8. Transferring sample to main port of QIAstat-Dx ME Panel Cartridge.

22 QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022

8. Firmly close the lid of the main port until it clicks (Figure 9, ).

Figure 9. Closing the lid of the main port.

9. Visually confirm that the sample has been loaded by checking the sample inspection
window of the QIAstat-Dx ME Panel Cartridge (Figure 10, ).
IMPORTANT: After the sample is placed inside the QIAstat-Dx ME Panel Cartridge, the
cartridge must be loaded into the QIAstat-Dx Analyzer 1.0 within 90 minutes.

Figure 10. Sample inspection window (blue arrow).

QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022 23

Starting the QIAstat-Dx Analyzer 1.0

1. Power ON the QIAstat-Dx Analyzer 1.0 by pressing 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.
2. Wait until the Main screen appears and the QIAstat-Dx Analyzer 1.0 status indicators
turn green and stop blinking.
3. 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.
4. 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 72, for additional information).

Running a test

1. Press the Run Test button in the top-right corner of the touchscreen of the QIAstat-Dx
Analyzer 1.0.
2. When prompted, scan the sample ID bar code on the CSF tube containing the sample, or
scan the specimen information barcode located on the top of the QIAstat-Dx ME 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.

24 QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022

Figure 11. Scanning sample ID bar code.

3. When prompted, scan the bar code of the QIAstat-Dx ME 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 ME 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 ME 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 Meningitis/Encephalitis Panel Cartridge bar code.

QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022 25

4. 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.
5. 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).

Figure 13. Confirming data entry.

6. Make sure that both sample lids of the swab port and main port of the QIAstat-Dx ME 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 ME Panel Cartridge with the bar
code facing to the left and the reaction chambers facing down (Figure 14).
Note: There is no need to push the QIAstat-Dx ME 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.
Note: The swab port is not used for the QIAstat-Dx ME Panel assay.

26 QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022

Figure 14. Inserting QIAstat-Dx ME Panel Cartridge into QIAstat-Dx Analyzer 1.0.

7. Upon detecting the QIAstat-Dx ME 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 ME 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 ME Panel Cartridge is not positioned in the port. If this occurs, repeat the
procedure starting with step 18.
8. While the test is running, the remaining run time is displayed on the touchscreen.

QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022 27

 9. After the test run is completed, the Eject screen will appear (Figure 15) 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, contact Technical Service.

Figure 15. Eject screen display.

10. Press Eject on the touchscreen to remove the QIAstat-Dx ME Panel Cartridge and dispose
of it as biohazardous waste in accordance with all national, state, and local health and
safety regulations and laws. The QIAstat-Dx ME Panel Cartridge should be removed when
the cartridge entrance port opens and ejects the cartridge. If the cartridge is not removed
after 30 seconds, it will automatically move back into the QIAstat-Dx Analyzer 1.0, and
the cartridge entrance port lid will close. If this occurs, press Eject to open the lid of the
cartridge entrance port again and then remove the cartridge.
IMPORTANT: Used QIAstat-Dx ME Panel Cartridges must be discarded. It is not possible
to re-use cartridges for tests for which the execution was started but then subsequently
canceled by the operator, or for which an error was detected.
11. After the QIAstat-Dx ME Panel Cartridge has been ejected, the results Summary screen will
appear. To begin the process for running another test, press Run Test.
Note: For further information on the use of the QIAstat-Dx Analyzer 1.0, refer to the
QIAstat-Dx Analyzer 1.0 User Manual.

28 QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022

Interpretation of Results
NOTE: Images of the QIAstat-Dx Analyzer 1.0 screen in this section are meant as an example
and may not represent the specific pathogen results provided for the QIAstat-Dx ME Panel.

Viewing results

The QIAstat-Dx Analyzer 1.0 automatically interprets and saves test results. After ejecting the
QIAstat-Dx ME Panel Cartridge, the results Summary screen is automatically displayed (Figure 16).

Figure 16. Results Summary screen example showing Test Data on the left panel and Test Summary in the main panel.

The main part of the screen provides the following lists and uses color-coding and symbols to
indicate the results:

 The first list, under the heading Detected, includes all pathogens detected and identified in
the sample, which are preceded by a sign and are colored red.
 The second list, under the heading Equivocal is not used. Equivocal results are not applicable
for the QIAstat-Dx ME Panel, therefore, the Equivocal list will always be empty.

QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022 29

 The third list, under the heading Tested, includes all pathogens tested in the sample.
Pathogens detected and identified in the sample are preceded by a sign and are
colored red. Pathogens that were tested but not detected are preceded by a sign and
are colored green. Invalid pathogens are also displayed in this list.

Note: Pathogens detected and identified in the sample are shown in both the Detected and
Tested lists.

If the test failed to complete successfully, a message will indicate Failed followed by the specific
Error Code.

The following Test Data is shown on the left side of the screen:

 Sample ID
 Patient ID (if available)
 Assay Type
 Sample Type

Further data about the assay is available, depending on the operator’s access rights, through
the tabs at the bottom of the screen (e.g., amplification plots and test details).

A report with the assay data can be exported to an external USB storage device. Insert the
USB storage device into one of the USB ports of the QIAstat-Dx Analyzer 1.0 and press Save
Report in the bottom bar of the screen. This report can be exported later at any time by selecting
the test from the View Result List.

The report can also be sent to the printer by pressing Print Report in the bottom bar of the
screen.

30 QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022

Viewing amplification curves

To view test amplification curves of pathogens detected, press the Amplification Curves tab
(Figure 17).

Figure 17. Amplification Curves screen (PATHOGENS tab).

Details about the tested pathogens and controls are shown on the left and the amplification
curves are shown in the center.

Note: If User Access Control is enabled on the QIAstat-Dx Analyzer 1.0, the Amplification
Curves screen is only available for operators with access rights.

Press the PATHOGENS tab on the left side to display the plots corresponding to the tested
pathogens. Press on the pathogen name to select which pathogens are shown in the
amplification plot. It is possible to select single, multiple, or no pathogens. Each pathogen in
the selected list will be assigned a color corresponding to the amplification curve associated
with the pathogen. Unselected pathogens will be shown in gray.

QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022 31

The corresponding CT and endpoint fluorescence (EP) values are shown below each pathogen
name.

Press the CONTROLS tab on the left side to view the controls in the amplification plot. Press the
circle next to the control name to select or deselect it (Figure 18).

Figure 18. Amplification Curves screen (CONTROLS tab).

The amplification plot displays the data curve for the selected pathogens or controls. To
alternate between logarithmic or linear scale for the Y-axis, press the Lin or Log button at the
bottom left corner of the plot.

The scale of the X-axis and Y-axis can be adjusted using the blue pickers on each axis.
Press and hold a blue picker and then move it to the desired location on the axis. Move a blue
picker to the axis origin to return to the default values.

32 QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022

Viewing test details

Press Test Details in the Tab Menu bar at the bottom of the touchscreen to review the results
in more detail. Scroll down to see the complete report.

The following Test Details are shown in the center of the screen (Figure 19):

 User ID
 Cartridge SN (serial number)
 Cartridge Expiration Date
 Module SN (serial number)
 Test Status (Completed, Failed or Canceled by operator)
 Error Code (if applicable)
 Test Start Date and Time
 Test Execution Time
 Assay Name
 Test ID
 Test Result:

 Positive (if at least one meningitis/encephalitis pathogen is detected/identified)

 Negative (if no meningitis/encephalitis pathogen is detected)
 Failed (an error occurred or the test was canceled by the user)

 List of analytes tested in the assay, with CT and endpoint fluorescence in the event of a
positive signal
 Internal Control, with CT and endpoint fluorescence

QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022 33

Figure 19. Example screen showing Test Data on the left panel and Test Details in the main panel.

Browsing results from previous tests

To view results from previous tests that are stored in the results repository, press View Results
on the Main Menu bar (Figure 20).

Figure 20. Example View Results screen.

34 QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022

The following information is available for every executed test (Figure 21):
 Sample ID
 Assay (name of test assay which is “ME“ for Meningitis/Encephalitis Panel)
 Operator ID
 Mod (Analytical Module on which the test was executed)
 Date/Time (date and time when the test was finished)
 Result (outcome of the test: positive [pos], negative [neg], failed [fail] or successful [suc])

Note: If User Access Control is enabled on the QIAstat-Dx Analyzer 1.0, the data for which the
user has no access rights will be hidden with asterisks.

Select one or more test results by pressing the gray circle to left of the sample ID. A checkmark
will appear next to selected results. Unselect test results by pressing this checkmark. The entire
list of results can be selected by pressing the checkmark circle in the top row (Figure 21).

Figure 21. Example of selecting Test Results in the View Results screen.

Press anywhere in the test row to view the result for a particular test.

QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022 35

Press a column headline (e.g., Sample ID) to sort the list in ascending or descending order
according to that parameter. The list can be sorted according to only one column at a time.

The Result column shows the outcome of each test (Table 2).

Table 2. Descriptions of the test results in View Results Screen

Outcome Result Description Action

Positive At least one pathogen is positive Refer to the Summary Result Screen or
pos
Result Printout for pathogen specific
results.

Positive with warning At least one pathogen is positive, Refer to the Summary Result Screen or
pos*
but the Internal Control failed Result Printout for pathogen specific
results.

Negative No analytes were detected Refer to the Summary Result Screen or

neg
Result Printout for pathogen specific
results.

Failed fail The test failed because either an Repeat the test using a new cartridge.
error occurred, the test was Accept the results of the repeat testing.
canceled by the user, or no If the error persists, contact QIAGEN
pathogens were detected and the Technical Services for further
internal control failed. instructions.

Successful The test is either positive or Login from a user profile with rights to
Suc
negative, but the user does not view the results.
have the access rights to view the
test results.

Press Save Report to save the report(s) for the selected result(s) in PDF format to an external
USB storage device.

Select the report type: List of Tests or Test Reports.

Press Search to search the test results by Sample ID, Assay, and Operator ID. Enter the search
string using the virtual keyboard and press Enter to start the search. Only the records containing
the search text will be displayed in the search results.

If the results list has been filtered, the search will only apply to the filtered list.

36 QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022

Press and hold a column headline to apply a filter based on that parameter. For some
parameters, such as Sample ID, the virtual keyboard will appear so the search string for the
filter can be entered.

For other parameters, such as Assay, a dialog will open with a list of assays stored in the
repository. Select one or more assays to filter only the tests that were performed with the
selected assays.

The symbol to the left of a column headline indicates that the column’s filter is active.

A filter can be removed by pressing Remove Filter in the Submenu bar.

Exporting results to a USB drive

From any tab of the View Results screen, select Save Report to export and save a copy of the
test results in PDF format to a USB drive (Figure 22 to Figure 24). The USB port is located on
the front of the QIAstat-Dx Analyzer 1.0. The interpretation of the results in the PDF file is shown
on Table below.

Table 3. Interpretation of test results on PDF reports.

Outcome Symbol Description

Pathogen result Detected Pathogen detected

Not Detected No symbol Pathogen not detected

Invalid No symbol The Internal Control failed there is not valid result for
this target and the sample should be retested

Test Status Completed The test was completed and the Internal Control and/or
one or more targets were detected

Failed The test failed

Internal Controls Passed The Internal Control passed

Failed The Internal Control failed

QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022 37

Figure 22. Sample test report

Figure 23. Sample test report showing details about the test

38 QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022

Figure 24. Sample test report showing assay data.

QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022 39

Printing results

Make sure a printer is connected to the QIAstat-Dx Analyzer 1.0 and the proper driver is
installed. Press Print Report to send a copy of the PDF test results to the printer.

Result interpretation

A result for a Meningitis/Encephalitis organism is interpreted as Positive when the

corresponding PCR assay is positive.

Internal Control interpretation

Internal Control results are to be interpreted according to Table 4.

Table 4. Interpretation of Internal Control results

Control result Explanation Action

Passed The Internal Control amplified The run was completed with success. All results
successfully are valid and can be reported. Detected
pathogens are reported as positive and
undetected pathogens are reported as negative.

Failed The Internal Control failed Positively detected pathogen(s) are reported, but
all negative results (tested but not detected
pathogen[s]) are invalid.
Repeat the testing using a new QIAstat-Dx
Meningitis/Encephalitis Panel Cartridge.

40 QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022

Quality Control
In accordance with QIAGEN’s ISO-certified Quality Management System, each lot of QIAstat-Dx
ME Panel is tested against predetermined specifications to ensure consistent product quality.

Limitations
 Results from the QIAstat-ME Panel are not intended to be used as the sole basis for
diagnosis, treatment, or other patient management decisions.
 Positive results do not rule out co-infection with organisms not included in the QIAstat-Dx ME
Panel. The agent or agents detected may not be the definite cause of the disease. Negative
results do not preclude central nervous system (CNS) infection, as not all potential etiological
agents are detected by this assay, and pathogens targeted by the QIAstat-Dx ME Panel may
be present in lower concentrations below the limits of detection of the system
 Not all agents of CNS infection are detected by this test, and sensitivity in clinical use may
differ from that described in the package insert.
 The QIAstat-Dx ME Panel is not intended for testing of specimens collected from
indwelling CNS medical devices.
 A negative result with the ME Panel does not exclude the infectious nature of the
syndrome. Negative assay results may originate from several factors and their
combinations, including sample handling mistakes, variation in the nucleic acid
sequences targeted by the assay, infection by organisms not included in the assay,
organism levels of included organisms that are below the limit of detection for the assay
and use of certain medications, therapies, or agents.
 The QIAstat-Dx ME Panel is not intended for testing of samples other than those described in
this Instructions for Use. Test performance characteristics have been established only with CSF.
 The QIAstat-Dx ME Panel is intended to be used in conjunction with standard of care (e.g.,
culture for organism recovery, serotyping, and antimicrobial susceptibility testing). The results
from the QIAstat-Dx ME Panel must be interpreted by a trained healthcare professional within
the context of all relevant clinical, laboratory, and epidemiological findings.

QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022 41

 The QIAstat-Dx ME Panel can be used only with the QIAstat-Dx Analyzer 1.0. *
 The QIAstat-Dx ME Panel is a qualitative assay and does not provide a quantitative value
for detected organisms.
 Bacterial, viral, and fungal nucleic acids may persist in vivo, even if the organism is not
viable or infectious. Detection of a target marker does not imply that the corresponding
organism is the causative agent of the infection or the clinical symptoms.
 Detection of bacterial, viral, and fungal nucleic acids depends on proper sample
collection, handling, transportation, storage, and loading into the QIAstat-Dx ME Panel
Cartridge. Improper operations for any of the aforementioned processes can cause
incorrect results, including false-positive or false-negative results.
 The assay sensitivity and specificity for the specific organisms and for all organisms
combined are intrinsic performance parameters of a given assay and do not vary
depending on prevalence. In contrast, both the negative and positive predictive values of
a test result are dependent on the disease/organism prevalence. Please note that a
higher prevalence favors the positive predictive value of a test result, while a lower
prevalence favors the negative predictive value of a test result.
 Accidental contamination of the CSF sample with Propionibacterium acnes – a common
commensal skin flora organism- can generate an unexpected signal (low positive) for
Mycoplasma pneumoniae target in the QIAstat-Dx ME panel. Standard CSF sample
handling should prevent this potential contamination.
 Results obtained during co-infection study in the analytical verification show a potential
inhibition of HSV1 detection when S.pneumoniae is present in the same sample. As this
effect was observed even with low concentrations of S.pneumoniae, negative results for
HSV1 in S.pneumoniae-positive samples should be interpreted with caution. The opposite
effect (inhibition of S.pneumoniae when HSV1 is present in the same sample) was not
observed at the highest tested concentration of HSV1 (1.00E+05 TCID50/ml).

*
DiagCORE Analyzer instruments running QIAstat-Dx software version 1.4 or higher can be used as an alternative to
the QIAstat-Dx Analyzer 1.0.

42 QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022

Performance Characteristics
Clinical performance

The performance characteristics of the QIAstat-Dx Meningitis/Encephalitis (ME) Panel was

assessed by an observational, retrospective, clinical performance study, which included the
testing of 585 eligible cerebrospinal fluid (CSF) residual specimens obtained by lumbar
puncture from patients with signs and symptoms of meningitis and/or encephalitis using the
QIAstat-Dx ME Panel across 3 clinical testing sites in Europe (Table 5).

Table 5. Number of participants per clinical testing site

Sites Number or eligible specimens

Germany 200

France 194

Denmark 191

Overall/Total 585

Table 6 provides a summary of demographic information specimens included in the study.

Table 6. Summary of demographics for the clinical performance study

Variable Subgroup N %

Age Group < 2 years 9 1.55

2-17 years 24 4.15

18-64 years 319 55.09

65+ years 212 36.61

N.S. 15 2.60

Gender Female 282 48.70

Male 282 48.70

N.S. 15 2.60

QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022 43

The performance of the QIAstat-Dx ME panel was evaluated by comparing the QIAstat-Dx ME
Panel test result against the FilmArray Meningitis/Encephalitis Panel. Where there was
disagreement between methods, the discordance was resolved by considering the standard of
care testing result for the site (RT-PCR or culture).

Out of the 585 eligible clinical specimens, 579 produced an evaluable result. Contrived
samples (n=367) were included to assess performance of pathogens with low prevalence
(Neisseria meningitidis, Streptococcus agalactiae, Enterovirus, Herpes Virus Simplex 1, and
Human Parechovirus) and for Mycoplasma pneumoniae and Streptococcus pyogenes. For
each pathogen that was contrived, the chosen strains were spiked into negative clinical matrix
in at least 10 different samples or pools of negative CSF. Once prepared, the contrived
samples were randomized and blinded then sent to each of the clinical sites for testing within
the standard workflow. Table 7 shows the samples included in the performance calculation.

Table 7. Distribution of clinical and contrived samples analyzed

Variable Subgroup N %

Clinical 579 61.20

Sample Type
Contrived Overall 367 38.80

Neisseria meningitidis 65 6.87

Streptococcus agalactiae 61 6.45

Streptococcus pyogenes 61 6.45

Mycoplasma pneumoniae 61 6.45

Enterovirus 60 6.34

Human parechovirus 59 6.24

Positive percent agreement (PPA) was calculated as 100% x (TP/(TP+FN)). True positive (TP)
indicates that both the QIAstat-Dx ME Panel and reference/comparator method had a positive
result for the specific analyte, and false negative (FN) indicates that the QIAstat-Dx result was
negative while the comparator result was positive. Negative percent agreement (NPA) was
calculated as 100% x (TN/(TN+FP)). True negative (TN) indicates that both QIAstat-Dx ME Panel
and the reference/comparator method had negative results, and a false positive (FP) indicates

44 QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022

that the QIAstat-Dx ME Panel result was positive but the comparator result was negative. The
exact binomial two-sided 95% confidence interval was calculated. Table 8 shows the overall
performance (PPA and NPA) for all pathogens in the QIAstat-Dx ME Panel adding clinical and
contriving sample results. Table 8 lists the PPA and NPA results for the QIAstat-Dx ME Panel. For
PPA, each target specifies if the performance calculation is based on clinical samples, contrived
samples or a combination of both. NPA is reported only based on clinical samples.

Table 8. Clinical Performance acceptance criteria assessment for sensitivity and specificity – after discordant resolution
to SoC Test

PPA NPA

Pathogen Target Testing TP/(TP+FN) % 95% CI TN/(TN+FP) % 95% CI

Type Source

All Overall Clinical 140/147 95.24 90.50% - 7381/7386 99.93% 99.84%-

97.67% 99.97%

Bacteria Escherichia coli Clinical 1/1 100.00% 20.65%- 579/579 100.00% 99.34%-
K1 100.00% 100.00%

Haemophilus Clinical 4/4 100.00% 51.01%- 573/575 99.65% 98.74%-

influenzae 100.00% 99.90%

Listeria Clinical 1/1 100.00% 20.65%- 578/578 100.00% 99.34%-

monocytogenes 100.00% 100.00%

Mycoplasma Contrived 61/61 100.00% 94.08%- NA NA NA

pneumoniae 100.00%

Neisseria Combined 66/66 100.00% 94.5%- 578/578 100.00% 99.34%-

meningitidis 100.00% 100.00%

Streptococcus Combined 63/64 98.44% 91.67%- 576/576 100.00% 99.34%-

agalactiae 99.72% 100.00%

Streptococcus Clinical 16/16 100.00% 80.64%- 563/563 100.00% 99.32%-

pneumoniae 100.00% 100.00%

Streptococcus Contrived 61/61 100.00% 94.08%- NA NA NA

pyogenes 100.00%

Bacteria Clinical 26/26 100.00% 87.13%- 3447/3449 99.94% 99.79%-

Overall 100.00% 99.98%

Continued on the next page

QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022 45

Table 8. (continued from the previous page)

PPA NPA

Pathogen Target Testing TP/(TP+FN) % 95% CI TN/(TN+FP) % 95% CI

Type Source

Virus Enterovirus Combined 66/69 95.65% 87.98%- 570/570 100.00% 99.33%-

98.51% 100.00%

Herpes Clinical 20/20 100.00% 83.89%- 561/561 100.00% 99.32%-

simplex virus 100.00% 100.00%
1 (HSV-1)

Herpes Clinical 23/25 92.00% 75.03%- 555/555 100.00% 99.31%-

simplex virus 97.78% 100.00%
2 (HSV-2)

Human Contrived 59/59 100.00% 93.89%- 579/579 100.00% 99.34%-

Parechovirus 100.00% 100.00%
(HPeV)

Human Clinical 10/11 90.91% 62.26%- 568/569 99.82% 99.01%-

herpes virus 98.38% 99.97%
6 (HHV-6)

Varicella Clinical 52/55 94.55% 85.15%- 523/525 99.62% 98.62%-

zoster virus 98.13% 99.90%

Virus Overall Clinical 113/120 94.17% 88.45%- 3356/3359 99.91% 99.74%-

97.15% 99.97%

Yeast Cryptococcus Clinical 1/1 100.00% 20.65%- 5578/5781 100.00% 99.34%-

gattii/ 100.00% 100.00%
Cryptococcus
neoformans

There were eleven (11) cartridges (out of 596 cartridge runs) that failed to provide a valid result,
yielding a 98.16% success rate on cartridge run.

Conclusion

The QIAstat-Dx Meningitis/Encephalitis Panel demonstrated robust clinical performance

characteristics to aid in the diagnosis of specific agents of meningitis and/or encephalitis and
results must be used in conjunction with other clinical, epidemiological, and laboratory data.

46 QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022

Analytical performance

Sensitivity (Limit of detection)

The Analytical Sensitivity or Limit of Detection (LoD) is defined as the lowest concentration at
which ≥95% of samples tested generates a positive call.

The LoD for each QIAstat-Dx Meningitis/Encephalitis Panel pathogen was assessed by
analyzing dilutions of analytical samples prepared from stocks obtained from commercial
suppliers (ZeptoMetrix® and ATCC®).

The LoD concentration was determined for a total of 40 pathogen strains. The LoD of the
QIAstat-Dx Meningitis/Encephalitis Panel was determined per analyte using selected strains
representing individual pathogens that are possible to detect with the QIAstat-Dx
Meningitis/Encephalitis Panel. All sample dilutions were prepared using negative clinical CSF.
To confirm the established LoD concentration, the required detection rate of all replicates was
≥95% .

At least 4 different cartridge lots and at least 3 different QIAstat-Dx Analyzers were used for
LoD determination for every pathogen.

Individual LoD values for each QIAstat-Dx ME Panel target is shown in Table 9.

QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022 47

Table 9. Limit of detection results

Pathogen Strain Supplier Units LoD

HSV1 HF ATCC TCID50/ml 2.81E+02

HSV1 Macintyre ZeptoMetrix TCID50/ml 3.38E+02

HSV2 G ATCC TCID50/ml 2.81E+01

HSV2 HSV-2. (Strain: MS) ZeptoMetrix U/ml 1.26E+01

Escherichia coli K1 Strain C5 [Bort]; ATCC CFU/ml 3.48E+02

O18ac:K1:H7

Escherichia coli K1 NCTC 9001. Serovar ATCC CFU/ml 7.86E+02

O1:K1:H7

Haemophilus influenzae type b (cap) ATCC CFU/ml 3.16E+02

Haemophilus influenzae Type e [strain AMC 36- ATCC CFU/ml 2.54E+03

A-7]

Listeria monocytogenes Type 1/2b ZeptoMetrix CFU/ml 5.89E+02

Listeria monocytogenes Type 4b. Strain Li 2 ATCC CFU/ml 6.64E+03

Neisseria meningitidis Serotype B. M2092 ATCC CFU/ml 8.28E-02

(encapsulated)
Neisseria meningitidis Serotype Y. M-112 [BO- ATCC CFU/ml 1.33E+01
(encapsulated) 6]

Streptococcus agalactiae Z019 ZeptoMetrix CFU/ml 1.75E+03

Streptococcus agalactiae G19 group B ATCC CFU/ml 3.38E+03

Streptococcus pneumoniae 19F ZeptoMetrix CFU/ml 7.14E+02

Streptococcus pneumoniae Serotype 1. NCTC 7465 ATCC CFU/ml 6.22E-01

Streptococcus pyogenes Z472; Serotype M1 ZeptoMetrix CFU/ml 1.80E+03

Streptococcus pyogenes Bruno [CIP 104226] ATCC CFU/ml 9.10E+01

Mycoplasma pneumoniae PI 1428 ATCC CFU/ml 9.48E+01

Mycoplasma pneumoniae M129 ZeptoMetrix CFU/ml 9.99E+01

Enterovirus A Coxsackievirus A16 ZeptoMetrix TCID50/ml 3.79E+00

Enterovirus A A6, species A. Strain ATCC TCID50/ml 1.60E+02

Gdula

Enterovirus B Coxsackievirus B5 ZeptoMetrix TCID50/ml 8.91E+01

Continued on the next page

48 QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022

Table 9 (continued from the previous page)

Pathogen Strain Supplier Units LoD

Enterovirus B Coxsackievirus A9, species B ZeptoMetrix TCID50/ml 4.36E+01

Enterovirus C Coxsackievirus A17, species C. ATCC TCID50/ml 1.58E+01

Strain G-12

Enterovirus C Coxsackievirus A24. Strain DN-19 ATCC TCID50/ml 4.99E+00

Enterovirus D EV 70, species D, strain J670/71 ATCC TCID50/ml 4.99E+01

Enterovirus D68. Strain

Enterovirus D ATCC TCID50/ml 5.06E+02
US/MO/14-18947

HHV6 HHV-6A. (Strain: GS) Lysate ZeptoMetrix cp/ml 3.13E+04

HHV6 HHV-6B. (Strain: Z29) ZeptoMetrix cp/ml 7.29E+04

HPeV Serotype 1. Strain Harris ZeptoMetrix TCID50/ml 1.07E+03

HPeV Serotype 3 ZeptoMetrix TCID50/ml 3.38E+01

VZV Ellen ZeptoMetrix cp/ml 1.71E+02

Cryptococcus neoformans Serotype D strain WM629, type ATCC CFU/ml 2.21E+03

VNIV

Cryptococcus neoformans C. neoformans H99 ATCC CFU/ml 1.64E+02

Cryptococcus gattii Serotype B strain R272, type VGIIb ATCC CFU/ml 1.32E+04

Cryptococcus gattii A6MR38 [CBS 11545] ATCC CFU/ml 2.60E+03

Continued on the next page

Inclusivity (Analytical Reactivity)

The inclusivity (analytical reactivity) Study extended the list of pathogen strains tested during
the QIAstat-Dx Meningitis/Encephalitis Limit of Detection (LoD) Study to confirm the reactivity
of the detection system in the presence of different strains of the same organisms at a
concentration near the respective Limit of Detection.

A variety of clinically relevant strains of each target organism of the QIAstat-Dx ME Panel
(Inclusivity Strains) representing organism sub-types, strains, and serotypes of different
temporal and geographic diversity of each analyte were included in the study. Analytical
Reactivity (Inclusivity) was performed in two steps:

QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022 49

 In vitro testing: analytical samples of every target included in the QIAstat-Dx ME Panel were
tested to assess the reactivity of the assay. A collection of 178 samples representative of
relevant strains, subtypes, serotypes, and genotypes for the different organisms (e.g. a
range of different meningitis/encephalitis strains isolated from around the world and in
different calendar years) were included in the study.
 In silico analysis: to make assay reactivity predictions of all primers-probe oligonucleotide
sequences included in the panel against publicly available sequence databases to detect
any possible cross-reaction or unexpected detection of any primer set, in silico analysis was
performed. In addition, strains not available for in vitro testing were included in in silico
analysis to confirm the predicted inclusivity of the different strains of the same organisms.

Table 10. Clinically relevant strains/subtypes detected per pathogen

Pathogen Clinically relevant strains/subtypes detected

Encapsulated serotypes (A, B, C, D, E, H, I, K, L, NG, W, W135, X,

Neisseria meningitidis (encapsulated) Y, Z, 29E)
Serotype A (C. neoformans var neoformans), serotype D (C.
Cryptococcus gattii/ neoformans var grubii), serotypes B and C (C. gattii including all
Cryptococcus neoformans VGI,VGII, VGIII, VGIV molecular types)
All human Parechovirus A strains with available 5'-UTR sequence (1,
2, 3, 4, 5, 6, 7, 8, 14, 16, 17, 18, and 19), including echovirus 22
(HPeV 1) and echovirus 23 (HPeV 2). Although there were polyprotein
sequences for HPeV A strains 9, 10, 11, 12, 13 and 15, no 5'-UTR
Human parechovirus sequence were available
Listeria monocytogenes Serotypes 1/2a,1/2b, 1/2c, 3a, 3b, 3c, 4a, 4b, 4c, 4d, 4e, 7
Human herpes virus 6 HHV6a and HHV6b
All encapsulated serotypes (a, b, c, d, e, f) and unencapsulated strains
Haemophilus influenzae (nontypeable, NTHi) including var. H. aegyptus
Coxsackievirus A (CV-A1 through CV-A24), coxsackievirus B (CV-B1
through CV-B6), Echovirus (E-1 through E-33), Enterovirus A (EV-A71,
EV-A76, EV-A89 through EV-A92, EV-A119, EV-A120), Enterovirus B
(EV-B69, EV-B73 through EV-B75, EV-B79, EV-B80 through EV-B88,
EV-B93, EV-B97, EV-B98, EV-B100, EV-B101, EV-B106, EV-B107, EV-
B111), Enterovirus C (EV-C96, EV-C99, EV-C102, EV-C104, EV-
C105, EV-C109, EV-C116 through EV-C118), Enterovirus D (EV-D68,
Enterovirus EV-D70, EV-D94), Poliovirus (PV-1 through PV-3)

Escherichia coli K1 K1 strains

Strains tested for inclusivity are detailed in Table 11.

50 QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022

Table 11. Strains tested for inclusivity

Pathogen Strain/Serotype Supplier

Strain C5 [Bort]; O18ac:K1:H7 ATCC

NCTC 9001. Serovar O1:K1:H7 ATCC

Strain Bi 7509/41; O7:K1:H- NCTC

NCDC Bi 7509-41
ATCC
Serotype O7:K1(L):NM

Escherichia coli K1 NCDC F 11119-41 ATCC

O-2, U9-41* BEI Resources

O-16, F1119-41* BEI Resources

Z136 CTX-M-15 ZeptoMetrix

Sc15 02:K1:H6 NCTC

Strain H61; O45:K1:H10 NCTC

type b (cap) ATCC

Type e [strain AMC 36-A-7] ATCC

Non-typeable [strain Rd KW20] ATCC

Non-typeable [strain 180-a] ATCC

Type a [strain AMC 36-A-3] ATCC

Haemophilus influenzae
Type b [strain Rab] ATCC

Type c [strain C 9007] ATCC

Type d [strain AMC 36-A-6] ATCC

Type f [strain GA-1264] ATCC

L-378 ATCC

Listeria monocytogenes Type 1/2b ZeptoMetrix

Type 4b. Strain Li 2 ATCC

Type 1/2a. Strain 2011L-2676 ATCC

Type 1/2a. Strain Li 20 ATCC

Type 4b ZeptoMetrix

Continued on the next page

QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022 51

Table 11 (continued from the previous page)

Pathogen Strain/Serotype Supplier

serotype 4b. Strain 1071/53 [LMG

ATCC
21264, NCTC 10527]

Li 23. Serotype 4a ATCC

Escherichia coli K1
FSL J2-064 BEI Resources

Gibson ATCC

EGDe ATCC

PI 1428 ATCC

M129 ZeptoMetrix

FH strain of Eaton Agent [NCTC

Mycoplasma pneumoniae ATCC
10119]

UTMB-10P ATCC

MAC ATCC

Serotype B. M2092 [CIP 104218,

ATCC
L. Cunningham]

Serotype Y. M-112 [BO-6] ATCC

Serogroup A, M1027 [NCTC10025] ATCC

Serogroup C, M1628 ATCC

Neisseria meningitidis Serotype D. M158 [37A] ATCC

(encapsulated)
sequence with variant ctrA gene IDT

W135 ATCC

MC58 ATCC

79 Eur. Serogroup B ATCC

Serotype B. M997 [S-3250-L] ATCC

Z019 ZeptoMetrix

G19 group B ATCC

Serotype III. Typing strain D136C(3) [3

Streptococcus agalactiae ATCC
Cole 106, CIP 82.45]

type III-ST283 ATCC

MNZ929 BEI Resources

Continued on the next page

52 QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022

Table 11 (continued from the previous page)

Pathogen Strain/Serotype Supplier

Typing strain H36B - type Ib ATCC

CDC SS700 [A909; 5541], type 1c ATCC

Streptococcus agalactiae
3139 [CNCTC 1/82] Serotype IV ATCC

Z023 ZeptoMetrix

19F ZeptoMetrix

Serotype 1. NCTC 7465 ATCC

Serotype 4. TIGR4 [JNR.7/87] ATCC

Serotype 5. SPN1439-106 [Colombia 5-19] ATCC

Serotype 11A. Type 43 ATCC

Streptococcus pneumoniae Serotype 14. VH14 ATCC

Serotype 19A. Hungary 19A-6 [HUN663] ATCC

Z319; 12F Zeptometrix

Diplococcus pneumoniae; Type 3. Strain [CIP

ATCC
104225]

DCC1476 [Sweden 15A-25] ATCC

Z472; Serotype M1 ZeptoMetrix

Bruno [CIP 104226] ATCC

Z018; Serotype M58 ZeptoMetrix

Serotype M1. MGAS 5005 ATCC

Lancefield's group A/C203 S ATCC

Streptococcus pyogenes NCTC 8709 (Type 6 glossy) ATCC

Group a, type 12. Typing strain T12 [F. Griffith SF

ATCC
42]

Group a, type 14 ATCC

Group a, type 23 ATCC

C203 -Type 3 ATCC

Continued on the next page

QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022 53

Table 11 (continued from the previous page)

Pathogen Strain/Serotype Supplier

Coxsackievirus A16 ZeptoMetrix

A6, species A. Strain Gdula ATCC

A10. M.K. (Kowalik) ATCC

Enterovirus 71. Strain H ATCC

Species A, Serotype EV-A71 (2003 Isolate) ZeptoMetrix

Enterovirus A
Tainan/4643/1998 BEI Resources

A2 Fl [Fleetwood] ATCC

A7 - 275/58 ATCC

A12 - Texas 12 ATCC

EV-A71. Strain BrCr ATCC

Coxsackievirus B5 ZeptoMetrix

Coxsackievirus A9, species B ZeptoMetrix

Species B, Serotype CV-B1, Strain Conn-5 ATCC

Species B, Serotype CV-B2. Strain Ohio-1 ATCC

Coxsackievirus B4 ZeptoMetrix
Enterovirus B
Echovirus 6 ZeptoMetrix

Echovirus 9 ZeptoMetrix

Coxsackievirus B3 ZeptoMetrix

Echovirus 18 NCPV

Species B, Serotype E-11 ATCC

Coxsackievirus A17, species C. Strain G-12 ATCC

Coxsackievirus A24. Strain DN-19 ATCC

Coxsackievirus A21. Strain Kuykendall [V-024-

Enterovirus C ATCC
001-012]

A11 - Belgium-1 ATCC

A13 - Flores ATCC

Continued on the next page

54 QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022

Table 11 (continued from the previous page)

Pathogen Supplier Catalog ID Strain/Serotype

ATCC VR-182* A22 - Chulman

ATCC VR-178* A20 - IH Pool 35

Enterovirus C ATCC VR-176* A18 - G-13

NCTC 0812075v CV-A21. Strain H06452 472

NCTC 0812074v CV-A21. Strain H06418 508

ATCC VR-836 EV 70, species D, strain J670/71

Enterovirus D68. Strain US/MO/14-

ATCC VR-1823
18947

ZeptoMetrix 0810237CF Enterovirus 68. 2007 Isolate

ATCC VR-1824 Enterovirus D68. Strain US/IL/14-18952

ATCC VR-1197 D68. Strain F02-3607 Corn

Enterovirus D
Type 68 Major Group (09/2014 Isolate
ZeptoMetrix 0810302CF*
2)

ATCC VR-1825 Enterovirus D68. Strain US/KY/14-18953

ATCC VR-1826 Enterovirus D68. Strain Fermon

BEI Resources NR-49130 Enterovirus D68. US/MO/14-18949

BEI Resources NR-51998 Enterovirus D68. USA/2018-23089

ATCC VR-260 HF

ZeptoMetrix 0810005CF Macintyre

ATCC VR-733 F

ATCC VR-1493* KOS

ATCC VR-1778* ATCC-2011-1

Herpes Simplex Virus 1
ATCC VR-1789* ATCC-2011-9

NCPV 0104151v 17+

NCTC 1806145v P5A

NCTC 1806147v P6

ZeptoMetrix 0810201CF* Isolate 20

Continued on the next page

QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022 55

Table 11 (continued from the previous page)

Pathogen Strain/Serotype Supplier

G ATCC

HSV-2. (Strain: MS) ZeptoMetrix

ATCC-2011-2 ATCC

131596 NCPV

HG52 NCPV
Herpes simplex virus 2
Isolate 1 ZeptoMetrix

132349 ACV-res NCPV

Isolate 11 Zeptometrix

Isolate 15 Zeptometrix

Isolate 20 Zeptometrix

HHV-6A. (Strain: GS) ZeptoMetrix

HHV-6B. (Strain: Z29) ZeptoMetrix

6B - strain SF ATCC
Human herpes virus 6 6B - strain HST NCPV

Human β-lymphotropic
ATCC
virus strain GS

6A – strain U1102 NCPV

Serotype 1. Strain Harris ZeptoMetrix

Serotype 3 ZeptoMetrix

Serotype 2. Strain
ZeptoMetrix
Williamson

Serotype 4 ZeptoMetrix
Human parechovirus Serotype 5 ZeptoMetrix

Serotype 6 ZeptoMetrix

type 3. Strain US/MO-

ATCC
KC/2014/001

Parechovirus A3. Strain

ATCC
US/MO-KC/2012/006

Continued on the next page

56 QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022

Table 11 (continued from the previous page)
Pathogen Strain/Serotype Supplier

Ellen ZeptoMetrix
Oka ATCC
Isolate A ZeptoMetrix

Isolate B ZeptoMetrix

Strain 275 ZeptoMetrix

Varicella-zoster virus
Webster ATCC
Strain 82 ZeptoMetrix
Isolate D ZeptoMetrix
Strain 9939 ZeptoMetrix
Strain 1700 ZeptoMetrix

Serotype D strain WM629, type VNIV ATCC

H99 ATCC
Strain, CBS 132 ATCC
Serotype A strain WM148, type VNI ATCC
M2092 ATCC
Cryptococcus neoformans Serotype AD strain WM628, type VNIII ATCC
Serotype A ZeptoMetrix

NIH9hi90 BEI Resources

NIH306 BEI Resources

Var grubiiYL99α BEI Resources

Serotype B strain R272, type VGIIb ATCC

A6MR38 ATCC

Serotype B strain WM179, type VGI ATCC

Serotype B strain WM161, type VGIII ATCC

Serotype C strain WM779, type VGIV ATCC

Cryptococcus gattii
A1M R265 ATCC

110 [CBS 883] ATCC

AIR265 BEI Resources

Alg166 BEI Resources

Alg254 BEI Resources

QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022 57

All inclusivity strains tested as part of the study were detected by the panel with the exception
of six strains. These are detailed in Table 12.

Table 12. Inclusivity Strains Not Detected by the QIAstat-Dx ME Panel

Pathogen Strain/Serotype

Herpes simplex virus 1 ATCC-2011-1

Escherichia coli K1 NCDC Bi 7509-41 Serotype O7:K1(L):NM
Escherichia coli K1 Z136 CTX-M-15
Enterovirus C CV-A21. Strain H06452 472
Enterovirus C CV-A21. Strain H06418 508
Streptococcus agalactiae Serotype III. Typing strain D136C(3) [3 Cole 106, CIP 82.45]

Exclusivity

The analytical specificity study was carried out by in vitro testing and in silico analysis to assess
the potential cross-reactivity and exclusivity of the QIAstat-Dx ME Panel. On-panel organisms
were tested to assess the potential for intra-panel cross-reactivity and Off-panel organisms were
tested to evaluate cross-reactivity with organisms not covered by the panel content.

In silico testing results

The result of the in silico analysis performed for all primer/probe designs included in the
QIAstat-Dx Meningitis Encephalitis Panel pointed at 6 potential cross-reactions with off-panel
targets (listed on Table 13)

Table 13. Potential cross reactions from in silico analysis

Off-panel organism On-panel signal

Streptococcus pseudopneumoniae* S. pneumoniae

Listeria innocua* L. monocytogenes
Haemophilus haemolyticus H. influenzae
Cryptococcus amylolentus
Cryptococcus depauperatus* Cryptococcus neoformans/gatti
Cryptococcus wingfieldii

*in silico cross-reactive risk was not confirmed by in vitro testing.

58 QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022

All the organisms on Table 13 were tested in the in vitro analytical specificity study.

In vitro testing results

To demonstrate analytical specificity performance of the QIAstat-Dx Meningitis Panel for

pathogens which might be present in the clinical sample but not covered by the panel content,
a selection of potential cross-reactive pathogens was tested (off-panel testing). In addition, the
specificity and absence of cross-reactivity with pathogens that are part of the QIAstat-Dx
Meningitis Panel has been evaluated at high titers (on-panel testing).

Samples were prepared by spiking potential cross-reactive organisms into artificial CSF matrix
at 105 TCID50/ml for viral targets and 106 CFU/ml for bacterial and fungal targets, or the
highest concentration possible based on the organism stock.

All strains tested for exclusivity are detailed on Table 14. For pathogens marked with * either
quantitative synthetic DNA or inactivated material was used.

Table 14. pathogens tested for exclusivity

Pathogen Strain Supplier Catalog ID

Escherichia coli K1 Strain C5 [Bort]; O18ac:K1:H7 ATCC 700973

Haemophilus influenzae Type e [strain AMC 36-A-7] ATCC 8142

Listeria monocytogenes Type 4b. Strain Li 2 ATCC 19115

Mycoplasma pneumoniae M129 ZeptoMetrix 801579

Neisseria meningitidis Serotype Y. M-112 [BO-6] ATCC 35561

Streptococcus pneumoniae 19F ZeptoMetrix 801439

Streptococcus agalactiae Z019 Zeptometrix 801545

Streptococcus pyogenes Z472; Serotype M1 Zeptometrix 804351

Enterovirus A A6, species A. Strain Gdula ATCC VR-1801

Enterovirus B Coxsackievirus B5 ZeptoMetrix 0810019CF

Enterovirus C Coxsackievirus A17, species C. Strain G-12 ATCC VR-1023

Enterovirus D Enterovirus D68. Strain US/MO/14-18947 ATCC VR-1823

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QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022 59

Table 14 (continued from the previous page)

Pathogen Strain Supplier Catalog ID

Herpes simplex virus 1 Macintyre ZeptoMetrix 0810005CF

Herpes simplex virus 2 HSV-2. (Strain: MS) ZeptoMetrix 0810006CF

Human herpes virus 6 HHV-6B. (Strain: Z29) ZeptoMetrix 0810072CF

Human parechovirus Serotype 3 ZeptoMetrix 0810147CF

Varicella-zoster virus Ellen ZeptoMetrix 0810171CF

Cryptococcus neoformans WM629 [CBS 10079] ATCC MYA-4567

Cryptococcus gattii Serotype B strain R272, type VGIIb ATCC MYA-4094

Adenovirus A12 Huie ATCC VR-863

Adenovirus C2 Adenoid 6 (NIAID 202-001-014) ATCC VR-846

Adenovirus D20 A.A ATCC VR-1090

Adenovirus E4 RI-67 ATCC VR-1572

Adenovirus F41 Tak ZeptoMetrix 0810085CF

BK polyoma virus N/A ATCC VR-837

Coronavirus 229E 229E ATCC VR-740

Coronavirus NL63 NL63 (Amsterdam I) BEI Resources NR-470

Coronavirus OC43 OC43 ATCC VR-1558

Dengue virus (Type 2)* New Guinea C ZeptoMetrix 0810089CFHI

Epstein-Barr Virus B95-8 ZeptoMetrix 0810008CF

Hepatitis B virus (HBV)* N/A ZeptoMetrix 0810031C

Hepatitis C virus (HCV)* N/A ZeptoMetrix 0810032C

Human herpes virus 7 SB ZeptoMetrix 0810071CF

Human herpes virus 8 N/A ZeptoMetrix 0810104CF

Human Immunodeficiency Quantitative Synthetic Human ATCC VR-3245SD

Virus* immunodeficiency virus 1 (HIV-1) RNA

Human Rhinovirus A1b 2060 ATCC VR-1559

Human Rhinovirus A16 11757 ATCC VR-283

Human Rhinovirus B3 FEB ATCC VR-483

Human Rhinovirus B83 Baylor 7 [V-190-001-021] ATCC VR-1193

JC polyoma virus MAD-4 ATCC VR-1583

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60 QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022

Table 14 (continued from the previous page)

Pathogen Strain Supplier Catalog ID

Measles Virus Edmonston ATCC VR-24

Mumps Virus Jones ATCC VR-1438

West Nile Virus* 1986 ZeptoMetrix VR-3274SD

Parainfluenza virus 2 Greer ATCC VR-92

Parainfluenza virus 4 N/A ZeptoMetrix 0810060CF

Parvovirus B19 B19 ZeptoMetrix 0810064C

Respiratory Syncytial Virus A2 ATCC VR-1540

Rotavirus RRV (Rhesus Rotavirus) ZeptoMetrix 0810530CF

Rubella Virus N/A ZeptoMetrix 0810048CF

St. Louis Encephalitis Parton ZeptoMetrix 0810080CFHI

Virus*

Candida glabrata CBS 138 ATCC 2001

Candida krusei N/A ATCC 14243

Candida lusitaniae Z010 ZeptoMetrix 801603

Candida metapsilosis MCO429 ATCC 96143

Candida orthopsilosis MCO471 ATCC 96140

Candida viswanathii PK 233 [NCYC 997, pK233] ATCC 20336

Candida parapsilosis CBS 604 ATCC 22019

Candida tropicalis Vitek #8935 ATCC 750

Cryptococcus albidus AmMS 228 ATCC 66030

Cryptococcus amylolentus NRRY Y-7784 ATCC 56469

Cryptococcus laurentii CBS 139 ATCC 18803

Cryptococcus uniguttulatus AmMS 234 ATCC 66033

Cryptococcus adeliensis = Cryptococcus adeliae ATCC 201412

Cryptococcus adeliae =
Naganishia adeliensis

Cryptococcus flavescens = Cryptococcus laurentii var. flavescens ATCC 10668

Papiliotrema flavescens (Saito) Lodder et Kreger­van Rij

Influenza A H1N1 A/Florida/3/2006 ATCC VR-1893

Influenza A H1N1-2009 A/California/08/2009 (H1N1pdm) ATCC VR-1895

Continued on the next page

QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022 61

Table 14 (continued from the previous page)

Pathogen Strain Supplier Catalog ID

Influenza A H3N2 A/Port Chalmers/1/73 ATCC VR-810

Influenza B B/Virginia/ATCC4/2009 ATCC VR-1784

Cryptococcus wingfieldii = OTU 26 Collection Belga CBS 7118

Tsuchiyaea wingfieldii

Cryptococcus depauperatus = K [ARSEF 2058, CBS 7842] ATCC 64866

Aspergillus depauperatus =
Filobasidiella depauperata

Filobasidium capsuligenum ML-186 ATCC 22179

Naeglaria fowleri* Genomic DNA from Naegleria ATCC 30174D

fowleri

Toxoplasma gondii Haplogroup 2 ATCC 50611

Aspergillus fumigatus Z014 ZeptoMetrix 801716

Candida albicans CBS 562 ATCC 18804

Candida dubliniensis Z145 ZeptoMetrix 801915

Bacillus cereus Z091 ZeptoMetrix 801823

Citrobacter freundii [ATCC 13316, NCTC 9750] ATCC 8090

Corynebacterium striatum CDC F6683 ATCC 43751

Corynebacterium urealyticus 3 [Garcia strain] ATCC 43044

Cronobacter (Enterobacter)
CDC 4562-70 ATCC 29544
sakazakii

Enterobacter aerogenes Z052 ZeptoMetrix 801518

Enterobacter cloacae CDC 442-68 ATCC 13047

Escherichia coli (non-K1) 2003-3055 ATCC BAA-2212

Escherichia fergusonii Z302 ZeptoMetrix 804113

Escherichia hermannii CDC 980-72 ZeptoMetrix 804068

Escherichia vulneris CDC 875-72 ATCC 33821

Haemophilus ducreyi CF101 ATCC 33940

Haemophilus haemolyticus NCTC 10659 ATCC 33390

Haemophilus
536 [NCTC 8479] ATCC 10014
parahaemolyticus

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62 QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022

Table 14 (continued from the previous page)

Pathogen Strain Supplier Catalog ID

Haemophilus parainfluenzae NCTC 7857 ATCC 33392

NCTC 9633
Klebsiella pneumoniae ATCC 13883
[NCDC 298-53, NCDC 410-68]

Listeria innocua SLCC 3379 ATCC 33090

Listeria ivanovii Li 1979 ATCC 19119

Morganella morganii AM-15 ATCC 25830

Streptococcus salivarius C699 ATCC 13419

Streptococcus sanguinis DSS-10 ATCC 10556

Streptococcus
CDC-SS-1757 ATCC BAA-960
pseudopneumoniae

Mycoplasma genitalium M30 ATCC 49895

Neisseria lactamica NCDC A7515 ATCC 23970

Neisseria mucosa AmMS 138 ATCC 49233

Neisseria sicca AMC 14-D-1 ATCC 9913

Neisseria gonorrhoeae Z017 ZeptoMetrix 801482

Pantoea agglomerans Enterobacter agglomerans ATCC 27155

Proprionibacterium acnes NCTC 737 ATCC 6919

Proteus mirabilis LRA 08 01 73 [API SA, DSM 6674] ATCC 7002

PRD-10 [CIP 103467, NCIB 10421,

Pseudomonas aeruginosa ATCC 15442
PCI 812]

Saccharomyces cerevisiae NRRL Y-567 ATCC 9763

Salmonella bongori CIP 82.33 ATCC 43975

Salmonella enterica CDC K-1891 [ATCC 25928] ATCC 13076

Serratia marcescens PCI 1107 ATCC 14756

Shigella boydii CDC C-123 ATCC 12033

Shigella flexneri Z046 ZeptoMetrix 801757

Shigella sonnei AMC 43-GG9 ATCC 9290

Staphylococcus aureus FDA 209 ATCC CRM­6538

Staphylococcus capitis PRA 360 677 ATCC 35661

Continued on the next page

QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022 63

Table 14 (continued from the previous page)

Pathogen Strain Supplier Catalog ID

Staphylococcus epidermidis FDA strain PCI 1200 ATCC 12228

Staphylococcus haemolyticus SM 131 ATCC 29970

Staphylococcus hominis Z031 ZeptoMetrix 801727

Staphylococcus lugdunensis LRA 260.05.79 ATCC 49576

Staphylococcus saprophyticus NCTC 7292 ATCC 15305

Streptococcus anginosus NCTC 10713 ATCC 33397

Streptococcus bovis Z167 ZeptoMetrix 804015

Streptococcus dysgalactiae Grouping strain C74 ATCC 12388

Streptococcus intermedius Z126 ZeptoMetrix 801895

Streptococcus oralis Z307 ZeptoMetrix 804293

Streptococcus mitis (tigurinus) Clinical Isolate ZeptoMetrix 801695

Streptococcus mutans LRA 28 02 81 ATCC 35668

All tested organisms/viruses showed negative results in all three replicates tested (no
unexpected positive signals detected), except for the pathogens shown in the table below.
Pathogens exhibiting cross-reactivity with the panel, and the lowest concentration where cross
reactivity is detected are listed in Table 15.

Table 15. Samples showing cross-reactivity with the panel

QIAstat-Dx Meningitis Target Potential cross-reactive organism† Claimed cross reactive

concentration in the IFU

Mycoplasma pneumoniae Propionibacterium acnes* ≥1.00E+04 CFU/ml

Mycoplasma pneumoniae Mycoplasma genitalium ≥1.00E+06 CCU/ml
Haemophilus influenzae Haemophilus haemolyticus ≥1.00E+03 CFU/ml
Cryptococcus neoformans/gattii Cryptococcus wingfieldii = Tsuchiyaea wingfieldii ≥1.00E+01 CFU/ml
Cryptococcus neoformans/gattii Cryptococcus flavescens = Papiliotrema flavescens ≥4.00E+03 CFU/ml
Cryptococcus neoformans/gattii Cryptococcus amylolentus ≥1.00E+01 CFU/ml

* Propionibacterium acnes was not predicted to cross-react with the Mycoplasma pneumoniae.
†
The in silico predicted cross-reactivity for Listeria innocua with the Listeria monocytogenes assay and Cryptococcus
depauperatus with Cryptococcus neoformans/gattii assay were not confirmed in vitro

64 QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022

Co-infections

Combined samples containing a mixture of two different targets spiked at low and high
concentrations into artificial CSF were tested. Bacterial, viral and yeast targets were included,
and organisms detected in the same reaction chamber were chosen for sample preparation
and testing. Selection and combinations of targets tested was based on clinical relevance.
Three replicates were tested per sample.

A summary of the final co-infection mixes whereby the High Percentage Analyte (HPA) does
not inhibit the Low Percentage Analyte (LPA) is shown in Table 16.

Table 16. Co-infection Mixes where concentration of the HPA does not inhibit the LPA

LPA HPA*

Pathogen Concentration Units Pathogen Concentration Units

Escherichia coli K1 3.30E+02 CFU/ml Haemophilus influenzae 1.00E+06 CFU/ml

Haemophilus CFU/ml
9.48E+02 CFU/ml Escherichia coli K1 1.00E+06
influenzae

Mycoplasma TCID50/ml
2.84E+02 CFU/ml HSV1 1.00E+05
pneumoniae

Mycoplasma CFU/ml
HSV1 2.67E+02 TCID50/ml 1.00E+03
pneumoniae

Haemophilus TCID50/ml
9.48E+02 CFU/ml HSV2 1.00E+02
influenzae

HSV2 3.78E+01 TCID50/ml Haemophilus influenzae 1.00E+06 CFU/ml

HHV6 9.39E+04 CFU/ml Listeria monocytogenes 1.00E+06 CFU/ml

Listeria cp/ml
5.58E+03 CFU/ml HHV6 1.00E+05
monocytogenes

Streptococcus CFU/ml
HSV1† 2.67E+02 TCID50/ml 1.00E+02
pneumoniae

Continued on the next page

QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022 65

Table 16. (continued from the previous page)

LPA HPA*

Pathogen Concentration Units Pathogen Concentration Units

Streptococcus
6.78E+02 CFU/ml HSV1 1.00E+05 TCID50/ml
pneumoniae
Haemophilus Streptococcus
9.48E+02 CFU/ml 1.00E+06 CFU/ml
influenzae pneumoniae
Streptococcus Haemophilus
6.78E+02 CFU/ml 1.00E+06 CFU/ml
pneumoniae influenzae
Listeria Streptococcus
5.58E+03 CFU/ml 1.00E+06 CFU/ml
monocytogenes pneumoniae
Streptococcus Listeria
6.78E+02 CFU/ml 1.00E+06 CFU/ml
pneumoniae monocytogenes
Cryptococcus Streptococcus
6.63E+03 CFU/ml 1.00E+06 CFU/ml
neoformans pneumoniae
Streptococcus Cryptococcus
6.78E+02 CFU/ml 1.00E+05 CFU/ml
pneumoniae neoformans
Neisseria Haemophilus
3.99E+01 CFU/ml 1.00E+06 CFU/ml
meningitidis influenzae
Haemophilus Neisseria
9.48E+02 CFU/ml 1.00E+06 CFU/ml
influenzae meningitidis
Neisseria
VZV 1.62E+02 CFU/ml 1.00E+06 CFU/ml
meningitidis
Neisseria
3.99E+01 CFU/ml VZV 1.00E+05 CFU/ml
meningitidis
Streptococcus
Enterovirus 4.80E+02 TCID50/ml 1.00E+06 CFU/ml
pyogenes
Streptococcus
1.71E+03 CFU/ml Enterovirus 1.00E+05 TCID50/ml
pyogenes
Parechovirus 1.01E+02 CFU/ml Enterovirus 1.00E+05 TCID50/ml

Enterovirus 4.80E+02 CFU/ml Parechovirus 1.00E+05 CFU/ml

HHV6 9.39E+04 cp/ml HSV1 1.00E+05 TCID50/ml

HSV1 2.67E+02 TCID50/ml HHV6 1.00E+05 cp/ml

Streptococcus
5.25E+03 CFU/ml HSV2 1.00E+05 TCID50/ml
agalactiae

* Lowest concentration that does not inhibit the LPA

†
The HPA concentration (S. pneumoniae) that does not inhibit the LPA (HSV1) was identified as 1.00E+02 CFU/ml.
However, this concentration is below the determined assay LoD for S. pneumoniae (7.14E+02 CFU/ml) and a drop-
out of the HPA was observed. (Note: comparable detection was demonstrated when S. pneumoniae was tested at
6.78E+02 CFU/ml and HSV1 was tested at 1.00E+05 TCID50/ml. As such it appears that high concentrations of
HSV1 do not interfere with S. pneumoniae detection, but S. pneumoniae does interfere with HSV1 detection).

66 QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022

Interfering Substances

The effect of potentially interfering substances on the detectability of the QIAstat-Dx ME Panel
organisms was evaluated. The substances tested in the study (31) included endogenous as well
as exogenous substances that are commonly found and/or introduced into CSF specimens
during specimen collection.

All QIAstat-Dx ME Panel target organisms were tested at 3x LoD in artificial CSF matrix and testing
was performed in triplicates. Potential interfering substances were spiked into the samples at a level
predicted to be above the concentration of the substance likely to be found in CSF sample.

Table 17. Summary of interfering substances tested

Name Concentration Tested Interference

Endogenous substances

Human Blood 10% (v/v) No

gDNA 20 µg/ml Yes

gDNA 2 µg/ml No

D(+)Glucose 10 mg/ml No

L-lactate (Na) 2.2 mg/ml No

Immunoglobulin G (human) 20 mg/ml No

Albumin (human) 30 mg/ml No

Peripheral blood mononuclear cells 10,000 cells/µl No

Exogenous substances

Chlorhexidine 0.4% (w/v) No

Ethanol 7% (v/v) No

Bleach 1% (v/v) Yes

Bleach 0.1% (v/v) Yes

Bleach 0.01% (v/v) No

Acyclovir 69 µg/ml No

Amphotericin B 5.1 µg/ml No

Continued on the next page

QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022 67

Table 17 (continued from the previous page)

Name Test Concentration Interferent

Ampicillin 210 µg/ml No

Ceftriaxone (aCSF) 840 µg/ml No

Ceftriaxone (PBS) 840 µg/ml No

Cefotaxime 645 µg/ml No

Ganciclovir 25 µg/ml No

Gentamicin 30 µg/ml No

Meropenem 339 µg/ml No

Vancomycin 180 µg/ml No

Voriconazole 11 µg/ml No

Oseltamivir 0.399 µg/ml No

Non-target microorganisms

Epstein-Barr virus 1E+05 cp/ml No

Influenza A H1N1-2009 1E+05 CEID50/ml No

Cutibacterium acnes 1E+06 CFU/ml No

Staphylococcus epidermidis 1E+06 CFU/ml No

Escherichia coli (non-K1) 1E+06 CFU/ml No

Staphylococcus aureus 1E+06 CFU/ml No

Measles Virus 1E+05 TCID50/ml No

Note: Any solvents or buffers used in the preparation of interfering substances were also tested for possible
interference, none was found.

All potentially interfering endogenous and exogenous substances have been evaluated and have
been confirmed not to interfere with any of the panel target assays at concentrations potentially
found in clinical samples. This is except for Bleach and gDNA, where interference was observed
and as such the lowest concentration of the substance causing interference has been determined.

68 QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022

Carryover

A carryover study was performed to evaluate the potential occurrence of cross-contamination

between consecutive runs when using the QIAstat-Dx Meningitis Encephalitis panel on the
QIAstat-Dx Analyzer 1.0. Pathogenic CSF samples with alternating high-positive (105-106
organism/ml) and negative samples, were conducted on two QIAstat-Dx Analyzer 1.0
instruments. No carryover between samples was observed in the QIAstat-Dx
Meningitis/Encephalitis panel, demonstrating that the system design and recommended
sample handling and testing practices are effective in preventing unexpected results due to
carryover or cross-contamination between samples.

Repeatability and Reproducibility

For the reproducibility assessment, a multi-site scheme was followed by testing both negative
and positive samples at two different study sites with varying workflow variables, such as sites,
days, instruments, operators and cartridge lots that could have an impact on the precision of
the system. Negative samples consisted of artificial CSF. Positive combined samples consisted
of artificial CSF spiked with a representative panel of pathogens covering all types targeted
by the QIAstat-Dx ME Panel (i.e. DNA virus, RNA virus, gram (+) bacteria, gram (-) bacteria
and yeast) at the limit of detection (1x LoD) and at 3x LoD. For each site, testing was performed
across 5 non-consecutive days per mix with 9 replicates per day per mix (leading to a total of
45 replicates per target, concentration, and site), a minimum of 9 different QIAstat-Dx
Analyzers per site, and at least 3 operators on each testing day.

Reproducibility testing was designed to evaluate the critical variables that may impact the
performance of the QIAstat-Dx ME Panel in the context of its routine and intended use.

For the repeatability study, the same sample panel was tested following a single-site scheme.
Repeatability testing was designed to evaluate the precision of a QIAstat-Dx ME Panel
cartridge under similar (intra laboratory) conditions. Repeatability study was assessed with
the same samples used for Reproducibility testing using Site 1.

QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022 69

Table 18. Proportion of Correct Repeatability Results
Two-Sided 95%
Grouping Variable(s) Proportion Confidence Limit
Cryptococcus 1x LoD 60/60 100.00% 94.04% 100.00%
neoformans/ gattii 3x LoD 61/61 100.00% 94.13% 100.00%
Enterovirus 1x LoD 60/60 100.00% 94.04% 100.00%
3x LoD 61/61 100.00% 94.13% 100.00%
Listeria 1x LoD 60/60 100.00% 94.04% 100.00%
monocytogenes
3x LoD 61/61 100.00% 94.13% 100.00%
Mycoplasma 1x LoD 60/60 100.00% 94.04% 100.00%
pneumoniae 3x LoD 61/61 100.00% 94.13% 100.00%

Negative Negative 60/60 100.00% 94.04% 100.00%

Streptococcus 1x LoD 60/60 100.00% 94.04% 100.00%

agalactiae
3x LoD 61/61 100.00% 94.13% 100.00%

Varicella Zoster 1x LoD 51/60 85.00% 73.43% 92.90%

Virus
3x LoD 60/61 98.36% 91.20% 99.96%

Table 19. Proportion of Correct Reproducibility Results

Two-Sided 95%
Grouping Variable(s) Proportion Confidence Limit
Target Concentration Site Fraction Percentage Lower Upper
Cryptococcus 1 45/45 100.00% 92.13% 100.00%
neoformans/ gattii
1xLoD 2 45/45 100.00% 92.13% 100.00%

All 90/90 100.00% 95.98% 100.00%

1 45/45 100.00% 92.13% 100.00%

3xLoD 2 45/45 100.00% 92.13% 100.00%

All 90/90 100.00% 95.98% 100.00%

Enterovirus 1 45/45 100.00% 92.13% 100.00%

1xLoD 2 45/45 100.00% 92.13% 100.00%

All 90/90 100.00% 95.98% 100.00%

1 45/45 100.00% 92.13% 100.00%

3xLoD 2 45/45 100.00% 92.13% 100.00%

All 90/90 100.00% 95.98% 100.00%

Continued on the next page

70 QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022

Table 20 (continued from the previous page)
Grouping Variable(s) Proportion Two-Sided 95% Confidence Limit

Target Concentration Site Fraction Percentage Lower Upper

1 45/45 100.00% 92.13% 100.00%

1xLoD 2 44/45 97.78% 88.23% 99.94%

Listeria All 89/90 98.89% 93.96% 99.97%

monocytogenes 1 45/45 100.00% 92.13% 100.00%

3xLoD 2 45/45 100.00% 92.13% 100.00%

All 90/90 100.00% 95.98% 100.00%

1 45/45 100.00% 92.13% 100.00%

1xLoD 2 45/45 100.00% 92.13% 100.00%
All 90/90 100.00% 95.98% 100.00%
Mycoplasma 1 45/45 100.00% 92.13% 100.00%
pneumoniae
3xLoD 2 45/45 100.00% 92.13% 100.00%

All 90/90 100.00% 95.98% 100.00%

1 44/44 100.00% 91.96% 100.00%

Negative Negative 2 45/45 100.00% 92.13% 100.00%

All 89/89 100.00% 95.94% 100.00%

1 45/45 100.00% 92.13% 100.00%

1xLoD 2 45/45 100.00% 92.13% 100.00%

All 90/90 100.00% 95.98% 100.00%

Streptococcus
agalactiae 1 45/45 100.00% 92.13% 100.00%

3xLoD 2 45/45 100.00% 92.13% 100.00%

All 90/90 100.00% 95.98% 100.00%

1xLoD 1 39/45 86.67% 73.21% 94.95%

2 38/45 84.44% 70.54% 93.51%
All 77/90 85.56% 76.57% 92.08%
Varicella Zoster
Virus 3xLoD 1 44/45 97.78% 88.23% 99.94%

2 45/45 100.00% 92.13% 100.00%

All 89/90 98.89% 93.96% 99.97%

In conclusion, reproducibility and repeatability of the tests performed with QIAstat-Dx

Meningitis Panel have been met.

QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022 71

Appendix A: Installing the Assay Definition File
The Assay Definition File of the QIAstat-Dx ME Panel must be installed on the QIAstat-Dx
Analyzer 1.0 prior to testing with QIAstat-Dx ME Panel Cartridges.

Note: Whenever a new version of the QIAstat-Dx ME Panel assay is released, the new
QIAstat-Dx ME Panel Assay Definition File must be installed prior to testing.

Note: Assay Definition Files are available at www.qiagen.com. The Assay Definition File
(.asy file type) must be saved onto a USB Drive prior to installation on the QIAstat-Dx
Analyzer 1.0. This USB Drive must be formatted with a FAT32 file system.

To import assays to the QIAstat-Dx Analyzer 1.0, proceed with the following steps:

12. Insert the USB storage device containing the Assay Definition File into one of the USB
ports on the QIAstat-Dx Analyzer 1.0.
13. Press the Options button and then select Assay Management. The Assay Management
screen appears in the Content area of the display (Figure 25).

Figure 25.Assay Management screen.

14. Press the Import icon in the bottom left of the screen.

72 QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022

15. Select the file corresponding to the assay to be imported from the USB drive.
16. A dialog will appear to confirm upload of the file.
17. If a previous version of the QIAstat-Dx ME Panel was installed, a dialog will appear to
override the current version by the new one. Press Yes to override.
18.The assay becomes active by selecting Assay Active (Figure 26).

Figure 26. Activating the assay.

19. Assign the active assay to the user by pressing the Options button and then the User
Management button. Select the user who should be allowed to run the assay. Next, select
Assign Assays from the User Options. Enable the assay and press the Save button (Figure 27).

Figure 27. Assigning the active assay.

QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022 73

Appendix B: Glossary
Amplification curve: Graphical representation of the multiplex real-time RT-PCR amplification
data.

Analytical Module (AM): The main QIAstat-Dx Analyzer 1.0 hardware module, in charge of
executing tests on QIAstat-Dx Meningitis/Encephalitis Panel Cartridges. It is controlled by the
Operational Module. Several Analytical Modules can be connected to one Operational
Module.

QIAstat-Dx Analyzer 1.0: The QIAstat-Dx Analyzer 1.0 consists of an Operational Module
and an Analytical Module. The Operational Module includes elements that provide
connectivity to the Analytical Module and enables user interaction with the QIAstat-Dx
Analyzer 1.0. The Analytical Module contains the hardware and software for sample testing
and analysis.

QIAstat-Dx ME Panel Cartridge: A self-contained disposable plastic device with all pre-loaded
reagents required for the complete execution of fully automated molecular assays for the
detection of meningitis/encephalitis pathogens.

IFU: Instructions For Use.

Main port: In the QIAstat-Dx ME Panel Cartridge, inlet for transport medium liquid samples.

Nucleic acids: Biopolymers, or small biomolecules composed of nucleotides, which are

monomers made of three components: a 5-carbon sugar, a phosphate group and a
nitrogenous base.

Operational Module (OM): The dedicated QIAstat-Dx Analyzer 1.0 hardware that provides the
user interface for 1–4 Analytical Modules (AM).

PCR: Polymerase Chain Reaction.

RT: Reverse Transcription.

User: A person who operates the QIAstat-Dx Analyzer 1.0/QIAstat-Dx ME Panel Cartridge in
the intended way.

74 QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022

Appendix C: Disclaimer of warranties
EXCEPT AS PROVIDED IN QIAGEN TERMS AND CONDITIONS OF SALE FOR THE QIAstat-Dx
ME Panel Cartridge, QIAGEN ASSUMES NO LIABILITY WHATSOEVER AND DISCLAIMS
ANY EXPRESS OR IMPLIED WARRANTY RELATING TO THE USE OF THE QIAstat-Dx ME Panel
Cartridge INCLUDING LIABILITY OR WARRANTIES RELATING TO MERCHANTABILITY,
FITNESS FOR A PARTICULAR PURPOSE, OR INFRINGEMENT OF ANY PATENT, COPYRIGHT,
OR OTHER INTELLECTUAL PROPERTY RIGHT ANYWHERE IN THE WORLD.

QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022 75

References
1. Meningitis and Encephalitis Fact Sheet. https://www.ninds.nih.gov/disorders/patient-
caregiver-education/fact-sheets/meningitis-and-encephalitis-fact-sheet

2. Meningitis. https://www.cdc.gov/meningitis/index.html

76 QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022

Symbols
The following table describes the symbols that may appear on the labeling or in this document.

Contains reagents sufficient for <N> reactions

<N>

Use by

In vitro diagnostic medical device

CE marking for European Conformity

Catalog number

Lot number

Material number (i.e., component labeling)

Rn R is for revision of the Handbook and n is the revision number

Temperature limitation

Manufacturer

Consult instructions for use

Caution

Serial number

Do not reuse

QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022 77

 Keep away from sunlight

Do not use if package is damaged

Global Trade Item Number

Flammable, risk of fire

Corrosive, risk of chemical burn

Health hazard, risk of sensitization, carcinogenicity

Risk of harm

78 QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022

Instructions for Use (Handbook) Revision History

Date Changes

Revision 1 Initial release.

January 2022
Revision 2 Updated images to reflect ADF SW Version 1.1
April 2022 Update to the Clinical Performance section.

Revision 3 Correction in Table 9

September 2022

Limited License Agreement for QIAstat-Dx ME Panel

Use of this product signifies the agreement of any purchaser or user of the product to the following terms:
1. The product may be used solely in accordance with the protocols provided with the product and this handbook and for use with components contained in the kit
only. QIAGEN grants no license under any of its intellectual property to use or incorporate the enclosed components of this kit with any components not included
within this kit except as described in the protocols provided with the product, this handbook, and additional protocols available at www.qiagen.com. Some of
these additional protocols have been provided by QIAGEN users for QIAGEN users. These protocols have not been thoroughly tested or optimized by QIAGEN.
QIAGEN neither guarantees them nor warrants that they do not infringe the rights of third-parties.
2. Other than expressly stated licenses, QIAGEN makes no warranty that this kit and/or its use(s) do not infringe the rights of third-parties.
3. This kit and its components are licensed for one-time use and may not be reused, refurbished, or resold.
4. QIAGEN specifically disclaims any other licenses, expressed or implied other than those expressly stated.
5. The purchaser and user of the kit agree not to take or permit anyone else to take any steps that could lead to or facilitate any acts prohibited above. QIAGEN
may enforce the prohibitions of this Limited License Agreement in any Court, and shall recover all its investigative and Court costs, including attorney fees, in any
action to enforce this Limited License Agreement or any of its intellectual property rights relating to the kit and/or its components.
For updated license terms, see www.qiagen.com.

Trademarks: QIAGEN®, Sample to Insight®, QIAstat-Dx®, DiagCORE® (QIAGEN Group); AirClean (AirClean Systems, Inc.); Bel-Art Scienceware® (Bel-Art Products); Clinical and Lab
(Clinical Laboratory and Standards Institute, Inc.). Registered names, trademarks, etc., used in this document, even when not specifically marked as such, are not to be considered un
HB-3002-004 R3 09/2022 © 2022 QIAGEN, all rights reserved.

QIAstat-Dx ME Panel Instructions for Use (Handbook) 09/2022 79

Ordering www.qiagen.com/shop | Technical Support support.qiagen.com | Website www.qiagen.com

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