Cartridge Reader | Meso Scale Diagnostics (MSD), LLC

General Description
The Cartridge Reader system uses MSD’s MULTI-ARRAY® electrochemiluminescence (ECL) technology to enable highly sensitive multiplexed immunoassay measurements in a compact, fully-automated format. The Cartridge Reader system consists of a compact reader instrument (12.5 lbs., 9” H x 8” W x 14” D) and single-use disposable cartridges that can conduct multiplexed measurements of up to 20 targets or controls per sample. The cartridges include integrated microfluidics to allow for fully automated sample processing and analysis without user intervention. Two cartridges types are available: one for analyzing liquid samples and the other for swab samples. To run an assay, the sample (liquid or swab) is inserted into the appropriate cartridge and the cartridge is then capped and loaded into the reader. All subsequent processing steps, including swab extraction (swab cartridge) and multiplexed ECL detection are fully automated. The system can detect and measure bacteria, viruses, and toxins with limits of detection many times lower than lateral flow immunoassays. The system is extremely simple to operate and provides a result in about 15 minutes. The Cartridge Reader system is still under development for laboratory and point-of-care clinical and environmental testing applications and is not yet commercially released. However, the instrument has been tested at DoD technology readiness evaluations (TREs) and has been through clinical evaluations in the U.S. and other locations worldwide for influenza diagnostics.

Technical Description
MSD’s PR2 and Cartridge Reader instruments employ MSD’s MULTI-ARRAY® technology that combines electrochemiluminescence (ECL) detection and array-based multiplexed measurements. ECL immunoassays enable highly sensitive measurement of samples for the presence of bacteria, viruses, and toxins. The measurements are performed on arrays printed on carbon ink electrodes that are incorporated into multi-well assay plates and cartridges. MULTI-ARRAY technology consistently has been demonstrated to provide high performance measurement capability in a wide range of matrices and in the presence of many interferents. While MULTI-ARRAY technology is primarily used for immunoassays, the technology can also be used for multiplexed nucleic acid measurements.

Evaluation Criteria

THROUGHPUT:

Between 15 and 30 minutes for detection
1 sample, >10 tests/sample per run
Less than 32 samples every 2 hours
The system or device is currently fully automated
Device or system is intended for multiple detection assays
0-1 solutions, buffer, eluents, and/or reagents
2 components
Less than 5 minutes is required for set-up
Automatic detection

LOGISTICS:

Very brief (minutes-hours) training and minimal technical skills
Approximately the size of a toaster
Between 5 and 25 kg
Wired connections are available
System or device has 110V electrical requirement
4-8 hours battery life

OPERATIONS:

Can be used from 4°C to 37°C
Components must be stored at 4°C
Performance is not influenced by relative humidity
Between 1 to 3 years shelf life
5-10 years expected life
Results cannot be viewed in real-time
The system could be adapted to a fully autonomous system with some effort
The system software is closed and not available for modification
The system hardware is closed and not available for modification

DETECTION:

Possible the system could receive 510K clearance, no current efforts at this time
Possible the system could receive FDA approval, no current efforts at this time
Less than 250 µL
Excellent specificity. System has occasional false alarms under certain conditions (<2%)
1,000-10,000 CFU per mL
10,000-100,000 PFU per mL
Less than 1 ng per mL
Spore lysis not necessary for detection by system