On Monday, Francesca D’Angelo went to see her doctor with a disturbing collection of symptoms and got a hard lesson in the reality of coronavirus testing.
D’Angelo, 39, lives and works in Bucks County, where a case has been confirmed. Her job is in a health-care facility and her Buckingham home is just minutes from schools that have been closed as a precaution. Yet her doctor wouldn’t test her for the new virus, even though she had fever, sore throat, and cough — and tested negative for seasonal flu.
“It was as if I was asking for a bar of gold,” D’Angelo said Tuesday from home, where she is taking over-the-counter medications. “The doctor said, ‘You don’t meet the criteria for testing because you haven’t been exposed to a confirmed case’ — and how am I to know? — `or traveled’ ” to an outbreak hot spot.
Contrary to President Donald Trump’s claim that anyone who wants a coronavirus test can get it, U.S. testing has been rationed both because of the federal government’s limited supply of test kits and because it has advised doctors to restrict the test to certain patients.
That is starting to change — slowly. With the blessing of the U.S. Food and Drug Administration, at least three big commercial diagnostic companies are now offering coronavirus testing. That should boost the meager capacity of the U.S. Centers for Disease Control and Prevention and public health labs, which had done fewer than 6,000 tests through last week, according to health officials.
In addition, the CDC announced much looser testing criteria on Sunday, so more people with symptoms will be eligible. Basically, physicians are advised to “use their judgment.”
But as D’Angelo learned, that doesn’t mean people who fall ill and fit the new criteria get tested.
“I think community spread is happening,” said D’Angelo, who is pursuing testing through the county and state Health Departments. “But if you’re sick, you can’t just get a test. It’s a big to-do. I want the public to know that.”
Public health officials say community spread — person-to-person transmission of an illness for which the infection source is unknown — is not occurring in Pennsylvania, which had 12 cases, as of Tuesday afternoon or New Jersey, with 14 cases and one death. But on Monday, Pennsylvania’s secretary of health, Rachel Levine, warned that it could happen. (New Jersey has tested 58 people in all; Pennsylvania won’t disclose its total.)
Many commercial diagnostics companies around the world are rushing to develop automated tests for coronavirus because rapid, close-to-clinical-care diagnosis is vital to begin screening asymptomatic people and track disease spread in real time.
The goal is still on the horizon.
Meanwhile, the FDA has given LabCorp, Quest Diagnostics, and Northwell Health Labs permission for emergency use of their own coronavirus tests in their specialized laboratories, according to the news releases.
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However, patients still have to go to a hospital or doctor, get evaluated, give a respiratory sample, then the sample must be shipped to the specialized commercial lab. Results take a day or more. (The thousands of LabCorp and Quest service centers that consumers are accustomed to walking into for lab tests are not collecting samples or doing tests.)
To speed up that cumbersome process, some practices are improvising. In Connecticut, Murphy Medical Associates — with offices not far from a Westchester, N.Y., outbreak — launched a “drive-by” service on Monday. Suspected coronavirus patients’ temperatures and throat swabs are taken while they sit in their cars, then the samples are sent to Quest.
“We got the 'drive-by’ idea from South Korea,” said Hannah Sutherland, the practice’s head of patient relations. “It’s much safer than having patients come into the office” where they might transmit the virus.
She added, “If the patient has symptoms, even with no known exposure, we’ll do the test.”
In Los Angeles, Mend Inc., a chain of urgent care and primary care centers, on Monday announced both in-clinic and at-home collection of specimens that will be sent to Quest.
“If you can’t come to Mend to get swabbed for the novel coronavirus, our medical team can come to you,” Mend medical director Anthony Cardillo said in a news release.
New York-based Northwell Health Labs, one of the nation’s largest diagnostic labs, will offer its newly authorized coronavirus test to the 23 hospitals, 800 clinics, and thousands of physician offices it serves.
But Northwell is an example of the too-little, too-late federal handling of the coronavirus crisis, say the growing chorus of critics. The FDA granted emergency authorization just hours after New York Gov. Andrew Cuomo visited the Northwell lab and lambasted the agency’s “outrageous and ludicrous” delays.
On March 6, Raul Perea-Henze, New York City’s deputy mayor for health and human services, wrote to FDA and CDC officials to complain that the kits provided so far “do not meet the needs of New York City, America’s most populated city with 8 million New Yorkers. ... The slow federal action on this matter has impeded our ability to beat back this epidemic.”
The costs and coverage of commercial coronavirus testing is still being worked out, but Aetna, Independence Blue Cross, and Medicare/Medicaid have announced they’ll cover the tests. Some states, including New Jersey, have mandated coverage without co-pays or deductibles.