STAT-Dx DiagCORE Respiratory Panel 2 Instructions For Use Manual
DiagCORE® Respiratory Panel 2
Instructions for use
PL-013-05/2018-EN
210002
2 DiagCORE Respiratory Panel 2 Instructions for Use
DiagCORE® Respiratory Panel 2 Instructions for Use (CE)
Cat # RP1: 210002
2018 May
This document is to be used solely for the purpose of analyzing a DiagCORE® Respiratory Panel 2
Cartridge on the DiagCORE® Analyzer. No part of this document may be reproduced or
transmitted by any means, whether electronic or mechanical, or for any purpose, without the
express written permission of STAT-Dx Life, S.L.
© Copyright 2018, STAT-Dx Life, S.L. All rights reserved.
A printed version of these instructions for use is available upon request.
This Instructions for Use can be accessed at http.support.qiagen.com.
STAT-Dx Life, S.L.
Baldiri Reixac 4
08028 Barcelona, Spain
Customer and technical support
If assistance is required, contact Technical Support using the contact information below.
Website: http.support.qiagen.com
When contacting Technical Support about an error with the DiagCORE® Analyzer or about an error
with the DiagCORE® Respiratory Panel 2 Cartridge, note the steps leading up to the error and any
information appearing in any dialog boxes. This will help us solve the problem.
When calling Technical Support about errors, please have the following information ready:
Analyzer serial number, type and version (if applicable)
Error code (if applicable)
Time point when the error occurred for the first time
Frequency of error occurrence (i.e., intermittent or persistent error)
Photo of error, if possible
Copy of support package
DiagCORE Respiratory Panel 2 Instructions for Use 3
Contents
Customer and technical support ............................................................................. 2
Contents ...................................................................................................................... 3
Table of symbols ......................................................................................................... 5
1 Information about the DiagCORE® Respiratory Panel 2 ............................. 6
1.1 Product name and intended use .................................................................... 6
1.2 Package contents .............................................................................................. 7
1.3 Storage and expiration date ............................................................................ 7
2 Safety information ......................................................................................... 8
3 General background .................................................................................... 9
3.1 DiagCORE® Respiratory Panel 2 Cartridge description ................................ 9
3.2 Detected pathogens ....................................................................................... 10
3.3 Description of the procedure ......................................................................... 12
3.4 Sample collection and cartridge loading .................................................... 13
3.5 Sample preparation, nucleic acid amplification, and detection ............ 13
4 Required materials and equipment that are not provided ..................... 15
5 Procedure for dry swab samples ............................................................... 16
5.1 Sample collection, transport, and storage ................................................... 16
5.2 Loading a sample into the DiagCORE® Respiratory Panel 2 Cartridge ... 16
5.3 Starting the DiagCORE® Analyzer .................................................................. 19
5.4 Running a test ................................................................................................... 19
6 Procedure for transport medium liquid samples ...................................... 25
6.1 Sample collection, transport, and storage ................................................... 25
6.2 Loading a sample into the DiagCORE® Respiratory Panel 2 Cartridge ... 25
6.3 Starting the DiagCORE® Analyzer .................................................................. 28
6.4 Running a test ................................................................................................... 29
7 Internal control ............................................................................................ 34
8 Interpretation of results ............................................................................... 35
8.1 Viewing results ................................................................................................... 35
8.2 Result interpretation ......................................................................................... 40
8.3 Internal Control interpretation ........................................................................ 41
4 DiagCORE Respiratory Panel 2 Instructions for Use
9 Installing the Assay Definition File .............................................................. 42
10 Limitations of the procedure .................................................................... 44
11 Performance characteristics. Clinical Performance ............................. 46
12 Performance characteristics. Analytical Performance ......................... 51
12.1 Sensitivity (Limit of Detection) ......................................................................... 51
12.2 Assay Robustness .............................................................................................. 52
12.3 Exclusivity (Analytical Specificity) ................................................................... 52
12.4 Inclusivity (Analytical Reactivity) .................................................................... 54
12.5 Co-Infections ..................................................................................................... 57
12.6 Interfering Substances ..................................................................................... 58
12.7 Carryover ........................................................................................................... 59
12.8 Reproducibility .................................................................................................. 59
12.9 Sample Stability ................................................................................................ 62
13 References ................................................................................................. 63
14 Appendices ............................................................................................... 64
14.1 Disposal information ......................................................................................... 64
14.2 Declaration of conformity ............................................................................... 64
14.3 Glossary .............................................................................................................. 64
14.4 Trademarks and copyright .............................................................................. 65
14.5 Copyright, disclaimer, and warranty ............................................................. 65
14.6 Patent statement ............................................................................................. 65
14.7 Software license agreement .......................................................................... 65
DiagCORE Respiratory Panel 2 Instructions for Use 5
Table of symbols
The following symbols can be found on the DiagCORE® Respiratory Panel 2 Cartridge, packaging,
and these instructions for use.
Description
Legal manufacturer
In vitro diagnostic medical device
CE marking for European Conformity
Catalog number
Storage temperature limitations
Consult instructions for use
Health hazard/hazardous to the ozone layer
Expiration date (YYYY MM DD)
Batch code
Serial number
Do not reuse
Keep away from sunlight
Sufficient for <n> tests
Do not use if package is damaged
Corrosive
n
6 DiagCORE Respiratory Panel 2 Instructions for Use
1 Information about the DiagCORE
®
Respiratory
Panel 2
1.1 Product name and intended use
The DiagCORE® Respiratory Panel 2 is a qualitative test intended for analyzing nasopharyngeal
swab (NPS) samples taken from patients suspected of respiratory infection for the presence of viral
or bacterial nucleic acids. The DiagCORE® Respiratory Panel 2 is able to accept both dry swabs
and transport medium liquid samples. The assay is designed for use with the DiagCORE® Analyzer
for integrated nucleic acid extraction and multiplex, RT-real-time PCR detection.
The following pathogens can be detected and differentiated with the DiagCORE® Respiratory
Panel 2: Influenza A, Influenza A subtype H1N1/2009, Influenza A subtype H1, Influenza A subtype
H3, Influenza B, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43,
Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Respiratory
Syncytial virus A/B, human Metapneumovirus A/B, Adenovirus, Bocavirus, Rhinovirus/Enterovirus,
Mycoplasma pneumoniae, Legionella pneumophila and Bordetella pertussis.
The results from the DiagCORE® Respiratory Panel 2 must be interpreted within the context of all
relevant clinical and laboratory findings.
Assay performance characteristics have been established only for individuals who have shown
respiratory symptoms.
The DiagCORE® Respiratory Panel 2 is intended for professional use only and is not intended for self-
testing.
For in vitro diagnostic use.
DiagCORE Respiratory Panel 2 Instructions for Use 7
1.2 Package contents
DiagCORE® Respiratory Panel 2
Catalog No.
Number of tests
210002
6
DiagCORE® Respiratory Panel 2 cartridge
6 individually packaged cartridges containing
all reagents needed for sample preparation
and multiplex RT-real time PCR plus internal
control
Cartridge composition:
The DiagCORE® Respiratory Panel 2 Cartridge contents includes the following: Ethanol, isopropanol,
enzymes, oligonucleotides, tris-EDTA, sodium azide, guanidine hydrochloride, guanidinium
thiocyanate, guanidine chloride, propylene glycol, triton-x-100 and D-(+)-trehalose dihydrate.
Transfer pipettes
6 individually packaged transfer pipettes for
dispensing liquid sample into the DiagCORE®
Respiratory Panel 2 Cartridge
1.3 Storage and expiration date
Store the DiagCORE® Respiratory Panel 2 Cartridges in a dry, clean storage space at room
temperature (15–25°C). Do not remove the DiagCORE® Respiratory Panel 2 Cartridges or the
transfer pipettes from their individual packaging until actual use. Under these conditions,
DiagCORE® cartridges can be stored until the expiration date printed on the individual packaging.
The expiration date is also included in the cartridge barcode and is read by the DiagCORE®
Analyzer when the cartridge is inserted into the instrument to run a test.
8 DiagCORE Respiratory Panel 2 Instructions for Use
2 Safety information
Always wear appropriate personal protective equipment, including but not limited to disposable
powder-free gloves, a lab coat, and protective eyewear. Protect skin, eyes, and mucus
membranes. Change gloves often when handling samples.
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 Guidelines M29, or other appropriate documents
provided by:
OSHA: Occupational Safety and Health Administration (United States of America)
ACGIH: American Conference of Government Industrial Hygienists (United States of America)
COSHH: Control of Substances Hazardous to Health (United Kingdom)
Follow your institution’s safety procedures for handling biological samples. Dispose of samples,
DiagCORE® cartridges, and transfer pipettes according to the appropriate regulations.
The DiagCORE® cartridge is a closed, single-use device that contains all reagents needed for
sample preparation and multiplex RT- real time PCR within the DiagCORE® Analyzer. Do not use a
DiagCORE® cartridge that is past its expiration date, appears damaged, or leaks fluid. Dispose of
used or damaged cartridges in accordance with all national, state and local health and safety
regulations and laws.
Observe standard laboratory procedures for keeping the working area clean and contamination-
free. Guidelines are outlined in publications like 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).
DiagCORE Respiratory Panel 2 Instructions for Use 9
3 General background
3.1 DiagCORE
®
Respiratory Panel 2 Cartridge description
The DiagCORE® Respiratory Panel 2 Cartridge is a disposable plastic device that allows
performance of fully automated molecular assays for the detection of respiratory pathogens. Main
features of the DiagCORE® Respiratory Panel 2 Cartridge include compatibility with the respiratory
dry swabs (Copan FLOQSwabs, Ref. 503CS01) and transport medium liquid samples, hermetical
containment of the pre-loaded reagents necessary for testing, and true walk-away operation. All
sample preparation and assay testing steps are performed within the cartridge.
All reagents required for the complete execution of a test run are pre-loaded and self-contained
in the DiagCORE® Respiratory Panel 2 Cartridge. The user does not need to come in contact with
and/or manipulate any reagents. During the test, reagents are handled in the Analytical Module
of the DiagCORE® Analyzer by pneumatically-operated microfluidics and make no direct contact
with the Analyzer actuators. The Analyzer 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 DiagCORE® Respiratory Panel 2 Cartridge containing the sample is introduced into the
Analyzer, the following assay steps occur automatically:
Resuspension of internal control
Cell lysis using mechanical and/or chemical means
Membrane-based nucleic acid purification
Mixing of the purified nucleic acid with lyophilized master mix reagents
Transfer of defined aliquots of eluate/master mix to different reaction chambers
Performance of RT-real-time, multiplex PCR testing within each reaction chamber. An increase
in fluorescence, indicating detection of the target analyte, is detected directly within each
reaction chamber.
10 DiagCORE Respiratory Panel 2 Instructions for Use
The layout of the DiagCORE® Respiratory Panel 2 Cartridge and its features are illustrated below.
DiagCORE® Respiratory Panel 2 Cartridge.
3.2 Detected pathogens
Acute respiratory infections can be caused by a variety of pathogens, including bacteria and
viruses, and generally present with nearly indistinguishable clinical signs and symptoms. The rapid
and accurate determination of the presence or absence of potential causative agent(s) helps
make timely decisions regarding treatment, hospital admission, infection control, and return of the
patient to work and family. It may also greatly support improved antimicrobial stewardship and
other important public health initiatives.
The DiagCORE® Respiratory Panel 2 Cartridge is a single-use cartridge that includes all reagents
needed for nucleic acid extraction, nucleic acid amplification, detection, and identification of 22
viral and bacterial pathogens that cause respiratory symptoms. Testing requires a small sample
volume and minimal hands-on time, and the results are available in approximately one hour.
Pathogens that can be detected and identified with the DiagCORE® Respiratory Panel 2 are listed
in Table 1.
DiagCORE Respiratory Panel 2 Instructions for Use 11
Table 1. Pathogens detected by the DiagCORE® Respiratory Panel 2
Pathogen
Classification (genome type)
Influenza A
Orthomyxovirus (RNA)
Influenza A, subtype H1N1/2009
Orthomyxovirus (RNA)
Influenza A subtype H1
Orthomyxovirus (RNA)
Influenza A subtype H3
Orthomyxovirus (RNA)
Influenza B
Orthomyxovirus (RNA)
Coronavirus 229E
Coronavirus (RNA)
Coronavirus HKU1
Coronavirus (RNA)
Coronavirus NL63
Coronavirus (RNA)
Coronavirus OC43
Coronavirus (RNA)
Parainfluenza Virus 1
Paramyxovirus (RNA)
Parainfluenza Virus 2
Paramyxovirus (RNA)
Parainfluenza Virus 3
Paramyxovirus (RNA)
Parainfluenza Virus 4
Paramyxovirus (RNA)
Respiratory Syncytial Virus A/B
Paramyxovirus (RNA)
Human Metapneumovirus A/B
Paramyxovirus (RNA)
Adenovirus
Adenovirus (DNA)
Bocavirus
Parvovirus (DNA)
Rhinovirus/Enterovirus
Picornavirus (RNA)
Mycoplasma pneumoniae
Bacterium (DNA)
Legionella pneumophila
Bacterium (DNA)
Bordetella pertussis
Bacterium (DNA)
Note: Enterovirus and rhinovirus are both detected but not differentiated in the DiagCORE®
Respiratory Panel 2.
12 DiagCORE Respiratory Panel 2 Instructions for Use
3.3 Description of the procedure
Diagnostic tests with the DiagCORE® Respiratory Panel 2 are performed on the DiagCORE®
Analyzer. Samples are collected and loaded manually into the DiagCORE® cartridge:
Option 1: Inserting the swab into the swab port in the case of dry swab sample type.
Option 2: Inserting the liquid into the main port using a transfer pipette in the case of
transport medium liquid sample type.
All of the sample preparation and analysis steps are performed automatically by the DiagCORE®
Analyzer.
DiagCORE Respiratory Panel 2 Instructions for Use 13
3.4 Sample collection and cartridge loading
The collection of samples and their subsequent loading into the DiagCORE® cartridge should be
performed by personnel trained in safe handling of biological samples.
The following steps are involved and must be executed by the user:
1. A nasopharyngeal swab sample is collected.
2. The nasopharyngeal swab is placed into transport medium only in the case of transport medium
liquid sample type.
3. The sample information is manually written on or a sample label is affixed to the top of a
DiagCORE® cartridge.
4. Sample is loaded manually into the DiagCORE
®
cartridge:
Dry swab sample type: The nasopharyngeal swab sample is inserted into the swab port of
the DiagCORE® cartridge.
Transport medium liquid sample type: 300 µL of the sample is transferred into the
DiagCORE® cartridge using a transfer pipette.
In the case of transport medium liquid sample loading, the user performs a visual check of
the sample inspection window (see image below) to confirm that the liquid sample has
been loaded.
5. The sample barcode and DiagCORE
®
cartridge QR code are scanned in the DiagCORE®
Analyzer.
6. The DiagCORE
®
cartridge is introduced into the DiagCORE® Analyzer.
7. The test is started on the DiagCORE
®
Analyzer.
3.5 Sample preparation, nucleic acid amplification, and detection
The extraction, amplification, and detection of nucleic acids in the sample are performed
automatically by the DiagCORE® Analyzer.
1. The liquid sample is homogenized, and cells are lysed in the lysis chamber of the DiagCORE
®
cartridge, which includes a rotor that turns at high speed.
14 DiagCORE Respiratory Panel 2 Instructions for Use
2. Nucleic acids are purified from the lysed sample via binding to a silica membrane in the
purification chamber of the DiagCORE® 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 DiagCORE®
cartridge.
4. The mixture of sample and PCR reagents is dispensed into the DiagCORE
®
cartridge PCR
chambers, which contain lyophilized, assay-specific primers and probes.
5. The DiagCORE
®
Analyzer creates the optimal temperature profiles to carry out effective RT-real
time PCR and performs real-time fluorescence measurements to generate amplification curves.
6. The DiagCORE
®
Analyzer Software interprets the resulting data and process controls and
delivers a test report.
DiagCORE Respiratory Panel 2 Instructions for Use 15
4 Required materials and equipment that are
not provided
The DiagCORE® Respiratory Panel 2 is designed for use with the DiagCORE® Analyzer. Before
beginning a test, make sure the following are available:
DiagCORE
®
Analyzer (at least one Operational module and one Analytical module)
DiagCORE
®
Analyzer User Manual
DiagCORE
®
Latest Assay Definition File software for Respiratory Panel 2 installed in the
Operational module
16 DiagCORE Respiratory Panel 2 Instructions for Use
5 Procedure for dry swab samples
5.1 Sample collection, transport, and storage
1. Collect nasopharyngeal swab samples according to the swab manufacturer’s recommended
procedures.
5.2 Loading a sample into the DiagCORE
®
Respiratory Panel 2 Cartridge
1. Open the package of a DiagCORE
®
Respiratory Panel 2 Cartridge using the tear notches on
the sides of the packaging.
After the package is open, sample should be introduced inside the DiagCORE® Respiratory
Panel 2 cartridge and loaded in the DiagCORE® Analyser within 120 minutes.
2. Take out the cartridge and position it so that the QR code on the label faces you.
DiagCORE Respiratory Panel 2 Instructions for Use 17
3. Manually write the sample information or place a sample information label on the top of the
DiagCORE® cartridge. Make sure that the label is properly positioned and does not block the
lid opening.
4. Open the sample lid of the swab port on the left side of the cartridge.
5. Insert the swab into the cartridge until the breakpoint is aligned with the access opening (the
swab will go no further).
18 DiagCORE Respiratory Panel 2 Instructions for Use
6. Break the swab shaft at the breakpoint, leaving the rest of the swab in the cartridge.
7. Firmly close the lid of the swab port until it clicks.
DiagCORE Respiratory Panel 2 Instructions for Use 19
After sample is introduced inside the DiagCORE® Respiratory Panel 2 cartridge, cartridge must
be loaded in the DiagCORE® Analyser within 90 minutes.
5.3 Starting the DiagCORE
®
Analyzer
1. Press the On/Off button on the front of the Analyzer to start the unit.
NOTE
The power switch at the back of the Analytical Module must be set in the “I”
position. The DiagCORE® Analyzer status indicators turn blue in this case.
2. Wait until the Main screen appears and the DiagCORE
®
Analyzer status indicators turn green
and stop blinking.
3. Log in to the DiagCORE
®
Analyzer 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. In case the Assay Definition File software has not been installed in the Analyzer follow the
instructions prior to running the test (See Section 9 of this document for additional information)
5.4 Running a test
1. Press the Run Test button at the top right corner of the touchscreen of the DiagCORE
®
Analyzer.
2. When prompted, scan the sample ID barcode on the nasopharyngeal swab, or scan the
specimen information barcode placed on the top of the DiagCORE® cartridge, using the front
barcode reader that is integrated into the DiagCORE® Analyzer See figure below).
20 DiagCORE Respiratory Panel 2 Instructions for Use
NOTE
It is also possible to enter the sample ID using the virtual keyboard of the
touchscreen by pressing on 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 DiagCORE® Analyzer appear in the Instructions Bar at
the bottom of the touchscreen.
3. When prompted, scan the barcode of the DiagCORE
®
Respiratory Panel 2 Cartridge to be used.
The DiagCORE® Analyzer automatically recognizes the assay to be run, based on the cartridge
barcode.
DiagCORE Respiratory Panel 2 Instructions for Use 21
NOTE
The DiagCORE® Analyzer will not accept cartridges with elapsed expiration
date, 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
cartridge will be rejected. Refer to the DiagCORE® Analyzer User Manual for
further details on how to install assays.
4. Select the appropriate sample type from the list (See image below).
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