Flowflex COVID-19 Antigen Home Test (1 Test/Kit)
Original price was: $9.99.$4.95Current price is: $4.95.
Over-the-Counter
1 Test per Kit
15-Minute Results
1 single-use test per kit
The Flowflex COVID-19 Antigen Home Test is an over-the-counter lateral flow test for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in anterior nasal swab samples. Results are read at 15 minutes.
- For use with symptoms or without symptoms when the required repeat-testing schedule is followed
- Self-collection for individuals aged 14 and older
- Adult collection for children ages 2–13
- One test cassette, extraction buffer tube and nasal swab per kit
Call for bulk pricing:
866-205-9215
Flowflex COVID-19 Antigen Home Test Overview
The Flowflex COVID-19 Antigen Home Test is an over-the-counter lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in anterior nasal swab samples. This EUA-authorized configuration contains one single-use test and provides results at 15 minutes.
Over-the-Counter
Anterior Nasal Swab
1 Test per Kit
Features and Benefits
Detects SARS-CoV-2 nucleocapsid protein antigen
Results are read at 15 minutes
Uses an anterior nasal swab sample
Non-prescription home use
Self-collection for individuals aged 14 and older
Adult collection for children ages 2–13
One single-use test per kit
Store at 36–86°F (2–30°C); do not freeze
L031-118B5
DTK-751500
1 Test per Kit
Who Can Use This Test?
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.
| Testing Situation | EUA Repeat-Testing Schedule |
|---|---|
| Symptoms of COVID-19 within 7 days of symptom onset | After an initial negative result, test again 48 hours later |
| No symptoms or another epidemiological reason to suspect COVID-19 | After an initial negative result, test two more times at least 48 hours apart |
Repeat testing does not need to be performed after a positive result. Always follow the complete instructions included with the kit.
How to Perform the Test
Using the same swab, firmly rub the inside of each nostril five times for approximately 15 seconds per nostril.
Place the swab in the extraction tube and swirl it for 30 seconds.
Rotate the swab at least five times while squeezing the tube, then remove the swab while continuing to squeeze.
Attach the dropper tip and add four drops to the cassette sample well.
Read the result at 15 minutes. Do not read the result after 30 minutes.
This overview does not replace the package insert. Read and follow the complete instructions supplied with the kit before testing.
Understanding the Results
| Result | What Appears | Next Step |
|---|---|---|
| Positive | Both the control line (C) and test line (T) are visible, even if the test line is faint | Follow current public-health guidance and seek appropriate follow-up care |
| Negative | The control line (C) is visible and the test line (T) is not visible | Follow the required repeat-testing schedule |
| Invalid | The control line (C) is not visible | Repeat the test with a new swab and new test device |
Clinical Performance
In the symptomatic clinical study summarized in the EUA package insert, the Flowflex test was compared with an FDA-authorized RT-PCR assay using specimens collected within seven days of symptom onset.
| Performance Measure | Result | 95% Confidence Interval |
|---|---|---|
| Positive Percent Agreement (PPA) | 93% | 78%–99% |
| Negative Percent Agreement (NPA) | 100% | 95%–100% |
PPA and NPA describe agreement with the comparator method and do not guarantee that every test result will be correct. Negative results are presumptive and do not rule out COVID-19.
Storage and Expiration
Store the unopened test at 36–86°F (2–30°C) and do not freeze it. The test is stable until the expiration date printed on the sealed pouch. Do not use the test after the printed expiration date.
Instructions and Regulatory Documents
Healthcare Provider Package Insert
FDA EUA Letter of Authorization
FDA Serial-Testing Revision
EUA Labeling Notification
Healthcare Provider Fact Sheet
Frequently Asked Questions
What does the Flowflex COVID-19 Antigen Home Test detect?
It qualitatively detects SARS-CoV-2 nucleocapsid protein antigen in an anterior nasal swab sample. It does not differentiate between SARS-CoV and SARS-CoV-2.
Is this an over-the-counter test?
Yes. This EUA-authorized configuration is intended for non-prescription 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.
Is repeat testing required after a negative result?
Yes. If symptoms are present, test again 48 hours after the first negative result. If symptoms are not present, perform two additional tests at least 48 hours apart.
What does a negative result mean?
A negative result is presumptive and does not rule out COVID-19. Consider the result together with recent exposures, medical history and symptoms, and follow the repeat-testing instructions.
How many tests are included?
This package contains one test cassette, one extraction buffer tube and one disposable nasal swab.
What is the shelf life?
Use the expiration date printed on the sealed test pouch. Store the test at 36–86°F (2–30°C), do not freeze it, and do not use it after the printed expiration date.
Need manufacturer instructions or support?
Review the Flowflex product-support page for instructions, testing information and customer support.
Additional information
| Weight | 0.125 lbs |
|---|---|
| Dimensions | 5 × 3 × 1 in |
