Respiratory Test Kit FlowFlex™ COVID-19 Antigen OTC 300 Tests per Case / 1 Test per Box CLIA Waived

Features

• Flowflex Covid-19 Antigen Home test is for use under an FDA EUA: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2
• 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
• Product ships with minimum 60 days dating
• 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
• 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
• Individuals who test positive should self-isolate and consult their healthcare provider 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 should be considered in the context of an individual’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19
• Clinical performance showed 93% sensitivity and 100% specificity

More Information

• FlowFlex COVID-19 Antigen Home Test FDA EUA Letter
• FlowFlex COVID-19 Antigen Home Test Package Insert
• FlowFlex COVID-19 Antigen Home Test Healthcare Providers Fact Sheet
• FlowFlex COVID-19 Antigen Home Test Package Insert for Healthcare Providers
• FlowFlex COVID-19 Antigen Home Test Quick Reference Instructions
• Acon FlowFlex Labeling Changes Mar 2023
• Flowflex COVID-19 Antigen Home Test Shelf-life Expiration Extension Letter 3.15.23
• Flowflex COVID-19 Antigen Home Test Shelf Life Update Lot Numbers