Orasure Intelliswab COVID-19 Visual Reference Panels Kit

Orasure Intelliswab™ COVID-19 Visual Reference Panels Kit

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.

Product Specifications

Application: Control Panel

For Use With: For use with IntelliSwab COVID-19 Rapid Test Kit

Levels: Limit of Detection, Low Positive Level, Negative Level

Tests Name: COVID-19 Rapid Test Pro

Test Type: Antigen Detection

Note: Actual Product May Vary. See Product Specifications for more detailed information.