Simple. Fast. Accurate.

The ASSURE-100 Rapid COVID-19 Test conveniently delivers rapid results in minutes. Rapid, regular testing will enable a safe reopening for schools, businesses and the world. The ASSURE-100 Rapid COVID-19 Test provides accurate and reliable results within 20 minutes, allowing for the COVID-19 testing of symptomatic patients within the first eight days of symptoms.

For use under FDA Emergency Use Authorization (EUA) only.

Learn how ASSURE-100 can help

Healthcare professionals can purchase the ASSURE-100 Rapid COVID-19 Test by providing their contact information below, or by emailing info@assure-test.com.

    Introducing The ASSURE-100 Rapid COVID-19 Test

    Open back up safely with Simple, Fast and Accurate testing.

    How Does the ASSURE-100 Rapid COVID-19 Test Work?

    The ASSURE-100 Rapid COVID-19 Test detects SARS-CoV-2 antigens directly from anterior nares swab specimens. It provides accurate and reliable results within 20 minutes, allowing for widespread COVID-19 testing of symptomatic patients within the first eight days of symptoms. The ASSURE-100 Rapid COVID-19 Test is simple, fast, accurate and affordable, enabling a safe reopening for schools, businesses, and organizations around the world. ASSURE-100 was designed by scientists and engineers in Hawaii and is distributed worldwide.

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    About Oceanit and its ASSURE-100 Rapid COVID-19 Test

    Oceanit is a Hawaii-based diagnostic manufacturer focused on improving the quality of healthcare throughout the globe. Founded in 1985 in Honolulu, Hawaii, Oceanit has earned a world-class reputation for breakthrough science & technology, sustainable engineering, and disruptive innovation built upon our values of Curiosity, Community, and Ohana. We are a skilled group of scientists, engineers, innovators, and entrepreneurs who solve the world's most difficult problems.

    Oceanit Foundry LLC is a subsidiary company of Oceanit Labs, Inc.

    Designed in Hawaii. Distributed Worldwide.

    The ASSURE-100 Rapid COVID-19 Test was proudly designed by scientists and engineers in Honolulu, Hawaii, bringing a world-class diagnostic tool to the rest of the world.

    Schools

    Regular, rapid, and affordable COVID-19 testing make it possible to identify and isolate infected students quickly. Rapid tests slow the virus' spread by enabling all at-risk students to be detected and effectively quarantined. Research studies from both Harvard University and Yale show that:
    • Rapid result time is far more important than sensitivity.
    • Frequency of testing is far more important than sensitivity.
    • Screening with rapid tests can drive and keep infections down to near zero. A slower protocol cannot.

    Businesses

    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.

    Airports

    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.

    Frequently Asked Questions

    Frequently asked questions to help you learn more about ASSURE rapid tests.

    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.

    Get in touch via email

    If you have any other questions, please contact Oceanit by clicking the button below and emailing us. Alternatively, you can get in touch by filling the contact form, here.

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      For FDA Emergency Use Authorization (EUA) only. For more information click here.

      The ASSURE-100 Rapid COVID-19 Test has been authorized by the U.S. FDA under an emergency use authorization for use by CLIA and CLIA waived laboratories in Point of Care settings. The ASSURE-100 Rapid COVID-19 Test is for use by authorized laboratories for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless authorization is terminated or revoked sooner. The ASSURE-100 Rapid COVID-19 Test has not been FDA approved.