Why has the US rollout of coronavirus testing been so poor?

Chloe Kent 16 March 2020 (Last Updated March 20th, 2020 15:16)

Novel coronavirus is spreading fast, with over 6,000 fatalities globally and more than 170,000 cases reported across 158 countries. However, access to reliable testing in the US has had more than a few teething issues and left many people unable to find out whether or not they have the virus.

Why has the US rollout of coronavirus testing been so poor?
The US government response in creating and distributing diagnostic tests has hit roadblock after roadblock. Credit: Shutterstock

Nearly 20,000 people are being tested every day for Covid-19 in South Korea. Screening has been aggressively rolled out, with people undergoing nose and throat swabs at drive-through testing stations without even having to leave their car. In a few days, they get a phone call if their result is positive, or a text if it’s negative.

Other countries have struggled to match this level of efficiency, with the US rollout in particular getting off to an exceptionally shaky start. US Centers for Disease Control and Prevention (CDC) statistics say just over 22,000 specimens or nose swabs have been taken in the US since the beginning of the outbreak, falling far behind other developed countries.

A recent survey of 2,243 Verdict Medical Devices readers found that 64% of people think a lack of widespread access to diagnostic testing has greatly exacerbated the spread of the disease.

Accurate diagnostic testing is critical in managing a pandemic, especially in its early stages, as people with confirmed diagnoses can be quarantined to prevent the spread of disease. Those who have been in close contact with infected individuals can also be quarantined in case they’re sick too, which will be particularly vital in the case of Covid-19. The virus is thought to be contagious both in patients with active symptoms and during the disease’s incubation period, which can range from five to 12 days according to the latest studies.

Testing has been marred by logistical let-downs

Since the first case of coronavirus was identified in the US on 20 January, the government response in creating and distributing diagnostic testing has hit roadblock after roadblock.

While the World Health Organisation began shipping out diagnostic tests developed in Germany to 159 labs around the world on 17 January, the US opted to develop its own test, which wasn’t approved by the US Food and Drug Administration (FDA) until 4 February.

The CDC tests then began to deliver inconclusive results during verification due to a problem with one of the chemicals ingredients needed to identify the virus. This meant that until new tests could reach healthcare providers, samples had to be sent to the CDC in Atlanta to confirm any diagnoses, causing a delay of up to 48 hours between testing and confirmation.

Academic hospital labs also weren’t allowed begin working on their own tests until 29 February. Private firms have now begun to pick up some of the testing slack from the CDC.

The CDC now claims to have distributed 75,000 test kits across all 50 states, but testing capacity continues to vary wildly across the country. According to the American Enterprise Institute, 16,030 coronavirus testing kits can be processed in the US per day, but this isn’t evenly distributed across every testing lab and many facilities simply aren’t receiving the tests they are waiting for.

On 9 March a long-term care facility in Seattle, which has become home to one of the biggest coronavirus outbreaks in the US, reported that it didn’t have enough testing kits for 65 symptomatic employees. Only around a third of the residents at the Life Care Center in Washington now remain after 25 residents died from illness caused by Covid-19.

Strict criteria for testing heavily criticised

Alongside these more administrative blunders, CDC guidelines for which patients are actually eligible to be tested have also been heavily criticised.

Testing in the US was initially limited exclusively to people who had recently travelled to China or been in contact with a lab-confirmed coronavirus patient within 14 days of symptom onset. This was then updated to people who had travelled to any impacted area, as well as those presenting with severe symptoms like pneumonia or bronchitis.

Due to the fact that the virus is thought to be infectious during its considerable incubation period, these criteria sparked ire among people at high risk of the disease who would not be able to get tested for the virus until they became extremely unwell.

“If you haven’t got a test that you can screen anyone with, you only test when you see symptoms and you have a long backlog of tests going through a lab, then every day a test isn’t back more people are being infected,” says UK pharma sector veteran and PharmaFlow managing consultant Hedley Rees.

CDC criteria has been updated, as of 8 March, to include hospitalised patients with symptoms suggesting Covid-19, as well as symptomatic individuals who are older, chronically ill or immunocompromised, and healthcare personnel who have been in close contact with a confirmed patient within 14 days.

Point-of-care testing is essential

It’s not just the US. A lack of available testing kits in China has led clinicians to use computed tomography (CT) scans and lung X-rays to obtain a diagnosis. Several African countries still have no capacity to screen for the disease, with only 37 out of 54 nations able to do so.

What is needed in the US is a point-of-care diagnostic test. In such a large country, screening for a pandemic disease using swabs which need to be sent to a laboratory is overly complicated, time-consuming and ultimately dangerous.

Fortunately, Aytu BioScience said on 10 March that is has exclusively licensed the US distribution rights for a point-of-care Covid-19 test developed by China’s Zhejiang Orient Gene Biotech. The test, which provides results in two to ten minutes, is already CE marked and Aytu has said it plans to pursue its FDA clearance through emergency use authorisation. If it can be rolled out across the US within the next few weeks, it could be crucial in slowing the spread of the disease – but with new cases surging outside of China, the clock is ticking.