FDA-authorized antibody tests now available in Routt County
STEAMBOAT SPRINGS — Most of us are eager to find out if that cold we had back in February might have been COVID-19.
With much of the infected populations experiencing only mild symptoms — and as many as 25% experiencing no symptoms — it’s hard to know whether or not we could have had it.
But now, we may be closer to those answers as antibody tests become more available in Routt County.
This week, the Steamboat Emergency Center is beginning to offer the Cellex qSARS-COV-2 IgG/IgM Rapid Test.
“We are very lucky to get these,” Medical Director Dr. Mathew Freeman said.
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After several weeks on a waitlist, the Emergency Center obtained 1,000 test kits and is now accepting appointments for the testing, which also includes the administration of the “gold standard” PCR nasal swab test to check for current infection.
The tests are being offered at an out-of-pocket cost of $199; however, according to Freeman, the language of the CARES Act requires insurance carriers to cover COVID-19 testing and vaccines without copays or deductibles.
There remains some ambiguity as to whether antibody tests are part of that and exactly how each insurance carrier will bill for those tests.
And the antibody tests come with a lot of caveats at this time, of which the Emergency Center doctors are spending time communicating to each patient who gets a test.
I know the antibody tests are not 100% reliable. I know that even a reliable positive result does not mean I am immune.
But I was curious. And I like data. I like information. I like the idea of an opportunity to be more empowered with knowledge about my own body and health and that of my 18-month old daughter’s.
I want to know if either of us has been exposed. But I fully understand that if I tested positive, I cannot use that information to think that I am not still capable of being a carrier and spreading the virus to those who are more vulnerable.
I don’t have any particular reason to think that my daughter or me were exposed. We both had a few different respiratory ailments early in the year.
My husband did travel to New York City at the end of February and was around large crowds of tightly packed people.
My hope was that all three of us had experienced mild cases or that we were among the asymptomatic carriers. I feel there’s a chance I’d fall in those categories, as I typically have a strong immune system.
That was my hope, because then — even though it isn’t known at this time — I could have at least know my daughter and me were building some immunity. I wanted that hope so that I could also hope my parents, both in their 70s, were at less risk because we’d already had it.
After our blood samples soaked on a test strip for about 15 minutes, I was disappointed to see we were both negative.
And I did debate whether it was worth it to put my daughter through the trauma of not only a blood draw but a nasal swab, and let me tell you, that nasal swab is a uniquely uncomfortable sensation. I’d prefer the blood draw any day.
But as I said, I wanted information. And my little girl is a tough cookie. She handled it like a champ and got a popsicle and stuffed puppy out of the deal.
While the test does have a chance of a false negative — meaning I was exposed but it didn’t detect the antibodies, or the antibodies were at too low a level to detect — if both she and I tested negative, I’m pretty confident we were never exposed.
If one of us gets something, the other one gets it. I literally pick her nose.
While I was hoping for positives on the antibody tests, the doctor made the case that our results were the best possible outcome.
We could rest with the knowledge we weren’t infected now. And that we hadn’t spread it to anyone in the past.
If my husband had contracted it in New York, knowing how incredibly contagious it is, I can’t imagine a scenario in which we wouldn’t have caught it from him.
And I appreciate the knowledge that until there is a vaccine, I now know that we are still at risk, and we need to continue to take all precautions both for our health, and even more so, for the health of others.
And maybe we won’t need to get exposed and take those risks in order to develop immunity. Maybe we can stave it off until there is a vaccine. Maybe we can stave it off until the world is a much safer, more certain place.
The tests in no way guarantee immunity, Freeman emphasizes, and in no way should change anyone’s behavior related to social distancing, hygiene, wearing masks and the other measures being taken to stop the spread of the virus.
However, there has been a lot about the pandemic that has been disempowering at the individual level, especially given the significant period of time during which people were told they could not get tested for the virus due to lack of supplies.
On the notion that information can be empowering, antibody tests are a next step in figuring out who has been exposed and thus the prevalence in the community.
Antibody tests in several locations across the country are showing the virus was spreading in January — well before anyone was even talking about it.
Antibody tests can also provide information on who may have some level of immunity.
The problem is it is too soon for scientists to know to what extent people have immunity, if they even do, and for how long.
Local, state, national and global health agencies are proceeding very cautiously on the antibody testing front. Until more is known about what the tests actually mean in terms of immunity, there is grave concern positive results will be misinterpreted as an “immunity passport.”
Historically, in terms of coronaviruses, antibodies do provide full or some level of immunity, Freeman said. But with COVID-19, he said there is no guarantee.
It will be months before there is enough data to be able to tell people whether they are immune and for how long, according to Dr. Jesse Sandhu with the Emergency Center. Significant time is required to see whether people who were infected once become infected again — and to gather that information in a scientific way.
There also are unknowns about whether the virus has or will mutate, he said, though historically coronaviruses are more stable than the flu virus.
These first antibody tests — if accurate — can play an important role by gathering information on people who have been exposed in the past without knowing it, so that it can then be determined whether those same people become infected for a second time.
But until more is known, anyone who does test positive for antibodies needs to “continue socially distancing, wear a mask and know that you still very well may a vector for the virus,” Freeman said.
So why are Freeman and his colleagues proceeding while many others are waiting?
“We are using the best test available,” he said. “We can wait, or we can act now.”
The Emergency Center doctors aren’t unaware they will be accused of trying to profit off the tests. But they argue that gathering data right now — while keeping intense focus on the educational aspect of the test administration — is a worthy goal. The doctors are spending about twice as much time on that education piece as the actual tests.
“Whatever data we can get to fight this invisible enemy is the only way we can light it up,” Sandhu said. “Even if it’s not the best data, it’s the best data available.”
And the more data we can have now, they argue, the better we as a community can be at staying ahead of an outbreak.
But no matter the test results, no one can say they are invincible, Sandhu stressed. No one can say with certainty they have any level of immunity.
The data from the 1,000 tests will be shared — as required — with public health agencies. And Sandhu stresses the importance of working together to share resources, gather the best possible data and provide the best possible care for the community.
“It’s about people’s health, not about money,” he said.
For getting the economy back up and running, those potential future immunity passports could be very valuable information.
The other problem is the accuracy of the antibody tests currently on the market. There are only a handful authorized by the U.S. Food and Drug Administration.
Many of the tests are showing high rates of both false negatives and false positives. And even accurate results may not have the desired effect.
“If the first results from antibody surveys, also known as ‘serosurveys,’ in the U.S. are anything to judge by, simply not enough people are immune,” according to an April 28 article in the Atlantic. “Too many Americans are still vulnerable to COVID-19 infection for these tests to be the ‘game-changer’ that many were hoping for.”
Routt County Public Health Medical Officer Dr. Brian Harrington said he is not getting an antibody test at this time.
“The current antibody tests cannot tell us if you are immune, and how long you might be immune for,” Harrington said.
And that doesn’t even address the issues with test accuracy, he added.
Harrington is just as eager as everyone else for useful information, and antibodies certainly matter, he said. It is a “fair assumption” that people who test positive have some level of immunity for some amount of time, Harrington said. He also believes the antibody tests can play an important role in opening the economy and getting people safely back to work — but the data and technology just isn’t there yet, he said.
UCHealth is working is to bring antibody testing to its network of hospitals but is waiting for a test with a higher sensitivity and specificity than the Cellex test before they begin offering it to patients.
“UCHealth’s laboratory scientists and experts have been working to test and validate many of the commercially-produced antibody tests that are available today,” said Dr. Richard Zane, UCHealth’s chief innovation officer, and professor and chair of emergency medicine at University of Colorado School of Medicine. “Unfortunately, the vast majority of tests available are not accurate, even if they are performed in a medical facility.
“Many of these tests have a greater chance of providing false positives or false negatives than correct results,” Zane explained. “Before taking an antibody test, I recommend that people ask if the test is FDA approved and if the specificity and sensitivities are both greater than 97%. If not, they should not use the test.”
For the Cellex tests, there are about 40 false negatives for every 1,000 tests — not an insignificant number, considering the implications.
That is part of why the Emergency Center is urging everyone to also get the more reliable PCR tests at the same time in order to detect an active infection.
If people do choose to get the antibody tests now, Harrington said people should not use those results to make decisions about their individual disease prevention activities.
The doctors at the Emergency Center agree wholeheartedly. At this time, no test result can give anyone reason to behave differently, they say.
Zane echoed the sentiment.
“Importantly, we do not know if the presence of antibodies means that someone has some immunity to the virus or that they might be less susceptible to contracting or spreading COVID-19 in the future,” Zane said. “People should continue to follow social distancing, wash their hands frequently and stay home if they develop symptoms of COVID-19 regardless of whether they receive an antibody test”.
In terms of public health and antibody testing, Harrington said antibody testing could play a role down the road.
“However, we must wait, because of the concerns about the tests and the lack of information to help us interpret those results,” he added.
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