We are dedicated to fight with YOU!! COVID-19 Resources from InnoBiopharm.

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.

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