Fragment Analyzer | Advanced Analytical Technologies, Inc. (AATI)

General Description
The FRAGMENT ANALYZER(TM) is capable of analyzing a variety of DNA and RNA fragments for identification. The instrument can be coupled with end-point PCR (polymerase chain reaction) for the determination pathogens such as salmonella, shigella, etc. The system is designed for laboratory analysis, and is versatile and adaptable for many matrices. The system is based on the use of capillary electrophoresis, and can analyze either 12 or 96 samples simultaneously. It can be used in a variety of applications, including end-point PCR (pathogen detection), genetic mutation screening, and as a tool to estimate the quality of genomic DNA and fragmented DNA for DNA sequencing.

Technical Description
Currently, real-time PCR (RT-PCR) is used as a method for the detection of pathogens. Multiplex RT-PCR can be used to analyze the presence or absence of multiple pathogens. The drawback to these technologies is that a false-positive reaction may occur. With the FRAGMENT analyzer technology, coupled with PCR or RT-PCR, the fragments can be analyzed after a positive response to confirm that the amplified DNA fragments are in fact the fragments of interest. The FRAGMENT Analyzer(TM) uses either 12 - or 96 capillaries to analyze samples in parallel, allowing users to evaluate a very large number of samples in a short period of time. Up to 3000 samples/day can be analyzed in a 96-channel system and 300 samples/day in a 12-channel system. The system is based on the use of a low-cost light-emitting diode detection technology, allowing the instrument cost to be one of the lowest in the industry.

Evaluation Criteria

THROUGHPUT:

Between 30 and 60 minutes for detection
Multiple samples, multiple tests/sample per run
349-96 samples in 2 hours
The system or device is currently semi-automated
Device or system is intended for multiple detection assays
3 solutions, buffer, eluents, and/or reagents
3 components
No set-up of the system is required
Almost instantaneous, no downtime

LOGISTICS:

A day of training and technical skills are required
Approximately the size of a carry-on luggage suitcase
Between 25 and 50 kg
Wired connections are available
System or device has 110V electrical requirement
2–4 hours battery life
Is commercially available

OPERATIONS:

Can be used from 4°C to 41°C
Components must be frozen (-20°C)
Performance is not influenced by relative humidity
Between 1 to 3 years shelf life
Greater than 10 years expected life
Results can be viewed in real-time
The system could easily be adapted into a fully autonomous system
The system software is open and available for modification
The system hardware is open and 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 50 µL
Superior specificity. System has a false alarm rate approaching zero (~0%)
1-100 CFU/mL of original sample
100-1,000 PFU/mL of original sample
Manual kit not integrated with the system handles spore lysis

Tier Selection