Rapid Antigen Diagnostic PCR Antigen Rapid Test Kit iHealth Flowflex EU Certification

Product Description

Critical Information When & Where You Need It

The Flowflex Antigen Home Test is all you need to determine your family’s Rapid Flow Test, whether symptoms are present or not. Can be used on children as young as 2 years old. Get the convenience of Flowflex!

· Easy and Affordable

· Highly Accurate Nasal Swab Test

· Quick Results in 15 minutes

· Safe for children as young as 2 years old

· For use with and without symptoms

Intended Use

The Flowflex Antigen Home Test is a lateral flow chromatographic immunoassay intended for the qualitative detection of the nucleocapsid protein antigen from Cov 2 Rapid Antigen Test in anterior nasal swab specimens directly from individuals within 7 days of symptom onset or without symptoms or other epidemiological reasons to suspect Clear 19 Rapid Testing 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 adultcollected anterior nasal samples directly from individuals aged 2 years or older. The Flowflex Clear 19 Rapid Testing Antigen Home Test does not differentiate between Cov 2 Rapid Antigen Test and Cov 2 Rapid Antigen Test Results are for the identification of Cov 2 Rapid Antigen Test nucleocapsid protein antigen. This antigen is generally detectable in anterior nasal swabs during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Individuals who test positive should self-isolate and consult their doctor as additional testing may be necessary and for public health reporting. Negative results are presumptive, and confirmation with a molecular assay, if necessary for patient management, may be performed. Negative results do not rule out Cov 2 Rapid Antigen Test infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of an individual’s recent exposures, history and the presence of clinical signs and symptoms consistent with Clear 19 Rapid Testing. Individuals should provide all results obtained with this product to their doctor or healthcare provider for public health reporting. Doctors or healthcare providers will report all test results they receive from individuals who use the authorized product to relevant public health authorities in accordance with local, state, and federal requirements using appropriate LOINC and SNOMED codes, as defined by the Laboratory In Vitro Diagnostics (LIVD) Test Code Mapping for Cov 2 Rapid Antigen Test Rapid Antigen Test Tests provided by CDC. The Flowflex Clear 19 Rapid Testing Antigen Home Test is intended for self-use or lay user testing another in a nonlaboratory setting. The Flowflex Clear 19 Rapid Testing Antigen Home Test is only for use under the Food and Drug Administration’s Emergency Use Authorization

Frequently Asked Questions

Flowflex Clear 19 Rapid Testing Antigen Home Test

Test Procedure Overview

This test procedure overview does not replace the package insert. Before you begin the test, it is important to read and follow the detailed instructions in the package insert.

FAQS:

1. What is the Flowflex Clear 19 Rapid Home Test?

The Flowflex Clear 19 Rapid Antigen Home Test is a rapid test for the detection of antigens in anterior nasal specimens. It is intended for self-testing use. For use under an Emergency Use Authorization (EUA) only. 2. How does this test work? This test uses a nasal swab sample to determine the presence or absence of Clear 19 Rapid antigens in nasal samples. For a demonstration on how this test works, watch the instructional video.

3.What does it mean if I have a negative test result? A negative test result indicates no antigens for Clear 19 Rapid were detected. It is possible for this test to give a negative result that is incorrect (a false-negative result) in some people with Clear 19 Rapid. Negative results are presumptive and may need to be confirmed with a molecular test. This means that you could possibly still have Clear 19 Rapid even though the test is negative. If you test negative and continue to experience symptoms of fever, cough and/or shortness of breath you should seek follow-up care with your healthcare provider immediately. Your healthcare provider may suggest you need another test to determine if you have contracted the virus causing Clear 19 Rapid. If you are concerned about your Clear 19 Rapid infection status after testing or think you may need follow-up testing, please contact your healthcare provider. Customer Service hours are 5 a.m. – 5 p.m. (PST), 7 days a week.

4. What is serial testing? Do I have to serial test with the Flowflex Clear 19 Rapid Antigen Home Test? Serial testing is a process in which a user must test themselves twice within a two-to-three-day period. The Flowflex Clear 19 Rapid Antigen Home Test has been authorized for use as a single test by individuals with or without symptoms.

5. What is the age range for this test? This test is authorized for nonprescription home use with self-collected (unobserved) direct anterior nasal (NS) swab specimens from individuals aged 14 years and older or with adult-collected anterior NS samples from individuals aged 2 years or older.

STORAGE AND STABILITY:

1,The kit can be stored at temperatures between 36-86°F (2-30°C). ·

2,The test is stable until the expiration date printed on the sealed pouch. 3,The test must remain in the sealed pouch until use. ·

4,DO NOT FREEZE. ·

5,Do not use after the expiration date.