Speedy Swab™COVID-19/Flu A and B Antigen Combo Rapid Test Cassette (Swab). Faster diagnosis for improved patient care and cost-effectiveness. Excellent test performance. Approved for persons aged 2 years and up (self-collection for persons at least 14 years of age).
- Highly accurate
- Faster diagnosis for improved patient care and cost-effectiveness
- Detect 3 viruses at once (SARS-CoV-2, Flu A and B)
- For symptomatic individuals within 5 days of symptom onset
- Shallow nasal swab sample collection
- Suitable for 2+ years old (swabbing should be performed by an adult for children aged 2 to 13). User must be aged 14+ to perform self test
- Results available in 15 minutes
The SpeedySwab™ Rapid COVID-19+ Flu A and B Antigen Test is a lateral flow immunochromatographic assay intended for in-vitro rapid, simultaneous qualitative detection and differentiation of influenza A and B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly from anterior nasal swab specimens of individuals with signs and symptoms of respiratory infection consistent with COVID-19 within the first five (5) days of symptom onset when tested at least 2×over 3 days with at least 48 hours between.
Specifications:
Specimen: Nasal swab
Time to results: 15 minutes
Store the test kit between 2 to 30 °C (36 to 86 °F)
Shelf life: 15 months
Positive Percent Agreement: SARS-CoV-2, 92.6%; Influenza A,82.9%; Influenza B, 90%.
Certifications: CLIA Waived under FDA EUA (Emergency Use Authorization.). Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, that meet the requirements to perform moderate, high, or waived complexity tests. FDA/EUA authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
Delivery information: Test kit contains 25× sterile swabs, 25× test tubes with buffer solution, 25× test cards, 2× controls, 5× tube holders, 2× instructions for use (1 English and 1 Spanish). External Quality Controls (Positive/Negative) included.
