Updated Thursday, April 16. This week the Food and Drug Administration approved new materials for self-administered COVID-19 testing. We asked Dan Wattendorf, our director of Innovative Technology Solutions, to update this post with additional information. His updates follow.
This week the FDA announced that COVID-19 samples can be collected using spun polyester swabs and can be stored in saline for delivery to the lab. What does this mean for the public—and the wider effort against COVID-19?
This announcement, we hope, is another step toward widespread access to safe and convenient COVID-19 testing, which we know remains our best strategy to lifting stay-at-home policies and allowing non-essential businesses and schools to reopen.
When the FDA approved a self-administered swab in late March, that was a big step towards improving the way COVID-19 samples are collected. But until now, those swabs had to be made of foam material and stored in what is called viral transport media (VTM), a very specific formulation that ensures safer storage and helps to prevent sample contamination while it is delivered to a lab. Unfortunately, many health care facilities have been running low on those types of sample collection materials.
Luckily, a simple saline is more readily available and polyester swabs can be made in large quantities very quickly. So, with this announcement, we now have a lot more tools in our toolbox to expand access to safe and reliable self-swabbing methods.
I should also be clear about something: With these materials, patients still have to swab themselves in a healthcare setting, like the testing centers many states have set up. There’s not approval for home testing yet. But we do know that if patients swab themselves in these settings, it dramatically reduces the risk of healthcare worker exposure to COVID-19.
The FDA made this decision based on results from a study conducted by United Health Group. The Gates Foundation provided technical support on the design of this study, led by my colleague Karen Heichman. This is similar to how we supported a previous study that determined that self-administered collection methods are comparable to the nasopharyngeal swabs administered by a healthcare worker.
You said there’s still not approval for home-based testing yet. Why is that? And does this announcement move us closer to people being able to test themselves for COVID at home?
There’s still some more research that needs to happen before these swabs can be used at home. Specifically, the FDA needs to make sure that the samples are still viable when stored at room temperature or at very high or very low temperatures, since there’s less control over the environment when samples are not collected in a healthcare setting. However, home-based self-administered testing is our goal, and having more materials to use for sample collection will help scale access quickly once home-based collection becomes a reality.
Updated Wednesday, March 25. After this week’s announcement that the Food and Drug Administration is moving forward with allowing self-administered swabs for use in collecting samples for COVID-19 testing, we asked Dan Wattendorf, our director of Innovative Technology Solutions, to update this post with additional information. His updates follow.
This week the FDA moved forward with allowing a new method for collecting samples for COVID-19 testing that uses simple swabbing of the nostrils. The procedure could be self-administered by people experiencing coronavirus symptoms. Why is this important?
We’re hopeful that it could be a game changer at a time when we will need to find ways to relieve stress on our healthcare system, reduce risk to our healthcare workers, and scale up equitable access to testing in the United States and around the world.
Right now, healthcare providers are the ones required to collect samples for coronavirus testing using either nasopharyngeal (NP) swabs or oropharyngeal (OP) swabs. These providers must first put on personal protective equipment (PPE)—a gown, a mask, and gloves—to minimize their risk of becoming infected. That doesn’t take a lot of time—maybe a minute or two—but in a pandemic, that step may need to be repeated dozens of times a day.
The result is a huge time burden for healthcare providers. It also causes a big drain on existing supplies of PPE because those gowns and masks must be recycled after every use to prevent unintended hospital-based viral transmission.
On the other hand, if a healthcare provider can have their patients swab their own nostrils and seal this self-administered sample in secure packet for safe delivery to a local lab, healthcare providers don’t need to change PPE, and their potential exposure to the virus is dramatically reduced.
So, the introduction of a simple swab could have a big impact on protecting healthcare providers and healthcare supplies over the next few weeks at a time when we expect a surge in cases.
The long-term vision for self-administered swabs is that they will make it possible for patients who are feeling ill to go online, report their symptoms, and qualify to receive a self-swabbing packet in the safety of their own homes.
Home-based self-swabbing is not yet approved because additional studies are required to determine that swabs can be administered at room temperature. Those studies are underway and close to being completed. Ultimately, we hope that home-based, self-administered swabbing, and sample collection will be available. This would ensure safer and more equitable access to testing, help to protect vulnerable populations, and help bring this pandemic under control.
What role did the Gates Foundation play in this approval?
We provided technical support to UnitedHealth Group on the design of a study to determine if self-administered collection methods are comparable to the nasopharyngeal swabs administered by a healthcare worker.
The Gates Foundation isn’t set up to manufacture or distribute these swabs, but we can lend our expertise to regulators and partners to help them answer the question of how and when they can be used.
The following section was previously published on Wednesday, March 18.
The foundation has been providing technical assistance to government agencies in the United States to support the development of a COVID-19 testing system that could enable people to provide samples from the safety of their own homes, have those samples analyzed in a lab and get their results. What’s the status of this effort?
We have been working to advance regulatory science with the U.S. Food and Drug Administration (FDA) to generate the evidence required to determine if home-based, self-administered collection methods are comparable to the current standard for diagnosis—which is a nasopharyngeal swab administered by a trained healthcare worker.
We’d actually been involved in conversations about this issue for some time. But the sudden emergence of COVID-19 has accelerated these discussions. In the past few weeks, we have quickly moved ahead with funding researchers to design and implement these trials.
What are your next steps?
We need to complete a few studies that are underway to determine whether the quality of the viral sample collected by a self-administered nasal swab is comparable to the current standard.
With the self-administered nasal swabs, people can insert a short swab similar to a Q-Tip into the fleshy, lower part of the nose. This swab could also be applied further back in the nose or just applied to the tongue. The nasopharyngeal swab, on the other hand, must be administered by a trained healthcare professional. It involves pushing a very long swab up through the nose to collect sample material from the back of the throat.
There are significant differences between these collection methods, so it’s essential for the FDA to evaluate their relative performance through rigorous, well-designed studies. Otherwise, people could be using a method that yields false negatives. This outcome would make the rapid diagnosis and treatment of patients a lot harder.
What else needs to happen?
If the data shows that these self-administered swabs are sufficient for diagnostic testing, then it will be helpful to have a web-based or mobile phone-based messaging service that would allow people to know whether they meet the criteria to do a self-swab.
That service would ideally show people how to order the test through their medical provider or the public health system. It would also, of course, guide users on how to collect the specimen and where to drop it off or send it.
It will be very important to make sure those who are most likely to benefit will have access to this service. That means prioritizing testing access for people who have active symptoms or have underlying conditions that make them more susceptible to severe disease.
When will we know more?
The FDA and CDC are working overtime to answer these two questions.
It’s important to note that—in the meantime—testing capacity and testing locations are increasing across the state of Washington and the United States after a few well-documented early challenges.
What is the potential advantage of home-based, self-administered sample collection vs. collection administered by a healthcare worker?
There are a couple of important advantages to this approach. It saves healthcare workers time and helps protect them from unnecessary risk of infection. Because healthcare providers are not exposed when people collect their own samples, it also reduces the need for personal protective equipment.
It also encourages people to stay at home and practice social distancing, which we know plays a critical role in reducing disease transmission and flattening the pandemic curve. That’s why we’re hopeful that this approach will work, and we’re excited that governments and public health authorities are doing everything they can to test this approach and make it ready to scale.
If it works, can this approach alleviate pressure on healthcare systems?
That’s the underlying goal of this whole effort. If we can create a reliable diagnostic system that empowers patients to administer and collect their own samples, that will spare stressed healthcare systems in the United States and around the world a lot of time, effort, and risk. It is possible that other countries could adopt this model for the current pandemic if it proves feasible. Ultimately, we hope that this approach can be applied to help healthcare systems in low- and middle-income countries enhance their capacity to serve patients. The driving goal is to create equity in healthcare access.