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FDA & Government News

FDA Approves First Home COVID-19/Flu Combo Test

FDA approval enables at-home differentiation of COVID-19 and influenza in just 15 minutes, with over 90% accuracy for both viruses.

Conexiant

The FDA has granted marketing authorization for the Healgen Rapid Check COVID-19/Flu A&B Antigen Test, marking the first over-the-counter combination test for COVID-19 and influenza to receive approval through the traditional premarket review pathway. This authorization allows for the test's continued availability beyond the scope of emergency use declarations.

Key Points:

  • Test detects SARS-CoV-2, influenza A, and influenza B proteins
  • Provides results in approximately 15 minutes
  • Authorized for home use without a prescription
  • Suitable for individuals aged 14 and older (self-testing) or 2 and older (adult-administered)
  • Demonstrated high accuracy in clinical studies

The Healgen Rapid Check test uses a nasal swab sample to detect proteins from SARS-CoV-2 (the virus causing COVID-19) and influenza A and B viruses. It is designed for individuals experiencing respiratory symptoms and can be used at home without a prescription.

"As we enter this year’s annual flu season with respiratory illnesses such as COVID-19 on many of our minds, our ability to detect these pathogens effectively and efficiently can be impactful on our daily lives. Today’s authorization expands the options for individuals with respiratory symptoms to receive information about their health from the comfort of their home," remarked Michelle Tarver, MD, PhD, acting director of the FDA's Center for Devices and Radiological Health. She also noted the FDA’s ongoing efforts to support the development of at-home tests for a variety of conditions.

Clinical Performance

A study involving symptomatic individuals showed the following accuracy rates:

  • SARS-CoV-2: 99% negative and 92% positive sample identification
  • Influenza A and B: 99.9% negative sample identification
  • Influenza A: 92.5% positive sample identification
  • Influenza B: 90.5% positive sample identification

Validation data for the test was gathered through the Independent Test Assessment Program (ITAP), a collaboration between the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx®) Tech program and the FDA.

Limitations and Precautions

As with all rapid antigen tests, there is a risk of false negative results. The FDA advises that individuals who test negative but continue to experience symptoms of fever, cough, or shortness of breath should seek follow-up care with their health care provider. Those who test positive are urged to take appropriate precautions to avoid spreading the virus and should consult with a health care provider.

Regulatory Implications

This authorization establishes special controls and regulatory classification for combination COVID-19 and influenza tests. Future devices of the same type may be eligible for the FDA’s streamlined 510(k) clearance process, which could accelerate the availability of similar tests.

The Healgen Rapid Check COVID-19/Flu A&B Antigen Test represents a significant advancement in home testing capabilities, offering a convenient option for individuals to simultaneously screen for multiple respiratory pathogens. As respiratory illnesses continue to be a public health concern, this authorization demonstrates the FDA's ongoing commitment to expanding diagnostic options for the general public.