Respiratory Test Kit OSOM® Covid-19 Antigen Home Test 40 Tests

Features

• The OSOM COVID-19 Antigen Home Test is only for in vitro diagnostic use under the Food and Drug Administration’s Emergency Use Authorization: https://www.fda.gov/medical-devices/covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2
• The OSOM® COVID-19 Antigen Home Test is a lateral flow immunoassay device intended for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus
• This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older or adult collected anterior nasal (nares) swab samples from individuals aged 2 years or older
• This test is authorized for individuals with symptoms of COVID-19 within the first 5 days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests
• 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 and the agent detected may not be the definitive cause of disease
• All negative results are presumptive and confirmation with a molecular assay, if necessary for patient management, may be performed; negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control measures such as isolating from others and wearing masks
• 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
• Individuals should provide all results obtained with this product to their healthcare provider for public health reporting and to receive appropriate medical care; all 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 SARS-CoV-2 Tests provided by CDC
• Can be performed in the comfort & privacy of your own home without the need for a doctor’s prescription or visit​
• Everything you need to test for COVID-19 in only 15 minutes​
• A noninvasive sample collection process that does not require deep nasal swabbing​
• In a clinical study, the OSOM COVID-19 Antigen Home Test identified positive cases 84.4% of the time and identified negative cases 100% of the time

More Information

• OSOM COVID-19 Antigen Home Test FDA EUA Letter
• OSOM COVID-19 Antigen Home Test HCP IFU
• OSOM COVID-19 Antigen Home Test IFU
• OSOM COVID-19 Antigen Home Test Healthcare Providers Fact Sheet