Flowflex Covid -19 At Home Test - 1 Count

Product Summary

Key features

• Requires just 1 test
• Can be used to test children as young as 2 years old
• For use with and without COVID-19 symptoms
• Accurate results in 15 minutes
• No need to send off to a lab to obtain results
• Compact packaging for “On-The-Go” testing

PLEASE NOTE: THIS PRODUCT IS NON-RETURNABLE AND NON-REFUNDABLE

Description

A rapid test for the detection of SARS-CoV-2 antigens in anterior nasal specimens. For self-testing use. The Flowflex™ COVID-19 Antigen Home Test is all you need to determine your family’s Covid-19 status, whether symptoms are present or not. Can be used on children as young as 2 years old. Get the convenience of Flowflex!

The Flowflex COVID-19 Antigen Home Test is a lateral flow chromatographic immunoassay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in anterior nasal swab specimens directly from individuals within 7 days of symptom onset or without symptoms or other epidemiological reasons to suspect COVID-19 infection.

This test is authorized for non-prescription home use with self-collected anterior nasal swab specimens directly from individuals aged 14 years and older or with adult-collected anterior nasal samples directly from individuals aged 2 years or older.

The Flowflex COVID-19 Antigen Home Test does not differentiate between SARSCoV and SARS-CoV-2.

Directions

See package insert for detailed instructions and result interpretation.

• Remove the foil from the top of the extraction buffer tube.
• Punch through the perforated circle on the kit box to form a tube holder. Place the tube in the tube holder. For 25 test quantity kit box, a tube holder is provided.
• Open the swab packaging at the stick end, not the swab end. Do not touch the swab head.
• Gently insert the entire absorbent tip of the swab head into 1 nostril (½ to ¾ of an inch). With children, the maximum depth of insertion into the nostril may be less than ¾ of an inch, and you may need to have a second person to hold the child’s head while swabbing. Note: A false negative result may occur if the nasal swab specimen is not properly collected.
• Firmly rub the swab in a circular motion around the inside wall of the nostril 5 times. Take approximately 15 seconds to collect the specimen. Be sure to collect any nasal drainage that may be present onto the swab. Repeat this in the other nostril.
• Remove the swab from the nostril and immediately place into the extraction buffer tube. Note: Test samples immediately after collection, and no more than one hour after the swab is added to the reagent solution, if stored at room temperature.
• Immediately place the swab into the tube and swirl for 30 seconds. Note: A false negative result may occur if the swab is not swirled at least 30 seconds.
• Rotate the swab 5 times while squeezing the tube. Note: A false negative result may occur if the swab is not rotated five times.
• Remove the swab while squeezing the tube. Dispose of the swab in the trash.
• Attach the dropper tip firmly onto the tube. Mix thoroughly by swirling or flicking the bottom of the tube.
• Gently squeeze the tube and dispense 4 drops of solution into the Sample Well. Dispose the tube in the trash. Note: A false negative or invalid result may occur if less than 4 drops of fluid are added to the Sample Well.
• Set the timer for 15 minutes. The result should be read at 15 minutes. Do not read after 30 minutes. Dispose of the test cassette in the trash. Note: A false negative or false positive result may occur if the test result is read before 15 minutes or after 30 minutes.

Contents

• 1 Test Cassette
• 1 Extraction Buffer Tube
• 1 Disposable Nasal Swab (Sterile Nasal Swab)
• 1 Package Insert (En/Es)

Warnings and Restrictions

• Read the Flowflex COVID-19 Antigen Home Test Package Insert carefully before performing a test.
• Failure to follow directions may produce inaccurate test results.
• The test is intended to aid in the diagnosis of a current COVID-19 infection. Please consult a healthcare professional to discuss your results and if any additional testing is required.
• Keep test kit and materials out of the reach of children and pets before and after use.
• Do not use on anyone under two years of age.
• Do not open the kit contents until ready for use. If the test cassette is open for an hour or longer, invalid test results may occur.
• Do not use the test after the expiration date shown on the test cassette pouch.
• Do not use the test if the pouch is damaged or open.
• Do not reuse any kit components. Do not use with multiple specimens.
• Make sure there is sufficient light when testing.
• Do not use nasal sprays for at least 30 minutes before collecting a nasal sample.

Storage

• Store at room temperature.

This product has not been FDA cleared or approved but has been authorized by FDA under an EUA.