QIAsymphony RGQ MDx (US)

For in vitro diagnostic (IVD) use in performing FDA cleared or approved nucleic acid testing in clinical laboratories

Products

The QIAsymphony RGQ MDx system is intended for in vitro diagnostic (IVD) use in performing FDA cleared or approved nucleic acid testing in clinical laboratories. It comprises the QIAsymphony SP, QIAsymphony AS, and Rotor-Gene Q MDx instruments. The QIAsymphony SP is an automated system for performing sample preparation for nucleic acid testing. The QIAsymphony AS is an automated system for performing assay setups for nucleic acid testing. The Rotor-Gene Q MDx is a real-time nucleic acid amplification and detection system which measures nucleic acid signals from amplified DNA using fluorescent detection.
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QIAsymphony RGQ MDx (US)

Cat. No. / ID:   9002341

QIAsymphony SP, QIAsymphony AS, Rotor-Gene Q MDx, Rotor-Gene AssayManager software; includes required accessories and consumables, installation, and training; includes 1-year warranty on parts and labor
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artus basic (US) plug-in for Rotor-Gene AssayManager

Cat. No. / ID:   9022910

Compact disc (CD) containing artus basic (US) plug-in for Rotor-Gene AssayManager
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QIAsymphony DSP Virus/Pathogen Mini Kit

Cat. No. / ID:   937036

For 192 preps (200 µl each): includes 2 reagent cartridges and enzyme racks and accessories
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QIAsymphony Cabinet SP/AS

Cat. No. / ID:   9020246

Accessory for correct positioning of the QIAsymphony SP/AS instruments

Features

  • IVD workflow optimization and utility
  • Maximized ease-of-use and convenience

Product Details

QIAGEN's premier sample-to-result in vitro diagnostic workflow solution comprises the QIAsymphony SP, QIAsymphony AS, and Rotor-Gene Q MDx instruments, and Rotor-Gene AssayManager software. QIAsymphony SP/AS is an integrated automated system for performing sample preparation using QIAsymphony DSP (Diagnostic Sample Prep) Kits and subsequent assay setups. Rotor-Gene Q MDx is a real-time nucleic acid amplification and detection system that measures nucleic acid signals from amplified DNA using fluorescent detection. Rotor-Gene AssayManager software performs automated analysis and data interpretation and is used in combination with QIAsymphony RGQ MDx (US) instruments to perform FDA cleared or approved nucleic acid testing. QIAGEN plans to expand the capabilities of QIAsymphony RGQ MDx (US) with new features, IVD assay menus, and workflows.

Principle

QIAsymphony RGQ MDx (US) can save you time by processing as many as 72 samples, from sample to result, in one integrated run.

QIAsymphony RGQ MDx (US) is the integrated system to maximize your efficiency and optimize your IVD workflows, from sample to result. QIAsymphony RGQ MDx (US) synergizes the automated sample preparation and assay setup on the QIAsymphony SP/AS with manual transfer to the Rotor-Gene Q MDx for detection. The QIAsymphony SP, together with the QIAsymphony DSP Virus/Pathogen Kits, automates sample preparation and the QIAsymphony AS delivers reliable and reproducible IVD assay setup. Rotor-Gene AssayManager provides fully automated analysis and interpretation of results, minimizes human error, and delivers results you can trust.

Kits currently available in the US for use with the QIAsymphony RGQ MDx (US)
Kits Instrument Method
QIAsymphony DSP Virus/Pathogen Kits QIAsymphony RGQ MDx (US) Purification of bacterial DNA from a variety of sample types
artus C. difficile QS-RGQ MDx Kit QIAsymphony RGQ MDx (US) Direct qualitative detection of toxigenic C. difficile toxin A and toxin B genes

Procedure

The QIAsymphony RGQ MDx (US) workflow starts with purification of nucleic acids on the QIAsymphony SP instrument. The eluates, containing purified nucleic acids from the sample preparation procedure, are automatically transferred to the QIAsymphony AS module, which performs assay setup. The assays are then manually transferred to the Rotor-Gene Q MDx for real-time amplification, detection, and data analysis.

Applications

The QIAsymphony RGQ MDx (US) is the platform for performing FDA cleared or approved nucleic acid tests.

Future applications will focus on:

  • Menu expansion for pathogen detection
  • Tests for personalized healthcare
  • Pharma co-developed tests

Specifications

FeaturesSpecifications
Elution volumeQIAsymphony SP — application dependent
FeaturesQIAsymphony SP/AS — compatible with as many as 4 Rotor-Gene Q MDx instruments Rotor-Gene Q MDx — dynamic range, 10 orders of magnitude
Operating temperatureQIAsymphony SP/AS — 18–26°C (64.4–78.8ºF) Rotor-Gene Q MDx — 18–30ºC (64–86ºF)
Samples per run (throughput)QIAsymphony SP — 1–96 samples in batches of 24 Rotor-Gene Q MDx — Strip Tubes 0.1 ml (4 tubes) - 72 samples/run
Storage temperatureQIAsymphony SP/AS — 5–40°C (41ºF to 104ºF) in manufacturer's package Rotor-Gene Q MDx — 15 to 30ºC (59ºF to 86ºF) in manufacturer’s package; max. 75% relative humidity (noncondensing); environmental class 1K2 (IEC 60721-3-1)
Pollution levelQIAsymphony SP/AS — 2; Environmental class 3K2 (IEC 60721-3-3); 3M2 (IEC 60721-3-3) Rotor-Gene Q MDx — 2; Environmental class 2K2 (IEC 60721-3-3)
Overvoltage categoryII
HumidityQIAsymphony SP/AS — relative humidity of 20–75% (noncondensing); maximum 75% relative humidity Rotor-Gene Q MDx — relative humidity of 10–75% (noncondensing)
Instrument dimensionsQIAsymphony SP/AS — QIAsymphony SP, width: 128 cm (50.4 in.), height: 103 cm (40.6 in.), depth: 73 cm (28.7 in.); QIAsymphony AS, width: 59 cm (23.2 in.), height: 103 cm (40.6 in.), depth: 73 cm (28.7 in.); QIAsymphony SP/AS (integrated operation), width: 185 cm (72.8 in.), height: 103 cm (40.6 in.), depth: 73 cm (28.7 in.) Rotor-Gene Q MDx — 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.)
ProcessingQIAsymphony SP/AS — automated
Heat dissipation/thermal loadRotor-Gene Q MDx — average, 0.183 kW (632 BTU/hour); peak, 0.458 kW (1578 BTU/hour)
Input volumeQIAsymphony SP — application dependent
Optical SystemRotor-Gene Q MDx — 6 channels; excitation sources: high energy light-emitting diodes; detector: photomultiplier; acquisition time: 4 seconds
SoftwareRotor-Gene Q MDx — Rotor-Gene Q software 2.1.0 or higher, supplied on the installation CD provided; Rotor-Gene AssayManager version 1.0 or higher
TechnologyQIAsymphony SP — QIAGEN magnetic-particles chemistry Rotor-Gene Q MDx — real-time PCR cycler
PowerQIAsymphony 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 MDx — 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
Place of operationFor indoor use only
Kits or Application Packs designed for this instrumentQIAsymphony SP — QIAsymphony DSP Virus/Pathogen Kits QIAsymphony AS — artus C. difficile QS-RGQ MDx Kit Rotor-Gene Q MDx — artus C. dificile QS-RGQ MDx Kit
Protocols/main application on this instrumentQIAsymphony SP — purification of bacterial nucleic acids from a variety of starting materials QIAsymphony AS — PCR setup Rotor-Gene Q MDx — qualitative detection of toxigenic C. difficile toxin A and toxin B genes
Thermal performanceRotor-Gene Q MDx — temperature range, 35°C to 99°C (95°F to 210.2°F); temperature accuracy, ±0.5°C; temperature resolution, ±0.02°C (smallest programmable increment); temperature uniformity, ±0.02°C (standard deviation)
Typical run timeRotor-Gene Q MDx — 40 cycles in 45 min with the QIAGEN RG Kits (assay dependent)
WeightQIAsymphony SP, 175 kg (385.8 lb.); QIAsymphony AS, 90 kg (198 lb.); QIAsymphony SP/AS (integrated operation), 265 kg (584 lb.); Rotor-Gene Q MDx, 12.5 kg (27.6 lb.) (standard configuration)
Transportation conditionsQIAsymphony SP/AS — –25 to 70°C (–13ºF to 158ºF) in manufacturer's package Rotor-Gene Q MDx — –25 to 60ºC (–13ºF to 140ºF) in manufacturer’s package; max. 75% relative humidity (noncondensing); environmental class 2K2 (IEC 60721-3-2)
WarrantyRotor-Gene Q MDx — 1 year on instrument; lifetime guarantee on excitation LEDs
AltitudeUp to 2000 m (6500 ft)

Resources

Safety Data Sheets (1)
Application/Protocol Documents for User-Validated Use (6)
Application/Protocol Documents for IVD Use (9)
Complex200_V6_DSP protocol

QIAsymphony DSP Virus/Pathogen Kit Protocol Sheet_V2_In Vitro Diagnostic use according to the Regulation (EU) 2017/746 on in vitro diagnostics medical devices
Complex200_OBL_V4_DSP protocol

QIAsymphony DSP Virus/Pathogen Kit Protocol Sheet_V2_In Vitro Diagnostic use according to the Regulation (EU) 2017/746 on in vitro diagnostics medical devices
Complex400_V4_DSP protocol

QIAsymphony DSP Virus/Pathogen Kit Protocol Sheet_V2_In Vitro Diagnostic use according to the Regulation (EU) 2017/746 on in vitro diagnostics medical devices
Complex400_OBL_V4_DSP protocol

QIAsymphony DSP Virus/Pathogen Kit Protocol Sheet_V2_In Vitro Diagnostic use according to the Regulation (EU) 2017/746 on in vitro diagnostics medical devices
Complex800_V6_DSP protocol

QIAsymphony DSP Virus/Pathogen Kit Protocol Sheet_V2_In Vitro Diagnostic use according to the Regulation (EU) 2017/746 on in vitro diagnostics medical devices
Complex800_OBL_V4_DSP protocol

QIAsymphony DSP Virus/Pathogen Kit Protocol Sheet_V2_In Vitro Diagnostic use according to the Regulation (EU) 2017/746 on in vitro diagnostics medical devices
Cellfree200_V7_DSP protocol

QIAsymphony DSP Virus/Pathogen Kit Protocol Sheet_V2_In Vitro Diagnostic use according to the Regulation (EU) 2017/746 on in vitro diagnostics medical devices
Cellfree500_V5_DSP protocol

QIAsymphony DSP Virus/Pathogen Kit Protocol Sheet_V2_In Vitro Diagnostic use according to the Regulation (EU) 2017/746 on in vitro diagnostics medical devices
Cellfree1000_V7_DSP protocol


QIAsymphony DSP Virus/Pathogen Kit Protocol Sheet_V2_In Vitro Diagnostic use according to the Regulation (EU) 2017/746 on in vitro diagnostics medical devices
Brochures & Guides (2)
For automated purification of nucleic acids or 6xHis-tagged recombinant proteins from a wide variety of sample types
Instrument User Manuals (2)

For use with QIAsymphony RGQ MDx instruments (QIAsymphony software version 5.0)

Labware Files and Documents (1)
For use with the QIAsymphony SP/AS instruments (software version 4.0)
Labware Documents (2)
QIAsymphony DSP Virus/Pathogen Kit Labware List_V2_In Vitro Diagnostic use according to the Regulation (EU) 2017/746 on in vitro diagnostics medical devices
Application/Protocol Documents (1)
Complex200_V6_DSP
PDF (169KB)
For use with software version 4.0
Kit Handbooks (2)
QIAsymphony DSP Virus/Pathogen Kit Handbook_V2_In Vitro Diagnostic use according to the Regulation (EU) 2017/746 on in vitro diagnostics medical devices
Instrument Technical Documents (2)
Script change document for software version 4.0
Software document for QIAsymphony software version 4.0.1
Certificates of Analysis (1)

FAQ

Is it possible to process samples on the AS-module while SP is running?
Yes. A connected as well as an independent operation between QS-SP and QS-AS is possible.
FAQ ID -2435