In the face of mixed messages and confusion about who can or should be tested for the coronavirus, the Centers for Disease Control and Prevention posted updated guidance for doctors on Sunday about when to test a patient.
The short answer is, if your doctor thinks a test is appropriate, he or she can request the test. But a request doesn't guarantee that you'll get one.
Confused? You're not alone.
There's still a big gap between what the federal government is promising and what state and local labs can deliver.
Right now the CDC is telling doctors in its new guidance that they should use their own medical judgment and then "work with their local health departments to coordinate testing through public health laboratories." But those labs have a limited capacity to test, so some have been turning down doctors' requests.
The novel coronavirus test isn't simple, like the ones for the flu, strep or pregnancy. The kits detecting the coronavirus are configured more for a research lab than a hospital — and certainly can't be run in a doctor's office. It takes four to six hours to perform the tests on patient samples. And while in principle tests can be run in batches of about 100, that's a challenge for smaller labs.
The contractor that is producing these test kits for public health labs is also mass-producing them for hospital labs, but it's unclear as of Tuesday to what extent hospital labs have acquired the kits, demonstrated that they are capable of getting reliable results and begun testing.
Secretary of Health and Human Services Alex Azar said Monday that over 1 million tests have been shipped and "are now out." Out where is not so clear. The American Hospital Association couldn't provide any information about the use of this test among its members.
"Our members are anxiously awaiting them," says Jan Emerson-Shea, vice president of external affairs for the California Hospital Association.
Kaiser Permanente, one of the major providers of health care along the heavily impacted West Coast, says it is currently sending samples from its patients to public health labs. Kaiser Permanente is developing its own test, but that may take several weeks, a spokesman tells NPR. Geisinger Health Plan, another large HMO in New Jersey and Pennsylvania, has not received test kits either.
Two big commercial labs, Quest Diagnostics and LabCorp, have announced that they have geared up to run tests. But if you are in the hospital or in precarious health, your doctor may not want to wait several days to get an answer from these labs. (Doctors and hospitals will collect the samples from patients — the lab companies do not want people potentially infected with coronavirus showing up in their waiting rooms.)
State health departments can run the test that the CDC has been sending out. Federal health officials said they sent public health labs enough kits to run 75,000 samples — among an at-risk population that is in the tens of millions, if not larger. And because doctors may submit more than one sample per patient, 75,000 tests will cover far fewer people. The samples are swabs from the nose and mouth or, in some seriously ill patients, may be fluid from the lungs.
Commercial companies are now working to develop tests that are faster and less cumbersome to run.
"Essentially, every company that has a molecular test is saying that they're working on a coronavirus test," says Dr. Mark Miller, chief medical officer of bioMérieux, a global testing company headquartered in France.
His company has a U.S. Defense Department grant to develop a test that will provide fast results. The company sells an automated instrument called the BioFire system that can sit on the counter in a hospital laboratory and produce test results in an hour or less, Miller says. Of course, these tests can be run only in labs that own this expensive piece of equipment, and most hospitals do not. Miller isn't ready to promise a delivery date for the rapid test.
Another testing company, Qiagen, is also trying to fast-track a rapid test. The company, headquartered in Germany, already sells a test that can analyze a nose or throat swab and look for 20 different viruses and microbes that can cause flu symptoms. Company CEO Thierry Bernard tells NPR that shortly after the coronavirus appeared, the company started working to add the new coronavirus to this panel of respiratory tests.
These 20 tests are run on a "simple cartridge that goes into a very simple reader, which is the size of your laptop," Bernard says. "So it's a very plug-and-play solution." Right now, Bernard says, only about 200 medical labs coast to coast have purchased these readers. But he says interest is growing rapidly.
To validate the test, Qiagen sent some of these kits to China to run them on people known to be sick with the novel coronavirus. With that data now in hand, Bernard says, the company has submitted an application to the U.S. Food and Drug Administration to use the test commercially. He hopes to get a thumbs-up sometime this month. The test costs about $100 per run, he says.
All these diagnostic tests are considered "essential" under the Affordable Care Act, which means they are covered by private insurers, Medicare and Medicaid — at no cost to consumers. (Uninsured people can be billed for the test at whatever rate the doctor or hospital chooses.)
The tests identify genetic material from the virus itself in fluids from the nose, mouth or lungs. That information allows doctors to identify people who are currently infected and potentially spreading the virus. Those tests — versions of which are widely available elsewhere in the world — do not identify people who contracted the virus and have since recovered.
Scientists in China and Singapore have been using a different kind of test — one that detects antibodies in the blood. The CDC's version of this test is still being developed. "We do have a test working with some of the samples from the first patients," says Dr. Nancy Messonnier, director of the National Center for Immunization and Respiratory Diseases at the CDC. In a conversation with NPR on Friday, she said, "As soon as we are sure about it, we will use it more broadly."