- Point-of-care test used to detect Respiratory Syncytial Virus (RSV)
Features:
- Test type:
- A rapid, qualitative immunoassay that detects RSV antigens from nasal swab specimens
- Intended use:
- Provides a quick, in-clinic result to help diagnose RSV infection, particularly important for young children and infants
- Regulatory status:
- The test is CLIA-waived, meaning it can be performed in a variety of healthcare settings outside of a traditional clinical laboratory
How it works:
- The Status RSV test uses a lateral flow immunoassay to detect RSV antigens
- After a specimen is collected with a swab, it is inserted into a test device with an extraction reagent
- The results are then shown on a test strip in the device
Important considerations:
- Sample collection:
- Proper specimen collection is crucial for accurate results
- Kit is designed for nasal or nasopharyngeal swabs, and detailed instructions are provided
- CLIA-waived:
- As a CLIA-waived test, it can be performed at the point of care in various healthcare settings
- Professional use:
- The test is intended for professional use only and requires trained personnel to administer
Contents:
- Each kit contains:
- 25 Individually packaged test devices
- 25 Extraction tubes
- 25 Sterile nasopharyngeal or nasal swabs for specimen collection
- 25 Pre-filled reagent tubes with dropper tips, or pre-measured extraction reagent capsules
- 1 Positive control swab
- 1 Negative control swab
- 1 Package insert with detailed instructions
- 1 Quick reference instruction card
