S_1272_6_MDx_ST_QIAstat_Dx
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QIAstat-Dx Analytical Module

Cat. No. / ID:  9002814

Module contains the hardware and software for sample testing and analysis
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InstrumentPanel
QIAstat-Dx Analytical Module
QIAstat-Dx Respiratory SARS-CoV-2 Panel
QIAstat-Dx Meningitis/Encephalitis Panel
QIAstat-Dx Gastrointestinal Panel 2
QIAstat-Dx Operational Module
QIAstat-Dx SARS-CoV-2/Flu A/B/RSV Panel
QIAstat-Dx Analyzer 1.0
The QIAstat-Dx Analyzer 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). Product availability may differ from country to country based on regulations and approvals. Contact your country representative for further details.
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Features

  • Intuitive workflow with minimal hands-on time
  • Uses real-time PCR to deliver comprehensive results in about an hour
  • Easily view Ct values and amplification curves for all detected pathogens
  • No precision pipetting required and unique direct swab protocol for input into the cartridge
  • QIAsphere-connected for real-time updates, proactive remote service 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 PCR technology – also known as syndromic testing – to quickly survey many different pathogens 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 1.0 is our flexible modular systems, perfect for labs of every size. Each instrument is made up of 1 Operational Module, which contains the intuitive touch-screen interface, and between 1 through 4 Analytical Modules, letting you test up to four samples at once (see "A flexible modular setup to meet your needs"). The QIAstat-Dx Analyzer 1.0 is a small benchtop unit that will fit in any corner of your lab.

And now you can see critical results even faster with the QIAstat-Dx Analyzer 2.0. With our new Operational Module PRO at the helm, the QIAstat-Dx Analyzer 2.0 blends all the QIAstat-Dx features our customers love with some exciting upgrades. This enhanced QIAstat-Dx instrument introduces our Remote Results Application*, which merges lab accuracy with clinical speed. Now you can review and confirm patient results from any location, paving the way for effortless collaboration between central and regional labs. The QIAstat-Dx Analyzer 2.0 is more than just an upgrade – it’s a giant leap towards a smarter, more interconnected healthcare future.

  • Break boundaries: Review and approve results from anywhere with the Remote Results Application, powered by QIAsphere.
  • Stay in the know: Automatically receive notifications and software updates on your instruments.
  • Customize to your heart’s desire: Easily switch languages, user roles, instrument configurations and more.

 

You’ll save even more time with QIAstat-Dx connectivity, powered by QIAsphere*. With QIAstat-Dx connectivity, you can remotely monitor your instruments in real-time, receive proactive technical support and get on-demand epidemiology reports to support your institution-wide surveillance efforts. Simply install the QIAsphere app on your preferred tablet or smartphone or by accessing the QIAsphere web app through your laptop or desktop browser.

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

 

Principle

The QIAstat-Dx Analyzers 1.0 and 2.0, combined with QIAstat-Dx assay cartridges, use real-time PCR to detect pathogen nucleic acids in human biological samples. The QIAstat-Dx Analyzers 1.0 and 2.0 and cartridges are designed as closed systems that contain on board 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. For our respiratory panels, you can alternatively apply the sample with a dry swab. 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. Position the cartridge on the instrument’s sample port. The cartridge will automatically move in and the test will start.
  5. After about an hour, view the comprehensive results.
See figures

Applications

QIAstat-Dx Respiratory SARS-CoV-2 Panel (V2): Qualitative test to analyze 23 viral and bacterial respiratory targets for common pathogens causing respiratory infections, including SARS-CoV-2.

QIAstat-Dx Respiratory SARS-CoV-2 Panel (V2) – 23 bacterial and viral pathogens
Viruses Bacteria

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

SARS-CoV-2

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 pneumophilia

Bordetella pertussis

Chlamydophila pneumoniae

 

QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1): Qualitative test to analyze 22 viral and bacterial respiratory targets for common pathogens causing respiratory infections, including SARS-CoV-2.

QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1)– 22 bacterial and viral pathogens
Viruses Bacteria

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

SARS-CoV-2

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 pneumophilia 

Bordetella pertussis 

 

QIAstat-Dx SARS-CoV-2/Flu A/B/RSV Panel: Qualitative test to analyze 4 pathogens for common respiratory pathogens to support efforts to provide accessible testing to meet the demands of the COVID-19 outbreak.

QIAstat-Dx SARS-CoV-2/Flu A/B/RSV Panel – 4 viral pathogens
Viruses

SARS-CoV-2

Influenza A

Influenza B

Respiratory syncytial virus A+B

 

QIAstat-Dx Gastrointestinal Panel: Qualitative test to analyze 24 most common pathogens causing gastrointestinal infections.

QIAstat-Dx Gastrointestinal Panel – 24 bacterial, viral and parasitic pathogens
Bacteria Viruses Parasites

Campylobacter (C. jejuni, C. upsaliensis, C. coli)

Clostridium difficile (toxin A/B)

Enteroaggregative E. coli (EAEC)

Shigella/Enteroinvasive E. coli (EIEC)

Enteropathogenic E. coli (EPEC)

Enterotoxigenic E. coli (ETEC) lt/st

Plesiomonas shigelloides

Salmonella spp.

Shiga-like toxin producing E.coli (STEC) stx1/stx2

Shiga-like toxin producing E.coli (STEC) O157:H7

Vibrio vulnificus

Vibrio parahaemolyticus

Vibrio cholerae

Yersinia enterocolitica

Adenovirus F40/41

Astrovirus

Norovirus (GI)

Norovirus (GII)

Rotavirus A

Sapovirus (GI, GII, GIV, GV)

Cryptosporidium

Cyclospora cayetanensis

Entamoeba histolytica

Giardia lamblia

 

QIAstat-Dx Gastrointestinal Panel 2: Qualitative test to analyze 22 most common pathogens causing gastrointestinal infections, including differentiation of Shiga-like toxin producing E. coli (STEC) stx1 and stx2.

QIAstat-Dx Gastrointestinal Panel 2 – 23 pathogens, corresponding to 22 bacterial, viral and parasitic pathogens
Bacteria Viruses Parasites

Campylobacter (C. jejuni, C. upsaliensis, C. coli)

Clostridium difficile (toxin A/B)

Enteroaggregative E. coli (EAEC)

Shigella/Enteroinvasive E. coli (EIEC)

Enteropathogenic E. coli (EPEC)

Enterotoxigenic E. coli (ETEC) lt/st

Plesiomonas shigelloides

Salmonella spp.

Shiga-like toxin-producing E. coli (STEC) stx1 and stx2 (including specific identification of E. coli O157 serogroup within STEC)***

Vibrio vulnificus

Vibrio parahaemolyticus

Vibrio cholerae

Yersinia enterocolitica

Adenovirus F40/41

Astrovirus

Norovirus (GI, GII)

Rotavirus A

Sapovirus (GI, GII, GIV, GV)

Cryptosporidium

Cyclospora cayetanensis

Entamoeba histolytica

Giardia lamblia

QIAstat-Dx Meningitis/Encephalitis Panel: Qualitative test to analyze 15 most common targets; causing central nervous system infections (meningitis and encephalitis).

QIAstat-Dx Meningitis/Encephalitis Panel – 15 bacterial, viral and fungal pathogens
Bacteria Viruses Fungi

Escherichia coli K1

Haemophilus influenzae

Listeria monocytogenes

Neisseria meningitidis (encapsulated)

Streptococcus agalactiae

Streptococcus pneumoniae

Mycoplasma pneumoniae

Streptococcus pyogenes

Enterovirus

Herpes simplex virus 1

Herpes simplex virus 2

Human herpes virus 6

Human parechovirus

Varicella zoster virus

Cryptococcus neoformans/gattii ****

 

Supporting data and figures

Resources

Instrument User Manuals (2)
For use with software version 1.5.2 or higher
For use with software version 1.5.1 or higher
Operating Software (1)
For use with the QIAstat-Dx Analyzer and the DiagCORE Analyzer
Software User Guides (3)
For use with QIAstat-Dx Respiratory SARS-CoV-2 Panel
For use with the QIAstat-Dx Analyzer 2.0 and software 1.6.0
Certificates of Analysis (1)