General Description
The QFlu Combo Test is intended to be used in point-of-care setting (initial response) for simultaneous diagnosis of influenza and drug resistance. There is only one key reagent, the master mix, and a handheld device for detection of the light signal. The assay is essentially a one-step assay (sample addition), which can be completed in 17 minutes with approximately 2 minute manual time. Analytical studies show that the test is at least 100,000 as sensitive as the lateral flow based flu test.
Technical Description
The QFlu Combo Test uses a specific substrate for detection of influenza viral neuraminidase activity (hence diagnosis of influenza) and inhibition of this enzyme (hence determination of resistance to Tamiflu and Relenza). The substrate is a conjugate between luciferin and modified neuraminic acid. In the presence of flu virus, the substrate is cleaved to liberate luciferin, which is immediately oxidized by luciferase to generate light signal. The reagents are formulated as a master mix. Sample testing involves sample addition and signal detection using a handheld luminometer.
Evaluation Criteria
THROUGHPUT:
- Between 2 and 15 minutes for detection
- Multiple samples, multiple tests/sample per run
- Less than 32 samples every 2 hours
- The system could easily be adapted into a fully automated system
- Device or system is intended for multiple detection assays
- 0-1 solutions, buffer, eluents, and/or reagents
- 1 component
- No set-up of the system is required for set-up
- 1-2 steps are required for detection
LOGISTICS:
- Very brief (minutes-hours) training and minimal technical skills
- Less than 1 kg
- Wired connections are available
- System or device uses batteries
- 4-8 hours battery life
OPERATIONS:
- Can be used from 25°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
- 1-3 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 open and available for modification
- The system hardware is open and available for modification
DETECTION:
- Efforts are underway to achieve 510K clearance
- Efforts are underway to achieve FDA approval
- Fair specificity. System has a consistent level of false
- alarms (5-10%)
- 100-1,000 PFU per mL of original sample
- 1-10 ng per mL