The Mercury News

California testing hamstrung by shortage of key chemical.

Newsom announces pilot program to find residents most at risk for COVID-19

- By Lisa M. Krieger lkrieger@bayareanew­sgroup.com

California’s rush to detect new cases of COVID-19 has been slowed by shortages of a key chemical needed to conduct the diagnostic tests, even as health officials sound alarms over potential community exposure.

Because of the shortage, the federal government has restrictio­ns on who gets tested, even as the cases and deaths mount.

Gov. Gavin Newsom said Sunday that the state is working to expand its capacity for testing and that new labs coming online soon could add the ability to do thousands more tests per day — in a state of nearly 40 million people.

“We are increasing our capacity (for testing) on an hourly basis,” Newsom said. He also announced a partnershi­p with Verily Life Sciences, a company owned by Google parent Alphabet, to offer screening to find those residents most at risk for the disease and get them tested sooner.

That program would begin this week on a pilot basis in Santa Clara and San Mateo counties, Newsom said. Last week, the governor sounded a more pessimisti­c tone about the state of testing.

“My great concern is we could be testing a lot more people,” Newsom said Thursday. “The tests are not complete. It is imperative that the federal government and labs across the United States get the benefit of all the ingredient­s that are components of the test.”

Newsom said Sunday that California had performed about 8,316 tests, a bare increase over the 8,227 the state had done by Thursday.

California is not alone, with other states and academic institutio­ns reporting that they’re low on crucial supplies.

Harvard Medical School’s two teaching hospitals — Massachuse­tts General and Brigham and Women’s — last week appealed for donations of kits, specific compounds and equipment. The University of Virginia’s hospital also asked research labs to share.

“Many of these items are either on back-order or do not exist for us to purchase,” Harvard’s hospital leaders wrote in a letter to the Boston biotech community.

The need for testing has increased demand for a specific chemical, called a reagent, which is a critical component used to run the coronaviru­s test.

The labs that make the chemical are running low, and it is not contained in many of the federally supplied tests. The shortage of reagents seems to be specific to the platform used in tests by the federal Centers for Disease Control and Prevention.

Newsom compared it to “going to the store and purchasing a printer but forgetting to purchase the ink. You need multiple components.”

Federal officials also are scrambling to get testing capacity increased quickly. A new 24-hour emergency hotline at the U.S. Food and Drug Administra­tion is being set up for laboratori­es having difficulty getting the reagent and other materials or facing other impediment­s.

The FDA also approved a new test developed by Pleasanton’s Roche Molecular Solutions that will speed

up by tenfold the ability to test patients and doesn’t rely on the same chemicals. Finally, the agency awarded nearly $1.3 million to two companies to develop a potential method for one-hour testing.

Still, the window of opportunit­y to detect the state’s initial infections is quickly closing, as community spread appears to be on the rise.

Concerned about suspicious symptoms in their 14-year-old daughter — and seeking to be responsibl­e — John Callon and his wife sought testing on Wednesday. But the Mountain View couple was rebuffed.

Their daughter had a headache, fever, light coughing and major fatigue. Over the past two weeks, she had mingled with an estimated 2,000 people at school, a major volleyball tournament and a weekend retreat, where she shared a bunk room with 11 others.

“They said, point blank, that they don’t have enough tests for everybody, and we understood they would only test her based on strict filtering criteria,” Callon said. She would only be eligible for a test, they were told by medical personnel at the Palo Alto Medical Foundation, if she had multiple symptoms, severe symptoms, recent travel to an internatio­nal region of risk and contact with someone with a confirmed diagnosis.

“If there is even a small probabilit­y she has this new coronaviru­s,” Callon said, “she should be tested immediatel­y, to know if she can be cleared — or to determine if some nearly 2,000 people need to be immediatel­y notified.

“This inability to test except for the most obvious and egregious cases is obviously a recipe for the rapid spread of this disease,” he said.

About 900 California­ns were in quarantine at Travis Air Force Base in Fairfield or Miramar Naval Station in San Diego after disembarki­ng from the Grand Princess cruise ship, and many still had not been tested.

As of Sunday, there were 335 confirmed positive cases of the virus in California, and six people had died.

To test 5% of California’s population over the coming three months, the state would need, on average, 22,222 tests made available every day.

By contrast, South Korea — with a population of 50 million, only one-fifth larger than California’s — is testing 10,000 people a day, around the clock, at 79 designated test centers, according to reports. In Australia, where actor Tom Hanks and his wife, Rita Wilson, have tested positive, no test shortages have been reported.

For help, California is turning to labs at four hospitals: Stanford, UCLA, UC San Diego and the City of Hope. By later this week, it hopes to also offer testing through UC Davis, UC Irvine and Kaiser. UCSF only has the capacity to do 80 tests per day and limits their use to patients who are hospitaliz­ed or in the emergency department.

The state also is contractin­g with Quest Diagnostic­s, a commercial lab, to conduct 1,200 tests a day and reduce the backlog of tests that had lacked all the components. Quest’s tools are automated and do

not need the missing chemical. Quest is expanding its facilities and has promised to conduct 5,000 tests a day by the end of March, although not just for California­ns, Newsom said.

“That would allow us to bypass the current restrictio­ns on testing that are in place today,” he said.

As the pandemic gains

momentum, many additional reagents or other critical components may become more difficult to find, say doctors.

“We are deeply concerned that as the number of tests increases dramatical­ly over the coming weeks, clinical labs will be unable to deploy them without these critical components,”

according to a statement released by the American Society of Microbiolo­gy.

“Increased demand for testing,” it said, “has the potential to exhaust supplies needed to perform the testing itself.”

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