CDC and FDA leaders expect more COVID-19 novel coronavirus testing capacity to be coming online

By March 6, 2020

As the COVID-19 novel coronavirus emerged abroad and here at home, the Centers for Disease Control and Prevention (CDC) devised a diagnostic testing kit and the criteria for who should be tested. Both of CDC’s processes have come under severe scrutiny.

The ramp up in US testing capacity for COVID-19 has been sluggish, in large part due to the initially problematic COVID-19 virus test kit that was devised and manufactured by CDC and shipped to state public health labs. Four COVID-19 virus genome sequences had been deposited in public databases by scientists in China by January 12th. On February 4th, the Food and Drug Administration (FDA) issued an emergency use authorization for the CDC test kit, and kits shipped to state public health labs soon thereafter. At that point, 178 people in the US had been tested. On February 12th, it was reported that some test kits were failing quality checks at state health labs. 360 people in the US had been tested by then. As of February 26th, only 12 out of over 100 US public health labs were able to test for the COVID-19 virus; 445 people in the US had been tested.

The problems with test kit components were due to a manufacturing issue, which according to the FDA, has been resolved. FDA has also authorized public health and hospital labs to use their own tests for the COVID-19 virus as shipments of the newly manufactured CDC test kit make their way to public health labs. An investigation into the exact nature of the CDC manufacturing issue is ongoing, and by the end of the week, the CDC expects to have provided public health labs with sufficient kits for 75,000 people to be tested.

Even so, the California Department of Public Health capacity is limited to 7,400 tests through the weekend. Washington State has very high demand for testing. And state officials in Florida on Thursday said that they do not have enough test kits to evaluate all the patients who could be evaluated according to new CDC guidelines.

The CDC COVID-19 criteria guiding healthcare providers’ and local health departments’ determinations of who should be tested for the virus have gradually changed since January, and have been criticized as being too narrow. Narrow criteria may have resulted in people infected by the COVID-19 virus going undiagnosed.

At the time its test kit was authorized by FDA, CDC recommended considering testing if an individual exhibited COVID-19 symptoms and had traveled from mainland China or had contact with a confirmed COVID-19 patient within 14 days of the beginning of symptoms. In addition to China and the US, there were 22 other countries with confirmed cases of COVID-19, and 36 US states and territories had people under investigation for potentially being infected. On February 12th, the CDC guidance was updated to recommend that severely ill patients without a known source of exposure to COVID-19 virus, but who also were without a known cause for their illness, be considered for evaluation for COVID-19. On February 27th, CDC added travel from Iran, Italy, Japan, and South Korea as well as China. As of February 29th, 472 people in the US had been tested, and there were 9 cases of person-to-person spread that were not travel related.

During Tuesday’s Senate Health, Education, Labor, and Pensions Committee hearing, Dr. Anne Schuchat, principal deputy director of the CDC, explained that CDC devises testing criteria so that tests are not used up on “low-risk situations,” which could reduce testing capacity for addressing situations that are critical. After the hearing, the CDC further amended its policy to recommending that “where there is community transmission in the US, clinicians and public health officials may consider testing patients without severe illness…decisions on which patients receive testing should be based on the local epidemiology of COVID-19, as well as the clinical course of illness.” Community transmission means that there is a person infected with the COVID-19 virus, but how the person became infected is unknown. And then on Wednesday, CDC recommended that clinicians nation-wide use their best judgment based on patients’ symptoms and epidemiological factors. As of Friday morning, there have been 233 confirmed COVID-19 cases in the US, and tragically, 14 deaths.

Out of the 14 people who have died, 13 lived in Washington State. At the hearing, Senator Patty Murray (D, WA), who represents Washington, raised her grave concern (1:19:52 mark in video) about delays in testing and how the COVID-19 virus could have been circulating for weeks, undetected, in her state.

The Committee was given assurances that US testing capacity would ramp up rapidly. By the end of this week, FDA commissioner Dr. Stephen Hahn expects 2,500 newly manufactured test kits, with 500 tests per kit, to be available to hospital labs, and Dr. Schuchat said public health labs will have sufficient kits for 75,000 people to be tested. Upon arriving at labs, the test kits need to clear quality controls, and a given public health lab, for example, can run about 100 tests per day.

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