SpeedySwab Rapid COVID-19 + Flu A&B Antigen Self-Test
Inovative Combo COVID-19 and Flu OTC Test empowers individuals with a convenient, reliable solution for at-home testing.
- FDA EUA240014
- For Emergency Use Authorization (EUA) Only
- For In Vitro Diagnostic Use
About
We are pleased to announce that PHASE Scientific has been appointed as a key distributor within the network of Biolabs International LLC, as an Authorized Distributor for SpeedySwab™ Rapid COVID-19 + Flu A&B tests. The ability to quickly and accurately differentiate between COVID-19 and flu symptoms is more crucial than ever. This innovative Combo COVID-19 and Flu OTC Test empowers individuals with a convenient, reliable solution for at-home testing.
Features
- Quick: With SpeedySwab, users can expect quick results in just 15 minutes.
- Easy: User-friendly testing with easy-to-follow instructions.
- Reliable: With a COVID-19 clinical sensitivity of 92.6%, Flu A clinical sensitivity of 82.9% and Flu B clinical sensitivity of 90%, this combo test allows users to accurately differentiate between COVID-19, Flu A, and Flu B.
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Specifications
| Product Code | EUA240014 |
|---|---|
| Items Per Box | 2 |
| Specimen Type | Nasal Swab |
| Result Time | 15 Minutes |
| Shelf Life | Up to 15 Month Shelf Life |
| Clinical Sensitivity | COVID - 92.6%, FLU A - 82.9%, FLU B - 90% |
| Test Components | Sterile Swab x2, Test Tube with Buffer Solution x2, Test Device x2, Tube Holder x1, Quick Reference Instructions |
Intended Use
The SpeedySwab™ Rapid COVID-19 + Flu A&B Antigen Self-Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens. This test is authorized for non-prescription home use with self-collected anterior nasal swab specimens from individuals aged 14 years or older, or with adult-collected anterior nasal swab specimens from individuals two (2) years or older. This test is only authorized for 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 twice over three days with at least 48 hours between tests.
*This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA; This product has been authorized only for the detection of proteins from SARS-CoV-2, influenza A and influenza B, not for any other viruses or pathogens; and, The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization
of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
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