General Description
StepOne™ 48 well and StepOnePlus™ 96 well Real-Time Polymerase Chain Reaction (PCR) System. This is a cost effective real-time PCR system. This system in conjunction with Life Technologies large menu of consumables and reagents can be used on a variety of applications. There are detailed user guides that describe all aspects of the workflow. We also have world-class field application scientists and engineers to support and help. Basically, the system takes processed DNA or RNA as inputs and amplifies them via real-time PCR (which allows for real time data collection). The data gathered allows for analysis to provide quantitative and/or qualitative information. The StepOne™ and StepOnePlus™ systems support any real time PCR application. Life Technologies offers predesigned or custom assays that exist for the following applications: SNP genotyping, Gene Expression profiling, MicroRNA expression, Methylation, Translocation analysis, Gene Detection, Viral Load Analysis and mutation scanning. Other application areas include human identification, food safety, agricultural biology and others.
Technical Description
These systems employ real-time (TaqMan®, SYBR® Green or other chemistries) polymerase chain reaction amplification of DNA/RNA samples on a peltier-based thermocycling apparatus using software to analyze data to offer quantitative and/or qualitative results.
Evaluation Criteria
THROUGHPUT:
- Between 60 minutes and 8 hours for detection
- Multiple samples, multiple tests/sample per run
- 349-96 samples every 2 hours
- The system could be adapted to a semi-automated system with some effort
- Device or system is intended for multiple detection assays
- 2 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
- Larger than 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 41°C
- Components must be frozen (-20°C)
- Between 1 to 3 years shelf life
- Greater than 10 years expected life
- Results can be viewed in real-time
- The system is not capable of autonomy
- The system software is closed and not available for modification
- The system hardware is closed and not available for modification
DETECTION:
- Efforts are underway to achieve 510K clearance
- Efforts are underway to achieve FDA approval
- Less than 10 µL
- Superior specificity. System has a false alarm rate approaching zero (~0%)
- 1-100 CFU per mL
- 1-100 PFU per mL
- Manual kit not integrated with the system handles spore lysis
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