High accuracy:
Sensitivity ~91 % and specificity ~100 % in clinical studies using nasopharyngeal swabs.
For anterior nasal samples within 6 days of symptom onset: sensitivity ~92.3% and specificity ~99.04%.
Flexible specimen type: Supports both anterior nasal and nasopharyngeal swabs, making sample collection easy and comfortable.
Robust detection limits: LoD at 1.11 × 10² TCID₅₀/mL, with strong detection even for Omicron at Ct ≤ 25.
All-inclusive kit (25 tests):
25 test cassettes,
25 swabs,
25 extraction tubes with buffer + filter caps.
Dropper tips, tube holder, paper/plastic tray, controls, and instructions.
CLIA-waived & professional use: For use in clinical settings under CLIA Waiver, Compliance, or Accreditation.
Wide regulatory coverage: Marketed and distributed globally (US, Europe, Asia, South America), also part of NIH RADx initiative.