Antigen Test Control Set OSOM® Flu A + B / SARS-CoV-2 Combo Positive Level / Negative Level 10 Swabs

Features

• The OSOM® Flu SARS-CoV-2 Combo Test is under FDA Emergency Use Authorization (EUA) only: 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® Flu SARS-CoV-2 Combo Control Kit is intended for in vitro diagnostic use in quality control testing with the OSOM Flu SARS-CoV-2 Combo Test - 10 Swabs per Kit
• The OSOM® Flu SARS-CoV-2 Combo Test is a lateral flow immunochromatographic assay intended for in vitro rapid, simultaneous qualitative detection and differentiation of influenza A and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly from anterior nasal swab specimens of individuals with signs and symptoms of respiratory infection consistent with COVID-19 by their healthcare provider within the first four (4) days of symptom onset when tested at least twice over three days with at least 48 hours between tests
• This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
• Positive results do not rule out bacterial infection or co-infection with other viruses; the agent detected may not be the definitive cause of disease
• All negative results are presumptive, and should be confirmed with a molecular assay, if necessary, for patient management
• Negative results do not rule out influenza or 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 each respiratory infection
• The OSOM Flu SARS-CoV-2 Combo Control kit includes five Flu A/Flu B/SARS-CoV-2 Positive Control Swabs and five Flu A/Flu B/SARS-CoV-2 Negative Control Swabs for external quality control testing
• Control is for use with OSOM Flu SARS-CoV-2 Combo Test Kit (1249728 /1080)

More Information

• OSOM Flu A + B and SARS-CoV-2 Combo FDA EUA Letter
• OSOM Flu A + B and SARS-CoV-2 Combo Control Kit
• OSOM Flu A + B and SARS-CoV-2 Combo Patients Fact Sheet
• OSOM Flu A + B and SARS-CoV-2 Combo Healthcare Providers Fact Sheet
• OSOM Flu A + B amd SARS-CoV-2 Combo Quick Ref Guide