Until recently, U.S. Food and Drug Administration rules made it very difficult for smaller clinics to conduct COVID-19 testing, and despite what most people believe, most clinics and hospitals are not set up for rapid mobilization of new technologies. However, tests have finally become available to private clinics, including at least one in Boulder.
Widespread testing is one critical element society needs to return to something that more resembles normalcy. Many carriers of COVID-19 don’t get sick and don’t display symptoms (percentages have not been determined, but some doctors suggest up to 40 percent), which wreaks havoc on a community trying to limit its spread. This, essentially, forces all of us to distance.
As soon as we have widespread testing, carriers will know and can stay home while contagious, which would greatly limit spread. Now, we have no idea if the person touching the oranges at Trader Joe’s just before us is contagious.
Boulder County does not yet have a register of private clinics who offer COVID-19 antibody testing, but one definitely is now: Rocky Mountain Regenerative Medicine, a Boulder clinic with a focus on integrative and regenerative medicine including stem cell therapies. Limits to more widespread testing include access to important items such as nasal swabs and culture media.
RMRM founders and doctors Vassily Eliopoulos, MD, and Khoshal Latifzai, MD, say accessing the research and test didn’t come with too much difficulty, as some tests have lighter protocol than others; the hard part was finding a test they had confidence in.
The two doctors, who are also emergency room physicians, started testing at their clinic on April 16. Yesterday they did 11 tests, but the onslaught of calls and emails continues, with more testings scheduled through the end of the week. They’ve been spreading the word through their website, social media and word of mouth.
“There are four tests manufactured state-side now available that have gone through the FDA expedited process,” says Vassily, who got access to one through RMRM’s clinical lab due to their longstanding relationship which they leveraged to get access to their state of the art equipment for early testing.
The antibody test, a blood-draw serum test, differs from the nasal swab test that actually diagnoses COVID-19. It allows people to learn whether they’ve been exposed to the virus and built up immunity to it with antibodies. The body creates antibodies when exposed to a pathogen — whether bacteria, virus or vaccination — by noticing foreign proteins — or antigens — and then developing antibodies that neutralize them.
RMRM’s COVID-19 antibody test, an American Manufactured antibody immunoassay, has a sensitivity rate of 89 percent and a specificity rate — which calculates how well a test determines who has a disease — of 96.5 percent for COVID-19 IgM/IgG. It costs $300, with a turnaround lab time of between 24-48 hours.
The nuance of the test, comes with identifying which antibodies get developed first — such as IgM antibodies which start dwindle within a few weeks of exposure. When the IgM levels start to decline, then IgG antibodies develop and can remain in the body and provide immunity from months to years. (Which is why we get a tetanus vaccination every 10 years to replenish those levels.)
The clinic also does nasal swab tests, but due to high demand and extremely limited supply of the swab and viral culture media, RMRM has about 12 nasal swab tests. The serum test and blood tubes, on the other hand, the clinic has in copious amounts. The doctors have found it relatively easy to continue obtaining those supplies for patients.
“The jury is out if you haven’t had symptoms,” says Vassily, “because insurance doesn’t cover it at the clinic — you’d be paying out of pocket. Also while the quality of the test varies, if you haven’t had the disease the test reliability does drop a little.”
Some insurance may cover COVID antibody testing, but RMRM doesn’t accept insurance at their office. Everything the clinic does is cash pay, which they feel partially contributes to the reason they were able to get early access.
“Since we’ve been trying to limit staff at our office,” Khoshal said, “Vass and I are doing a lot of legwork ourselves that usually our office staff takes off our hands and we don’t notice. We’re going to be busy!”
To further help inform Boulderites, the two put together an informational sheet that includes links to manufacturer of test, the lab they deal with, and various calculators like biological medical calculators.
Some of the information coming down from government officials can be contradictory and confusing; “wear a mask, don’t wear a mask, go out in public, don’t go out in public.” RMRM wants to take some of that uncertainty off the table.
“There’s got to be a solution and we want to be a part of it,” Khoshal says.