- A professional-grade, rapid lateral-flow chromatographic immunoassay. It is utilized by healthcare providers for the qualitative detection of the SARS-CoV-2 nucleocapsid protein antigen
Uses
- Acute Infection Screening:
- Diagnoses active SARS-CoV-2 infections in individuals suspected of having COVID-19 within the first 7 days of symptom onset
- Serial Point-of-Care Testing:
- Used in healthcare settings to evaluate symptomatic or asymptomatic individuals across serial testing frequencies spaced 48 hours apart
- Professional Healthcare Triage:
- Deployed in physician offices, urgent care centers, hospitals, and outpatient clinics for immediate clinical containment decisions
Features
- CLIA Waived Status:
- Certified for point-of-care environments, permitting general nursing or clinic personnel to legally run the assay without complex laboratory machinery
- Healthcare Provider Collection:
- Validated specifically for direct, provider-collected mid-turbinate (MT) nasal swab specimens
- Master 40-Test Configuration:
- Packed as a high-volume commercial box containing 40 individual visual test devices, 40 sterile swabs, and 40 pre-filled buffer extraction tubes
- EUA Authorized Pathway:
- Distributed under an active FDA Emergency Use Authorization (EUA) specifically for prescription in vitro diagnostic use
- Domestic Logistics Stability:
- Formulated and manufactured in the USA, protecting facility supply chains from international customs delays
Benefits
- Rapid Care Turnaround:
- Yields highly readable, clear visual results in exactly 15 minutes to speed up patient treatment and isolation protocols
- Reduces Diagnostic Risk:
- Delivers a high positive percent agreement (PPA) and negative percent agreement (NPA) to lower the risk of misdiagnosis and inappropriate viral treatment
- Zero Capital Investment:
- Operates completely manually with a quick, 5-drop fluid dispensing step, eliminating the need for expensive reader machines or digital instruments
