Flowflex™ SARS-CoV-2 Antigen Rapid Test is a rapid test for the detection of SARS-CoV-2 antigens in anterior nasal specimens directly from individuals within 7 days of symptom onset or without symptoms or other epidemiological reasons to suspect COVID-19 infection. For self-testing use. For use under an Emergency Use Authorization (EUA) only.
|Specimen Format||Nasal Swab|
|Detects||The nucleocapsid protein antigen from SARS-CoV-2|
|Sample Volume||4 to 5 drops of the prepared specimen|
|Relative Sensitivity||97.1% (83.8%-99.9%) 95% Confidence Intervals|
|Relative Specificity||99.6% (97.7%-99.9%) 95% Confidence Intervals|
|Accuracy||99.3% (97.5%-99.9%) 95% Confidence Intervals|
|Test Time||15 minutes|
|Shelf Life||24 Months|
|Store Temperature||2 – 30 °C|
IMPORTANT: Carefully read the instructions before performing the test. Failure to follow the instructions may result in inaccurate test results.
CPT Code for COVID-19: 87811QW
FEATURES & BENEFITS
- Cassette Format
- Detects the nucleocapsid protein antigen from SARS-CoV-2
- Nasal Specimen sample
- Results in 15 minutes
- FDA Emergency Use Authorization (EUA)
- Relative Sensitivity: 97.1% (83.8%-99.9%)*
- Relative Specificity: 99.6% (97.7%-99.9%)*
- Accuracy: 99.3% (97.5%-99.9%)*
*95% Confidence Intervals
You may place order by giving us a call
|Catalog Number||Description||Units of Measurements|
|IDL031-118B5||Flowflex™ SARS-CoV-2 Antigen Rapid Test||1 Test/Kit|
|IDL031-125P5||Flowflex™ SARS-CoV-2 Antigen Rapid Test||25 Tests/Kit|
DOCUMENTATION AND VIDEOS
Flowflex™ SARS-CoV-2 Antigen Rapid Test brochure, package inserts, authorized FDA letter and additional literature provided below:
Jant Pharmacal is an Authorized Distributor for the Flowflex™ SARS-CoV-2 Antigen Rapid Test.
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 more information on EUAs please visit: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization
For the most up to date information on COVID-19, please visit: www.cdc.gov/COVID19