Healgen® COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab), Rx
- For Emergency Use Authorization (EUA) only*
- For in vitro diagnostic use
- For Prescription Use Only
Sensitivity & Specificity:
- COVID‑19: 92.0% / 99.0%
- Influenza A: 92.5% / 99.9%
- Influenza B: 90.5% / 99.9%
Key Benefits
- Detect 3 viruses at once (SARS-CoV-2, Flu A&B)
- For symptomatic individuals within 5 days of symptom onset
- Shallow nasal swab sample collection
- Suitable for 2+ years old-Swabbing should be performed by an adult for children aged 2 to 13
Specifications
- Specimen: Nasal Swab
- Time to results: 15 minutes
- Store the test kit between 36-86°F (2-30°C)
- CPT Code: 87428‑QW
Healgen® COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab) is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly from anterior nasal swab specimens of individuals with signs and symptoms of respiratory infection consistent with COVID-19 by their healthcare provider within the first 5 days of symptom onset when tested at least twice over three days with at least 48 hours between tests. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar.
Results are for the in vitro detection and differentiation ofSARS-CoV-2, influenza A virus, and influenza B virus protein antigens, but do not differentiate, between SARS-CoV and SARS-CoV-2 viruses and are not intended to detect influenza C antigens.
These viral antigens are generally detectable in anterior nasal swab specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of the disease.