Antigen Detection Control Panel IntelliSwab® COVID-19 Rapid Test Pro Limit of Detection, Low Positive Level, Negative Level

Features

• The InteliSwab® COVID-19 Rapid Test Pro is for use under the Food and Drug Administration’s Emergency Use Authorization (EUA) only: 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 InteliSwab® COVID-19 Rapid Test Pro Visual Reference Panel contains: InteliSwab® COVID-19 Limit of Detection (1 device)
• InteliSwab® COVID-19 Low Positive (1 device)
• InteliSwab® COVID-19 Negative (1 device)
• Instructions for Use Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA)
• 42 U.S.C. §263a
• that meet the requirements to perform moderate
• high or waived complexity 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 Laboratories within the United States and its territories are required to report all results to the appropriate 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 (LVID) Test Code Mapping for SARS-CoV-2 Tests provided by CDC Positive results indicate that viral antigens have been detected
• but clinical correlation with patient history and other diagnostic information is necessary to determine infection status; positive results do not exclude bacterial infection or coinfection with other viruses Negative results should be treated as 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 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 COVID-19 The InteliSwab™ COVID-19 Rapid Test Pro is intended for use by medical professionals or trained operators who are proficient in performing tests and trained clinical laboratory personnel or individuals trained in POC settings