Healgen Rapid Check COVID-19/Flu A&B Antigen OTC Test
The Healgen® Rapid Check® COVID-19/Flu A&B Antigen Test 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 in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection.
| Catalog Number | Description | Units of Measurements |
| IDGCFC525SKAH2 | Healgen® Rapid Check® COVID-19/Flu A&B Antigen Test | 2 Tests/Kit |
| IDGCFC525SKAH4 | Healgen® Rapid Check® COVID-19/Flu A&B Antigen Test | 4 Tests/Kit |
The Healgen® Rapid Check® COVID-19/Flu A&B Antigen Test 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 in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection.
FEATURES & BENEFITS
- Detect 3 viruses at once (SARS-CoV-2, Flu A&B)
- For symptomatic individuals within 5 days of symptom onset
- Easy-to-use nasal swab test
- Can be used to test children as young as 2 years old
- Results in 15 minutes
- No need to send off to a lab to obtain results
- Medical-grade technology used in doctor’s offices
- FDA 510(k) cleared
- Compact packaging for “On-The-Go” testing
Product Description
The Healgen® Rapid Check® COVID-19/Flu A&B Antigen Test 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 in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection. Symptoms of respiratory infections due to SARS-CoV-2 and influenza can be similar. This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older.
All negative results are presumptive and should be confirmed with an FDA-cleared molecular assay when determined to be appropriate by a healthcare provider. Negative results do not rule out infection with influenza and SARS-CoV-2 or other pathogens. Individuals who test negative and experience continued or worsening respiratory symptoms, such as fever, cough and/or shortness of breath, should therefore seek follow-up care from their healthcare provider.
Positive results do not rule out co-infection with other respiratory pathogens and therefore do not substitute for a visit to a healthcare provider or appropriate follow-up.
Excellent Clinical Performance:
|
PPA (Positive Percent Agreement) |
NPA (Negative Percent Agreement) |
|
| SARS-CoV-2 | 92.0% | 99.0% |
| Influenza A | 92.5% | 99.9% |
| Influenza B | 90.5% | 99.9% |
