Flowflex PLUS COVID-19 and Flu A/B Home Test (5 Tests/Kit)
$49.75
Over-the-Counter
3-in-1 Home Test
15-Minute Results
5 tests per kit
•
$9.95 per test
This over-the-counter home antigen test detects and differentiates COVID-19, influenza A and influenza B using an anterior nasal swab. It is intended for individuals with signs and symptoms of respiratory tract infection and provides results in 15 minutes.
- Tests for COVID-19, Flu A and Flu B with one nasal swab
- Self-collection for ages 14 and older
- Adult collection for children ages 2–13
- Five single-use tests per kit
- Up to 24-month shelf life when stored as directed
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Flowflex Plus COVID-19 and Flu A/B Home Test Overview
The Flowflex Plus COVID-19 + Flu A/B Home Test is an over-the-counter lateral flow immunoassay for the qualitative detection and differentiation of SARS-CoV-2, influenza A and influenza B protein antigens in anterior nasal swab samples. This kit includes five single-use tests and provides results in 15 minutes.
Over-the-Counter
COVID-19 + Flu A/B
5 Tests per Kit
Features and Benefits
Detects and differentiates COVID-19, Flu A and Flu B
Results are read at 15 minutes
Uses an easy anterior nasal swab sample
No prescription or laboratory processing required
Self-collection for individuals aged 14 and older
Adult collection for children ages 2–13
Five test cassettes, buffer tubes and swabs per kit
Up to 24-month shelf life when stored at 36–86°F (2–30°C)
L03A-R0845
DTK-751508
5 Tests per Kit
What the Test Detects
| Target | Result Position | Test Type |
|---|---|---|
| SARS-CoV-2 | CoV | Qualitative antigen detection |
| Influenza A | A | Qualitative antigen detection |
| Influenza B | B | Qualitative antigen detection |
The test does not detect influenza C and does not differentiate SARS-CoV from SARS-CoV-2. Positive results do not rule out co-infection with other respiratory pathogens.
Who Can Use This Test?
The test is for non-prescription home use by individuals with signs and symptoms of respiratory tract infection. Individuals aged 14 years or older may collect their own anterior nasal swab sample. An adult should collect the sample and perform the test for children ages 2–13. Do not use the test for children younger than 2 years.
How to Perform the Test
Collect an anterior nasal swab sample from both nostrils.
Process the swab in the supplied extraction buffer tube.
Add four drops of the processed sample to the cassette sample well.
Read the result at 15 minutes; do not read it after 30 minutes.
This overview does not replace the Quick Reference Instructions. Read and follow the complete instructions supplied with the kit before testing.
Clinical Performance
In the clinical study summarized in the FDA 510(k) decision, results were compared with highly sensitive RT-PCR comparator methods.
| Target | Positive Percent Agreement (PPA) | Negative Percent Agreement (NPA) |
|---|---|---|
| SARS-CoV-2 | 90.4% | 99.3% |
| Influenza A | 91.6% | 99.8% |
| Influenza B | 93.6% | 99.7% |
PPA and NPA describe agreement with the comparator method and should not be interpreted as a guarantee that every result will be correct. Repeat testing is needed after an initial negative COVID-19 result. Follow the instructions included with the kit.
Storage and Shelf Life
Store the unopened kit at 36–86°F (2–30°C). Do not freeze. The manufacturer lists a shelf life of up to 24 months when the test is stored as directed. Always verify the expiration date for the lot number printed on the kit box and do not use an expired test.
Instructions and Regulatory Documents
Spanish Instructions
Quick Instruction Card
Spanish Quick Instruction Card
Healthcare Provider IFU
Healthcare Provider Fact Sheet
Product Brochure
Product FAQ
FDA 510(k) Clearance Letter
Frequently Asked Questions
What does the Flowflex Plus home test detect?
It qualitatively detects and differentiates protein antigens from SARS-CoV-2, influenza A and influenza B using one anterior nasal swab sample.
Is this an over-the-counter test?
Yes. The Flowflex Plus COVID-19 + Flu A/B Home Test is FDA 510(k) cleared for non-prescription over-the-counter home use.
Who can collect the nasal swab sample?
Individuals aged 14 years or older may self-collect the sample. For children ages 2–13, an adult should collect the sample and perform the test.
How quickly are results available?
Read the result at 15 minutes. Do not interpret the result before 15 minutes or after 30 minutes.
What should I do after a negative result?
Negative results are presumptive and do not rule out infection. Repeat testing is needed after an initial negative COVID-19 result. Follow the kit instructions, and seek follow-up care if respiratory symptoms continue or worsen.
How many tests are included?
This package includes five single-use test cassettes, five extraction buffer tubes and five nasal swabs.
What is the shelf life?
The manufacturer lists a shelf life of up to 24 months when stored at 36–86°F (2–30°C). Verify the expiration date using the lot number printed on the kit box.
Need manufacturer instructions or support?
Review the Flowflex product page for current instructions, videos, expiration information and customer support.
Additional information
| Weight | 0.2 lbs |
|---|---|
| Dimensions | 7 × 4 × 3 in |
