What are all the coronavirus tests coming to Idaho? We explain your options

Apr. 25--Maybe you have a cough and can't smell anything, and you want to know whether you're infected with the coronavirus. Maybe you spiked a fever in early March, and you suspected it was COVID-19 but couldn't get a test. Maybe you work in health care, and you worry about bringing the virus home to your family.

There are many reasons people have shared with the Idaho Statesman for wanting to be tested for COVID-19, the disease caused by the new coronavirus.

Testing in the U.S. and locally has been fraught with delays, supply shortages and other problems. The Food and Drug Administration's multi-tiered approach to shepherding COVID-19 tests has opened the door to a slew of new testing options -- but some confusion, too.

Here is what to know about tests for the novel coronavirus, based on the information available April 24:

Why does coronavirus testing matter?

Experts see robust testing as key to emerging from the COVID-19 crisis without a vaccine or treatment. Testing is not a panacea, they are quick to say. But it can help contain the virus. And Idaho Gov. Brad Little's plan to reopen the state hinges in large part on Idaho's capacity to test people and follow trends in the test results.

Little on Friday announced the creation of a coronavirus testing task force whose members mostly come from Idaho's public health agencies and private health systems.

"We know we need to reopen our economy based upon sound principles that allow progress while maintaining safety," said task force co-chair Dr. Jim Souza, chief medical officer for St. Luke's Health System, in a news release. "Testing will be a key tool to inform these decisions."

The task force will set Idaho's criteria "for when and how frequently someone should be tested and how to move toward a common reporting platform across the state," Little said in the release.

The group's first priority is to make sure every region in Idaho has safe and efficient testing for people with symptoms -- reaching Idahoans who are older, lower-income, racial and ethnic minorities or living in rural areas, and especially health care workers.

What kinds of COVID-19 tests are there?

Let's start with the test most people refer to when they talk about coronavirus or COVID-19 tests: the coronavirus PCR test, short for polymerase chain reaction.

For this test, someone swabs your nasal cavity and/or throat and sends the sample to a laboratory. The lab processes it, looking for traces of the SARS-CoV-2 virus in your bodily fluids. While a positive test result isn't a diagnosis of COVID-19, this is the quasi-official diagnostic test for the coronavirus disease. It's the one public health agencies, including the Idaho Department of Health and Welfare, are looking at when they report the number of confirmed cases.

Because of the supplies, equipment, regulatory processes and manpower needed to run the test, use of the PCR test has been severely limited in Idaho and throughout the U.S.

Health care providers statewide are administering the PCR test, to varying degrees. Some providers, like St. Luke's Health System and Primary Health Medical Group, have drive-up testing locations for PCR tests. Rite Aid recently announced a PCR test option where patients swab their own noses.

But in some cases, "testing" could refer to something else: the coronavirus antibody test.

For that test, someone takes a small amount of your blood and sends it to a lab. The lab processes it, looking for antibodies that can show up when your body mounts an immune response to the SARS-CoV-2 virus. It doesn't find the virus -- it finds the calling card left behind by the virus.

This is useful for epidemiologists and researchers who can use the data to track the virus and determine how prevalent it is in a community.

There is debate over how useful it is for patients, though. A positive test for antibodies can't tell patients whether they're immune to the coronavirus, or whether they're still contagious.

Cole Diagnostics, a lab in Garden City, was the first to introduce this type of test to Idaho last month.

Since then, a group of local companies formed a coalition called Crush The Curve Idaho, which now offers antibody testing -- as well as PCR testing -- in the Treasure Valley, with plans to offer it widely in Idaho and a goal of testing 20,000 people by May 1.

Crush The Curve found a low rate of antibodies in its first two days of testing. There were 34 people whose samples tested positive in the first 1,946 tests.

Which test should I get?

A doctor or primary care provider should decide that. But here's what we know:

-- The PCR test can detect an active infection.

-- The antibody test can detect a past or recent infection.

-- Both have varying levels of accuracy, depending on the test and how and when it is administered.

-- Neither test requires you to have symptoms. The continual shortages in PCR testing have forced public health officials to create a tiered system that favors patients who have symptoms.

--

No test can say for certain whether you're currently infected with COVID-19.

Those who advocate for forging ahead with tests before they have the FDA's blessing argue that imperfect tests are better than no tests, especially as more of Idaho reopens from the stay-home order.

Crush The Curve leader Mike Boren, founder of Clearwater Analytics and a member of the governor's new testing task force, said the group's early antibody testing wasn't "anything like perfection" in terms of figuring out how far COVID-19 has spread in the Treasure Valley.

"But let me be clear, we're not going for perfection here," he said. "We're going for a better idea than we had, and hopefully some good data so we can make better decisions than we would make without good data."

How accurate are these tests?

Some tests have performed more accurately than others, in terms of detecting signs of the virus -- without accidentally detecting signs of a virus that looks similar to it.

But even the best laboratory can't find what isn't there, and all the tests on the market today can misfire for several reasons: The swab didn't catch enough of the right bodily fluid; the patient was tested too early or too late; the sample went bad before reaching the laboratory's test machine; or the patient's immune system didn't build enough antibodies.

Health care researchers and industry leaders have said the PCR test may fail to identify active infections as often as 30% of the time. That's why many health care providers tell patients who test negative to keep assuming they have COVID-19, so they don't risk infecting others if they actually have it.

Antibody testing accuracy varies, among those who are disclosing that information.

Crush The Curve Idaho is using a just-released antibody test from the University of Washington, using an Abbott COVID-19 system.

How accurate is that test? A lab director there told the Statesman on Friday that it had an accuracy rate of 100% for finding COVID-19 positive cases and 99.9% for finding COVID-19 negative cases, based on 60 blood samples from confirmed COVID-19 patients and 1,020 blood samples that were drawn before the COVID-19 era. The small print: That accuracy rate applies to blood samples taken 15 days after symptoms appear.

Are they FDA approved?

No. But some of them are allowed by the FDA through a fast-track process.

The FDA approval process is long, so the agency decided early in the pandemic to issue "emergency use authorizations" for tests it believed were more likely to help than hurt the public. That allowed some PCR -- and, more recently, antibody -- tests to hit the market before they'd gone through the full FDA approval process.

For antibody tests in general, the FDA last month relaxed the rules even more. It said it won't object to certain high-level laboratories using them, as long as they follow a set of rules and include caveats to avoid misleading people.

None of the antibody tests being offered in Idaho currently have the "emergency use authorization." However, the FDA guidance says they must start the EUA process if they want to offer the unauthorized tests to the public. (Cole Diagnostics says its test is already under review for an EUA.)

The state earlier this month issued some cautionary guidance on antibody testing.

"The Idaho Division of Public Health discourages persons who have a positive serology test from relaxing the precautions such as social distancing that are recommended for all Idahoans to prevent spread of coronavirus, and strongly discourages employers (from) relaxing the employee protections for an employee solely based upon a positive serology test," it said.

How much will coronavirus testing cost me?

Idaho's major health insurance companies have agreed to cover PCR tests since early in the pandemic, with no cost to the patient.

It's unclear whether health insurance companies are willing to cover antibody testing. Most procedures are covered based on medical necessity. Could that include a retrospective test for a virus whose long-term effects we don't yet understand?

Blue Cross of Idaho -- Idaho's largest health insurer and a supporter of Crush The Curve Idaho's antibody testing program -- wouldn't say whether it covers the tests.

Antibody tests through Crush The Curve are about $100. According to founder Tommy Ahlquist, that amount is based on the estimated cost of supplies and staff, transporting the samples to the University of Washington and the lab's costs to process the tests. The group, which formed a nonprofit for the initiative, says it will not turn away patients who can't afford the tests.

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