InBios International SCoV-2 Ag Detect™ Rapid Test

Description

The SCoV-2 Ag Detect™ Rapid Test is a lateral flow chromatographic immunoassay intended for the qualitative detection of the SARS-CoV-2 nucleocapsid protein antigen in direct anterior nasal swab specimens from individuals who are suspected of COVID-19 by their healthcare provider.

• Point of Care: CLIA Waived test can be performed in a variety of settings, from physician offices to school health clinics, with symptomatic individuals. Do not use for individuals who have no symptoms or have had symptoms longer than 4 days
• Sequence analysis performed at InBios suggests test will detect variants currently in circulation, including KP.3.1.1
• Identifies acute infection in symptomatic patients: PPA (Relative Sensitivity): 84.2%, NPA (Relative Specificity): 99.8%
• Unique patent pending design – no mixing step
• Quick visual results – no instrumentation needed
• 50 test pack, includes positive and negative controls
• Room temperature storage
• 100% manufactured in the USA

Specifications

• Certifications/Compliance: FDA 510(k) Cleared
• Content And Storage: 20 to 30°C
• CPT Code: 87811
• CE Marker: CE-IVD
• Clia Complexity: Waived
• Detectable Analytes: SARS-CoV-2
• Detection Method: Visual
• DoA Calibrators: No
• Type: rapid test
• Disposable: Single-use
• Includes: 50 tests, 50 swabs, 4 vials buffer, postive control swab
• Quantity: 50 Tests
• Sterility: Non-sterile
• Form: Swab