Validated antibody test; now contributing to ongoing pandemic research
[ By Katherine Nettles ]
Gunnison County residents have been a significant part of a scientific research study that helped get a new COVID antibody test approved. The same study, using local test subjects and regular antibody testing has contributed to a better understanding of how our bodies react to the virus and now to the vaccine roll-out.
Vibrant America, a science and technology manufacturing facility based in San Carlos, California began studying our relatively small Gunnison Valley population for COVID immune responses in spring of 2020, and has published the earliest results of its ongoing research for the medical and research community. It is now conducting further research with locals who have received a COVID vaccine.
The study last spring was used to validate antibody tests for Vibrant America, and involved about 200 people who had tested positive for COVID. Of those participants, 132 were from Gunnison County through a collaborative effort between the tech company, Gunnison Valley Hospital (GVH) and local naturopathic doctor Roanne Houck. Since then a more recent, ongoing antibody study with the company has included about 50 locals who are post-vaccination.
Houck first got involved in the research project when Vibrant America reached out to her regarding its finger stick diagnostic test; she then coordinated efforts with the GVH laboratory as well. “They were looking for about 600 people who had tested positive for COVID,” she says. Gunnison County appealed to the company because it was fairly isolated, and had been hit hard early on by the pandemic.
“We took a bad situation, which was our valley having so many people sick in the spring. And we were invited to be involved in these studies. It seemed like we were weeks if not months ahead of the Front Range,” says Houck in terms of infection rates and subsequent responses.
GVH participated in the antibody study in April 2020, and GVH laboratory director Tina Wilson explains that GVH reached out to patients who had previously tested positive. Patients had to be at least seven days post positive from a COVID-19 test to participate, and they would receive free antibody test kits and the results of the tests as they became available.
The participants had their blood drawn and throat swabbed from either Houck or one of 10 GVH lab workers, and participants performed a finger prick on themselves to collect an additional dried blood specimen on filter paper.
“So, for most patients we had three different specimen types. We created a database, recorded all the pertinent information, then packaged and shipped all of the specimens,” says Wilson. Vibrant America then used the specimens to validate their tests, and subsequent tests on 50 participants showed how long the antibodies lasted after someone had contracted the virus.
GVH received all results, and shared them with the participants.
Wilson says patients were happy to volunteer, and the study size was only limited due to the hospital’s resources that were already being challenged by the growing pandemic. “This process overwhelmed our registration staff and the laboratory staff,” she said of the enthusiastic community response.
“We (the lab and registration) were inundated with phone calls for patients who wanted to participate and then with patients wanting results,” she says.
The antibody testing began after the April validation test, and has continued. “When we rolled this out in May, we tested 579 patients and in June about 200, so those are all in addition to our normal workload. As of the end of December we had tested approximately 1,100 patients with antibody tests,” says Wilson.
Vibrant America published the results of its initial study at the end of 2020 out of Aurora, titled “Antibody profiling and prevalence in US patients during the SARS-CoV2 pandemic.” The study can be found at www.vibrant-america.com.
As the publication states, “Antibody diagnostics play an important role in disease detection and can potentially aid in monitoring of the immune responses to see if an individual has developed immunity. Developing ‘high throughput diagnostics’ which does not involve handling of infectious material becomes imperative in the case of pandemics such as the recent outbreak of SARS-CoV2.”
Suzanne Gross, the Colorado representative for Vibrant America, points to the study results in two ways. First, the results showed results very specific to Gunnison County in terms of antibody levels. Second, the company has gotten USDA approval for its unique, finger poke microchip technology. “It is unlike any others and eliminates a lot of human error,” she says.
The results demonstrated that patients showed strong likelihood of having had the virus and that the antibody testing was highly accurate.
Houck reflects that both the validation study and the ongoing antibody studies have been worthwhile, and given some insight into how antibodies were tracking even before a vaccine became available.
”I think it’s been helpful. And it’s also been helpful for people in the valley to learn about our antibodies. And through RE1J, I think all the cleaning, social distancing and masking is working well, because our antibodies were showing an overall reduction,” she says of the pre-vaccine antibody tests.
Houck emphasizes that one of the most fulfilling aspects of the research has been “how we as a little community were able to participate in something much bigger.”
“This was a great opportunity and helpful to the FDA approval for [the Vibrant America] home collection kits,” says Wilson. “We validated and brought in COVID antibody testing to one of the first labs on the Western Slope and had a huge turn-out for antibody testing.”
Antibody studies continue
Houck has been in communication with the post-vaccine antibody participants, answering questions and helping to de-code the technical data.
“Generally speaking, just as the news has reported, I too am seeing very strong IgG antibody responses two weeks after the 1st shot and another boost two-three weeks after the second shot,” she said. “This is great! It suggests a nice strong antibody response.”
As Houck has explained to her participants, “IgG antibodies are the ‘long term’ antibodies that everyone is talking about with regard to potential ‘long term’ immunity. Based on what I have seen, which is in alignment with the CDC and multiple other institutions, Covid IgG antibodies, induced by the actual virus, generally last at least 90 days from infection, often up to six months and in some people longer than six months. IgG antibodies in the ‘positive’ range do not guarantee immunity against COVID-19 or a variant but in most people do offer some or full protection. We don’t know yet how long vaccine induced IgG antibodies will last, that’s the purpose of this study.”
Houck characterizes the whole effort as very collaborative, as does Wilson.
“I really cannot put into words how our many departments have continued to turn on a dime with the ever changing landscape of COVID. We continue to make our processes better, more efficient with constantly keeping the patients as front and center. These teams have not had any reprieve since COVID began, but continue to show up with new ideas for continued success,” says Wilson.
“Lastly, we have a phenomenal Laboratory Team that has endured for the last 12 months. We all remember Friday, March 13, 2020 well – Our first remote collection day for COVID-19—and we continue,” concludes Wilson.