Flowflex® COVID-19 Antigen Home Test

Manufacturer: JANT PHARMACAL CORP.
Manufacturer: JANT PHARMACAL CORP.

Flowflex® COVID-19 Antigen Home Test is a rapid test for the detection of SARS-CoV-2 antigens in anterior nasal specimens directly from individuals within 7 days of symptom onset or without symptoms or other epidemiological reasons to suspect COVID-19 infection. For self-testing use. For use under an Emergency Use Authorization (EUA) only.

Features:

  • Cassette Format
  • Detects the nucleocapsid protein antigen from SARS-CoV-2
  • Nasal Specimen sample
  • Results in 15 minutes
  • FDA Emergency Use Authorization (EUA)
  • Positive Percent Agreement (PPA): 93% (95% Cl: 81%-99%)
  • Negative Percent Agreement (NPA): 100% (95% Cl: 97%-100%)
  • Analytical Sensitivity: Limit of Detection (LoD): 2.5 x 103 TCID50/mL

CLIA Complexity: Waived

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