QIAstat-Dx Respiratory SARS-CoV-2 Panel

QIAstat-Dx

For multiplex syndromic testing applications

  • QIAstat-Dx Respiratory SARS-CoV-2 Panel is authorized by FDA under an Emergency Use Authorization (EUA)
  • Enables detection of the SARS-CoV-2 virus that causes COVID-19, in addition to 20 other respiratory pathogens
  • Intuitive workflow with less than one-minute hands-on time
  • All wet and dry reagents onboard and room temperature stable
  • Comprehensive qualitative results available in about an hour

 

To support the efforts for acessible testing to meet the demands of the COVID-19 outbreak, QIAGEN developed the QIAstat-Dx Respiratory SARS-CoV-2 Panel. This version of our multiplex syndromic cartridge detects and differentiates* 21 respiratory targets, including SARS-CoV-2 from nasopharyngeal swabs (NPS) eluted in universal transport media (UTM).



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.



The QIAstat-Dx Respiratory SARS-CoV-2 Panel is for in vitro diagnostic use under Emergency Use Authorization (EUA) only. 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.

The QIAstat-Dx Respiratory SARS-CoV-2 Panel has not been FDA cleared or approved; 

The QIAstat-Dx Respiratory SARS-CoV-2  Panel has been authorized by FDA under an EUA for use by authorized laboratories; 

The QIAstat-Dx Respiratory SARS-CoV-2  Panel has been authorized only for the detection and differentiation of nucleic acid of SARS-CoV-2 from multiple respiratory viral and bacterial organisms; and 

The QIAstat-Dx Respiratory SARS-CoV-2 Panel is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

 


* Enterovirus and Rhinovirus are both detected, but not differentiated, with the QIAstat-Dx® Respiratory SARS-CoV-2 Panel.

Product Cat. no. List price:
QIAstat-Dx Respiratory SARS-CoV-2 Panel

6 individually packaged cartridges containing all reagents needed for sample preparation and multiplex RT-real time PCR plus internal control, including 6 transfer pipettes

691223
Log in
QIAstat-Dx Analytical Module
Module contains the hardware and software for sample testing and analysis.
9002814
Log in
QIAstat-Dx Analyzer
Instrument consists of both the Operational Module and Analytical Module.
9002824
Log in
QIAstat-Dx Operational Module
Module enables interaction with the QIAstat-Dx Analyzer.
9002813
Log in

The QIAstat-Dx Respiratory SARS-CoV-2 Panel is for in vitro diagnostic use under Emergency Use Authorization (EUA) only. 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.

  • Main Image Navi
QIAsymphony workflows.|Highly sensitive detection of CMV DNA.|Highly sensitive detection of EBV DNA.|Highly sensitive detection of HBV DNA.|Highly sensitive detection of HCV RNA.|Highly sensitive detection of HIV-1 RNA|
There are 2 modes of system operation: integrated or independent.|Probit analysis: CMV (QIAsymphony RGQ system). Analytical sensitivity of the artus CMV QS-RGQ Kit with the QIAsymphony RGQ system using EDTA plasma.|Probit analysis: EBV (QIAsymphony RGQ system). Analytical sensitivity of the artus EBV QS-RGQ Kit with the QIAsymphony RGQ system using EDTA plasma.|Probit analysis: HBV (QIAsymphony RGQ system). Analytical sensitivity of the artus HBV QS-RGQ Kit with the QIAsymphony RGQ system.|Probit analysis: HCV (QIAsymphony RGQ system). Analytical sensitivity of the artus HCV QS-RGQ Kit with the QIAsymphony RGQ system.|Probit analysis: HI Virus-1 (QIAsymphony RGQ system). Analytical sensitivity of the artus HI Virus-1 QS-RGQ Kit with the QIAsymphony RGQ system.|
Performance

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

Pathogen Strain Source Concentration Detection rate
SARS-CoV-2 Clinical Sample Hospital from Barcelona, Spain 500 copies/mL 20/20

 

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.

                                                                        SARS-CoV-2 Targets
Sample Sample type N % positive (95% Cl) % Negative (95%Cl)
Positives Positive clinical sample 10 (10/10) 100% N/A 0/0

N/A

  Low positive contrived sample (1x–2x LOD) 20 (20/20) 100% N/A 0/0 N/A
  Total Positive Samples 30 (30/30) 100% 85.8–100% 0/0 N/A
Negative Total Negative Samples 30 0/0 N/A (30/30) 100% 85.8–100%

 

Principle

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.

The QIAstat-Dx Respiratory SARS-CoV-2 Panel is intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the following organism types and subtypes: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, SARS-CoV-2, Human Metapneumovirus A+B, Influenza A, Influenza A H1, Influenza A H3, Influenza A H1N1/pdm09, Influenza B, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Rhinovirus/Enterovirus, Respiratory Syncytial Virus A+B, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae.

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.

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. The QIAstat-Dx Respiratory SARS-CoV-2 Panel is only for use under the Food and Drug Administration’s Emergency Use Authorization.

Feature
Specifications
Altitude Up to 2000 m (6500 ft.)
Elution volume QIAsymphony SP — 30–500 µl (application dependent)
Features Rotor-Gene Q — dynamic range, 10 orders of magnitude
Heat dissipation/thermal load Rotor-Gene Q — average, 0.183 kW (632 BTU/hour); peak, 0.458 kW (1578 BTU/hour)
Humidity QIAsymphony SP/AS — relative humidity of 15–75% (noncondensing); maximum 75% relative humidity for temperatures up to 31°C, decreasing linearly to 50% humidity at 32°C
Rotor-Gene Q — relative humidity of 10–75% (noncondensing)
Input volume QIAsymphony SP — minimum input volume: 200 µl (application dependent)
Instrument dimensions QIAsymphony SP/AS — QIAsymphony SP, 128 x 103 x 73 cm; QIAsymphony AS, 59 x 103 x 73 cm; QIAsymphony SP/AS (integrated operation), 185 x 103 x 73 cm
Rotor-Gene Q — width, 37 cm (14.6 in.); height, 28.6 cm (11.3 in.); depth (without cables), 42 cm (16.5 in.); depth (door open), 53.8 cm (21.2 in.)
Kits or Application Packs designed for this instrument QIAsymphony SP — QIAsymphony DSP Virus/Pathogen Kits and other QIAsymphony Kits; QIAsymphony AS — artus QS-RGQ Kits (not available in all countries), Rotor-Gene Kits and other QIAGEN real-time and end-point PCR kits
Rotor-Gene Q — artus QS-RGQ Kits (not available in all countries), RG SYBR Green PCR Kits; RG SYBR Green RT-PCR Kit; RG Probe PCR Kits; RG Probe RT-PCR Kit; RG Multiplex PCR Kit
Operating temperature QIAsymphony SP/AS — 15–32°C (59–89.6ºF)
Rotor-Gene Q — 18–30ºC (64–86ºF)
Optical System Rotor-Gene Q — up to 6 channels spanning UV to infra-red wavelengths; excitation sources: high energy light-emitting diodes; detector: photomultiplier; acquisition time: 4 s; the software allows to create new excitation/detection wavelength combinations
Overvoltage category II
Place of operation For indoor use only
Pollution level QIAsymphony SP/AS — 2
Rotor-Gene Q — 2; Environmental class 3K2 (IEC 60721-3-3)
Power QIAsymphony SP/AS — 100–240 V AC, 50–60 Hz, 1400 VA, mains supply voltage are not to exceed 10% of nominal supply voltages
Rotor-Gene Q — 100–240 V AC, 50–60 Hz, 520 VA (peak); Power consumption 8 VA (standby); Mains supply voltage fluctuations are not to exceed 10% of the nominal supply voltages; F5A 250 V fuse
Processing QIAsymphony SP/AS — automated
Protocols/main application on this instrument QIAsymphony SP — purification of DNA, RNA, and bacterial and viral nucleic acids from a wide range of starting materials
QIAsymphony AS — PCR setup
Rotor-Gene Q — gene expression analysis, microRNA detection, virus detection, SNP genotyping, SNP genotyping, High Resolution Melt analysis (HRM)
Samples per run (throughput) QIAsymphony SP — 1–96 samples in batches of 24
Rotor-Gene Q — tubes 0.2 ml; strip tubes 0.1 ml (4 tubes); Rotor-Disc 72; Rotor-Disc 100; up to 100 samples per run using a Rotor-Disc 100
Software Rotor-Gene Q — Rotor-Gene Q software, supplied on the provided installation CD
Storage temperature QIAsymphony SP/AS — 5–40°C (41ºF to 104ºF) in manufacturer's package
Rotor-Gene Q — 15 to 30ºC (59ºF to 86ºF) in manufacturer’s package; max. 75% relative humidity (noncondensing); environmental class 1K2 (IEC 60721-3-1)
Technology QIAsymphony SP — QIAGEN magnetic-particles chemistry
Rotor-Gene Q — real-time PCR cycler
Thermal performance Rotor-Gene Q — temperature range, 35 to 99ºC; temperature accuracy, ±0.5ºC (type, measured 30 seconds after clock start); temperature resolution, ±0.02ºC (smallest programmable increment); temperature uniformity, ±0.02ºC; ramp rate (peak ramp rates, air), >15ºC/s heating, >20ºC/s cooling
Transportation conditions QIAsymphony SP/AS — –25 to 70°C (–13ºF to 158ºF) in manufacturer's package
Rotor-Gene Q — –25 to 60ºC (–13ºF to 140ºF) in manufacturer’s package; max. 75% relative humidity (noncondensing); environmental class 2K2 (IEC 60721-3-2)
Typical run time Rotor-Gene Q — 40 cycles in 45 min with the QIAGEN RG Kits (assay dependent)
Warranty Rotor-Gene Q — 1 year on instrument; lifetime guarantee on excitation LEDs
Weight QIAsymphony SP, 175 kg; QIAsymphony AS, 90 kg; QIAsymphony SP/AS (integrated operation), 265 kg; Rotor-Gene Q, 12.5 kg (27.6 lb.) (standard configuration)

You are not authorized to download the resource

Software User Guides
1
Protocol Files
2
Safety Data Sheets
1
Download Safety Data Sheets for QIAGEN product components.
View
Instrument User Manuals
4
For use with software version 1.2.x or higher
Show details
For use with software version 1.4.x or higher
Show details
For use with software version 1.3.x or higher
Show details
For use with software version 1.2.x or higher
Show details