Coronavirus testing shortages in the US are spurring private companies to develop at-home kits — but the FDA is not on board (yet).
One of the biggest obstacles the US is facing in the wake of the coronavirus pandemic is a severe shortage of test kits and the supplies needed to perform the tests. Given that testing is crucial to get the people most at risk the care they need, the lack of testing and an increase in demand over supply is critical in determining how the next several weeks and months of the pandemic will play out. Adequate and accurate testing is also crucial to help stop the spread of disease since many who have been exposed can display no symptoms.
In theory, at-home testing kits seem like a solution to a desperate problem. But it’s not that simple and the tests may not be as helpful as you think — at least not yet. “This may not be as good as it sounds — collecting a proper sample from the nose or mouth takes training and shipping delays of the specimen back to the lab could impact the quality of the sample,” Dr. Edo Paz, Lead Physician at K Health and cardiologist at Heartbeat Health, a cardiology practice located in New York City tells CNET.
“There could be a high false negative rate, leading people who are actually infected to believe they are not, potentially contributing to the crisis,” says Paz.
Here’s what to know about the at-home test kits, the FDA’s stance on the kits and how to get tested if you have symptoms of COVID-19, or think you’ve been exposed to someone who is sick.
How to get tested now
The best action to take if you or someone you know is feeling sick is to call your doctor or use telemedicine services (including K Health, which is offering anyone free COVID-19 consults with doctors) first. The CDC says potential symptoms of COVID-19 are fever, cough and shortness of breath. It’s important to avoid going to a doctor’s office, urgent care or ER if you have symptoms that match the coronavirus because you can expose health care workers and those who are most at risk of getting fatally ill to the virus.
During a video or phone consultation with a doctor, they can determine if you need immediate care or testing. If a doctor decides you need to be tested, they will order a test and you can go to a drive-through testing center where a medical professional will perform the test.
Right now, the only way to be tested for the coronavirus is if a doctor evaluates your symptoms and decides that you meet enough of the criteria to get a test. You can’t simply ask for a test from your doctor — there are strict requirements in place, including that you meet set criteria and are also considered at risk for serious health complications. If you are younger than 70 and have no severe symptoms or preexisting health conditions, you will likely not be tested even if you do have the coronavirus.
The exception to this is if you have any emergency warning signs for COVID-19, which do require immediate medical attention. These can include difficulty breathing or shortness of breath, persistent pain or pressure in the chest, new confusion or inability to arouse and/or bluish lips or face. If you have time to call the hospital to tell them you are coming, try to do that so they can prepare appropriately.
At-home tests and the FDA’s stance
EverlyWell, Scanwell and Nurx announced during the week of March 16 that they would make and distribute at-home tests directly to consumers. The companies, at the time of the announcement, believed they were operating within the FDA’s Emergency Use Operation guidelines.
But on March 20, the FDA issued a warning against companies trying to get the tests directly into the hands of consumers that the tests could be “fraudulent” since they are “unauthorized.” Basically, the warning said that the FDA is working with companies and labs to develop a test that can be done at home, but at this time, there are no home tests that are authorized by the FDA.
It’s important that a trained medical professional perform the test for the most accurate and reliable results. Most companies have paused orders for the testing in the wake of the FDA warning, but EverlyWell is still making its test kits available to medical professionals only.
Amazon also announced that it’s working with the Gates Foundation to provide delivery and pickup service for at-home test kits in Seattle only. Amazon’s arrangement does not breach the FDA’s Emergency Use Operation guidelines since the test kits and samples are not transported through the regular mail, which is one factor that makes the other proposed at-home test kits potentially fraudulent.
In the UK, Sharon Peacock, director of the National Infection Service at Public Health England, told the UK parliament that they have developed finger-prick testing kits that could potentially be available for consumers to purchase from Amazon in coming weeks. But UK Chief Medical Officer Chris Whitty voiced concerns, saying the test needs more testing to validate its accuracy before it can be offered to the public.
On April 13, the FDA announced authorization for a saliva-based test kit developed by researchers at Rutgers University. According to a press release from Rutgers, saliva testing allows patients to self-collect samples at home, which helps protect healthcare professionals from being exposed to the coronavirus while performing the commonly-used swab tests, and helps reduce the demand for PPE, which is already hard to come by. Two companies, Vault Health and 1Health.io announced plans to sell the saliva tests for at-home use via supervision from a doctor through telemedicine. Even though the testing method itself is approved by the FDA Emergency Use Authorization, the FDA has not cleared the tests for use at-home.
According to the FDA’s website, its stance has not changed, even in light of the saliva test. “At this time, the FDA has not authorized any COVID-19 test for at-home testing, including self-collection of a specimen with or without the use of telemedicine. The FDA sees the public health value in expanding the availability of COVID-19 testing through safe and accurate tests that may include home collection, and we are actively working with test developers in this space.”
Potential problems with at-home COVID-19 test kits
The current COVID-19 tests employ a specific mechanism called PCR (polymerase chain reaction) to detect the virus. According to Paz, these types of samples are not that easy to collect and ship with accuracy. “PCR is a chemical process that can amplify segments of DNA. When applied to COVID-19, a positive test indicates the presence of active virus in the nose or mouth sample,” Paz says.
One of the concerns over the at-home tests is that the person collecting a sample at home may not be able to do so as accurately as a trained medical professional. However, this could be mitigated with video training or telehealth services that could allow someone to walk the patient through the test over video call in real time.
Paz’s other concern is that shipping and processing samples through the mail can impact the sample, damaging it in transit so that it’s not usable to test. But since Amazon and Seattle found a way around it, perhaps other cities can too. In the meantime, stick to following the CDC’s and your own doctor’s protocols for getting tested over trying to order an at-home test.
“While it is exciting that new options are coming available, it’s still recommended that you be evaluated by a doctor as soon as possible if you have symptoms. A doctor can help decide whether you need testing and can provide a referral for proper testing if you do,” Paz says.
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