Flowflex PLUS COVID-19 and Flu A/B Home Test (1 Test/Kit)
$8.95
Over-the-Counter
3-in-1 Home Test
15-Minute Results
1 test per kit • $8.95 per test
The Flowflex® Plus COVID-19 + Flu A/B Home Test is an over-the-counter antigen test that detects and differentiates SARS-CoV-2, influenza A and influenza B using one anterior nasal swab. It is intended for people 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
- For symptomatic individuals during the first 5 days of symptom onset
- Self-collection for ages 14 and older
- Adult collection for children ages 2–13
- One single-use test per kit
Call for bulk pricing: 866-205-9215
Flowflex Plus 3-in-1 Respiratory Home Test
The Flowflex® Plus COVID-19 + Flu A/B Home Test is a lateral flow immunoassay for the qualitative detection and differentiation of SARS-CoV-2, influenza A and influenza B protein antigens directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection.
This FDA 510(k)-cleared test is intended for non-prescription home use. Individuals ages 14 years and older may collect and test their own sample, while an adult must collect the sample and perform the test for children ages 2–13.
Over-the-Counter
COVID-19 + Flu A/B
1 Test per Kit
Features and Benefits
Detects and differentiates COVID-19, influenza A and influenza B
Provides visual results at home in 15 minutes
FDA 510(k) cleared for non-prescription home use
Uses an anterior nasal swab collected from both nostrils
Self-testing for ages 14+ and adult-administered testing for children ages 2–13
One complete single-use test per kit
Product Details
L03A-R0645
DTK-751506
1 Test per Kit
K250377
Technical Specifications
| Specification | Details |
|---|---|
| Test method | Lateral flow immunoassay |
| Targets | SARS-CoV-2, influenza A and influenza B protein antigens |
| Sample | Anterior nasal swab |
| Intended population | Symptomatic individuals ages 2 years 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), away from direct sunlight; do not freeze |
| Package size | 1 test per kit |
What Does the Test Detect?
| Respiratory Virus | Result Marker | Detected Target |
|---|---|---|
| COVID-19 | CoV | SARS-CoV-2 protein antigens |
| Influenza A | A | Influenza A protein antigens |
| Influenza B | B | Influenza B protein antigens |
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 another respiratory pathogen.
Who Can Use This Test?
| Age | Collection and Testing |
|---|---|
| 14 years and older | May self-collect the anterior nasal swab and perform the test. |
| 2–13 years | An adult must collect the sample and perform the test. |
| Younger than 2 years | Do not use this test. |
How to Perform the Test
The original test-procedure illustration is preserved below. It is an overview only and does not replace the current Quick Reference Instructions supplied with the kit.
Prepare: Wash or sanitize and dry your hands. Place the cassette on a clean, flat surface and secure the opened buffer tube in the holder formed from the kit box.
Collect: Using the same swab, rub the inside wall of each nostril 5 times for approximately 15 seconds.
Extract: Place the swab in the buffer tube and swirl for 30 seconds. Rotate the swab 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: The control line is visible and any visible line—even a faint line—appears at CoV, A and/or B. The test is positive for the corresponding virus or viruses.
Negative: The control line is visible and no line appears at CoV, A or B.
Invalid: The control line is not visible, even if another line appears. Retest with a new kit and a new sample.
All negative results are presumptive and do not rule out influenza, COVID-19 or another infection. A healthcare provider may determine that confirmation with an FDA-cleared molecular assay is appropriate. Seek follow-up care if respiratory symptoms continue or worsen.
Clinical Performance
In the clinical study summarized in the current manufacturer Instructions for Use, results were compared with FDA-cleared RT-PCR molecular assays.
| Target | Positive Percent Agreement | Negative Percent Agreement |
|---|---|---|
| COVID-19 | 90.4% | 99.4% |
| Influenza A | 91.6% | 99.8% |
| Influenza B | 93.6% | 99.7% |
PPA and NPA describe agreement with the comparator methods used in the clinical study and should not be interpreted as a guarantee that every individual result will be correct.
Storage and Handling
Store at 36–86°F (2–30°C), away from direct sunlight
Keep the cassette sealed until immediately before use
Do not freeze the test or its components
Do not use after the expiration date printed on the packaging
The manufacturer has announced a shelf-life extension to 24 months for eligible lots. Always use the expiration date printed on the current packaging or verify the applicable expiration date by lot number.
Instructions and Regulatory Documents
Spanish Quick Reference Instructions
Healthcare Provider Instructions for Use
Consumer Quick Start Guide
Spanish Consumer Quick Start Guide
FDA 510(k) Clearance Letter
Frequently Asked Questions
What does the Flowflex Plus 3-in-1 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 home use.
Who can collect the nasal swab?
Individuals ages 14 and older may collect their own sample and perform the test. An adult must collect the sample and perform the test for children ages 2–13. Do not use the test on anyone younger than 2 years.
When should the test be used?
Use it for individuals with signs or symptoms of respiratory tract infection during the first 5 days after symptoms begin. Do not use it when no symptoms are present or when symptoms began more than 5 days ago.
How quickly are results available?
Read the result at 15 minutes. Do not interpret 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 COVID-19, influenza or another respiratory infection. Contact a healthcare provider if symptoms persist or worsen; the provider may recommend molecular confirmation.
Can the test detect more than one virus?
Yes. More than one test line may appear, indicating that antigens from multiple respiratory viruses were detected. Positive results do not rule out another infection.
How many tests are included?
This product configuration contains one complete single-use test per kit.
Need Manufacturer Instructions or Support?
Visit the official Flowflex support page for current instructions, videos, expiration information and customer support.
Additional information
| Weight | 0.125 lbs |
|---|---|
| Dimensions | 5 × 3 × 2 in |
