General Description
LLMDA is a broad-spectrum microarray with over 360,000 probes that can detect all sequenced bacteria, viruses, fungi, protozoa, and archaea as of the probe design date. It was designed for laboratory analysis of complex samples that were not negative for available PCR assays. LLMDA fills the gap between PCR panels and metagenomic sequencing for biodefense, biosurveillance, human/animal/plant health, food and product safety, etc.
Technical Description
LLMDA uses microarray technologies that provide probes of at least 60bp. Originally developed using NimbleGen array technology, it has also been transitioned to Agilent. The array probes are designed at family, species, and strain taxonomic levels to ensure that novel strains and even species might be recognized.
Evaluation Criteria
THROUGHPUT:
- Greater than 8 hours for detection
- 1 sample, >10 tests/sample per run
- Less than 32 samples every 2 hours
- The system could be adapted to a semi-automated system with some effort
- Device or system is designed for a single use
- 4 solutions, buffer, eluents, and/or reagents
- 4 components
- No set-up of the system is required
- 9-12 steps are required for detection
LOGISTICS:
- More than a day of training and significant 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
OPERATIONS:
- Can be used from 25°C to 37°C
- Components must be stored at 4°C
- Device or system has peak performance at normal relative humidity conditions
- Between 1 to 6 months shelf life
- Results cannot be viewed in real-time
- The system is not capable of autonomy
- The system software is closed and not available for modification
- The system is single use or this question does not apply to this device
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 10 µL
- Good specificity. System has a consistently low level of false alarms (2-5%)
- 100-1,000 CFU per mL
- 1,000-10,000 PFU per mL
- Manual kit not integrated with the system handles spore lysis