Remote County is the First in the U.S. to Test for COVID-19 Antibodies

SAN MIGUEL COUNTY, Colo. April 6, 2020 — On March 11, 2020 the World Health Organization declared the COVID-19 virus a pandemic and the world stopped. Now that we’re here, how do we find a mid-ground? Armed with scientifically based data, government can make decisions to return their communities to their new normal. And the superhero of this story may be found in the field of antibody testing. That’s why it’s remarkable that a remote county is the first in the U.S. to test for COVID-19 antibodies.

The COVID-19 antibody tests first used in San Miguel County were developed and created by United Biomedical Inc. (UBI). The company’s principals, Mei Mei Hu and Lou Reese live in Telluride, the San Miguel County seat.

The tests identify antibodies in a person’s blood that when present can protect them against reinfection, thus creating immunity. They also provide data to help companies, like UBI, develop a vaccine to protect people against contracting this highly contagious, devastating disease.

San Miguel was the first, and now there are other counties in Colorado and across the country conducting antibody testing. Acquiring more antibody test results will help establish a national model for re-opening communities.

Where We’ve Come From

Less than a month ago widespread testing of the virus was not available in any state. Conventional nasal swab tests that test for live infection were still mostly unavailable in Colorado unless you were symptomatic. These swab tests are reported to have a 50 percent false negative (i.e., a missed positive) rate. This low identification rate is due to the nature of the virus, which creates mucus in the lungs rather than the throat and is difficult to collect with a nasal swab.

Many lawmakers in Colorado, including Governor Jared Polis, voiced concern that more testing was needed. Mei Mei and Reese were paying attention and created the company c19, a subsidiary of UBI.

Using the company’s knowledge and development of other successful antibody tests and vaccines, UBI quickly developed the SARS-CoV-2 ELISA antibody test. Then they offered to test and pay for their county neighbors’ tests. That’s about 7,500 people.

Antibody Testing: The Path Towards the New Normal

In an interview last week, Reese explained their motivation. “We decided to get San Miguel County back to the new normal as fast as possible by implementing antibody testing and making it free for everybody in the county.  That’s never been done. It’s a best-in-class practice where literally within weeks we’ll know everyone who’s been infected. So it’s a rapid path to creating a safe zone in San Miguel County and it’s a model for the rest of the country. And I think the world. So it’s an opportunity to really solve the problem.”  

Mei Mei and Reese say the results of testing are important for moving forward and she hopes that the data gathered from the test results will identify how far the disease has spread, how deadly it is and whether strict quarantines can stem the tide of COVID-19. The couple hopes to eventually roll the c19 antibody tests out nationwide and then worldwide. Reese said, “We are already increasing our (production) capabilities…it’s going to scale up super fast.”

What do the results of antibody tests tell you? “Then you know what the disease prevalence is in your community, you know who needs to be isolated, who’s still susceptible, and who’s essentially more protected from it and people can start going back to their new normal. Besides the ones who are actively infected, you can start going out again. The idea then is to roll it out to larger and larger regions.”

Mei Mei Hu, co-CEO of UBI

County Government Reacts

When UBI announced their plans to roll out their antibody test to representatives of San Miguel County government, the response was emotional. “We are thankful for UBI/c19 for taking the leadership to offer these accurate blood tests to our entire county, free of charge, which can be instrumental in saving lives,” said Sharon Grundy, Public Health Medical Officer for San Miguel County and Medical Director of Primary Care at the Telluride Medical Center. Grundy continued, “When we reported this in our county meeting, yesterday, the entire team cried.”

Crying is not surprising in these uncertain times. Many of us are emotionally and financially stressed. We aren’t sleeping well. We are worried by lack of work and loss of ability to meet with family members and friends. So, armed with a solution to help lift the uncertainty, UBI arrived just in time with their COVID-19 antibody test.

The Living Legacy of UBI: Hard Work, Ingenuity and Success

UBI appears to be very qualified to develop the COViD-19 antibody test. Dr. Chang Yi Wang is the mother of Mei Mei and the founder of UBI. Since the mid-1980s Chang Yi has been a legend in the areas of infectious disease, immunology and biochemistry. She has two PhDs and has developed tests for HIV and Hepatitis C, conducted pioneering research into an HIV vaccine and, as of last week, her work on an Alzheimer’s vaccine is on the verge of becoming a reality. UBI is a giant drug development company with offices and labs in the U.S., Taiwan and mainland China. It is Chang Yi’s years of research that have gone into the development of the COVID-19 antibody test used in San Miguel County.

Following the New FDA Guidelines

There are new guidelines from the Food and Drug Administration (FDA) that allow for quick development and deployment of the antibody test under an Emergency Use Authorization (EUA). UBI submitted a EUA application for its ELISA antibody test and was allowed to test residents of the county as it awaits formal approval from the FDA for its tests. 

Setting aside some local mistrust of capitalism expressed on social media, UBI’s test goals and those volunteering to take the test, are mutually beneficial and mostly shared. UBI says its antibody testing goal is to detect and contain community spread, to get a more accurate assessment of disease prevalence so that communities can stay safe while staying open.

The goal for test participants is to know if they have antibodies and whether they are immune. The UBI FAQs explain how antibodies work. “When you are infected by SARS-CoV-2, the virus that causes the coronavirus disease, COVID-19, your immune system will produce antibodies against the virus to fight the infection. A COVID-19 antibody blood draw test is able to detect the antibodies made by your body against the SARS-CoV-2 virus to diagnose whether a person has or previously had COVID-19.”

Testing Begins in the West End

The free antibody blood tests were administered in San Miguel County starting with first responders, teachers, clinic staff and their families, followed by county residents.

A small amount of participants’ blood was drawn and tested for COVID-19 antibodies. Those tested consented to voluntarily comply with the state quarantine and then are re-tested, if their first test outcome was negative. Follow-up tests will be scheduled soon.

UBI claims that their test is very accurate with greater than 95 percent specificity and sensitivity. They claim that it’s precise: it can differentiate between SARS-CoV-2 versus other coronaviruses circulating in the U.S. They say it’s fast and that you can get your results in 2-3 hours.

Once the blood is drawn, test vials are flown out of the county via TEX (Telluride airport) and delivered to a lab for processing but during this crisis labs are under processing constraints due to high demand, so delayed results are probable.

Each person who tests for antibodies is called, texted or emailed directly by the county with their results.

Where Do We Go From Here?

Being first in the world to be antibody tested raises scientific, political and economic issues of whether we stay safe and stay open, which UBI and the scientific antibody testing results support, or stay safe and stay home, which is the government’s prescription for now.

In the face of these laws that now extend through May 1, 2020, being immune to COVID-19 appears to be a moot point. Will the county approve a certificate of immunity necessary to carry on with life in society?

And some of us are wondering whether our governments have made the right decision to quarantine in the first place. “Is Sweden right? (A reference to whether Sweden’s reliance on inducing herd immunity is a proper response to COVID-19. These are the questions that all of us stuck in our homes have plenty time to ponder.

Destroy the Curve with a COVID-19 Vaccine

Amid the antibody testing, UBI is also progressing on a vaccine against COVID-19, now in animal testing, that will be ready for testing in humans this summer. They are hoping to have the COVID-19 vaccine developed and ready for use by August 2020.

In the economic holocaust caused by COVID-19 perhaps many more lives are being shattered by “the cure,” that is, the shutting down of the economy, rather than by COVID-19. Governments are walking a tightrope between the loss of life and the loss of livelihood. Antibody tests reveal whether certain parts of a community are immune and could signal the all clear, so that economies can reopen.

The unique and varied communities of San Miguel County, from the international resort destination of Telluride on its eastern edge to the remote ranches and empty desert of the west end, will provide UBI with an assessment and baseline of COVID-19 prevalence. Ultimately, the goal is to establish a model for the rest of the nation to follow in the efforts to create a new vaccine and to destroy the curve of the COVID-19 pandemic.

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