Healgen Scientific Covid-19 / Flu A&B Ag Combo Rapid Test Cassette (Swab) EUA, 25/Box

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

Controls are available HERE

“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.”

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.

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.

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”
•  

Specifications

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

*EUA Statement

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.

Product Resources

Healgen Covid-19 / Flu A&B Combo Instructions For Use (IFU) EUA

Healgen Covid-19 / Flu A&B Combo POC Patient Fact Sheet

Healgen Covid-19 / Flu A&B Combo POC Healthcare Providers Fact Sheet (HCP)

Healgen Covid-19 / Flu A&B Combo Quick Refrence Guide (QRG)

Healgen Covid-19 / Flu A&B Combo Control Kit Instructions For Use (IFU) EUA

Interpreting Your Results

Positive Test Results

Both ‘C’ lines must be PRESENT

Positive Result: The COVID-19, Flu A and/or Flu B virus(es) were detected in your sample. It is very likely that you have the respective infection(s) and are contagious.

Please contact your healthcare provider or your local health authorities and follow local guidelines for self-isolation. There is a small chance that this test can give you a positive result that is incorrect (a false positive).

Report your test result(s) at MakeMyTestCount.Org–this voluntary and anonymous reporting helps public health teams understand COVID-19 spread in your area and across the country.

Negative Test Result

Both ‘C’ lines only

Negative Result: The virus from COVID-19, Flu A, and/or Flu B were not detected in the sample.

A negative result does not mean it is certain that you do not have COVID-19, Flu A and/or Flu B infection. There is a higher chance of false negative results with antigen tests compared to laboratory-based molecular tests.

If you tested negative and continue to experience COVID-19, Flu A and/or Flu B-like symptoms, you should seek follow-up care with your healthcare provider.

Invalid Test Results

Missing ‘C’ line on ONE or BOTH strips

Invalid Result: Check to see if a line is visible at the Control Line labeled “C” on the device. If an individual does not see either Control Line, or only see’s one Control Line, do not continue reading the results. The results are invalid. Repeat the test with a new sample and a new test kit.

Some causes of invalid results are because of not following the directions correctly or the test may have deteriorated beyond the expiration date. It is recommended a specimen be re-tested using a new test.