Respiratory Test Kit InteliSwab
COVID-19 Rapid Test Pro 25 Tests CLIA Waived
Orasure 1001-0614

Respiratory Test Kit InteliSwab
COVID-19 Rapid Test Pro 25 Tests CLIA Waived
Orasure 1001-0614

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 two or three days with at least 24 hours and no more than 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

Manufacturer # 1001-0614 Brand InteliSwab® Manufacturer Orasure Technologies Country of Origin United States Application Respiratory Test Kit CLIA Classified CLIA Waived Contents 1 (25) Pouches each containing Test Device, Absorbent Packet and 0.75 mL Developer Solution Vial, (5) Test Stands, Instructions for Use, Quick Reference Guide HCPCS U0002 Number of Tests 25 Tests

Purchase Program Type Standard Purchase Reading Type Visual Read Sample Type Nasal Swab Sample Specialty Immunoassay Test Format Test Device Format Test Kit Type Rapid Test Method Lateral Flow Immunoassay Test Name COVID-19 Rapid Test Pro Test Type Antigen Detection Time to Results 30 to 40 Minute Time to Results UNSPSC Code 41116205