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

Description

Rapid, qualitative detection of respiratory syncytial virus fusion protein in nasopharyngeal swabs or 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.

• Rapid, qualitative detection of respiratory syncytial virus fusion protein in nasopharyngeal swabs or 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.
• 510(k) Cleared and CLIA Waived for Prescription Use Detection of fusion protein of respiratory syncytial virus Nasopharyngeal swab and nasal aspirate specimen
• Each kit 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 Instructions for Use
• Premier Test Performance: Positive % Agreement: 93. 9% Negative % Agreement: 97.7%

Specifications

• Control Sets: Positive and Negative
• CPT Code: 87807
• CE Marker: No
• Clia Complexity: Waived
• DoA Calibrators: No
• Format: Test Kit
• Sample Type: Nasopharyngeal Swabs, Nasal Aspirates
• Type: RSV Rapid Test
• For Use With (Application): Testing 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, 1 Instructions for Use
• Quantity: 20 tests/kit
• Test Time: 15 mins.