SpeedySwab­™ Rapid COVID-19 + Flu A&B Antigen Test | 25 Tests (POC)

The Speedy Swab™ Rapid COVID-19 + Flu A&B Antigen Test is a lateral flow immunochromatographic assay designed for the simultaneous and qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B antigens. Utilizing anterior nasal swab specimens, this test provides rapid results for individuals exhibiting symptoms of respiratory infection within the first five days of onset. Authorized for use in CLIA-certified laboratories and Point-of-Care settings, the test combines accuracy and convenience, supporting efficient clinical decisions. Its integrated quality controls and comprehensive instructions ensure reliability and ease of use in diverse healthcare environments.

Key Features

• Multiplex Detection: Simultaneously detects and differentiates antigens from SARS-CoV-2, influenza A, and influenza B viruses.
• Intended Use: Designed for use with anterior nasal swab specimens from individuals with symptoms of respiratory infections within the first 5 days of symptom onset.
• Ease of Use: Suitable for Point of Care (POC) testing in settings operating under a CLIA Certificate of Waiver, Compliance, or Accreditation.
• Rapid Results: Employs a lateral flow immunochromatographic assay for quick and qualitative detection.
• Built-In Quality Control: Internal control line ("C") on the test device ensures the reliability of results. Includes external quality controls as part of the kit.
• Complementary Instructions: Comes with detailed “Instructions for Use” and “Quick Reference Instructions.”
• FDA Authorization: Authorized under the EUA for emergency testing needs during public health emergencies.
• Clinical Relevance: Results support differential diagnosis for respiratory infections, particularly during flu season coinciding with COVID-19 outbreaks.
• Ancillary Materials: Additional materials for sample collection, processing, and testing are provided or specific for authorized use.
• Training Requirements: Requires operators to be trained in test performance and result interpretation.