SpeedySwab Rapid COVID-19 + Flu A&B Antigen Test
Innovative Combo COVID-19 and Flu A&B POC test provides quick, accurate diagnosis and timely treatment decisions.
- FDA EUA230037
- 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 POC Test empowers providers with a convenient and reliable solution for in-clinic testing.
Benefits
- Efficiency:: The ability to simultaneously detect COVID-19, Flu A, and Flu B with a single test reduces the need for multiple tests, saving time and resources.
- Speed: Provides quick results, within 15 minutes, enabling prompt decision-making for patient management and treatment.
- Improved Patient Flow: Quick results can help manage patient flow more effectively in clinics and hospitals, reducing wait times and improving the overall efficiency of healthcare services.
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Specifications
| Product Code | EUA230037 |
|---|---|
| Items Per Box | 25 |
| Specimen Type | Nasal Swab |
| Result Time | 15 Minutes |
| Shelf Life | Up to 18 Month Shelf Life |
| Clinical Sensitivity | COVID - 92.6%, FLU A - 82.9%, FLU B - 90% |
| Test Components | Sterile Swab x25, Test Tube with Buffer Solution x25, Test Card x25, Controls x2, Tube Holder x5, Instructions for Use x2 (1 English & 1 Spanish) |
Intended Use
The SpeedySwab™ Rapid COVID-19 + Flu A&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 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.
SpeedySwab POC DOWNLOADS
| FDA Letter of Authorization |
| SpeedySwab Sales Sheet |
| Instructions for Use (IFU) |
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