SIENNA™ COVID-19 Rapid Antigen Test Cassettes-Point of Care (POC)
SIENNA™ COVID-19 Rapid Antigen Test Cassettes
*For Professional In-Vitro Diagnostic Use Only. CLIA number is required for purchase.*
10 Minute Point of Care (POC) Rapid Antigen Test created for the qualitative detection of COVID-19 antigen.
It is intended to aid in the rapid diagnosis of COVID-19 infections.
The Sienna COVID-19 Antigen Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of COVID-19 antigen in Nasopharyngeal swab. The identification is based on the monoclonal antibodies specific for the Nucleocapsid protein of SARS-CoV-2.
The Sienna nasal swab test kit is a point-of-care immunodiagnostic test that can be administered anywhere, does not require samples to be sent to a lab and delivers a result in ten minutes.
Rapid antigen tests are commonly used in the diagnosis of respiratory pathogens, including influenza viruses and respiratory syncytial virus (RSV).
The Sienna test kit is 100% manufactured in Finland (with no components sourced from China) by a leading European in vitro diagnostics company.
Visual Results: Easy to interpret.
Fast Results: 10-minute test time.
Individual Buffer Vials and Swabs:Helps in testing multiple individuals simultaneously.
The kit includes:
(25) Individually Pouched cassettes
(25) buffer tubes
(25) sterile swabs
Procedure: During the testing process, the extracted specimen reacts with the antibody of the SARS-CoV-2 nucleocapsid protein that are coated onto particles. The mixture migrates into the membrane to react with the antibody for the SARS-CoV-2 nucleocapsid protein on the membrane and will generate one colored line in the test regions. The presence of this colored line in the test regions indicates a positive result. A colored line will always appear in the control region to serve as a procedural control if the test has been performed correctly.
iHealth®COVID-19 Antigen Rapid Home Test Kit (2 Tests/Pack)
iHealth® COVID-19 Antigen Rapid Home Test Kit
2 Tests/Pack | 90 Tests/Case | FDA EUA Authorized OTC at-Home Self Test | Results in 15 Minutes with Non-invasive Nasal Swab | Easy to Use & No Discomfort |For In Vitro Diagnostic Use Only
The iHealth® COVID-19 Antigen Rapid Test is a lateral flow assay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2.
This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 15 years or older with symptoms of COVID-19 within the first 7 days of symptom onset. This test is also authorized for non-prescription home use with adult-collected nasal swab samples from individuals aged 2 years or older with symptoms of COVID-19 within the first 7 days of symptom onset.
This test is also authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 15 years or older, or adult collected anterior nasal swab samples from individuals aged 2 years or older, with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over 3 days with at least 24 hours (and no more than 48 hours) between tests.
FDA AUTHORIZED 15 MINS SELF-TEST The test is a 15-minute self-test to detect whether or not an individual has the COVID-19. The test can be completed in the comfort of your own home without the need to ship your sample to a lab.
EASY TO USE ZERO DISCOMFORT Test can be done by inserting only 1/2 to 3/4 inch with a simple non-invasive nasal swab, easy to use and zero discomfort. Step-by-step instructional videos are available in our app for easy following. (Installation of app is optional.)
FOR AGES 2 AND ABOVE The self-administered test is recommended for individuals aged 15 years and older. Adult-collection is required for testing children 2-14 years old.
DETECT CURRENT AND NEW COVID VARIANTS iHealth has completed testing on several heat inactivated variant strains and the iHealth COVID-19 Antigen Rapid Test was able to detect the mutations.
GROUP TESTING MANAGING VIA MOBILE APP The iHealth Test app allows the administrator of a small group to monitor and track the group members’ test results when needed at school, work or event.
Expiration Date Extension- On March 29, 2022, the FDA granted a three-month shelf-life extension for the iHealth COVID-19 Antigen Rapid Test, which extended the shelf-life of all iHealth tests from 6 months to 9 months. For example, if the expiration date printed on your box says 2022-07-21 (YYYY-MM-DD), the updated expiration date is 2022-10-20 (YYYY-MM-DD). Please refer to the FDA website for the detailed list: https://www.fda.gov/media/158007/download
Legal Disclaimer- 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; and, 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 in vitro diagnostics 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.
Flowflex™ COVID-19 Antigen Rapid Home Test (1 Test/Pack)
Flowflex™ COVID-19 Antigen Rapid Home Test
Accurate results in 15 minutes | Easy-to-use nasal swab test | For use with and without COVID-19 symptoms | Can be used to test children as young as 2 years old | No need to send off to a lab to obtain results | Compact packaging for “On-The-Go” testing
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. You do not have to be a medical professional to use these tests, which work by detecting SARS-CoV-2 antigens from nasal swabs. FlowFlex antigen rapid tests provide precise, reliable results in 15 minutes. These tests are intended to be used twice within two to three days, with 24 to 48 hours between each test.
The Flowflex COVID-19 Antigen Home Test was compared to an FDA authorized molecular SARS-CoV-2 test. The Flowflex COVID-19 Antigen Home Test correctly identified 93% of positive specimens and 100% of negative specimens.
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 require serial testing.
Anterior nasal swab specimens
Sample self-collection ages 14 and older
Results in 15 minutes
Sample collection by an adult in children ages 2 to 13
12 Months shelf life
Store between 36 to 86° F
Excellent performance when compared to an FDA authorized molecular SARS-CoV-2 test
Test Cassette(s) | Package Insert Extraction Buffer Tube(s) |Nasal Swab(s) | External Tube Holder - Package of 25 tests.
Find peace of mind with Flowflex!
For use under an Emergency Use Authorization (EUA) only for the duration of the COVID-19 declaration justifying the emergency use of in vitro diagnostics (IVD), unless it is terminated or revoked by the FDA (after which the test may no longer be used)
The FlowFlex™ COVID-19 Antigen Home Test is authorized for non-prescription home use with self-collected direct anterior nasal (nares) swab samples from individuals aged 14 years or older or adult collected direct anterior nasal swab samples from individuals aged two years or older.
OSANG COVID-19 Antigen Self Test (2 Tests/Pack)
OSANG COVID-19 Antigen Self Test
2 Tests/Pack | FDA EUA Authorized OTC at-Home Self Test | Results in 15 Minutes with Non-invasive Nasal Swab | Easy to Use & No Discomfort |For In Vitro Diagnostic Use Only
Self testing and monitoring both you and our family members for SARS-CoV-2 variants can help protect the community.
Large population testing option with a faster & economical way to test without the need for Doctor’s appointment or RT-PCR
The World Health Organization acknowledges self testing as a valid way to conducting COVID-19 testing.
Clinical Performance vs. RT-PCR
A multi-site, Prospective lay-user self-testing clinical performance of OHC COVID-19 Antigen Self test, intended for self-testing of the qualitative detection of SARS-CoV-2 antigens in nasal swab from individuals who are suspected of SARS-CoV-2 within the first 7 days of the onset of symptoms for assessment of sensitivity and specificity in comparison with RT-PCR result.