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Healgen® Rapid Check® COVID-19/Flu A&B Antigen Test Pro

Box image of the Healgen Rapid Check COVID-19 Flu A&B test for professional use

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Healgen® Rapid Check® COVID-19/Flu A&B Antigen Test (Pro)

The Healgen® Rapid Check® COVID-19/Flu A&B Antigen Test Pro is a lateral flow immunochromatographic assay designed for the qualitative detection and differentiation of SARS-CoV-2 nucleocapsid antigen, influenza A nucleoprotein antigens, and influenza B nucleoprotein antigens. This professional COVID-19/Flu A&B test uses anterior nasal swab samples from individuals experiencing signs and symptoms of a respiratory tract infection.

Because COVID-19 and influenza may cause similar respiratory symptoms, including fever, cough, and shortness of breath, this combined antigen test helps distinguish between SARS-CoV-2, Flu A, and Flu B. Individuals ages 14 and older may self-test, while adults may administer the test to children ages 2 and older.

However, all negative results are presumptive. When appropriate, a healthcare provider should confirm negative results using an FDA-cleared molecular assay. In addition, a negative result does not rule out infection with influenza, SARS-CoV-2, or other respiratory pathogens. Individuals with continued or worsening symptoms should seek follow-up care from their healthcare provider.

Likewise, positive results do not rule out co-infection with other respiratory pathogens. Therefore, a positive result should not replace a visit to a healthcare provider or appropriate medical follow-up.

For In Vitro Diagnostic Use Only.
For Professional Use.

Key Benefits:

  • Detect 3 viruses at once (SARS-CoV-2, Flu A&B)
  • Two result windows for easy readability.
  • 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
  • Stability: 24 months
  • Storage: 36-86°F (2-30°C)

Positive Results

COVID-19 Positive
Flu A Positive
Flu B Positive
COVID-19 & Flu A Positive
COVID-19 & Flu B Positive
COVID-19, Flu A, & Flu B Positive
Flu A & Flu B Positive

Negative Result

Negative Result

Invalid Results

Invalid Result 1
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Invalid Result 24

Ordering Information:

Product DescriptionSpecimenCatalog No.Kit SizeRegulatory Clearance
Healgen® Rapid Check® COVID-19/Flu A&B Antigen Test ProNasal Swab
GCFC-525SKa-10T10 Test/kit
510(k)
Healgen® Rapid Check® COVID-19/Flu A&B Antigen Test ProNasal Swab
GCFC-525SKa-25T25 Test/kit510(k)
External Controls:
Healgen® Rapid Check® COVID-19/Flu A&B Antigen Test Pro		GCFC-PNK21 Positive Control Swab
1 Negative Control Swab		FDA Exempt
External Controls:
Healgen® Rapid Check® COVID-19/Flu A&B Antigen Test Pro		GCFC-PNK2010 Positive Control Swab
10 Negative Control Swab		FDA Exempt
External Controls:
Healgen® Rapid Check® COVID-19/Flu A&B Antigen Test Pro		GCFC-PNK4020 Positive Control Swab
20 Negative Control Swab		FDA Exempt
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