About ASSURE-19

ASSURE stands for: Accelerated Sensor Solution for Urgent Response to Epidemics. ASSURE-19 is an ‘Antigen Diagnostic COVID-19 test’ for rapid point-of-care testing.

ASSURE-19 is a novel approach to lab- and machine-free testing for the SARS-CoV-2 coronavirus. The test kits are developed utilizing Oceanit’s TRIAD platform technology, leveraging Artificial Intelligence to design engineered molecules, built for purpose.  These molecules are designed to specifically target SARS-CoV-2 viral proteins, thus enabling “lab-on-a-chip” testing – making point-of-care testing as simple as a home pregnancy test or ancestral DNA kit.

ASSURE-19 uses a saliva specimen to screen for viruses without having to uncomfortably swab high up in a person’s nasal passage, or draw blood. It requires no expensive or complex lab equipment, no training or technicians, and no delays while samples are transported or cultured. ASSURE-19 can provide results within just minutes.

ASSURE-19 is still under development and has not yet been granted an FDA EUA for diagnostic or screening use. ASSURE-19 is not available for sale in the U.S.

Early assure-19 test sticks
Early prototypes of the ASSURE-19 test

ASSURE-19 is an ASSURE variant currently being developed by Oceanit to utilize saliva specimens to detect Covid-19. The test kits contain a saliva swab and a test cassette, known as Lateral Flow Assays (LFAs). Test cassettes work by simply reacting to a user’s specimen and displaying a control line and a positive line if Covid-19 is detected.

ASSURE-19 tests take just minutes to run. Each test kit contains a swab, vial of buffer solution, pipette and a sealed ASSURE cassette. Users swab under their tongues for approximately 15 seconds to absorb saliva. Once the specimen is collected, the swab is plunged into the vial of solution, mixing with the ASSURE buffer.

The solution is then applied to the test cassette via the pipette and results begin to show up in just minutes. A positive result can be read in as little as 5 minutes. ASSURE-19 tests can be done at room temperature, do not require laboratory processing time – either on-site or at lab facilities – and do not require any specialized equipment.

Safely reopening schools around the world is a critical piece of recovery.

Speed Is Key

Health care propfessionals across the United States have been using the gold standard “PCR test” for detecting and tracking COVID-19 and the SARS-CoV-2 virus.  However, as tests and materials remain in short supply across the country, health experts advise that the best chance to combat the pandemic spread is with the use of rapid, slightly less accurate tests, with regularity and at scale.

“What’s really important, in terms of a public health perspective, is to have a rapid test, which is not perfect, but good enough to say you (probably) have COVID-19, so you can go get a Polymerase Chain Reaction (PCR) test and quarantine yourself until you get those results.”

– Roy Parker, Professor of Chemistry and Biochemistry at the University of Colorado, Boulder.

Health experts agree that increased rapid and frequent testing would identify those who need immediate medical care, allow for asymptomatic person testing, and perhaps even pinpoint those at greatest risk of spreading the disease. Saliva tests are one such rapid test, however, many that available now still rely on specialized machines at a testing site, processing times measured in hours, and trained technicians.  They are also neither cheap nor easy to produce in bulk.

“We can’t have these (current rapid tests) in every household,” – Michael Mina, Epidemiologist at Harvard University’s School of Public Health.

Social distancing and rapid, regular testing can lead to reopening.

Broad distribution of ASSURE-19 would ease the demand for PCR tests, with PCR serving still as the gold standard for detection, but being moderated to those who test positive using antigen saliva tests.

In a recent paper, Dr. Daniel Larremore, an applied mathematician who models infectious diseases at the University of Colorado, Boulder, showed through mathematical models that a test less-sensitive than PCR, rolled out twice a week, vastly outperformed more accurate tests, administered once every two weeks, in curbing the spread of disease. Other studies pitting speed against sensitivity have come to similar conclusions.

ASSURE-19 is still under development and has not yet been granted an FDA EUA for diagnostic or screening use.