Respiratory Test Kit InteliSwab® COVID-19 Rapid Test Pro 25 Tests CLIA Waived

Features

• The InteliSwab COVID-19 Rapid Test Pro 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
• The InteliSwab™ COVID-19 Rapid Test Pro is a single-use lateral flow immunoassay with an integrated swab, intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in anterior nasal samples from individuals 18 years or older when the sample is self-collected or in individuals 2 years or older when the sample is collected by an adult or healthcare provider
• The test is authorized for individuals who are suspected of COVID-19 by their healthcare provider within 7 days of symptom onset or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 48 hours between tests; or from 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
• 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
• 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
• 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
• 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

More Information

• InteliSwab COVID-19 Rapid Test Pro FDA EUA Letter
• InteliSwab COVID-19 Rapid Test Pro HCP IFU
• InteliSwab COVID-19 Rapid Test Pro Healthcare Providers Fact Sheet
• InteliSwab COVID-19 Rapid Test Pro Individuals Fact Sheet
• InteliSwab Shelf-Life Extension Notification Sep 2023
• InteliSwab COVID-19 Pro Test Quick Ref Guide