Description

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.

Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, that meet the requirements to perform moderate, high, or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

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. User must be aged 14 + to perform self test

Specifications: 

• Specimen: Nasal Swab
• Time to results: 15 minutes
• Store the test kit between 36-86°F (2-30°C)