Flowflex COVID-19 Antigen Home Test (2 Tests/Kit)
Original price was: $19.98.$8.50Current price is: $8.50.
2 Tests per Kit
2 COVID-19 antigen tests per kit
Rapid lateral-flow home test for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in anterior nasal swab samples. Results are read in 15 minutes.
- For use with or without COVID-19 symptoms under the EUA labeling
- Self-collection for individuals ages 14 and older
- Adult-collected samples for children ages 2 and older
- Repeat testing is required after an initial negative result
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Flowflex COVID-19 Antigen Home Test Overview
The Flowflex COVID-19 Antigen Home Test is a visually read lateral-flow immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in anterior nasal swab samples.
This two-test kit is intended for non-prescription home use. Individuals ages 14 and older may collect their own sample. Samples from children ages 2 through 13 must be collected by an adult.
15-Minute Results
Anterior Nasal Swab
2 Tests per Kit
Features and Benefits
Read the result at 15 minutes and do not interpret it after 30 minutes.
Uses a nasal swab sample collected from both nostrils.
No laboratory equipment or sample shipment is required.
Self-collection for ages 14 and older or adult collection for ages 2 and older.
Applies to the EUA-labeled version described on this page. Follow the labeling included with your kit.
Two individually packaged tests support required repeat testing for symptomatic users.
L031-125M5
DTK-751502
2 tests per kit
Authorized Use
Under the EUA labeling, the Flowflex COVID-19 Antigen Home Test is authorized for:
- Individuals with COVID-19 symptoms that began within the previous seven days, when tested at least twice over three days with at least 48 hours between tests.
- Individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests.
- Self-collected anterior nasal swab samples from individuals ages 14 and older.
- Adult-collected anterior nasal swab samples from individuals ages 2 and older.
How to Perform the Test
Wash or sanitize your hands. Open the test pouch and place the cassette on a clean, flat surface.
Insert the absorbent swab tip approximately one-half to three-quarters of an inch into one nostril. Rub it around the inside wall five times, then repeat in the other nostril.
Place the swab in the extraction tube and swirl for 30 seconds. Rotate it five times while squeezing the tube, then remove it while continuing to squeeze.
Dispense four drops into the sample well. Read the result at 15 minutes. Do not interpret the test after 30 minutes.
Always read and follow the complete package insert included with the test before beginning.
Understanding the Results
| Result | What You Will See | What It Means |
|---|---|---|
| Positive | A control line at C and any visible red or pink test line at T | SARS-CoV-2 antigen was detected. A faint T line should be interpreted as positive. |
| Negative | A control line at C and no line at T | Antigen was not detected, but the negative result is presumptive. Follow the repeat-testing instructions. |
| Invalid | No visible control line at C | The test did not work correctly. Repeat the procedure using a new swab, cassette and extraction tube. |
Clinical Performance
In the clinical study described in the EUA healthcare-provider package insert, results from symptomatic participants were compared with an FDA-authorized RT-PCR test.
| Performance Measure | Result | 95% Confidence Interval |
|---|---|---|
| Positive Percent Agreement | 93% | 78%–99% |
| Negative Percent Agreement | 100% | 95%–100% |
Positive and negative percent agreement are measures of agreement with the comparator method and should not be interpreted as guarantees of an individual result. Test performance can vary with sample collection, timing, viral levels and circulating variants.
Storage and Expiration
- Store the kit between 36°F and 86°F (2°C and 30°C).
- Keep the test cassette sealed in its pouch until immediately before use.
- Do not freeze the kit.
- Do not use the test after the expiration date printed on the box or cassette pouch.
Previous Flowflex expiration-date extensions applied only to specified lot numbers. ACON now states that all lot numbers eligible for those extensions have expired, so follow the dates printed on the current product packaging.
Instructions and Regulatory Documents
Complete EUA instructions for performing and interpreting the test.
Spanish-language instructions for performing and interpreting the test.
Condensed step-by-step testing instructions from the manufacturer.
Spanish-language condensed testing instructions from the manufacturer.
Detailed intended-use, performance and test-limitation information.
FDA Emergency Use Authorization documentation for EUA210494.
Frequently Asked Questions
What does the Flowflex COVID-19 Antigen Home Test detect?
It detects nucleocapsid protein antigen from SARS-CoV-2 in an anterior nasal swab sample. It does not test for influenza, RSV or other pathogens.
How quickly are results available?
Results should be read at 15 minutes. Do not read the result before 15 minutes or after 30 minutes.
Can children use this COVID-19 test?
The test may be used for children ages 2 and older. Children ages 2 through 13 must have their nasal sample collected and their test performed by an adult. Individuals ages 14 and older may collect their own sample.
Can the test be used without symptoms?
The EUA-labeled version can be used by people with or without symptoms when its required repeat-testing schedule is followed. The separately 510(k)-cleared version is intended only for symptomatic individuals. Follow the instructions included with your specific kit.
Do I need to repeat the test after a negative result?
Yes. Under the EUA instructions, symptomatic individuals with an initial negative result should test again after 48 hours. People without symptoms should test two additional times, at least 48 hours apart.
What does a negative result mean?
A negative result means SARS-CoV-2 antigen was not detected in the sample, but it does not rule out infection. Repeat testing is required, and people with continuing or worsening symptoms should contact a healthcare provider.
How many tests are included?
Each kit contains two Flowflex COVID-19 Antigen Home Tests.
How should I determine the expiration date?
Follow the expiration date printed on the kit box and cassette pouch. Do not use a test beyond its printed expiration date.
Is this product FDA cleared?
The instructions currently linked to this listing identify the product as authorized under FDA EUA210494 and not FDA cleared or approved. ACON also markets a separately labeled Flowflex COVID-19 Antigen Home Test cleared under K230828. Check the labeling included with your kit to determine which instructions apply.
More Flowflex Product Information
Visit the manufacturer’s website for current instructions, support resources and product information.
Additional information
| Weight | 0.125 lbs |
|---|---|
| Dimensions | 5 × 3 × 2 in |
