1. Where can I get ASSURE-19 tests?
ASSURE-19 is not yet available to the public. Currently, all ASSURE-19 manufactured tests are being used in our clinical trials. Following clinical testing and FDA Emergency Use Authorization (EUA), tests should be available through a variety of distribution partners, including drug stores and health centers.
2. How much do ASSURE-19 tests cost?
Right now, ASSURE-19 is not available for public purchase. Once an FDA Emergency Use Authorization is obtained, the cost is expected to be around $20 per saliva test. As production scales up, we expect the cost per unit to drop significantly. Our end goal is to make ASSURE-19 tests so affordable that anybody who needs it can access multiple tests – no matter where they are or what their current financial condition may be.
3. How does this saliva test work?
ASSURE-19 uses a saliva specimen to detect COVID-19 using a Lateral Flow Assay (LFA) – similar to a home pregnancy test. Saliva is captured in a tube and mixed with a reagent that attaches a specially designed DNA molecule to work like a “lock and key”, detecting and locking on to a piece of the SARS-CoV-2 virus. Thereafter, a nanomarker attached to this DNA molecule accumulates to form lines on the test paper. There are two lines – one to show that the test is working properly, a second line that is either present – positive result, indicating that SARS-CoV-2 virus was found, or no line – indicating that the virus is absent.
4. Does the test tell me if I was infected and now immune?
No, ASSURE-19 is different from an antibody test. Antibody tests detect whether a person was previously infected with COVID-19 and now carries antibodies in their blood designed to fight off the virus.
ASSURE-19 detects if a person is currently infected with COVID-19 and if they are reaching the infectiousness levels that typically occur around days 4-6 of carrying the disease. ASSURE-19 is ideally for regular use, over multiple days, to pick up a ‘positive’ once an infected person approaches infectious levels.
5. How accurate is the ASSURE-19 test?
ASSURE-19 is estimated to have 97% specificity (true positive rate) and will be sensitive enough to detect the virus, just as viral levels are approaching infectiousness states. The key to managing the pandemic is to inform asymptomatic or pre-symptomatic persons who would otherwise unwittingly infect their friends, family or co-workers.
6. How fast does the test give results?
ASSURE-19 tests can deliver results in a few minutes. Once a saliva specimen is mixed with our unique reagent and applied to the Lateral Flow Assay (LFA) test stick, results will be traceable in just a few minutes.
7. How is ASSURE-19 different to other saliva tests?
While many saliva tests are being developed, ASSURE-19 uses an AI-designed molecule specifically to seek out and lock onto proteins in the SARS-CoV-2 virus. It is designed to be used in the privacy of your home, or in other locations like schools, airports, or offices. ASSURE-19 works without special equipment, with no refrigeration and without other complicated steps like mailing your sample. You collect a saliva specimen as you would for an ancestry test, then mix your specimen in a tube before applying it to the test stick. The test stick acts like a pregnancy test. Once the specimen is applied, simply wait for a result (visible red line) to appear.
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