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

*For Emergency Use Authorization (EUA) Only. Suitable for 2+ years old.

The 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 type of flu, either 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.

Positive results do not rule out bacterial infection or co-infection with other viruses.

Features & Benefits

• Detect Three Respiratory Flu and Covid-19 Viruses Simultaneously from a Single Sample
  • Faster diagnosis for improved patient care and cost-effectiveness
• Rapid Detection
  • Results available in 15 minutes
• Excellent Test Performance (comparator method RT-PCR)
• Simple and Effective
  • CLIA Waived testing at the point-of-care for use with minimally trained healthcare professionals
• External Quality Controls Available
  • Facilitates routine quality procedures
• Shelf Life that Spans Viral Seasonality
  • 24 months from date of manufacture at room temperature storage

Test Procedure

Interpretation of Results

Start timer. Read results between 15 minutes and 20 minutes.
Note: Interpreting results before 15 or after 20 minutes can give false results.

Invalid Result: The test could not tell whether or not the patient has COVID-19, influenza A (Flu A), or influenza B (Flu B). The test needs to be repeated with a new kit and sample.

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 the patient does 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 the patient tested negative and continues to experience COVID-19, Flu A and/or Flu B-like symptoms, the patient should seek follow-up care with the healthcare provider.

Note: COVID-19 Negative (-) Result

To increase the chance that the negative result for COVID-19 is accurate, you should: Test again in 48 hours if the individual has symptoms on the first day of testing.

Positive Result: The COVID-19, Flu A, and/or Flu B virus(es) were detected in the patient sample. It is very likely that the patient has the respective infection(s) and are contagious. Please contact the healthcare provider or local health authorities and follow local guidelines for self-isolation. There is a small chance that this test can give a positive result that is incorrect (a false positive).

Note: COVID-19 Positive (+) Result

Repeat testing does not need to be performed if patients have a positive result at any time.

Note: *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. 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.

Expected Yearly Infections of COVID-19 and Influenza for 2024 and 2025

As we move into 2024 and 2025, the Centers for Disease Control and Prevention (CDC) anticipates fluctuating patterns in yearly infections of COVID-19 and influenza. The landscape of these respiratory viruses is influenced by several factors, including vaccine uptake, viral mutations, public health measures, and population behavior.

COVID-19 Projections

COVID-19 is expected to persist as an endemic virus, with seasonal peaks likely during colder months, similar to influenza. The CDC predicts that yearly infections will vary, influenced by the emergence of new variants and the degree of population immunity. In the past, new variants like Omicron have caused significant surges, and this trend could continue.

The CDC is particularly focused on the uptake of updated vaccines that target circulating variants. These vaccines are crucial in reducing severe outcomes, including hospitalizations and deaths. However, vaccine coverage may vary, potentially leaving some populations at higher risk for infection. Public health campaigns will likely continue to emphasize the importance of vaccination, especially for vulnerable groups such as the elderly and those with underlying health conditions.

Influenza Outlook

Influenza remains a significant public health concern, and the CDC expects its yearly infection rates to align with pre-pandemic levels, although this could fluctuate. The reduced circulation of flu during the early COVID-19 years, due to public health measures like masking and social distancing, has led to concerns about lower immunity in the population. This "immunity gap" could result in more severe flu seasons in the coming years.

Flu vaccine formulations are updated annually to match the most prevalent strains. The effectiveness of these vaccines can vary, but they remain the primary tool for preventing widespread outbreaks. The CDC expects that yearly flu cases could range from moderate to severe, depending on the match between the vaccine strains and circulating viruses.

Interactions and Public Health Implications

The coexistence of COVID-19 and influenza presents unique challenges. Coinfections, though relatively rare, can occur and lead to more severe illness. The overlapping seasons of these viruses could strain healthcare systems, especially if both reach peak transmission simultaneously.

Public health efforts will focus on promoting vaccination for both COVID-19 and influenza, improving access to antiviral treatments, and maintaining surveillance to monitor and respond to viral activity. The CDC's ongoing research and data collection will play a crucial role in shaping responses and mitigating the impact of these viruses.

In summary, while the CDC expects a continuing presence of COVID-19 and influenza, the scale of infections will largely depend on public health measures, vaccine uptake, and the behavior of the viruses themselves. Ongoing vigilance and adaptability will be key in managing these infections in 2024 and 2025.

Important Notes.

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.