It’s always a good time to be ready to test your family for influenza A & B and COVID-19. The Centers for Disease Control and Prevention (CDC) estimates that there have been at least 20 million flu illnesses this season and 5.1 to 9.5 million cases of COVID-19.
An innovative over-the-counter test is helping efficiently diagnose cases of COVID and Flu A and B, while also empowering users to follow up on the result with a healthcare provider. The test, SpeedySwab™ Rapid COVID-19 + FLU A&B Antigen Self-Test, is considered a testing breakthrough because it can test for multiple illnesses and promote follow-up care.
The upcoming app enables the user to take a picture of the test result, which is then verified with AI. The app then provides resources to the user to schedule an appointment with a healthcare professional and get any necessary prescriptions.
The non-prescription home test, which has Emergency Use Authorization from the Food and Drug Administration (FDA), uses self-collected anterior nasal swab samples from individuals 14 years or older, or nasal swab samples from individuals 2 years or older.
Manufactured by Watmind USA™, this test is exclusively distributed by Biolabs International LLC. Biolabs was created in 2020 during the early days of the pandemic, distributing COVID test kits and reporting data for 50,000 to 80,000 COVID tests a day, utilizing the first version of their connected app.
Accuracy
SpeedySwab™ is one of the most accurate combined COVID, Flu A, and Flu B tests on the market, with a COVID clinical sensitivity of 92.5%, a Flu A clinical sensitivity of 82.9%, and a Flu B clinical sensitivity of 90%, according to data available on the FDA’s website.
Gino Ajodani
President, Biolabs International LLC
“I care about the accuracy of the product that I’m presenting to my clients and our citizens,” said Biolabs president Gino Ajodani. “I’m honored to have this type of accuracy in our hands with SpeedySwab™.”
Expanded testing
Just like the name would imply, SpeedySwab™ delivers results quickly.
“Our result is coming back mostly in about 10 minutes. We say 15 minutes, but it shows up quite a bit quicker than that.” Ajodani said. “And our lines are incredibly solid. There is no second guessing.”
As a leader in medical testing supplies, Biolabs International is excited to be growing. SpeedySwab™ kits are available now at over 100 retailers across the United States, including Walgreens, Kroger, BevMo, and Amazon. Published Walgreens customer reviews indicate a high level of satisfaction. Barb from Virginia says, “Easy to use, easy to read. [It] lets you KNOW what you are suffering with as it identifies THREE conditions. Covid and two flu strains. Good solid value.”
Ajodani also shared that as part of their mission to offer expanded testing access and options, they have selected 2San LLC, a global distributor of innovative and easy-to-use diagnostics, to further expand distribution of the SpeedySwab™ COVID-19 + Flu A&B Self-Test beyond Biolabs’ current distribution model to ensure consumers have readily available access to this combination diagnostic solution.
“The distribution network of 2San is quite impressive”, Ajodani stated, “and we are delighted to be able to leverage their network in getting these important products into the hands of consumers globally through our partnership.”
SpeedySwab™, in collaboration with Biolabs International LLC, has been updated and improved. The vertical improved packaging allows SpeedySwabTM to take up less shelf space while clearly displaying the contents of the package. This packaging also incorporates an integrated tube holder to improve the testing experience for the user, and upcoming packaging proudly displays the American flag, indicating that assembly now takes place in the United States, creating more domestic jobs and fortifying domestic supply chains of these critical diagnostic tools.
These test kits are available in different kit sizes, ranging from a single pack, two pack, and four pack, and have an 18-month shelf life to ensure it can be used when you need it. Biolabs International’s partner, Watmind USA™, is in the process of completing FDA 510k approval, which may result in a 21-month expiration date extension.
What’s next for Biolabs International?
Through a strategic partnership spanning the previous 2 years, BioLabs International and Safe Health Systems Inc. are revolutionizing clinical studies by reducing costs and timelines, enabling new diagnostics to reach the market faster and more efficiently while creating U.S. jobs. The first of its kind DCT approach, facilitates borderless recruitment and at-home participation, ensuring study results reflect real-world use cases. By eliminating the inefficiencies and costs of traditional CROs and IRBs brick-and-mortar sites, the DCT platform delivers faster, more affordable ways to bring new tests to market while ramping up U.S. manufacturing and assembly.
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