Germaine™ Laboratories Rapid Check™ Respiratory Syncytial Virus RSV Antigen Test

Description

Rapid, qualitative detection of respiratory syncytial virus fusion protein in nasopharyngeal swabs/nasal aspirate specimens in children less than 6 years and adults over 60. Intended as an aid in the rapid laboratory diagnosis of acute respiratory syncytial virus infection in patients with such symptoms.

• Viable air samplers are networked devices that can be remotely controlled and monitored
• Strict regulation of air flow and will alarm the operator if the air flow deviates beyond the acceptable range
• System also monitors and indicates a variety of operational parameters including sample's volume and elapsed time
• Lightweight polymer
• Surfaces compatible with chemical disinfection
• Display graphics keep user informed in real time of air flow and remaining sample time
• 8-hour run time
• Touchscreen works with gloved hands

Specifications

• Control Sets: Positive and Negative Controls Included.
• CPT Code: 87807
• CE Marker: No
• Clia Complexity: Waived
• DoA Calibrators: No
• Sample Type: Nasopharyngeal Swabs/Nasal Aspirates
• Sensitivity: Premier Test Performance: Positive Percent Agreement: 93. 9%, Negative Percent Agreement: 97.7%
• Type: RSV Rapid Test
• For Use With (Application): For Children Less than 6 Years Old and Adults Over 60 Years
• Includes: 20 Individually Packaged Test Devices, Nasopharyngeal Swabs with Each Kit, 1 R1 (Extraction Reagent Solution) 2 mL, 20 Extraction Tubes, 40 Disposable Pipettes, 1 PC (Positive Control Reagent) 1.0 mL, 1 NC (Negative Control Reagent) 1.0 mL, and 1 Instructions for Use.
• Quantity: 1 Kit
• Test Time: 15 min.