Flowflex™ Covid-19 Antigen Home Test DOES NOT require Serial Screening as BinaxNOW or QuickVue OTC Tests.
Serial testing is a process in which a user must test themselves twice within a two-to-three-day period.
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.
Features and Benefits
- Anterior nasal swab specimens
- Results in 15 minutes
- Store between 36 to 86° F
- Sample self-collection ages 14 and older
- Sample collection by an adult in children ages 2 to 13
- Excellent performance when compared to an FDA authorized molecular SARS-CoV-2 test
- 12 Months shelf life
Notes:
- This product has not been FDA cleared or approved but has been authorized by FDA under an EUA.
- This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.
- The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of IVDs for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated, or authorization is revoked sooner.
- For the most up to date information on COVID-19, please visit: www.cdc.gov/COVID19
Clinical Performance
The performance of Flowflex COVID-19 Antigen Home Test was established in an all-comers clinical study conducted between March 2021 and May 2021 with 172 nasal swabs self-collected or pair-collected by another study participant from 108 individual symptomatic patients (within 7 days of onset) suspected of COVID-19 and 64 asymptomatic patients. The Flowflex COVID-19 Antigen Home Test results were compared to an FDA EUA RT-PCR COVID-19 assay to determine test performance in the table below:
Analytical Sensitivity: Limit of Detection (LoD) :
LoD was determined as the lowest virus concentration that was detected ≥ 95% of the time. Based on this testing, the LoD in nasal matrix was confirmed to be 2.5 x 103 TCID50/mL
Materials Included
- (1) Test Cassette
- (1) Extraction Buffer Tube
- (1) Nasal Swab
- (1) Package Insert
- (1) External Tube Holder
Test Procedure and Interpretation
Documentation
Brochure
FDA EUA Letter
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