Ziplex® Automated Work Station | Axela, Inc.

General Description
The Ziplex® is a automated microarray platform that is designed for routine and focused multiplex analysis for both RNA and protein research. The Ziplex uses a highly reproducible, medium density array to provide users with expression information. It uniquely combines and automates three separate functions (biomolecular binding, washing/labeling and imaging) into a single bench top instrument. Other features of the Ziplex® include:

Flow-Thru Microarray Chip Technology that enables fast oligonucleotide hybridization and protein binding
Medium Density Microarrays that provides quantitative data on 120 or more different biomarkers
Automated functionality minimizing user interaction to only sample preparation, workflow entry, and sample/reagent loading
Rapid Throughput running up to 8 gene expression samples per run in just 3 hours allowing up to 24 tests per day
Built-in image capture and analysis software
High Sensitivity for low abundant biomarkers
Single, Robust Platform for both gene and protein expression analysis
Affordable with low cost per data point.

Technical Description
Axela’s automated Ziplex System uses a unique flow thru technology within a single-use TipChip consumable. The TipChip is a disposable device consisting of a 6.5 mm square chip mounted on a plastic tube. The chip is made of porous silicon with >200,000 microchannels. This approach facilitates the interaction between target molecules and immobilized probes resulting in fast oligonucleotide hybridization or protein binding. Features of the TipChip Arrays are the following:

Ideal for automated multiplex analysis of gene and protein expression
Designed to contain up to 576 spots per chip (“features”)
Each microarray can provide quantitative data on120 or more different biomarkers.
Up to eight TipChip arrays can be run on the Ziplex system simultaneously
Binding activity on each feature is detected by chemiluminescence using a CCD camera

The embedded software built into the Ziplex System automatically analyzes the images, quality controls the data and outputs the microarray data.

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 or device is currently fully automated
Device or system is intended for multiple detection assays
5 or more solutions, buffer, eluents, and/or reagents
2 components
Less than 5 minutes is required for set-up
6-8 steps are required for detection

LOGISTICS:

An afternoon of training and some technical skills 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 4°C to 37°C
Components must be frozen (-20°C)
Device or system has peak performance at normal relative humidity conditions
Between 1 to 3 years shelf life
5-10 years expected life
Results cannot be viewed in real-time
The system is not capable of autonomy
The system software is open but modification requires licensing
The system hardware is open but modification requires licensing

DETECTION:

Possible the system could receive 510K clearance, no current efforts at this time
Efforts are underway to achieve FDA approval
Less than 50 µL
Excellent specificity. System has occasional false alarms under certain conditions (<2%)
1-100 CFU per mL
1-100 PFU per mL
Less than 1 ng per mL
Manual kit not integrated with the system handles spore lysis.