COVID-19: US providers should get testing relief soon as high-throughput rolls out

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Erin McCallister Senior Manager, Health Research Institute, PwC US 23/03/20

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The recent availability of high-throughput testing to diagnose COVID-19 should start to help triage some of the individuals at greatest risk of severe illness.

As of March 17, the FDA has granted emergency use to two new diagnostics for the SARS-CoV-2 virus, which causes COVID-19. The tests can run on platforms that analyze about 960 samples in eight hours.

The platforms, known as high-throughput systems, are available in numerous research and commercial labs in the US and could dramatically increase the capacity to quickly screen patients for COVID-19.

Testing for the SARS-CoV-2 virus has been plagued by problems in the US. As of March 17, providers were still reporting difficulties securing tests for their patients. Last week, in congressional testimony, National Institute of Allergy and Infectious Diseases Director Anthony Fauci called the US diagnostic testing situation “a failing.”

A daily tracker maintained by the American Enterprise Institute (AEI) found that as of March 16, public health labs with tests have the combined capacity to process 11,350 tests per day while commercial labs have the capacity to perform over 18,000 tests per day.

At a press briefing March 16, the White House and Assistant HHS Secretary Brett Giroir outlined the steps the administration is taking to make high-throughput testing more widely available across the US, including the deployment of drive-through testing sites.

“We will have 1.9 million of these high-throughput tests available this week with numerous labs, up to 2,000, starting to turn the lights on beginning this week and rolling out over the week,” Giroir, who is also the COVID-19 testing czar, said at the briefing.

Giroir said the administration would launch drive- or walk-through units that could screen 2,000 to 4,000 individuals per day with a focus first on states that are the “hardest hit right now or are on the rise and the CDC advises us that that’s where they need the testing.”

Within those states, the focus will be on healthcare workers, first responders and people age 65 or older who have a respiratory symptom and a fever of 99.6 degrees.

Until now, much of the testing has relied on the technologies employed by the public health labs across the US, which do not have the technology to run high-throughput tests, according to March 11 House committee testimony by Robert Redfield, director of the Centers for Disease Control and Prevention. “My role [at the CDC] was to get [the testing] into public health labs, so we built it on a platform that they had the instrumentation” for, he said, adding that if the CDC had developed the COVID-19 diagnostic for a high-throughput system, “we couldn’t have run it on our public health labs.”

HRI impact analysis

The moves by the federal government to deploy high-throughput COVID-19 tests to specific subgroups of individuals should start to make a dent in the populations most at risk for severe infection and should dwarf the capacity of public health laboratories.

HRI’s analysis shows that the frail elderly population is the most at risk for succumbing to the serious side effects of COVID-19 as well as the most likely to encounter infected individuals, given how much these patients interact with the healthcare system.

In its “Six things health organizations should be considering (but might not be)” report, HRI recommended that healthcare organizations understand the care patterns of the people most at risk: the frail elderly and those with respiratory disease. The report highlighted the use of mail-order pharmacies and even providing services such as grocery delivery to minimize the risk of infection for these high-risk populations.

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Trine K. Tsouderos

HRI Regulatory Center Leader, PwC US

Tel: +1 (312) 241 3824

Crystal Yednak

Senior Manager, Health Research Institute, PwC US

Erin McCallister

Senior Manager, Health Research Institute, PwC US

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