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Labs scrambling to test for Covid-19 face same obstacle: Not enough supplies

Clinical laboratories in Western New York racing to find new ways of testing for the novel coronavirus face the same problem many people find at the supermarket these days.

A dearth of products, especially nasal swabs, transport tubes and reagents – substances used in chemical testing – has handcuffed efforts to process more coronavirus tests in the county, said Dr. John E. Tomaszewski, professor and chairman of pathology and anatomical sciences in the University at Buffalo’s Jacobs School of Medicine and Biomedical Sciences.

“Like there’s a run on toilet paper, there’s a run on all these things,” said Tomaszewski, who also serves as chief of service, pathology and laboratory medicine for Kaleida Health. “We really need access to reagents. That’s the A No. 1 thing.”

Less than a month ago, about 130 public health laboratories in the country, including one in Erie County, were the only labs authorized by the Centers for Disease Control and Prevention to test for novel coronavirus, using a CDC testing regimen approved by the U.S. Food and Drug Administration.

But the spread of the virus overwhelmed the ability of public health labs to keep pace, and the FDA has since allowed many clinical laboratories to process tests – a move that allowed New York State to rapidly expand testing, particularly in New York City and downstate counties. Testing took off as well in upstate counties such as Albany, Monroe, Onondaga and Saratoga, according to state figures.

The University of Rochester Medical Center and Rochester Regional Health, for example, have conducted many of the 2,196 tests taken in Monroe County, which does not have a public health laboratory, according to Julie J. Philipp, a spokeswoman for Monroe County Executive Adam J. Bello.

Erie County’s pace of testing, though, continues to lag several smaller counties, even as its number of confirmed cases of Covid-19 has grown.

“In general, it’s very clear the testing measures that have been available have gone downstate, and so it should be, because they are a couple weeks ahead of this thing,” said Tomaszewski.

He said he’s not sure why smaller upstate counties have been able so far to test more.

Erie County officials haven’t been able to explain the gap, either.

Clinical labs may start coronavirus testing only if they have lab instruments for which the FDA has given an “emergency use authorization.” The FDA so far has approved 19 such authorizations to companies such as Roche Molecular Systems, Thermo Fisher Scientific and Abbott Molecular, which manufacture instruments and test kits used in laboratories for virology testing.

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A newly arrived batch of Western New York samples ready to be tested for Covid-19 at a Kaleida Health lab in Amherst. (Robert Kirkham/Buffalo News)

Some counties may have clinical labs with instruments that already received an emergency use authorization, as well as test kits that go along with the devices, said Tomaszewski.

Gov. Andrew M. Cuomo on Thursday encouraged greater testing to help flatten the escalating curve of cases across the state. But he said he also recognized that some communities don’t have what they need to do more widespread testing.

“It’s a capacity issue, right. If you have the capacity to test, test,” he said. “If you don’t have the capacity to test and you can only test people, for example, who are coming into your hospitals, then you don’t have the ability to do it. But if you have the ability to do it, do it, because it’s a way to flatten the curve.”

In Erie County, Catholic Health officials have said they are trying to buy 72,000 tests from Cepheid, a California company that received an emergency use authorization March 20 for its GeneXpert Xpress system. The purchase would allow Catholic Health, which already has the GeneXpert Xpress system, to do 800 tests per day. But it’s unclear if or when the deal will happen, and Catholic Health officials have said they still would need help getting additional supplies, such as nasal swabs, to do the tests.

Kaleida Health started March 22 doing 100 to 200 tests per day, because it was able to purchase reagents for testing on its Abbott RealTime system, said Tomaszewski. Abbott Molecular, which makes the system and testing materials, received an authorization for them March 18.

“But it’s not enough,” he said.

With the limited supplies, Kaleida is primarily testing health care workers to ensure that it can maintain robust health care in its hospitals as the virus surges in Western New York, Tomaszewski said. To conserve tests, county officials have been discouraging people who suspect they have been exposed to coronavirus from seeking a test, unless they are health care workers, first responders or older people with Covid-19 symptoms, per the recommendations of the Association of Public Health Laboratories.

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Senior clinical lab scientist Karen Baryza places a rack of samples into a molecular analyzer at a Kaleida lab in Amherst. (Robert Kirkham/Buffalo News)

Another emergency use authorization granted Tuesday may also help boost testing in Western New York, he said.

PerkinElmer developed a diagnostic procedure to be used with its chemagic 360 instrument. The University at Buffalo uses those instruments in its biorepository, a facility that collects, process, stores and distributes biological specimens for research.

Tomaszewski said he is working on a way to bring the biorepository’s research instruments into a clinical setting to conduct coronavirus testing.

“This is where the innovation comes in,” he said. “All the labs in the community have been scrambling to adopt alternatives.”

Tomaszewski said he is currently scouring the market for reagents that would work with five different testing systems. Two of those systems combined could process as many 2,000 tests per day, he said.

But much of the world also is in the market for testing materials. Some of the upstate counties that have outpaced Erie in testing so far also are running out of those materials and scrambling for more.

Albany County Executive Daniel P. McCoy this week cautioned residents not to get a “false sense of security” about the county’s lowering rate of increase in positive cases of Covid-19 because the county’s ability to test had slowed with the depletion of test kits.

“They just can’t make enough, as quickly as you want up front,” said Tomaszewski. “The real issue is the manufacturing of millions of these kits.”

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