COVID-19 Resource Center
COVID-19 Resource Center
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Disclosures: Adalja, Erdmann and Shapiro report no relevant financial disclosures.
March 13, 2020
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Limited COVID-19 testing capacity has US physicians ‘flying blind’

Source/Disclosures
Disclosures: Adalja, Erdmann and Shapiro report no relevant financial disclosures.
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Amesh A. Adalja
Eugene Shapiro

Testing capacity issues for COVID-19 have hindered laboratories from effectively identifying cases of the virus in the United States since the beginning of the outbreak — leaving some experts concerned for the country’s ability to contain its spread.

“Testing capacity has us largely flying blind, not knowing where cases are and hampering response efforts,” Amesh A. Adalja, MD, senior scholar at Johns Hopkins Center for Health Security, told Healio. “I do, however, foresee testing capacity improving in the coming weeks.”

President Trump on Friday declared a national emergency over COVID-19 and announced efforts to improve testing capabilities in the U.S., including making millions of test kits available next week. The announcement came amid a wave of criticism that the federal response has been too slow, particularly in regards to testing.

Eugene Shapiro, MD, Infectious Disease News Editorial Board Member and professor of pediatrics and epidemiology at Yale School of Public Health, also said testing capacity issues for COVID-19 in the U.S. have set back the country’s pandemic response.

“Without more widespread testing, our understanding of the clinical epidemiology of this infection is greatly impaired,” Shapiro, an Infectious Diseases in Children Editorial Board Member, told Healio.

The CDC submitted an Emergency Use Authorization package on Feb. 3 to the FDA with the hope of accelerating the FDA-permitted use of the CDC diagnostic panel for the virus. However, shortly after distribution of the test kits began, a manufacturing problem related to one of the testing reagents was identified — leaving several laboratories unable to verify test performance.

Nathan Erdmann, MD, PhD, instructor in the University of Alabama at Birmingham’s department of infectious diseases, said failure to implement testing early has hindered efforts to mitigate the virus’s spread.

“The lack of early testing has greatly hampered the ability to identify and aggressively contact trace cases, leading to wide dissemination of infections and, without question, accelerating the timing and number of cases,” Erdmann told Healio. “While testing is now starting to come online, the number of tests and cases will continue to present challenges to capacity, and the benefits of identifying cases is diminished as the virus is now circulating widely in the community.”

In response to the reagent testing issues, the FDA issued guidance for laboratories throughout the country outlining an “accelerated policy” enabling laboratories to quickly use tests they develop to “achieve more rapid testing capacity.” Laboratories, including Cleveland Clinic, have validated the CDC test in their own labs, which enables them to initiate onsite testing for the virus, in some cases leading to faster results and the ability, in some cases, to confirm results within 1 day. The FDA also issued an Emergency Use Authorization today for the first commercial test for the virus, which may further expedite testing efforts.

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The U.S. has the potential to test a little over 25,000 people per day if all labs are testing at full capacity. The CDC has currently confirmed 1,629 cases and 41 deaths in the U.S. across 47 jurisdictions, with an additional 49 cases among persons repatriated from Wuhan, China and the Diamond Princess Cruise Ship.

Shapiro noted testing capacity in the U.S. may improve in the coming weeks. He also told Healio that, to improve testing capabilities in future pandemics, measures must be taken to “respond much more quickly to produce and distribute tests for the new agent.”

Erdmann also said that improvements to testing capacity are “already beginning to occur,” but also that “supply chain issues with reagents” are compounding the U.S.’s late start.

“Any outbreak is going to present major challenges, but investing in our public health systems and empowering our scientific leaders to directly inform policy would dramatically increase the likelihood of having a more organized and effective response to future (inevitable) infections,” Erdmann said.

“Situational awareness” regarding the virus’s trajectory now is critical, Adalja added.

“Diagnostics must be a key pillar of pandemic preparedness. This pandemic has exposed a vulnerability that threatens our pandemic resiliency.” – by Eamon Dreisbach

Reference:

AEI. COVID-19. https://www.aei.org/2019-coronavirus-coverage/. Accessed March 13, 2020.

CDC. CDC tests for COVID-19. https://www.cdc.gov/coronavirus/2019-ncov/about/testing.html. Accessed March 13, 2020.

CDC. Coronavirus disease 2019 (COVID-19) in the U.S. https://www.cdc.gov/coronavirus/2019-ncov/cases-in-us.html. Accessed March 13, 2020.

Cleveland Clinic. Coronavirus (COVID-19) media information. https://newsroom.clevelandclinic.org/2020/03/12/coronavirus-covid-19-media-information/. Accessed March 13, 2020.

U.S. FDA. Policy for diagnostics testing in laboratories certified to perform high complexity testing under CLIA prior to emergency use authorization for coronavirus disease-2019 during the public health emergency. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-diagnostics-testing-laboratories-certified-perform-high-complexity-testing-under-clia-prior. Accessed March 13, 2020.

Disclosures: Adalja, Erdmann and Shapiro report no relevant financial disclosures.