Biocontrol Assurance GDS Rotor-Gene Q User manual

55190.R000.082010
User Manual

Assurance GDS User Manual
2 55190.R000.082010
Assurance GDS®_____________________________________________________________ 3
Overview________________________________________________________________________ 3
Required Materials _______________________________________________________________ 3
Designated Assurance GDS Equipment ____________________________________________ 3
Assurance GDS Rotor-Gene ___________________________________________________ 4
Components_____________________________________________________________________ 4
Operating Conditions ____________________________________________________________ 4
Dimensions ______________________________________________________________________ 4
Installation ______________________________________________________________________ 4
Rotor-Gene (front view) __________________________________________________________ 5
Rotor-Gene (rear view) ___________________________________________________________ 5
Loading the Assurance GDS Rotor-Gene ___________________________________________ 6
Unloading the Assurance GDS Rotor-Gene_________________________________________ 6
Assurance GDS Rotor-Gene Software ___________________________________________ 7
Overview________________________________________________________________________ 7
System Start up__________________________________________________________________ 7
User Levels ______________________________________________________________________ 7
Entering Sample Information _____________________________________________________ 8
Viewing Results __________________________________________________________________ 9
Interpreting Results _____________________________________________________________ 11
Virtual Mode / Analysis Only Mode _______________________________________________ 12
Reports ________________________________________________________________________ 12
Maintenance _______________________________________________________________ 13
Preventive Maintenance _________________________________________________________ 13
Service and Support_____________________________________________________________ 13
Contamination Prevention ___________________________________________________ 14
Recommended Laboratory Organization and Workflow ____________________________ 14
Recommended Laboratory Practices for Contamination Control____________________ 16
Use of Vapor-Lock with Positive Controls _________________________________________ 16
Routine Cleaning and Decontamination of Assurance GDS®Equipment______________ 17
Decontamination ___________________________________________________________ 17
Environmental sampling for DNA contamination with Assurance GDS ______________ 17
Assurance GDS®Equipment Warranty Terms ___________________________________ 18

Assurance GDS User Manual
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Assurance GDS®
Assurance GDS (Genetic Detection System) is an automated nucleic acid amplification system for the detection of
pathogenic organisms in foods, ingredients, and environmental samples.
Overview
Enrichment: Each sample must be enriched via the appropriate protocol, specific to the target organism,
prior to amplification and detection with the Assurance GDS Rotor-Gene®.
Sample Preparation: Following enrichment, target organisms, if present, are concentrated and separated
from the enriched sample.
Amplification and Detection: The concentrated sample is transferred to amplification tubes containing
polymerase enzyme and lyophilized reagents specific for the detection of the target organism. If present,
amplified nucleic acid sequences specific to the target organism generate a fluorescent signal which is read and
interpreted by the Assurance GDS Rotor-Gene to determine test results.
Required Materials
Assurance GDS Test Kit
Polymerase Enzyme
Instrumentation and Supplies
Additional instrumentation and supplies are required to perform Assurance GDS assays. All instrumentation
is included in the Assurance GDS start-up package. Supplies are available for purchase through BioControl
Systems, Inc.
Instrumentation Supplies
Assurance GDS Rotor-Gene Assurance GDS PickPen tips
Laptop computer Pipette tips
Vortex mixer Assurance GDS Sample wells
Assurance GDS Pick-Pen®Resuspension plates
Pipetters Adhesive film strips
Incubator (60°C for Listeria)
Designated Assurance GDS Equipment
The instrumentation supplied with the Assurance GDS start-up package must be designated for use exclusively
with the Assurance GDS system. Use of any of these instruments for general microbiology work may lead to
contamination of samples and or reagent solutions.
The supplied repeater pipette should only be used to dispense GDS reagents.
The supplied 1mL (1,000 µL) micropipette should only be used to prepare the polymerase enzyme.
(A separate pipettor must be used to extract enriched sample aliquots.)
The supplied 8-channel micropipette should only be used to transfer samples from the resuspension plate to
the amplification tubes.
The Assurance GDS PickPen is for use with Assurance GDS and reagents only.
All associated pipette and PickPen tips must be used with the Assurance GDS system only.

Assurance GDS User Manual
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Assurance GDS Rotor-Gene
Components
The Assurance GDS Rotor-Gene includes the following components:
Assurance GDS Rotor-Gene unit
Assurance GDS Rotor-Gene serial cable
Assurance GDS Rotor-Gene USB cable
Assurance GDS 36-well rotor and locking ring
Assurance GDS aluminum cooling block
International power cord set (USA, UK, European Union, Switzerland, and Australia)
Operating Conditions
Power 100-240 V AC, 50-60Hz. 520 VA (peak)
Power consumption 8 VA (standby)
Mains supply voltage fluctuations are not to exceed 10% of the nominal
supply voltages.
Fuse F5a 250 V fuse
Heat dissipation/thermal load Average: 0.183 kW (632 BTU/hour)
Peak: 0.458 kW (1578 BTU/hour)
Over voltage category II
Air temperature 18 to 30°C (64 to 86°F)
Relative Humidity 10 to 75 % (noncondensing)
Altitude Up to 2,000 m (6,500 ft.)
Place of operation For indoor use only
Dimensions
Width 37 cm (14.6 in.)
Height 27.5 cm (10.8 in.)
Depth (without cables) 42 cm (22 in.)
Depth (door open) 56 cm (22 in.)
Mass 12 kg (26.5 lb.)
Installation
To install the Assurance GDS Rotor-Gene, remove it from its packing materials and place it on a secure bench
top. Connect the power cable to a suitable line conditioner and battery backup (i.e. APC Back-UPS RS, 600
watts/1000VA, Input 120V/Output 120V and Tripp Lite LC1200 Line Conditioner or equivalent) connected to
a grounded electrical outlet.
The Assurance GDS Rotor-Gene can be connected to the communications port of the Assurance GDS lap
top computer (provided by BioControl) via either the serial cable or USB cable included with the Assurance
GDS Rotor-Gene. It is important to only use the authorized laptop provided by BioControl with the
Assurance GDS Rotor-Gene.
Note: The side exhaust vent and the air intake vent on the bottom off the unit must remain
unobstructed to ensure suitable air flow and proper operation of the Assurance GDS
Rotor-Gene.

Assurance GDS User Manual
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Rotor-Gene (front view)
Rotor-Gene (rear view)
Air vents
Lid handle
Rotor chambe
r
Instrument status lights
Exhaust vent
Power switch
Cooling fan USB
p
ort
Serial por
t
Serial numbe
r
Power supply port