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QIAstat-Dx Respiratory Panel Plus

Cat no. / ID.   691224

6 individually packaged cartridges containing all reagents needed for sample preparation and multiplex RT-PCR, plus internal control, including six transfer pipettes.
ProductInstrument
QIAstat-Dx Respiratory Panel Plus
QIAstat-Dx Analyzer 2.0
QIAstat-Dx Operational Module PRO
QIAstat-Dx Analytical Module
The QIAstat-Dx Respiratory Plus Panel can be used with the QIAstat-Dx Analyzer 1.0, QIAstat-Dx Analyzer 2.0 and QIAstat-Dx Rise.
QIAstat-Dx instruments and QIAstat-Dx panels are intended for in vitro diagnostic use. For up-to-date licensing information and product-specific disclaimers, see the respective QIAGEN kit instructions for use or user manual. QIAGEN instructions for use and user manuals are available at www.qiagen.com or can be requested from QIAGEN Technical Services (or your local distributor).
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Features

  • Intuitive workflow with minimal hands-on time
  • Uses RT-PCR to deliver comprehensive results in about an hour
  • Provides Ct values and amplification curves for all detected pathogens directly on the instrument touchscreen
  • No precision pipetting required
  • QIAsphere-connected for real-time updates and custom epidemiology reports*

 

Product Details

QIAstat-Dx simplifies infectious disease diagnostics so you can get faster results for your patients. All you need are a patient sample, a QIAstat-Dx assay cartridge and our intuitive QIAstat-Dx instrument.

The QIAstat-Dx assay cartridges use multiplex real-time (RT) PCR technology – also known as syndromic testing – to quickly survey many different targets in a single patient sample. The cartridges come ready with all reagents preloaded and use our trusted assay chemistry to provide comprehensive results in about an hour.

The QIAstat-Dx Analyzer 2.0 is our flexible modular system, perfect for labs of every size. Each instrument is made up of 1 Operational Module PRO, which contains the intuitive touchscreen interface, and between 1 to 4 Analytical Modules, letting you test up to 4 samples at once (see "A flexible modular setup to meet your needs"). 

Save time in the lab and streamline your testing with QIAstat-Dx connectivity, powered by QIAsphere*. With QIAsphere, you can:

  • Remotely monitor your instruments in real-time and get test status updates sent to your mobile devices
  • Access on-demand epidemiology reports to support your institution-wide surveillance efforts
  • Reduce instrument downtime with remote troubleshooting and maintenance

Visit our resource hub to learn how syndromic testing with QIAstat-Dx can help you provide the best care possible for your patients.

*Some features require a QIAstat-Dx Connectivity plan. Flexible plans are available to meet your needs.

 

Principle

The QIAstat-Dx Analyzer 2.0, combined with QIAstat-Dx assay cartridges, use real-time PCR to detect target nucleic acids in human biological samples. The QIAstat-Dx Analyzer 2.0 and cartridges are designed as closed systems that contain all necessary reagents, enabling hands-off sample preparation. Detected real-time amplification signals are interpreted by the integrated software and are reported via an intuitive user interface.

Procedure

Setting up and running a QIAstat-Dx test requires minimal hands-on time and just a few simple steps (see " Multiplex panel testing doesn't get easier than this").

  1. Add the patient sample to the main port of the QIAstat-Dx cartridge using the plastic pipette provided. This step is fast and easy to perform and requires no precision pipetting.
  2. Press the Run Test button on the QIAstat-Dx touch screen and scan the sample ID barcode.
  3. Scan the barcode of the cartridge you’re using.
  4. For our QIAstat-Dx Gastrointestinal Panel 2 test, select the sample type (Para-Pak C&S or FecalSwab).
  5. Position the cartridge on the instrument’s sample port. The cartridge will automatically move in and the test will start.
  6. After about an hour, view the comprehensive results.

 

Applications

QIAstat-Dx Respiratory Panel Plus: Our FDA-cleared test to analyze 21 viral and bacterial targets for common pathogens causing respiratory symptoms, including SARS-CoV-2. 

QIAstat-Dx Respiratory Panel Plus – 21 bacterial and viral targets
Viruses Bacteria
  • Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2)
  • Influenza A
  • Influenza A H1N1 pdm09
  • Influenza A H1
  • Influenza A H3
  • Influenza B
  • Human Coronavirus 229E
  • Human Coronavirus HKU1
  • Human Coronavirus NL63
  • Human Coronavirus OC43
  • Parainfluenza virus 1
  • Parainfluenza virus 2
  • Parainfluenza virus 3
  • Parainfluenza virus 4
  • Adenovirus
  • Respiratory syncytial virus
  • Human metapneumovirus
  • Human Rhinovirus/Enterovirus (not differentiated)
  • Mycoplasma pneumoniae
  • Bordetella pertussis
  • Chlamydophila pneumoniae

This version of our assay replaces the QIAstat-Dx Respiratory SARS-CoV-2 Panel. 

The QIAstat-Dx Respiratory Panel Plus can be used on the QIAstat-Dx Analyzer 1.0, QIAstat-Dx Analyzer 2.0 and QIAstat-Dx Rise.

 

QIAstat-Dx Respiratory Panel Mini: Our FDA-cleared test to analyze 5 viral targets for common pathogens causing respiratory symptoms, including Human Rhinovirus. This targeted panel is ideal for low-risk patients.

QIAstat-Dx Respiratory Panel Mini – 5 viral targets
Viruses 
 
  • Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2)  
  • Influenza A  
  • Influenza B
  • Respiratory syncytial virus
  • Human Rhinovirus 

The QIAstat-Dx Respiratory Panel Plus can be used on the QIAstat-Dx Analyzer 1.0, QIAstat-Dx Analyzer 2.0 and QIAstat-Dx Rise.

 

QIAstat-Dx Gastrointestinal Panel 2: Our FDA-cleared test to analyze 16 bacterial, viral and parasitic targets for common pathogens causing gastrointestinal symptoms using preserved stool samples (Para-Pak C&S and FecalSwab). This is our extended panel for high-risk, inpatient testing.

QIAstat-Dx Gastrointestinal Panel 2 – 16 bacterial, viral and parasitic targets
Bacteria   Viruses Parasites
  • Campylobacter (C. jejuni, C. coli and C. upsaliensis)
  • Shigella/Enteroinvasive Escherichia coli (EIEC)
  • Enteropathogenic Escherichia coli (EPEC)
  • Enterotoxigenic Escherichia coli (ETEC) It/st
  • Shiga-like toxin-producing Escherichia coli (STEC) stx1/stx2 (including specific identification of E. coli O157 serogroup within STEC)
  • Salmonella
  • Plesiomonas shigelloides
  • Yersinia enterocolitica
  • Adenovirus F40/41
  • Astrovirus
  • Norovirus GI/GII
  • Rotavirus A
  • Cryptosporidium
  • Cyclospora cayetanensis
  • Entamoeba histolytica
  • Giardia lamblia**

The QIAstat-Dx Gastrointestinal Panel 2 is available for use on the QIAstat-Dx Analyzer 2.0 and the QIAstat-Dx Rise.

QIAstat-Dx Gastrointestinal Panel 2 Mini B&V: Our FDA-cleared test to analyze 4 bacterial and 1 viral target for common pathogens causing gastrointestinal symptoms using preserved stool samples (Para-Pak C&S and FecalSwab). This is our targeted seasonal panel, ideal for outpatient testing.

QIAstat-Dx GI Panel 2 Mini B&V – 5 bacterial and viral targets
Bacteria Viruses
  • Campylobacter
  • Salmonella 
  • Shiga-like toxin E. coli (STEC)
  • Shigella
  • Norovirus

The QIAstat-Dx GI Panel 2 Mini B&V is available for use on the QIAstat-Dx Analyzer 2.0 and the QIAstat-Dx Rise.

QIAstat-Dx Gastrointestinal Panel 2 Mini B: Our FDA-cleared test to analyze 5 bacterial targets for common pathogens causing gastrointestinal symptoms using preserved stool samples (Para-Pak C&S and FecalSwab). This is our targeted panel, ideal for outpatient testing.

QIAstat-Dx GI Panel 2 Mini B – 5 bacterial targets
Bacteria 
  • Campylobacter
  • Salmonella
  • Shiga-like toxin E. coli (STEC)
  • Shigella
  • Yersinia enterocolitica

 

The QIAstat-Dx GI Panel 2 Mini B is available for use on the QIAstat-Dx Analyzer 2.0 and the QIAstat-Dx Rise.

QIAstat-Dx Meningitis/Encephalitis Panel: Our FDA-cleared test to analyze 9 bacterial, viral and fungal nucleic acids from cerebrospinal fluid specimens obtained via lumbar puncture from individuals with signs and/or symptoms of meningitis and/or encephalitis.

QIAstat-Dx Meningitis/Encephalitis Panel – 9 bacterial, viral and fungal targets
Bacteria Viruses Fungi
  • Escherichia coli K1
  • Haemophilus influenzae
  • Listeria monocytogenes
  • Neisseria meningitidis (encapsulated)
  • Streptococcus agalactiae
  • Streptococcus pneumoniae
  • Streptococcus pyogenes
  • Enterovirus
  • Cryptococcus neoformans/gattii***

The QIAstat-Dx Meningitis/Encephalitis Panel is only available for use on the QIAstat-Dx Analyzer 1.0 and QIAstat-Dx Analyzer 2.0.

QIAstat-Dx BCID GPF Plus AMR Panel (cat. no. 691822): Qualitative test to analyze 20 of the most common gram-positive bacteria and fungi causing bloodstream infections and 10 antimicrobial resistance (AMR) markers to support treatment decisions.  

The QIAstat-Dx BCID GPF Plus AMR Panel also contains targets designed to detect a broad range of organisms with a potentially misleading Gram stain result or organisms that may be missed by Gram staining altogether, for example in the case of co-infections. 

The QIAstat-Dx BCID GPF Plus AMR Panel is intended for use in patients with gram-positive bacterial or fungal infections identified as such via Gram stain from positive blood cultures.*

QIAstat-Dx BCID GPF Plus AMR Panel – 20 pathogen targets (15 bacterial and 5 fungal) and 10 AMR targets
Bacteria Fungi AMR targets
  • Bacillus cereus group
  • Corynebacterium
  • Enterococcus faecalis
  • Enterococcus faecium
  • Listeria monocytogenes
  • Micrococcus spp.
  • Staphylococcus aureus
  • Staphylococcus capitis/hominis**
  • Staphylococcus epidermidis
  • Staphylococcus lugdunensis
  • Streptococcus agalactiae
  • Streptococcus anginosus group
  • Streptococcus pneumoniae
  • Streptococcus pyogenes
  • Pan Gram Negative***
  • Cryptococcus neoformans/gattii ****
  • Fusarium
  • Candida auris
  • Candida Group 1*****
    • Candida albicans
    • Candida tropicalis
    • Candida kefyr
    • Candida dubliniensis
    • Candida famata
    • Candida guilliermondii
  • Candida Group 2*****
    • Candida glabrata
    • Candida krusei
    • Candida parapsilosis
    • Candida lusitaniae 
  • aac(6')-aph(2'')
  • cfr
  • ermA
  • ermC
  • tetK
  • tetM
  • mecA
  • mecC
  • vanA
  • vanB

QIAstat-Dx BCID GN Plus AMR Panel (cat. no. 691824): Qualitative test to analyze 13 of the most common Gram-negative bacteria causing bloodstream infections and 18 AMR markers to support treatment decisions.

The QIAstat-Dx BCID GN Plus AMR Panel is intended for use in patients with gram-negative bacterial infections identified as such via Gram stain from positive blood cultures.* 

QIAstat-Dx BCID GN Plus AMR Panel – 13 bacterial targets and 18 AMR targets
Bacteria AMR targets  

Acinetobacter calcoaceticus-baumannii complex

  • Bacteroides fragilis
  • Enterobacter spp.
  • Escherichia coli
  • Haemophilus influenzae
  • Klebsiella spp.
  • Neisseria meningitidis (Encapsulated)
  • Proteus spp.
  • Pseudomonas aeruginosa
  • Salmonella spp.
  • Serratia spp.
  • Stenotrophomonas maltophilia
  • Pan Enterobacterales**
  •  aac(6’)-Ib
  • ampC (CMY/LAT/DHA/FOX)
  • armA
  • CTX-M
  • GES
  • IMP
  • KPC
  • NDM
  • OXA-23
  • OXA-24/40
  • OXA-48-like
  • OXA-58
  • PER
  • SHV
  • SPM
  • TEM
  • VEB
  • VIM

Supporting data and figures

Resources

Kit Handbooks & Protocols (1)
User Manuals (4)
For use with software version 1.2.x or higher
November 2024

Download the QIAstat-Dx Analyzer 1.0 User Manual for setup, operation, maintenance & troubleshooting of QIAGEN's fast, accurate syndromic testing system.
November 2024

For use with software version 1.5.x




For use with software version 1.6.x

March 2026

Essential instructions for setup, use, and maintenance of the QIAstat‑Dx Analyzer 2.0.

Safety Data Sheets (1)
Download Safety Data Sheets for QIAGEN product components.
Certificates of Analysis (1)
Brochures & Guides (5)
QIAGEN Service Solutions for QIAstat-Dx
Maximize uptime. Enhance lab efficiency. Optimize output.
Discover which service agreement best fits your needs and budget.
Operating software (1)

FAQ

Can QIAstat-Dx Analyzer 2.0 connect to HIS (Hospital Information System) and LIS (Laboratory Information System)?

Yes. QIAstat-Dx Analyzer 2.0 can be connected to an HIS/LIS system. Please refer to QIAstat-Dx Analyzer 2.0 User Manual for more information regarding HIS/LIS connectivity.

The LIS Interface Specification Guide is available upon request to QIAGEN Technical Service.

For security considerations regarding the connection, please see QIAstat-Dx Analyzer 2.0 Security and Privacy Guide.

 

 

FAQ-4175
How can I save the data/results?

We strongly recommend that you perform regular system backups according to your organization's policy for the availability of data and protection from data loss. Please see QIAstat-Dx Analyzer 2.0 User Manual for instructions regarding system backup.

Assay data can be saved as a Result Report in PDF to an external USB storage device or for printing.

Selected results can be archived with a subsequent removal option to free memory space on QIAstat-Dx Analyzer 2.0 and/or to support your organization's policy on data retention.

 

FAQ-4176
Can I use any USB storage device on QIAstat-Dx Analyzer 2.0?
QIAstat-Dx Analyzer 2.0 is delivered with a USB storage device which should preferably be used for short-term data storage and general data transfer. It should have the FAT32 format type. Please refer to QIAstat-Dx Analyzer 2.0 Security and Privacy Guide for security considerations.
FAQ-4177
Can QIAstat-Dx Analyzer 2.0 connect to a printer?

Yes. You can connect a printer directly via USB or have a network printer connected via ethernet. Please see QIAstat-Dx Analyzer 2.0 User Manual for the list of recommended and tested printers. 

Additional guidance regarding printer setup troubleshooting and avoiding common printer issues is available upon request. Please contact QIAGEN Technical Service.

FAQ-4178
What happens if the administrator forgets the password? How can the password be reset on QIAstat-Dx Analyzer 2.0?
The user has 3 attempts to enter the correct password. If a user forgets their password, a system administrator can reset it. If the administrator forgets their password, it can only be reset by QIAGEN. This would require an onsite visit by a QIAGEN service engineer. Therefore, we recommend that you create an additional administrator account.
FAQ-4179
How often should I change the air filter on QIAstat-Dx Analyzer 2.0?
The air filter must be replaced every year to ensure appropriate airflow rate inside the unit. Please see QIAstat-Dx Analyzer 2.0 User Manual for instructions regarding air filter change.
FAQ-4180
What is the part number for the QIAstat-Dx air filter in order to replace it?
The catalog number for the air filter is 9026189, Air Filter Tray, AM, QSTAT.
FAQ-4181
Any recommendations for detergents that can be used for cleaning QIAstat-Dx Analyzer 2.0?
QIAstat-Dx Analyzer 2.0 User Manual details the cleaning procedure for the instrument. We recommend using a mild non-abrasive detergent to clean the surfaces.
FAQ-4182
How can we verify the QIAstat-Dx panels?

We have guidelines for laboratory verification of QIAstat-Dx panels performance. Please see Application Notes in this product page to find the applicable resource.

External controls can be purchased separately. Quality control requirements should be performed in conformance with local, state, and/or federal regulations or accreditation requirements and your laboratory's standard quality control procedures.

FAQ-4183
How can we install/uninstall or pack/unpack the Analytical Module (AM)?

Please watch these video tutorials for details:

Installing the AM

QIAstat-Dx instruction video - Installation

Uninstalling the AM

QIAstat-Dx instruction video – Uninstallation

FAQ-4184