OraSure designed the InteliSwab tests to include a built-in swab that is fully integrated into the test stick
The InteliSwab Covid-19 rapid test. (Credit: OraSure Technologies, Inc.)
OraSure Technologies has secured the US Food and Drug Administration (FDA) Emergency Use Authorisation (EUA) for three of its InteliSwab brand rapid antigen tests to detect active Covid-19 infection.
The US agency authorised the InteliSwab Covid-19 rapid test as an over-the-counter (OTC) home test without a prescription for use in people aged 15 years or above.
InteliSwab Covid-19 rapid test pro is a professional test, packaged in bulk configurations, for professional use in point of care (POC) in CLIA certified healthcare settings.
The test is authorised for use in individuals aged 15 years and above who are suspected of Covid-19 by their healthcare provider within seven days of symptom onset.
InteliSwab Covid-19 rapid test Rx is a prescription home test approved for the use of self-collected anterior nasal samples from people aged 18 years and above.
The test also uses samples collected by adults from individuals aged 15 years and above who are suspected of Covid-19 infection by their healthcare provider.
OraSure president and CEO Stephen Tang said: “OraSure is on a mission to make COVID-19 testing dramatically simpler. We believe that this easy and intuitive ‘swab, swirl and see’ test will be one of the simplest Covid-19 tests on the market.
“We expect that InteliSwab’s simplicity and accuracy will give users peace of mind that they performed the test correctly and can rely on the results.”
The company said that its InteliSwab tests are designed to include a built-in swab that is fully integrated into the test stick.
The use of an integrated swab simplifies the testing process and ensures supply continuity, as the test does not require sourcing nasal swabs, which are scarce.
In a US clinical study at five independent sites, InteliSwab showed strong performance, with 84% positive results agreeing with highly sensitive FDA-authorised PCR tests of the time, and negative results agreeing 98% of the time.
The company currently has an installed manufacturing capacity of 55 million InteliSwab units annually and is planning to enhance it to 70million units in the third quarter of 2021.
Tang added: “Simple and accessible at-home tests, like InteliSwab, make it easier for individuals to know if they are infectious and to quickly self-isolate if they test positive.
“With InteliSwab, we believe OraSure will play an even larger role in safely reopening – and keeping open – workplaces, schools and other places where people congregate.”
In November last year, the company obtained FDA EUA for its ORAcollect·RNA saliva collection device to collect, stabilise and transport Covid-19 suspected saliva specimens.