1. What is ASSURE-100?
The ASSURE-100 Rapid COVID-19 Test is a point-of-care rapid antigen test that uses an anterior nasal specimen to detect COVID-19, the disease caused by the SARS-CoV-2 virus. ASSURE is an acronym for: Accelerated Sensor Solution for Urgent Response to Epidemics.
2. Where was ASSURE-100 developed?
The ASSURE technology and ASSURE-100 rapid COVID-19 test was developed by Oceanit in Hawaiʻi and was put through testing and clinical trials in Hawaii and in other states across the US.
3. How do ASSURE tests work?
ASSURE-100 uses shallow nasal specimens to detect COVID-19 using a lateral flow assay (LFA) test cassette. A shallow anterior nasal swab specimen is mixed with buffer solution and then poured into the well on the test cassette. ASSURE tests are visually read, and do not require an external device to interpret results.
4. Does ASSURE-100 detect the new omicron and delta variants? Other variants?
Yes, clinical trial data showed that ASSURE-100 does detect the delta and omicron variants. Omicron clinical samples were confirmed via sequencing. Additionally, testing of the nucleocapsid proteins of the alpha, beta, and gamma variants demonstrated that ASSURE-100 detects these variants. Inactivated SARS-CoV-2 alpha and beta variants showed the same limit of detection as the original strain.
5. How quickly will ASSURE-100 detect a result if positive?
Results should be read at 20 minutes.
6. Where can I get ASSURE-100 tests?
ASSURE-100 will be sold via authorized distributors. Under the current EUA, ASSURE-100 rapid COVID-19 test kits will be only sold for point of care use to organizations with a CLIA waiver.