EXELFIA™ COVID-19 Antigen Test
Bring Life without COVID-19 Worry.
INTENDED USE:
The EXELFIA™ COVID-19 Antigen test is a immuno-chromatographic rapid detection test for the qualitative detection of COVID-19-specific antigens in human nasal samples from persons with a reasonable suspicion and/or symptoms of COVID-19 infection as well as from asymptomatic persons. The EXELFIA™ COVID-19Antigen rapid test is a diagnostic aid to detect and/or rule out a respiratory tract infection with COVID-19 in connection with other clinical and laboratory findings. Negative results do not rule out infection with COVID-19 and should not be used as the sole basis for diagnosis. The product is intended for professional in-vitro use.
FEATURES AND BENEFITS:
High sensitivity and specificity compared to PCR based assays.
Results in 15 minutes or less.
Does not need device and highly trained lab personnel.
Complete technical documents and will apply USFDA EUA and EU CE certification.
For more detailed instructions, watch the video.
We want it simple for you!!!
The relationship between product clinical test sensitivity and Ct value.
Technical Data
Verified and reported by independent laboratory in US.
Clinical Verification
Performed and reported by US CLIA laboratory for EUA filing.
CE-IVD
Sufficient to file by now, and to be certified by end of May/2021.
Technical Data
- LoD: 100 – 150 TCID50 per mL.
- Cross-reactivity: no cross-reactivity.
- Interference: no interference based on USFDA EUA standard.
- Reproducible and highly sensitive/specific.
Clinical Performance
- First tier: 10 Covid-19 positive and 10 negative patient.
- 100% correct with RT-PCR.
Clinical Performance – Cont.
- Second tier: 30 Covid-19 positive and 30 Covid-19 negative.
- 100% correct, data only show positive testing.
- Third tier: Ct value where testing is 100% positive for EXELFIA™ compared with RT-PCR.
- Testing is performed that Ct value at 33 or lower were tested positive with EXELFIA™, confirming useful screen with EXELFIA™ for high Ct value (30 to 33) asymptomatic carriers.
- Report will be submitted to US FDA.
- Further testing of Ct 34, 35, and 36 patients are on-going for statistical data.
- Population broad screening using EXELFIA™ is on-going.
Clinical Testing Data – Initial Results
Data of 30 positive clinical sample are shown below:
Fourth tier:
- Q: How comfortable are we when Ct is between 30 to 40 (low amount of virus)?
- Within 154 RT-PCR positive clinical samples, we have 33 samples Ct values are within 30-40 or above (N protein Ct).
- Our product tested 31 positive within 20 minutes.
- Highest Ct value tested positive by our kit is 37.
- Of the two not shown positive by our kit, was shown positive in 30 minute.
- These two samples were likely having dead virus (at least one viral gene was not detected by RT-PCR).
Clinical Data — Conclusion
- Exclude pts with dead virus, detection sensitivity is 100% .
- Detection in pts with Ct 30 or above is very easy.
- Highly sensitive, range up to Ct 37.
- As a good 3rd generation rapid antigen test for community check and back to school/back to Park tool.
PRODUCT KEY FEATURES:
- Ct 31.9 or less, sensitivity 100%.
- Specificity close to 100%.
- High analytical sensitivity, 156 TCID50/mL.
- Cross-reactivity and interference tested.
- Easy, individually packed solution.
- Can be used in public testing places, laboratory, or gathering forum.
- Visually readout, no equipment needed.
- Everything included in kit, only need PEP.
Documents and words related to the performance of the products are drafts and are subject to revision according to the proper regulatory agencies.
For more details, please contact:
todd.juan@innobiopharm.com or info@innobiopharm.com