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ARE THE NUMBERS EVEN CLOSE? Local doctor believes state testing process, results are flawed

By Allen Edmonds

HARRISONVILLE – On March 23, less than three weeks ago, medical professionals believed they were exercising the utmost in caution by screening outpatients who visited the specialty clinics at Cass Regional Medical Center as they arrived at the door for appointments in the early days of the coronavirus pandemic that has since turned the nation upside down.

Kevin Latinis, MD, PhD

A man showed up as scheduled for his visit to the podiatry clinic. He was funneled through one of only three doors that remained open for the entire complex – one for employees, one of the emergency department and one for all other patients.

At the patient door, he responded properly to all the screening questions: he felt fine, had experienced no recent fever and had no known contacts with any COVID 19 victims.

The podiatry clinic shares nurses with other specialties and professionals, including rheumatologist Kevin Latinis, M.D., who also holds a Ph.D. in immunology.

Over the next several days, the podiatry patient became ill, tested positive for COVID 19 at the CRMC emergency room and was transferred to Research Medical Center in Kansas City, where he remained on a ventilator earlier this week.

Since then, two clinic nurses (who work on different days of the week) have become ill. One, a 25-year-old female, began having fever temperatures of 103 beginning on March 30, one week after probable exposure.

“I called her when I found out she was out sick, and asked, ‘what’s going on?’ She said she just felt like crap. She had a headache, and I asked if she had other symptoms. She said she’d had diarrhea for about five days.”

Latinis immediately focused on the possibility that she had been exposed to the virus that had been sweeping the nation.

“The bottom line is that any sort of symptom that involves the respiratory tract – sinus headaches, sore throats and issues that involve the (gastrointestinal tract) are major presenting symptoms, because the virus enters our body through receptors in or nasal pharyngeal lining and our GI lining. And so diarrhea is a very common symptom, and you often have to ask people, or they will not feely share that they’ve had diarrhea.” His mind began to race.

“The implications of her having this are such that it could cause a major crisis within our local system, right?”

So Latinis immediately had her tested. She arrived at the driveway to the CRMC emergency department. A nurse, fully outfitted with personal protective gear, met her in the parking lot and did a nasal swab.”

Over the next several hours, she became even more seriously ill. “This is a 25-year-old healthy female with no medical problems.” Latinis said she happened to have an oxygen measuring device at home, so he had her test herself.

“For a normal, healthy physiology, you really have no reason to ever fall below 95 percent. By 11 that night, when I called to check on her, she was down to 94, she was out of breath just walking across her room and had a fever of 103.”

He declared the situation an emergency and ordered her to the emergency room immediately, where she was taken into the negative pressure room where she was tested for the flu, which came back negative.

But, he said, she was clinically stable and appropriately discharged that night. However, in the week that has passed, she has remained sick.

On Tuesday of this week, Latinis said, “I talked to her just before talking to you, and for the first time, she is finally beginning to feel a little better.

Because she is a healthcare worker, the State Testing Laboratory in Jefferson City made her case a priority

, “which is fantastic, they should,” Latinis said.

The surprise was, the test came back negative.

“At that point, I was like ‘oh, thank goodness, we don’t have an employee (with COVID),’ and this could’ve been a disaster, right?”

Meanwhile, Latinis said, the second nurse from the clinic became ill “with exactly similar issues, and she’s been home since about the same time. And her test comes back negative, within the same 72-hour time frame.”

At first, he said he questioned himself.

But then, he reviewed the course of events, asking himself, “what if these tests aren’t accurate?”

The sequence of events following the specimen collection at Cass Regional Medical Center, as Latinis described, is similar to any site within the state, he believes.

“It’s completely inefficient to run the tests to Jeff City on an individual basis. Back four weeks go, you could do that. Now you can’t. So the (Cass County Health Department) has solved that problem by saying we’re going to batch collect and send a courier once a day to Jeff City. “So what happened was the courier locally came to pick it up from (Cass Regional) and delivered it appropriately to the county health department, where it just missed their daily cutoff to take it to Jeff City.”

He said the health department stored the specimen appropriately, and sent it to the state lab the following day.

“So, it arrived on April 3,” after being collected from the patient on April 1.

Because the tests take a few hours to run, Latinis said, the state lab usually runs the tests in the morning. “Unfortunately, I think the timing of the transport from Cass County to the state lab is such that it gets there after their daily run. So, the test was not done until 72 hours after specimen collection.”

Seventy-two hours also happens to be the accepted cutoff for specimen adequacy, he said, putting the entire test on the edge of its expiration time.

Polymerise chain reaction (PCR) testing is how the majority of COVID tests are being done worldwide. The tests detect the genetic information of the virus, the RNA, and it is only possible if the virus is there and someone is actively infected. A lack of detection means the sample tests negative.

However, according to Latinis, who spoke with a state laboratory scientist as part of his investigation in the days following the negative results, “I believe there is a situation that occurs in which there’s a time after patients are symptomatic that they clearly are infected. But even the best test we have available is not sensitive enough to detect their infection.

“And that’s exactly what this test shows. It’s not false-negative rates because people are running the test wrong,” but rather a combination of possible flaws.

Between a specimen transport system that requires up to 72 hours before lab processing, a sample collection process that could be inconsistent because of the required invasiveness of the nasal swab, and the inherent instability of RNA itself, Latinis said he has found evidence that the current PCR testing process may only detect approximately 73 percent of all COVID positive patients.

“And in that test, they were running their specimens immediately after sample collection,” he said. “So you don’t even have to factor in the expiration, the (inconsistent) collection and bad transport incidences.)

Under the best of conditions, he said, up to 25 percent of people that are tested, and are sick with the virus, will have a negative result on their test.

The Centers for Disease Control, he said, is “basically saying our tests of negative rate is 3 percent, but they’re calculating that off of scientifically flawed logic. It’s not because they’re intentionally trying to deceive anybody.”

Latinis has devoted himself to this cause in recent weeks, going so far as to let his hospital administrators know he is willing to work without pay for the duration of the crisis.

He considers himself fortunate to be working comparatively independently, and in the case of CRMC, for a hospital free of corporate restrictions on where he must focus his time, due to the significant threat he believes the virus, and our apparent inability to detect it consistently, poses.

The exponential nature of the spread, which is naturally difficult to comprehend for most, who tend to naturally focus on linear data, is what keeps Latinis up at night.

His son was recently diagnosed with Type 1 diabetes, which places him in an at-risk class. He also feels a protective sense over his rheumatology patients and society, as a whole.

While he knows that time will present solutions in terms of what he believes will be more reliable serological testing, and approval of more testing labs to loosen the backlog, it’s still frustrating, he said.

“It just so happens that I know scientists that have (idle) PCR testing machines on their benchtops - hundreds of them.

“But they’re lying idle, because their local institution says, ‘you guys aren’t allowed to use your machines for anything because we don’t trust that you’re not going to start doing rogue COVID 19 testing.”

He said it’s not financial pressure that’s keeping the machines inactive, but rather regulatory pressure.

“They’re afraid to get in trouble with their boss, which is an institution, and their bosses are afraid to get in trouble with the federal government and lose their funding.”

Latinis said he is able to discuss what he’s found, “because I’m beholden to nobody. I work for myself, and my goal is to protect my family’s health.”

And he said we have reached the critical stage in our fight.

“It is critical. We have these (resources) right under our noses in Kansas City. And if we want to protect our families, we need to scream from the top of our lungs in a grassroots effort that we do have the resources to flatten the curve.

“We’re running out of time. And we’re still on the linear phase of this curve in Kansas City and in Cass County. But once we’re in the exponential phase, there’s no point in screaming because we’re in a crowded field and nobody’s going to hear us above the roar. Right now, we can scream, and there are a few people that will listen.”

Once our region hits the point on the “curve” that the New York area has already reached, emergency solutions are more likely to be enacted, regulations eased and testing increased, but it may already be too late.

“It’s really difficult to flatten the curve, okay? But it’s easier today than it’s going to be tomorrow.”

• • •

Next week: What it’s like to go through the virus, and what are the potential testing solutions?


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