The FDA is currently evaluating clinical trial data and has not yet granted an EUA to ASSURE-100 for diagnostic or screening use. Unlike Laboratory and PCR tests, ASSURE tests deliver rapid results in just a few minutes. The simple antigen test requires no special processing, no long waits, and no advanced equipment. Rapid, regular infectiousness tests can enable a safer reopening for schools and the economy.
Rapid, regular, and affordable infectiousness tests for COVID-19 will enable a safer reopening.
Regular, rapid, and affordable COVID-19 testing will make it possible to identify and isolate infected students more quickly. Rapid tests could help slow the virus' spread by enabling all at-risk students to be detected and effectively quarantined. Research shows that if done properly, rapid and regular testing protocols could drive down infections close to zero.
In the workplace, rapid tests could prevent 88% of viral transmissions if repeated regularly (twice a week) and with isolation of those who test positive, according to research published by Dr. Daniel Larremore, an applied mathematician who models infectious diseases at the University of Colorado, Boulder.
World travel is a critical part of our global economy. Rapid tests could enable airports to safely reopen, testing both departing and arriving passengers, with follow-up testing for several days following travel. This would allow tourism industries to reopen for business while protecting both visitors and airport & hospitality staff.
There are many existing tests and many more that are being rapidly developed and deployed in the global fight against the SARS-CoV-2 pandemic.
ASSURE does not need lab work, nor any equipment or lengthy waits for results. The FDA is currently evaluating clinical trial data to grant an EUA to ASSURE-100 for diagnostic use.
PCR testing is the current gold standard for detecting COVID-19 infection, but requires a lab with specialized equipment to amplify genetic material, which can take days to return results.
'Loop-mediated Isothermal Amplification' testing is performed by medical professionals that must have expensive special equipment, and wait times are measured in hours.
Frequently asked questions to help you learn more about ASSURE rapid tests.
ASSURE-100 and ASSURE-19 are not available for sale in the U.S. Currently, ASSURE-100 tests are under evaluation as an in-vitro diagnostic by the U.S. FDA for Emergency Use Authorization (EUA).
ASSURE is not yet available for public purchase. Our goal is to make ASSURE tests so affordable that anybody can affordably access multiple tests – no matter where they are or what their current financial condition may be.
ASSURE tests use swabbed specimens to detect COVID-19 using a test cassette, similar to a home pregnancy test. ASSURE-100 uses a shallow nasal swab specimen that is mixed with buffer solution. This mixture is then dropped on the test cassette. ASSURE tests are visually read, and do not require a device or lab to interpret results.
A positive result can be read on ASSURE tests in as little as 5 minutes. It is recommended that you wait up to 20 minutes to confirm a negative result. Results should not be read after 30 minutes.
Unlike other rapid antigen tests, the ASSURE-100 Rapid COVID-19 Test has demonstrated that it is highly specific and does not falsely detect other coronaviruses as positive. It has been wet-tested with Human coronavirus 229E, oc43, nl63, SARS-CoV, and MERS-CoV.
ASSURE had no cross-reactivity when tested with a panel of coronaviruses, high prevalence disease agents, and normal or pathogenic flora. ASSURE had no interference when tested with a panel of coronaviruses, high-prevalence disease agents, normal or pathogenic flora, household substances, and nasal medications.
Click below to access a full list of frequently-asked-questions on ASSURE tests.
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