Healgen® COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab)

For Emergency Use Authorization (EUA) only* | For in vitro diagnostic use | For Prescription Use Only

The Healgen® COVID-19/Flu A&B Ag Combo Rapid test Cassette (Swab) has not been FDA cleared or approved but has been authorized by FDA under an EUA for use by authorized laboratories.

This product has been authorized only for the detection of proteins from SARS-CoV-2, influenza A and influenza B, not for any other viruses or pathogens.

The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

Authorized Laboratories:
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 product 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.

INTENDED USE: 

The Healgen® COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab) is a lateral flow immunochromatographic assay intended for in vitro rapid, simultaneous 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 within the first five (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.

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.

All negative results are presumptive and should be confirmed with a molecular assay, if necessary, for patient management. Negative results do not rule out influenza or SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control measures such as isolating from others and wearing masks. Negative results should be considered in the context of an individual’s recent exposures, history, and the presence of clinical signs and symptoms consistent with each respiratory infection.

The Healgen^® COVID-19/Flu A&B Ag Combo Rapid test Cassette (Swab) is only for in vitro diagnostic use under the Food and Drug Administration’s Emergency Use Authorization. This product has not been cleared or approved.

ACCURACY:

KEY BENEFITS: 

• Detects 3 viruses at once (SARS-CoV-2, Flu A&B)
• For symptomatic individuals within 5 days of symptom onset
• Shallow nasal swab sample collection
• Time to results: 15 minutes
• 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

NUMBER OF TESTS: 25

STORAGE CONDITIONS: Room temperature, between 36-86°F (2-30°C), in a place out of direct sunlight. Reagents and devices must be used at room temperature (59-86°F/15-30°C).

CPT CODE: 87428-QW

DOCUMENTATION:

FACT SHEET FOR HEALTHCARE PROVIDERS

FACT SHEET FOR PATIENTS

QUICK REFERENCE GUIDE

INSTRUCTIONS FOR USE

INSTRUCTIONS FOR USE - External Controls