OraSure Technologies InteliSwab™ COVID-19 Rapid Test Pro

Description

Rapid antigen test provides results in 30 minutes with unique all-in-one test device and nasal swab

• Self-collected, visual read lateral flow test
• Both symptomatic and asymptomatic use
• Intuitive workflow: just swab, swirl and see
• Workflow requires less than 1 minute of active, hands-on time
  • 30-minute time for results
• Gentle lower nasal swab
• Overall test performance:
  • Positive percent agreement 84%
  • Negative percent agreement 98%
• No pipetting and no precise number of drops required
• Clinical performance proven with untrained and unproctored lay-users

Specifications

• Certifications/Compliance: FDA EUA
• Content And Storage: 35°F to 86°F
• Control Sets: For purchase separately
• CPT Code: 87811
• CE Marker: No
• Clia Complexity: Waived
• Detectable Analytes: SARS-CoV-2 Nucleocapsid Protein Antigen
• Sample Type: Anterior Nasal Swab
• Sensitivity: 84%
• Type: COVID-19 Rapid Antigen Test
• Packaging Type: Kit
• Quantity: 25 Tests
• Specificity: 0.98
• Test Time: 30 min.

This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.