The Flowflex Plus RSV + Flu A/B + COVID Home Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of respiratory syncytial virus (RSV), influenza A, influenza B, and SARS-CoV-2 protein antigens directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection.
- The first FDA-cleared 4-in-1 respiratory home test
- The first FDA-cleared RSV home test
- The first FDA-cleared respiratory infection home test for children aged 6-23 months
| Catalog Number | Description | Units of Measurements |
| IDL03AR1445 | Flowflex® Plus RSV + Flu A/B + COVID Home Test | 1 Test/Kit |
| IDL03AR1545 | Flowflex® Plus RSV + Flu A/B + COVID Home Test | 2 Tests/Kit |
FEATURES & BENEFITS
- Detect 4 viruses at once (RSV, Flu A&B, SARS-CoV-2)
- Easy-to-use nasal swab test
- Can be used to test children as young as 6 months 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 Flowflex® Plus RSV + Flu A/B + COVID Home Test is a lateral flow immunoassay intended for the rapid, simultaneous qualitative detection and differentiation of respiratory syncytial virus (RSV), influenza A, influenza B (Flu A/B), and SARS-CoV-2 (COVID) protein antigens. This test is authorized for non-prescription home use with self-collected anterior nares nasal swab specimens. This is not only the first device of its kind with four analytes in one test (4-in-1), and the first RSV home test, but it is also the first respiratory home test to earn FDA clearance for children aged 6-23 months when administered by an adult using ACON’s proprietary nasal swab guard.
This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged six (6) months 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 RSV, influenza, SARS-CoV-2 or other pathogens.
Individuals who test negative and/or experience continued or worsening 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 | 91.6% | 99.9% |
| Influenza A | 92.9% | 99.8% |
| Influenza B | 92.9% | 99.9% |
| RSV | 94.1% | 99.8% |
Test Procedure Overview
