CareStart Covid-19 Antigen Test- 2 Test Kit

Product Summary

• Over the counter, no prescription needed
• For use with and without COVID-19 symptoms
• Manufactured in the USA
• Accurate results in 10 minutes
• No need to send off to a lab to obtain results
• Compact packaging for “On-The-Go” testing
• NON-RETURNABLE AND NON-REFUNDABLE
• PRODUCT EXPIRATION EXTENSION TO 7/31/2022



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! PRODUCT EXPIRATION EXTENSION TO 7/31/2022 https://accessbio.net/wp-content/uploads/2022/01/CareStart-COVID-19-Ag-Home-Test_Exp-Date-Extension-Notification_01.pdf




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 selfcollected 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.




1.Remove the foil from the top of the extraction buffer tube. 2.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 the tube holder is provided. 3.Open the swab packaging at the stick end, not the swab end. Do not touch the swab head. 4.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. 5.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. 6.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. 7.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. 8.Rotate the swab 5 times while squeezing the tube. Note: A false negative result may occur if the swab is not rotated five times. 9.Remove the swab while squeezing the tube. Dispose the swab in the trash. 10.Attach the dropper tip firmly onto the tube. Mix thoroughly by swirling or flicking the bottom of the tube. 11.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. 12.Set the timer for 15 minutes. Result should be read at 15 minutes. Do not read after 30 minutes. Dispose 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.




WARNINGS

Keep out of reach of children. 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. This product has not been FDA cleared or approved but has been authorized by FDA under an EUA.