Rapid Point-of-Need Testing for the SARS-CoV-2 Virus.

Unlike Laboratory or point-of-care tests, ASSURE-19 tests deliver results in just a few minutes and can be done anywhere. The simple test takes no special processing, no advanced equipment, and has no delay for results. Rapid, regular infectiousness tests can enable a safer reopening for schools and the economy.

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.

Safer Reopening

Rapid, regular, and affordable infectiousness tests for COVID-19 will enable a safer reopening.

Schools

Regular, rapid, and affordable COVID-19 testing will make it possible to identify and isolate infected students more quickly. ASSURE-19 tests could help slow the virus' spread by enabling all at-risk students, including pre- or asymptomatic ones, to be detected and effectively quarantined. Research shows that if done properly, rapid and regular testing protocols could drive down infections close to zero.

Businesses

In the workplace, ASSURE-19 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

ASSURE-19 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.

COVID-19 Testing

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-19 Testing Partners

Oceanit Laboratories has partnered with researchers, physicians, and academics from The University of Hawaii and The Queen's Medical Center to drive ASSURE-19 forward from 'Mind to Market'

University of Hawaii at Mānoa
John A. Burns School of Medicine

Oceanit has teamed with researchers at the John A. Burns School of Medicine (JABSOM) at the University of Hawai‘i at Mānoa, one of the leading medical education institutions in the United States. For the last three years, JABSOM has ranked #1 in National Institutes of Health research awards among community-based public medical schools.

Oceanit Laboratories
Honolulu, Hawaii

Oceanit is a ‘Mind to Market’ company that employs a unique discipline called Intellectual Anarchy to move fundamental scientific breakthroughs from the lab to the market. Oceanit’s teams deliver cutting-edge solutions, services, and products to customers across a vast range of industries.

The Queen's Medical Center
Honolulu, Hawaii

The Queen's Medical Center is a nonprofit hospital with a 160-year legacy of caring for the people of Hawaii and the Pacific Basin. A member of The Queen’s Health Systems family of hospitals, The Queen’s Medical Center is the largest private hospital in Hawaii.

Frequently Asked Questions

Below is a list of frequently asked questions to help you learn more about ASSURE-19.

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.

Other questions?

Do you have questions that aren’t answered here?  Please click below to contact Oceanit and submit your question.

About Oceanit

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.

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