Flowflex® Plus RSV + Flu A/B + COVID Home Test (1 Test/Kit)
$9.50
FDA 510(k) Cleared
4-in-1 Test
1 Test/Kit
1 test per kit • $9.50 per test
The Flowflex® Plus RSV + Flu A/B + COVID Home Test is an over-the-counter
lateral flow test for the qualitative detection and differentiation of RSV,
influenza A, influenza B and SARS-CoV-2 antigens in an anterior nasal swab.
It is intended for people with respiratory symptoms and provides results in
15 minutes.
- Tests for RSV, Flu A, Flu B and COVID-19 with one cassette
- For symptomatic individuals within the first 5 days of symptom onset
- Self-testing for ages 14+; adults may test children ages 6 months+
- Includes a pediatric swab guard for children ages 6–23 months
- 24-month shelf life when stored as directed
included swab guard with at least two adults present. Do not use on children
younger than 6 months. Read and follow the complete instructions before use.
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Flowflex 4-in-1 Respiratory Home Test
The Flowflex® Plus RSV + Flu A/B + COVID Home Test is a rapid lateral flow immunoassay for the simultaneous qualitative detection and differentiation of respiratory syncytial virus (RSV), influenza A, influenza B and SARS-CoV-2 protein antigens. It uses an anterior nasal swab and is cleared for non-prescription home use in people with signs and symptoms of a respiratory tract infection.
Individuals ages 14 years and older may collect and test their own sample. Adults may collect samples and perform the test for children ages 6 months through 13 years. Children ages 6–23 months require the included pediatric swab guard and at least two adults during sample collection.
Over-the-Counter
RSV + Flu A/B + COVID-19
1 Test per Kit
Features and Benefits
Detects and differentiates RSV, influenza A, influenza B and COVID-19 antigens
Provides visual results at home in 15 minutes
FDA 510(k) cleared for non-prescription home use
Self-testing for ages 14+ or adult-administered testing for children ages 6 months+
Includes a pediatric swab guard for children ages 6–23 months
One single-use test per kit
Product Details
L03A-R1445
DTK-751601
1 test/kit
K251749
Technical Specifications
| Specification | Details |
|---|---|
| Test method | Lateral flow immunoassay |
| Analytes | RSV, influenza A, influenza B and SARS-CoV-2 protein antigens |
| Sample | Anterior nasal swab |
| Intended population | Symptomatic individuals ages 6 months and older, within the first 5 days of symptom onset |
| Result time | Read at 15 minutes; do not read after 30 minutes |
| Storage | 36–86°F (2–30°C); do not freeze |
| Shelf life | 24 months; always verify the expiration date printed on the sealed pouch |
Who Can Use This Test?
| Age | Collection and Testing |
|---|---|
| 14 years and older | May self-collect and perform the test. |
| 2–13 years | An adult collects the sample and performs the test. |
| 6–23 months | Use the pediatric swab guard. At least two adults must be present to perform sample collection. |
| Younger than 6 months | Do not use this test. |
How to Perform the Test
The illustration below is the product’s existing test-procedure image. It is an overview only and does not replace the complete Quick Reference Instructions or Instructions for Use.
Prepare: Wash or sanitize and dry your hands. Place the cassette on a clean, flat surface and place the opened buffer tube in the box holder.
Collect: Swab both nostrils with the same swab, rubbing the inside wall of each nostril 5 times for 15 seconds. Follow the separate swab-guard instructions for children ages 6–23 months.
Extract: Place the swab in the buffer tube and swirl for 30 seconds. Rotate it 5 times while squeezing the tube, then remove it while continuing to squeeze.
Add sample: Attach the dropper tip, mix the tube and add 4 drops to the cassette sample well.
Read: Read the result at 15 minutes. Do not interpret the cassette after 30 minutes.
Understanding the Results
Positive: Both control lines are visible and any visible line—even a faint line—appears at R, A, B and/or CoV. The test is positive for the corresponding virus or viruses.
Negative: Both control lines are visible and no line appears at R, A, B or CoV.
Invalid: A control line is missing from either test strip. Retest with a new kit and a new sample.
Negative results are presumptive and do not rule out RSV, influenza, COVID-19 or another respiratory infection. A healthcare provider may decide that confirmation with an FDA-cleared molecular test is appropriate.
Positive results do not rule out infection with another respiratory pathogen.
Clinical Performance
In the manufacturer’s prospective study of symptomatic individuals tested within 5 days of symptom onset, results were compared with FDA-cleared RT-PCR molecular assays.
| Target | Positive Percent Agreement | Negative Percent Agreement |
|---|---|---|
| COVID-19 | 91.6% | 99.9% |
| Influenza A | 92.9% | 99.8% |
| Influenza B | 92.9% | 99.9% |
| RSV | 94.1% | 99.8% |
PPA and NPA describe agreement with the comparator method and should not be interpreted as a guarantee that every result will be correct.
Important Use Information
- Use only when respiratory symptoms are present and within the first 5 days of symptom onset.
- Do not use on anyone younger than 6 months.
- People with signs of severe illness or certain risk factors should seek medical care promptly instead of relying on home testing.
- Contact a healthcare provider if symptoms persist or worsen, regardless of the result—especially for children ages 6–23 months.
- The test detects viral antigens and does not measure the amount of virus present.
- FluMist or FluMist Quadrivalent may cause false-positive influenza A or B results.
- Always follow the current instructions supplied with the kit.
Instructions and Regulatory Documents
Frequently Asked Questions
What does the Flowflex 4-in-1 home test detect?
It qualitatively detects and differentiates RSV, influenza A,
influenza B and SARS-CoV-2 protein antigens from one anterior nasal
swab sample.
Is this test over the counter?
Yes. It is FDA 510(k) cleared for non-prescription home use.
Who can use the test?
People ages 14 and older may test themselves. Adults may test children
ages 6 months and older. For children ages 6–23 months, use the
included swab guard and have at least two adults present during sample
collection.
When should the test be used?
Use it for individuals with signs or symptoms of a respiratory tract
infection during the first 5 days after symptoms begin. Do not use it
for someone without symptoms or whose symptoms began more than 5 days
ago.
How quickly are results available?
Read the test at 15 minutes. Do not read the cassette before 15
minutes or after 30 minutes.
What does a negative result mean?
A negative result is presumptive and does not rule out RSV,
influenza, COVID-19 or another infection. Contact a healthcare
provider if symptoms persist or worsen; the provider may recommend
molecular confirmation.
Can more than one virus be detected at the same time?
Yes. The cassette can show positive lines for more than one target.
A positive result does not rule out another respiratory infection.
How many tests are included?
This product configuration contains one test per kit.
Respiratory-Virus Information
Review current information about respiratory viruses, symptoms and
prevention from the CDC.
Additional information
| Weight | 0.125 lbs |
|---|---|
| Dimensions | 5 × 3 × 2 in |
