About ASSURE-100

ASSURE stands for: Accelerated Sensor Solution for Urgent Response to Epidemics. ASSURE-100 is an antigen test for rapidly detecting COVID-19. ASSURE-100 is a novel approach to lab- and machine-free testing for the SARS-CoV-2 coronavirus.

ASSURE-100 uses a shallow nasal specimen to screen for SARS-CoV-2 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.

The FDA is currently evaluating clinical trial data, and has not yet granted an EUA to ASSURE-100 for diagnostic or screening use. ASSURE-100 is not available for sale in the U.S.

ASSURE-100 test cassettes resemble a home pregnancy test, which are widely known as Lateral Flow Assays (LFAs). ASSURE-100 kits contain a specimen swab, vial of buffer solution, pipette, and test cassette. The cassette works by simply reacting to a user’s specimen and displaying a control line and a positive line, if COVID-19 is detected.

Users swab approximately 1/2 – 3/4 inches in each nostril for approximately 15 seconds. 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-100 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.

ASSURE-100 rapid COVID-19 Test Kit

Speed Is Key

Health care professionals 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.

“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.

ASSURE tests can be done with no laboratory machines or specially trained personnel required — and at a cost far lower than that of other testing methods. There would be no delays of hours or days for results – results would be delivered in minutes.

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.

The FDA is currently evaluating clinical trial data, and has not yet granted an EUA to ASSURE-100 for diagnostic or screening use.