A Safe Reopening

DO WE STILL NEED TESTS?

COVID-19 vaccines are here and being rolled out around the world, so why do we still need testing? Testing is the only way to remain vigilant against new variant outbreaks, spreading of the virus by unvaccinated people, and seasonal trends which may hit as fall and winter arrive.

Rapid tests, like ASSURE-100, can help save thousands of lives by making frequent, easy, affordable testing the norm for individuals who may unintentionally spread the SARS-CoV-2 virus. Rapid antigen tests look for the virus’s proteins and detect infectious levels of virus, even if the subject is not experiencing any symptoms at all.

New guidance from the U.S. CDC allows vaccinated individuals to stop following social distancing guidelines and to remove masks in a wide variety of settings. Despite the progress made, we believe that rapid testing can provide an easy way to ensure COVID numbers don’t spike once again. Regular rapid testing can allow infectious people to know they are infected and isolate quickly, to keep from spreading the virus to others.

 

THE ALOHA PROTOCOL

The Aloha Protocol is a COVID-19 vigilance testing plan that was originally designed with travelers and Hawaii’s tourism-based economy in mind. However, the flexible protocol of multiple, regular tests over a period of days can be adapted for schools, events, workplaces, and more.

The Aloha Protocol objective is to use ASSURE rapid testing to create safe environments that enable a full reopening of our economy.

Healthcare professionals and disease experts are in agreement: we need rapid and regular testing to move us safely back towards normalcy. Research studies from both Harvard University and Yale show that 1. rapid result time is far more important than sensitivity, 2. frequency of testing is far more important than sensitivity, and 3. screening with rapid, regular testing protocols could drive down infections close to zero.

According to the U.S. Centers for Disease Control and Prevention website, 50% of Covid-19 transmission occurs prior to symptom onset, and some 40% of infections remain asymptomatic throughout. On average, an infected person reaches peak infectiousness between days 4-6 after exposure, but with the lack of pre-symptomatic and asymptomatic testing, SARS-CoV-2 is still being transmitted at high rates.

ASSURE rapid testing kits power ‘The Aloha Protocol’: a regular testing regimen to detect SARS-CoV-2 before it reaches infectious levels.

Utilizing the ASSURE rapid tests, the Aloha Protocol can be readily adapted for groups of people who are in positions at high risk of exposure or for those who may have been exposed to the SARS-CoV-2 virus through close contact.

Under the Aloha Protocol, individuals test at regular intervals over a course of days. With a negative test result reported, that person is able to move freely, going to school, work, traveling, attending events, etc. A positive test result allows the person to immediately isolate and schedule further medical diagnostics or doctor’s visits.

With a mass-scale availability of affordable ASSURE tests, everyone who is high-risk can get tested: medical professionals, students and teachers, travelers, particularly those who are pre-symptomatic or asymptomatic. The Aloha Protocol will allow for persistent early testing to detect SARS-CoV-2 with the objective of allowing schools, airports, and businesses to operate with confidence while stemming the exponential threat of unchecked viral spread.

The National Economy

With PCR tests being expensive and taking more than a day top process, the nation needs alternatives to support the PCR gold standard of COVID-19 testing. 50% of transmissions that occur before symptom onset and 40% of infections that remain asymptomatic throughout will continue to spread unimpeded.

Experts are revising viewpoints on the best methods to detect infections, setting aside sole dependence on PCR testing so that the spread of the virus can be more quickly tracked and contained. Doctors are now calling for rapid, cheap, and scalable tests which can help turn the tide of the fight in this pandemic:

“Even if you miss somebody on Day 1,” said Omai Garner, director of clinical microbiology in the U.C.L.A. Health System. “If you test them repeatedly, the argument is, you’ll catch them the next time around.”

The call has been made by many experts to promote speed and regularity of testing over hypersensitivity in tests. In order to persistently test, solutions for an affordable, rapid, specific, sensitive, and lab-free are needed.  ASSURE rapid tests are one such solution.

ASSURE tests are designed for regular use by those who are exposed to COVID-19, but pre- or asymptomatic. ASSURE answers the call for testing that is maximally efficient in terms of speed and cost. With sufficient but reasonable resources, millions of ASSURE rapid test kits could be manufactured and distributed to satisfy the exigent demand, globally.

A fast and inexpensive test such as ASSURE is less sensitive to viral presence than the gold standard PCR tests, but what is critical is sensitivity to infectiousness, and ASSURE is sensitive to viral loads at which one is infectious. Under the Aloha Protocol, regular rapid testing is more than sufficient for determining whether a person should self-quarantine or can return to the office, to school, or generally to society. Couple this with its speed and ease of use, ASSURE is the optimal tool for routine public health screening.

ASSURE rapid tests can be administered daily at home, at schools, offices—anywhere and everywhere.

Hawaii's Economy

Conservatively, economists estimate that tourism currently represents about 25 percent, or $2 billion per month, of Hawaii’s economy. Because Hawaii is surrounded by water and thousands of miles from the mainland, nearly all travelers enter via an airport.

As of October 16, 2020, every inbound passenger to Hawaii must be tested within 72 hours of their departure to avoid the 14-day mandatory state quarantine. Travelers who provide written confirmation from a state-­approved COVID-19 testing partner of a negative result are allowed to bypass the quarantine. But this current plan leaves significant gaps for possible infection.

Travelers may be exposed and infected between their test and departure time, and will reach peak infectiousness 4-6 days later, on average. They possibly could remain asymptomatic throughout that period and become spreaders of Covid-19 unwittingly, despite a negative test just days earlier.

The Aloha Protocol, applied for Hawaii’s transpacific travelers would mean daily – or near daily – testing after arrival to Hawaii using ASSURE rapid tests over a span of five days. This protocol is designed to plug the gap in testing and catch anyone who may be becoming infectious with Covid-19.

As long as the test results comes up negative, travelers remain a non-threat for infecting others.  A rapid ASSURE test upon arrival would back-up the negative result from pre-flight tests and allow them to continue avoiding the 14-day quarantine.

Research shows that it takes approximately 5 days on average to reach maximum infectiousness, after initial exposure to the SARS-CoV-2 virus.  If tested several times during this 5-day window, the risk of infecting others is significantly reduced.  After this window of ASSURE rapid testing, the risk of infecting others significantly declines. If a positive Covid-19 test result occurs, the individual would need to immediately enter quarantine.

The Aloha Protocol could be implemented in the state of Hawaii to allow for visitors to return and enjoy the islands fully, while protecting both the travelers and residents.

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