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.
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 | 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
| Features | Specifications |
|---|---|
| Elution volume | QIAsymphony SP — application dependent |
| Features | QIAsymphony SP/AS — compatible with as many as 4 Rotor-Gene Q MDx instruments Rotor-Gene Q MDx — dynamic range, 10 orders of magnitude |
| Operating temperature | QIAsymphony 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 temperature | QIAsymphony 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 level | QIAsymphony 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 category | II |
| Humidity | QIAsymphony SP/AS — relative humidity of 20–75% (noncondensing); maximum 75% relative humidity Rotor-Gene Q MDx — relative humidity of 10–75% (noncondensing) |
| Instrument dimensions | QIAsymphony 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.) |
| Processing | QIAsymphony SP/AS — automated |
| Heat dissipation/thermal load | Rotor-Gene Q MDx — average, 0.183 kW (632 BTU/hour); peak, 0.458 kW (1578 BTU/hour) |
| Input volume | QIAsymphony SP — application dependent |
| Optical System | Rotor-Gene Q MDx — 6 channels; excitation sources: high energy light-emitting diodes; detector: photomultiplier; acquisition time: 4 seconds |
| Software | Rotor-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 |
| Technology | QIAsymphony SP — QIAGEN magnetic-particles chemistry Rotor-Gene Q MDx — real-time PCR cycler |
| 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 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 operation | For indoor use only |
| Kits or Application Packs designed for this instrument | QIAsymphony 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 instrument | QIAsymphony 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 performance | Rotor-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 time | Rotor-Gene Q MDx — 40 cycles in 45 min with the QIAGEN RG Kits (assay dependent) |
| Weight | QIAsymphony 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 conditions | QIAsymphony 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) |
| Warranty | Rotor-Gene Q MDx — 1 year on instrument; lifetime guarantee on excitation LEDs |
| Altitude | Up to 2000 m (6500 ft) |
Resources
Safety Data Sheets (1)
Performance Data (10)
Application/Protocol Documents for User-Validated Use (6)
Application/Protocol Documents for IVD Use (9)
Brochures & Guides (1)
Instrument User Manuals (2)
Labware Files and Documents (1)
Labware Documents (2)
Application Notes (1)
Application/Protocol Documents (1)
Kit Handbooks (2)
Protocol Files (1)
Instrument Technical Documents (2)
Certificates of Analysis (1)
FAQ
Is it possible to process samples on the AS-module while SP is running?