The CareStart COVID-19 Antigen Rapid Test is a quick and reliable way to detect proteins from the SARS-CoV-2 virus. It provides results in just 10 minutes, making it an efficient tool for point-of-care testing. This test is minimally invasive and includes built-in quality control to ensure accurate readings. It is intended for in-vitro diagnostic use only and is available exclusively to facilities with a CLIA certificate or waiver, ensuring compliance with the Clinical Laboratory Improvement Amendments. The test has received FDA Emergency Use Authorization and is designed for use by qualified healthcare professionals in settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. Providers are responsible for conducting and reporting COVID-19 test results.
Features and Benefits
- FDA EUA Authorized for emergency use
- Includes 20 sealed test devices, assay buffer, extraction vials and caps, anterior nasal specimen collection swabs, positive and negative control swabs, and instructions for use
- Detects SARS-CoV-2 nucleocapsid protein antigen
- Storage temperature: 34 degrees - 86 degrees F
- Processing time: approximately 10-15 minutes
- Minimally invasive specimen collection
- Lateral flow assay technology
- Rapid results within 10-15 minutes (do not read after 15 minutes)
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