RSV Antigen Rapid Test (25/bx)

• Detects Respiratory Syncytial Virus (RSV) Fusion Protein Antigen
• Provides Qualitative Results in Approximately 15 Minutes
• Uses Anterior Nasal Swab Specimens
• Includes 25 Complete Tests w/ External Controls
• Features CLIA-Waived Performance for Eligible Testing Sites .

The Clarity Diagnostics RSV Antigen Rapid Test is a rapid lateral flow immunochromatographic assay intended for the qualitative detection of Respiratory Syncytial Virus (RSV) fusion protein antigen from directly collected anterior nasal swab specimens. Designed for professional in vitro diagnostic use, the assay delivers fast and accurate results, providing healthcare professionals with an efficient tool for the evaluation of patients presenting with signs and symptoms consistent with RSV infection.

✔ RSV ANTIGEN DETECTION | ✔ CLIA-WAIVED | ✔ RESULTS IN 15 MINUTES

RAPID RSV DETECTION

• QUALITATIVE ANTIGEN ASSAY: Detects RSV fusion protein antigen directly from anterior nasal swab specimens to aid in the diagnosis of acute RSV infection in patients with compatible clinical signs and symptoms.
• AGE-SPECIFIC INDICATION: Intended for testing children from 6 months through 6 years of age and adults 60 years of age and older, consistent with the manufacturer's intended use.
• FAST VISUAL RESULTS: Test and control lines provide qualitative results in approximately 15 minutes without requiring an analyzer or other laboratory instrumentation.

COMPLETE TESTING SOLUTION

• 25-TEST KIT: Each kit contains 25 individually packaged test devices, 25 prefilled extraction reagent tubes with dropper tips, 25 anterior nasal swabs, one positive control swab, one negative control swab, Instructions for Use, and a Quick Reference Guide.
• EXTERNAL QUALITY CONTROLS: Positive and negative control swabs are supplied to support routine quality control procedures according to the manufacturer's Instructions for Use.
• CLIA-WAIVED OPERATION: Eligible healthcare facilities can perform testing under a CLIA Certificate of Waiver when the assay is used according to the manufacturer's Instructions for Use.

The Clarity Diagnostics RSV Antigen Rapid Test combines rapid turnaround, CLIA-waived simplicity, and complete testing components in a single kit, helping healthcare professionals efficiently evaluate eligible patients for acute RSV infection in point-of-care settings.

WARNING: This product can expose you to chemicals known to the State of California to cause cancer. For more information, go to www.P65Warnings.ca.gov.