QIAstat-Dx Respiratory SARS-CoV-2 Panel

• QIAstat-Dx Respiratory SARS-CoV-2 Panel is authorized by FDA under an Emergency Use Authorization (EUA)
• Intuitive workflow with less than one minute 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 all reagents preloaded
• QIAsphere-connected for real-time updates, proactive remote service and custom epidemiology reports

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 is our flexible modular system, 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 condenses dozens of pathogen real-time PCR tests into one small benchtop unit.

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.

The Limit of Detection (LOD) value obtained for the SARS-CoV-2 target tested with the QIAstat-Dx Respiratory SARS-CoV-2 Panel.

The performance of SARS-CoV-2 target in the QIAstat-Dx Respiratory SARS-CoV-2 Panel was evaluated using retrospective nasopharyngeal swab clinical specimens in transport medium.

The QIAstat-Dx Analyzer, combined with QIAstat-Dx assay cartridges, uses real-time PCR to detect pathogen nucleic acids in human biological samples. The QIAstat-Dx Analyzer and cartridges are designed as a closed system that contains 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.

Setting up and running a QIAstat-Dx test requires minimal hands-on time and just a few simple steps. 

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. 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

QIAstat-Dx Respiratory SARS-CoV-2 Panel: Qualitative test to analyze 21 viral and bacterial respiratory targets for common pathogens causing respiratory infections, including SARS-CoV-2.

QIAstat-Dx Respiratory SARS-CoV-2 Panel Intended Use

The QIAstat-Dx Respiratory SARS-CoV-2 Panel is a multiplexed nucleic acid real-time PCR test intended for the qualitative detection and differentiation of nucleic acid from multiple respiratory viral and bacterial organisms, including the SARS-CoV-2 virus, in nasopharyngeal swabs (NPS) eluted in universal transport media collected from patients suspected of COVID 19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity and moderate complexity tests.

SARS-CoV-2 RNA and nucleic acids from the other respiratory viral and bacterial organisms identified by this test are generally detectable in nasopharyngeal swabs (NPS) during the acute phase of infection. Positive results are indicative of the presence of the identified microorganism, but do not rule out co-infection with other pathogens not detected by the test, or lower respiratory tract infection that is not detected by a nasopharyngeal swab. The agent detected may not be the definite cause of disease.

For SARS-CoV-2 positive specimens; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Laboratories within the United States and its territories are required to report all SARS-CoV-2 positive results to the appropriate public health authorities.

Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or other patient management decisions. Negative SARS-CoV-2 results must be combined with clinical observations, patient history, and epidemiological information. Negative results for other organisms identified by the test may require additional laboratory testing (eg., bacterial and viral culture, immunofluorescence and radiography) when evaluating a patient with possible respiratory tract infection.

The QIAstat-Dx Respiratory SARS-CoV-2 Panel is intended for in vitro diagnostic use.

• This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories;
• This product has been authorized only for the detection and differentiation of nucleic acid of SARS-CoV-2 from multiple respiratory viral and bacterial organisms; and
• This emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

Testing with the QIAstat-Dx Respiratory SARS-CoV-2 Panel is intended for use by qualified and trained operators who are proficient in performing the tests using the QIAstat-Dx Analyzer System.