Safe Reopening

THE ALOHA PROTOCOL

Our objective with ASSURE-19 rapid testing is to create safe environments that enable a 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. And 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-19 rapid testing kits power ‘The Aloha Protocol’: a regular testing regimen to detect SARS-CoV-2 before it reaches infectious levels.

The Aloha Protocol is a regular interval testing plan originally designed with travelers and Hawaii’s tourism-based economy in mind.  Utilizing the ASSURE-19 rapid point-of-need test, the Aloha Protocol can be readily adapted for many use cases… Particularly 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, a person tests at regular intervals and upload results to a secure app. 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-19 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 test materials in short supply, the nation needs alternatives to the gold standard of Covid-19 testing.  With swab tests being reserved for those exhibiting symptoms, the 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-19 is one such solution.

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

A fast and inexpensive test such as ASSURE-19 is less sensitive to viral presence than the gold standard PCR tests, but what is critical is sensitivity to infectiousness, and ASSURE-19 is sensitive to viral loads at which one is infectious. Under the Aloha Protocol, regular ASSURE-19 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, and ASSURE-19 is the optimal tool for routine public health screening.

ASSURE-19 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 16th, 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 testing after arrival to Hawaii using the ASSURE-19 rapid test for 5 consecutive 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 daily test result comes up negative, they remain a non-threat for infecting others and can enjoy Hawaii.  An arrival ASSURE-19 test 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 you test once per day, with a rapid 10 minute test, your risk of infecting others is significantly reduced.  After five days of ASSURE-19 rapid testing, the risk of infecting others significantly declines. If a positive ASSURE-19 result occurs, the test taker 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. Arriving passengers would take the first test upon arrival and be provided with five test kits each to be taken daily, plus a smartphone app to upload results to. Passengers would self-test for the next five days, which cover the average incubation period before symptoms appear.

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