Sekisui Diagnostics OSOM RSV Test

Description

Rapid immuno chromatographic assay for the qualitative detection of respiratory syncytial virus (RSV) nucleoprotein antigen in anterior nasal swab specimens from patients with signs and symptoms of respiratory infections.

• The OSOM™ RSV Test is a rapid immunochromatographic assay for the qualitative detection of respiratory syncytial virus (RSV) nucleoprotein antigen in anterior nasal swab specimens from patients with signs and symptoms of respiratory infections
• This test is intended for in vitro diagnostic use to aid in the diagnosis of RSV infections in infants and pediatric patients aged 6 months to 6 years old, and adults over 60 years of age
• Test results are interpreted at 15 minutes visually
• REAGENTS AND MATERIALS Provided
• 27* - Test devices in sealed aluminum foil pouch with desiccant
• 27* - Reagent tubes prefilled with extraction buffer (350 μL) and dropper tips
• 25 - Sample collection swabs (Anterior Nasal)
• 1 - Positive control swab (noninfectious RSV antigen)
• 1 - Negative control swab (noninfectious nasal clinical matrix)
• 1 - Instructions for Use (IFU)
• 1 - Quick Reference Guide (QRG)
• NOTE: Two extra test devices have been included for external QC testing.

Specifications

• CE Marker: No
• Clia Complexity: Waived
• DoA Calibrators: No
• Type: Anterior Nasal Swab
• For Use With (Application): RSV
• Form: Swab