- A rapid, point-of-care lateral-flow immunochromatographic assay that qualitatively detects Respiratory Syncytial Virus (RSV) nucleoprotein antigens directly from symptomatic patient nasal secretions
Uses
- Acute Respiratory Screening:
- Diagnoses active RSV viral infections in patients presenting with cold-like upper respiratory tract symptoms
- Point-of-Care Diagnostics:
- Deployed across physician offices, community clinics, nursing homes, and emergency centers for quick patient isolation decisions
- Targeted High-Risk Screening:
- Uniquely cleared to evaluate and support the two demographic groups most vulnerable to severe respiratory illness: young pediatric patients and older adults
Features
- Expanded Patient Demographics:
- FDA-cleared for use in children aged 6 months to 6 years and adults aged 60 and older
- CLIA Waived Status:
- Certified for decentralized clinic spaces, permitting standard nursing and medical staff to legally execute testing without a complex laboratory structure
- Anterior Nasal Swabbing:
- Utilizes a shallow, comfortable, less-invasive nasal swab to capture viral load rather than deep, uncomfortable nasopharyngeal options
- Commercial 25-Test Layout:
- Formulated as an all-inclusive box containing 25 visual test devices, pre-filled extraction buffer tubes, sterile swabs, and a workstation grid
- "QC Inside®" Allocation:
- Ships with 2 extra test sticks strictly designated for running external positive and negative quality controls, delivering a total of 27 test sticks per package
Benefits
- Accelerated Treatment Path:
- Delivers clear, diagnostic results at the point of care in just 15 minutes to help clinicians prescribe anti-virals or supportive care immediately
- Informed Differential Diagnosis:
- Aids clinicians in distinguishing overlapping respiratory symptoms (like COVID-19 or Flu) to apply correct, distinct therapy protocols
- Streamlined Clinical Workflows:
- Requires zero specialized equipment, digital automated readers, or timing machinery to interpret
- Ensured Logistics Stability:
- Formulated and manufactured in the USA, insulating healthcare networks from international customs delays and product shipping shortages
