U.S. Slow To React To COVID-19 Swab Test Shortage, Despite Adequate Warnings

05/26/2020
COVID-19 Test Kit

After months of receiving complaints that coronavirus test shortages are a problem among states, President Trump and his administration team stated that they will now spend billions of dollars helping make the tests more widely available to the public.

However, many labs claim that they have plenty of tests, which indicates that there is some kind of a holdup elsewhere. As it turns out, the coronavirus testing process is much more complex than making a single device. It involves many steps and each one requires different supplies. The problem is that there are shortages of different supplies at different stages within the test creation process.

Health experts and governors warned the federal government about possible supply shortages by as early as February of this year. However, they did not respond or begin to ramp up domestic production of swabs, the most common ingredient needed for a coronavirus test, until late April.

Swabs are an integral part of the testing process to detect a sick person. A swab test checks for active COVID-19 infections. On the other hand, an antibody test involves drawing blood to check whether a person has recovered from the virus.

Understanding The Swab Testing Process

There are several steps involved in a swab test. The first is to collect a sample. This is most commonly done by swabbing a potentially infected person’s nose or throat. Collecting a sample involves a swab, a tube, and viral transport media, which is a chemical salutation that keeps the sample fresh as it is transported to a lab for evaluation. The FDA has approved dozens of different types of swab tests. Swab tests are mostly performed at hospitals, drive-through testing sites, and community health centers.

The second step takes place at the lab. This is where genetic material is extracted from the sample. This step requires chemicals called reagents and special machines. Once the material is extracted, step three can be performed, which requires a machine to check whether the material contains the coronavirus. If it does, then the sample is marked as positive for COVID-19.

According to senior director of the science policy and regulatory counsel at the Association of American Medical Colleges Heather Pierce, a test requires many different compounds. It’s not a single-component device. If any part of the device is missing or is not provided in the proper quantities, then the entire test will not work.

The coronavirus testing process is affected by missing parts, including swabs, the chemical solution that keeps the sample fresh, and reagents. On any given week, there might be a shortage of some parts but not others, or one location has the supplies they need while another does not.

For example, health care experts are able to work with any approved swab test. But swabs are more complicated than they perceive to be. The name suggests that they are as simple as making a Q-tip. However, medical swabs are more sophisticated than the cotton swabs you get at the drugstore. They’re known as nasopharyngeal swabs and they are considered a medical device. These devices must be long and flexible enough to reach through a patient’s nose and to the back of the throat.

Problems with supplies developed when the United States failed to understand the swab test process and what it entails. According to a press briefing on April 17, President Trump stated that the federal government would be sending millions of swabs to the states within the next few weeks. He stated that it’s not a big deal because the swabs are cotton.

However, the swabs utilized for COVID-19 testing are not made of cotton. In fact, cotton can interfere with the test’s results by interacting with the swab’s own genetic material. Because of this, nasopharyngeal swabs are made of nylon, foam, polyester, or another synthetic material that will not interact with other components in the test.

During a public speaking event held on April 20 about a phased reopening of the country, Vice President Pence stated that he estimated that they will have enough testing capacity for every state in America to go into Phase 1.

However, testing capacity does not mean that testing will occur. This is because the testing process involves so much more than swabbing. These test swabs need to be analyzed at a lab. Many labs are well stocked with the machines that analyze the samples, but if there is a lack of swabs, then these machines are sitting idle. A shortage of swabs may prevent labs from operating at full capacity.



Swab Shortages Are Due To Lack Of Preparation

One of the biggest problems that the United States is facing against the fight against COVID-19 is the lack of swabs. Why is this? First, up until now, there had only been two major swab manufacturers in the whole world, including Maine’s Puritan Medical Products and Italy’s Copan Diagnostics. When the pandemic first occurred, the demand for swabs skyrocketed. These companies could not keep up with the overwhelming demand for swabs.

According to Timothy Templet, Puritan's executive vice president of global sales, the United States was not prepared. He stated that Puritan was not prepared, either. Customers were prepared and the government wasn’t prepared. He stated that it’s really nerve-racking to think about what this might mean for the company in the next few years.

The United States government should have been gathering supplies such as swabs in the Strategic National Stockpile, which is a federal warehouse of medical supplies, but did not. The government also issued the Defense Production Act, which is a tool that the Trump administration used to have General Motors switch from making cars to making ventilator parts for COVID-19 patients back in late March. The administration did not act as quickly to use the act for swab shortages, even though they were warned about possible shortages.

Washington Governor Jay Inslee told NRP on April 16 that he spoke to the president and urged him to invoke the Defense Production Act weeks ago. He stated he wanted the president to mobilize the incredible supply chains from the Department of Defense and ask them to convert some of the manufacturing from other hardware and software to swabs. He also suggested that these companies focus their efforts on machine and contact vials that can do analysis. He stated that the president did not agree with his suggestions and the United States lost weeks against the fight against the virus due to the decision not to act in a timely manner.

The federal government had previously been warned about potential swab shortages. For example, on February 12, a hearing on pandemic preparedness was held by a group of health experts. They told the United States Senate committee that the country has a problem within its testing supply chain. Then, on March 16, former FDA commissioner Scott Gottlieb tweeted that swabs could be a weak point in the testing process. Rhode Island Governor Gina Raimondo told CNN on March 17 that there is a problem within the supply chain due to lack of swabs. Other distress calls regarding the swab shortage also came out during this period.

The government acted in the middle of March by sending out a few shipments of swabs from Italy to the United States. However, these swabs still did not meet the increasing demand within our country. Complaints about shortages were coming in around the middle of April. President Trump stated on April 19 that he would use the Defense Production Act to increase swab production. Then, on April 29, the government awarded Puritan Medical Products $75.5 million to make more swabs.

Puritan stated that their goal was to create an additional 20 million swabs per month. They are even building a new factory to meet this goal. However, it’s hard to say whether or not this is enough to meet demand. It’s still unclear how much COVID-19 testing the United States should be doing and how many swabs need to be made to meet these numbers.

Back in the middle of April, the American Society for Microbiology asked to speak with Dr. Deborah Birx of the White House’s coronavirus task force. They wanted to know what has been done to address testing supply shortages. They found out that the White House needed to know the same thing.

Dr. Robin Patel, the prescient of the American Society for Microbiology, stated that several surprising things happened when they contacted the white house. First, Dr. Patel stated that Ambassador Birx is a wonderful person with good insight into the challenges of what the country is facing against the fight against COVID-19. However, instead of providing help, the White House asked the American Society for Microbiology for help with the swab shortage. Dr. Patel stated that this is not why they reached out to them in the first place. They were there to ask for information.

Dr. Patel’s group stated that despite being shocked by the request, they were pleased to help. Dr. Patel stated that the pandemic is a complicated situation and everyone needs to work together to solve it. Dr. Patel stated that this came as a surprise to the agency as they were not there to volunteer. They were shocked to hear of the White House’s request for help.

FDA Approves Additional Testing To Make Up For Swab Shortages

The American Society for Microbiology made it clear that nearly three months into the pandemic, the Trump administration did not fully understand the effect that the shortage of swabs and other test supplies would have on the pandemic. They also did not know how to fix it.

Luckily, the FDA stepped in to approve more types of swabs that could be used in COVID-19 testing kits. Additionally, an Ohio-based company converted its manufacturing plant to make swabs. The FDA also approved a saliva test that does not need a swab to check for coronavirus infections.

In the middle of May, the White House stated that it would send $11 billion to the states to expand their testing resources. The White House also stated that they would make sure the states have enough testing supplies. However, it made it clear that they want to focus on testing high-risk areas first, such as nursing homes. It remains unclear what the testing process will be like for the rest of the United States.