BeadXpress Reader | Illumina, Inc. | WMD Detector Selector

General Description
The BeadXpress Reader is the optimal solution for both small and high-throughput laboratories conducting molecular testing that benefit from robust, multiplexed-based assays. It employs a dual-color laser detection system that identifies the unique holographic codes embedded in VeraCode microbeads, and detects the signal intensity associated with each bead. This system supports the development of both single- and two-color assays, across genotyping, methylation, and protein-based assays. The BeadXpress System comes with VeraScan software, which provides a user-friendly graphical interface to control the BeadXpress Reader, enabling users to load assays, perform real-time scans, and view scan data for up to 96 samples per run. The software features administrator control of setting user specific accounts and rights, configuration of default file locations, and security options, including alerts via email. It also offers customization of scanning protocols, enables acquisition and viewing of intensity data, and report generation.

Technical Description
VeraCode glass microbeads provide an ideal surface for numerous bioassays including genotyping, gene expression, and protein-based assays. Illumina’s proprietary technology precisely embeds digital holographic elements within glass microbeads to create unique bead types. Each microbead can easily carry high-density codes (24-bit), for virtually unlimited development of bead types. When excited by a laser, each VeraCode bead emits a unique code image, allowing for quick and specific detection by Illumina’s BeadXpress Reader System.

Evaluation Criteria

THROUGHPUT:

Between 60 minutes and 8 hours for detection
Multiple samples, multiple tests/sample per run
Less than 32 samples every 2 hours
The system could be adapted to a fully automated system with some effort
Device or system is intended for multiple detection assays
5 or more solutions, buffer, eluents, and/or reagents
5 or more components
Less than 5 minutes is required for set-up
Greater than 12 steps are required for detection

LOGISTICS:

A day of training and technical skills are required
Approximately the size of a home dishwasher
More than 50 kg
Wired connections are available
System or device has 110V electrical requirement

OPERATIONS:

Can be used from 25°C to 37°C
Components must be stored at 4°C
Performance is not influenced by relative humidity
Between 1 to 6 months shelf life
Greater than 10 years expected life
Results can be viewed in real-time
The system could be adapted to a fully autonomous system with significant effort
The system software is closed and not available for modification
The system hardware is closed and not available for modification

DETECTION:

System currently has 510k clearance
System currently has FDA approval
Greater than 250 µL
Excellent specificity. System has occasional false alarms under certain conditions (<2%)
Less than 1 ng per mL
Manual kit not integrated with the system handles spore lysis .

Tier Selection