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Agenda

1. Introduction to Storm
2. Storm Software Suite
3. Hardware
4. System Architecture
5. Support

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1. Introduction to Storm: What is it?

Storm consists of the Storm Software Suite running in conjunction with a ThunderBolt
and/or Bolt analyzer.

Components:
▪ Storm Test Designer
▪ Storm System Configuration
▪ Storm Report Editor
▪ Storm Instrument Manager
▪ Storm Server Database
▪ Instrument/s (ThunderBolt and/or Bolt)

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1. Introduction to Storm: What can it do?

▪ Enzyme Immunoassay (EIA)


▪ Chemiluminescence (CLIA)
▪ 96 well or Strips (mono-test) format
▪ Microarray - planned for Storm 2.0 release
▪ Data Review & Storage
▪ Laboratory quality control (Levey-Jennings)

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2. Storm Software Suite: Components

Test Designer: Program assay protocols according to IFU, called Test Files

System Configuration Tool: Set, update, and maintain system settings, including adding test files
Test Designer
Instrument Manager: Execute Test Files and maintain Instrument

Instrument Manager Evaluation: Review results, analyze test performance (Levey-Jennings), and search the data server

Data Server: Background service that provides storage and access to result data

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2. Storm Software Suite: Test Designer

▪ Clinical
▪ Infectious Disease
Program any ▪ Autoimmune
EIA, CLIA, or ▪ Endocrinology
▪ Microbiology
Microarray
▪ Oncology
IFU as a Storm ▪ Food & Feed
Test File ▪ Allergen
▪ Toxin
▪ Enzymatic Assays
▪ Veterinary applications
▪ Environmental Safety
▪ And many more….

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2. Storm Software Suite: Test Designer

Powerful test design capability in a completely open system gives you full control of protocols

▪ Infinite design limits with complete control over every protocol setting
▪ Hundreds of assays have been programmed
▪ Flexible and easy data reduction functions:
▪ Index Calculation; Conc = f(OD)
▪ Point to Point
▪ Cubic Spline
▪ 4PL Curve Fit; 5PL Curve Fit
▪ Regression
▪ Polynomial
▪ 4PL Parameter set ABCD; 5PL Parameter set ABCDE
▪ Multiple Result Calculations per test
▪ Runtime Variables – Adjustable lot specific information at runtime
▪ No need to change test file with lot change
▪ Information automatically saved until next lot
▪ Recalculate with new lot information even after run completion
▪ Open System lets you program any assay you choose

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2. Storm Software Suite: System Configuration Tool

▪ User Manager
▪ Create and define system users and user permissions
▪ Test File Database
▪ Add, remove, and organize test files
▪ Report Configuration
▪ Customize logo & address
▪ Ask your technical service rep. about fully customizeable reports
▪ LIS Settings
▪ Easy control of LIS communications
▪ Data Management
▪ Back-up, archive, or purge data from a single location

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2. Storm Software Suite: Instrument Manager

▪ Pairs with compact, powerful, and robust automation options:


▪ ThunderBolt
▪ The Bolt
▪ Precisely executes Test Files per programming specifications
▪ Review, Release, & Export Data
▪ Search Active and Archived Data
▪ Monitor Quality and Performance with Levey-Jennings Plugin
▪ Instrument Maintenance & Recording

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2. Storm Software Suite: Instrument Manager – Evaluation Only

Performs all essential data functions without connecting to the


machine

▪ Review, Release, & Export Data


▪ Search Active and Archived Data
▪ Monitor Quality and Performance with Levey-Jennings Plugin

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2. Storm Software Suite: Instrument Manager

Test File Execution: Individual Well Tracking

• Precisely time each well ▪ Excellent temporal uniformity


• Individually time incubation and processing steps. ▪ Consistent results regardless of position

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2. Storm Software Suite: Storm Data Server

▪ Saves worklist data for later retrieval


▪ Allows report export to common files formats (Excel, PDF, etc.)
▪ Export raw data directly to Excel
▪ Action log file available for every run
▪ All reports and logs automatically saved
▪ Access previous run data at any time

Runs in the background, and stores all data automatically!

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3. Hardware: ThunderBolt & The Bolt Common Features

▪ Open Architecture: EIA or CLIA


▪ Fully Automated: Load and walk away
▪ Adaptable: Run multiple tests from different manufacturers
in one batch
▪ Minimal Consumables: No disposable tips /Reagent Adaptors
▪ Elegant Simplicity: Easy maintenance, use, and service
▪ LIS Compatible: Bidirectional communication
▪ Space Saving: Reclaim valuable space and process more tests
▪ The Bolt: 48.3cm x 53.3cm x 55.8cm
▪ ThunderBolt: 64cm x 57cm x 45cm
▪ All-in-One: Innovative hardware design combines multiple
machines/functions in our compact instrumentation

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3. Hardware: multiple machines in one!

Fluid
Handling

Reader

Chamber
Incubator

Shaker

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3. Hardware: Initialization

Automatically initializes at startup and


performs checks before each worklist run
▪ Homing
▪ Alignment check
▪ Clog check
▪ Plate check
▪ Strip check

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3. Hardware: Single Probe, Dual Needle

Unique probe system benefits:


▪ Spindle-driven Z-axis movement minimizes damage
▪ Liquid detection/level sensing via conductivity
▪ Minimizes dead volume
▪ Clog detection mechanisms
▪ Beveled needle prevents waste aspiration seal
▪ Minimal consumable costs - no disposable tips
▪ Well by well processing of all test steps for consistent results

Some tests not possible in USA – e.g. HIV or Hepatitis

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3. Hardware: High Precision Micro Syringe

Smallest Aspiration Volume In its Class


▪ Aspirate 1µl with less than 3% CV across a full plate*
▪ Minute volume minimizes carryover
▪ 1:101 dilution directly into reaction wells
▪ Two-step dilutions up to 1:30,000 using optional pre-
dilution plate

*As concentrate in a 1:101 dilution

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3. Hardware: On-Board Reader

Reliable, Ultra-compact Reader


▪ On-Board EIA and/or CLIA reader reads results accurately and efficiently:
▪ Ultra-compact and fully integrated – no need for plate movement or separate chamber
▪ EIA
▪ LED technology
▪ Multiple wavelengths (custom available)
▪ Energy efficient, low heat
▪ Increased bulb life by 100x vs. incandescent
▪ CLIA: adjustable integration time
▪ Microarray

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3. Hardware: Multi Function Carrier

Streamlined Automation, Consistent Results


All major protocol steps performed on the multi-function carrier:
▪ Reaction Plate/s and 1 optional Pre-dilution Plate
▪ Direct-to-well Dilutions*
▪ Heated Incubation
▪ Shaking
▪ Photometric/Chemiluminescent Detection

*High Precision Micro Syringe aspirates 1µl for 1:101 dilution directly into reaction wells.

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3. Hardware: Troubleshooting

Advanced troubleshooting tools,


quick problem resolution
▪ Log and archive of every operation and
work list
▪ Easy transfer of logs to support
technicians
▪ Option to take corrective actions to
resolve errors without aborting run

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3. Hardware: Forced Convection Incubator

Eliminate “Edge Effect” for Consistent Results


▪ EVEN heating of each well
▪ Rapid heating
▪ Maximum flexibility

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Key differences: The Bolt vs. ThunderBolt

The Bolt ThunderBolt


Plates 1 reaction plate + 1 predilution plate 2 reaction plates + 1 predilution plate
Samples 96 192
Sample Racks 1 3
Custom sample racks Either 12/13mm or 16mm 12, 13, and/or 16mm
Intelligent sample racks No Yes
Reagent positions 9 16
Modular Yes, optional Reader, Shaker, Incubator No, sold as whole unit
Wash/Waste Sensors No Yes
Barcode scanner No Yes
Camera No Yes
Size 48.3cm x 53.3cm x 55.8cm 64cm x 57cm x 45cm
Weight 20 Kg 28 Kg

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4. System Architecture: Scalable

▪ Small size allows better use of valuable lab space


▪ Multiple ThunderBolts® or Bolts® in the same space as one of the competitors
▪ Scalable solution for low and high volume environments

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5. Support

▪ Website Customer Portal


▪ Videos for Instrument Operations and Maintenance (with transcripts)
▪ Service Videos (with transcripts)
▪ Current Revisions of all Documents available for download
▪ 24 hr technical support
▪ Email: inttechservice@gsdx.us

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2851 Spafford Street
Davis, California, 95618 USA
Phone: +1 (530) 759-8000
Email: info@gsdx.us
Web: http://www.gsdx.us

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