United States / Coronavirus Insights
Implications of New COVID-19 Testing Modalities

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by Dan Spitzer, Industry Research Analyst
May 20 2020

While hospitals and ambulances (IBISWorld reports 62211, 62191) have been at the forefront of treating and saving lives, diagnostic testing remains a key tool in preventing the spread of the highly infectious COVID-19 coronavirus. Accordingly, as the outbreak continues, people who have been exposed to the coronavirus have shown a wide array of symptoms. Many display symptoms associated with a cold such as cough, fever and sore throat, however some progress to more serious cases as breathing becomes more difficult, among other symptoms. On the opposite spectrum, some people have displayed no symptoms, highlighting the need for accurate testing.

In order for a commercial test to be manufactured and sold to a medical diagnostic lab (62151), it must go through the Food and Drug Administration’s (FDA) rigorous guidelines to show that is accurate and reproducible. However, in March when the coronavirus began spreading rapidly in the United States, the FDA used its Emergency Use Authorization (EUA) authority to allow the use of unapproved diagnostic products to combat the public health emergency. This led to a wide range of tests flooding the market from existing major diagnostic manufacturers to smaller companies. These tests rely on swabs collected from the patients’ nasal cavity run on instruments that detect specific viral nucleic acid. Though, the FDA recently approved the use of tests using saliva instead of swabs as well as home collection kits, making it easier to collect samples.

 

 

However, these diagnostic tests only detect whether or not a patient has the virus and requires several hours for the assay to run. Early in May, the FDA issued its first EUA for an antigen diagnostic test that quickly detects viral fragments. This test can provide results in as little as 15 minutes greatly decreasing the turnaround time, though it has its own limitations compared to more common nucleic acid tests. Still, diagnostic tests are only one aspect of controlling the spread of the coronavirus.

The other tool that recently has become more available is the antibody test. Generally used after a full recovery from COVID-19, the antibody test requires a blood sample and then detects whether or not you have antibodies to the virus. If positive, it indicates that a patient was likely exposed to the virus and that they might have some immunity to another exposure. Again, this test has its own limitations in terms of accuracy and importance as more medical research continues, though it is currently the main tool in determining whether individuals can return to work. The general idea is that if someone has immunity to the coronavirus, they will have a very low chance of spreading the virus or becoming re-infected.

One industry that has begun to implement testing strategies mentioned above is the Meat, Beef & Poultry Processing industry (31161). Up until recently, there have been almost 5,000 reported cases of COVID-19 across more than 100 meat or poultry processing facilities. This has resulted in more than a dozen plants being idled or slowed, threatening to disrupt domestic food supply chains. Consequently, how the industry implements new testing strategies to protect workers and operations may have larger implications on the broader economy as other sectors view the meat industry as an example. Going forward, both diagnostic and antibody testing is seen as an integral part to the virus mitigation process. Accordingly, there will likely be an ongoing coordinated effort in expanding testing availability and efficiency in the coming months. 

 

For further analysis on the supply chains of COVID-19 testing, see our recent article on the Supply Chain Analysis of COVID-19 Testing