The Race To Find An Accurate At-Home Test Kit

There are at at-home test kits available now - with a doctor's prescription. But doubts remain - and emphasis continues to focus, appropriately, on the word 'accurate.' JL

Mercey Livingston reports in CNET:

Medical testing companies started developing coronavirus home test kits back in March, but the FDA has been slow to authorize them. As of May 2020, there are a few kits that have the FDA's blessing for at-home testing, but you'll still need a doctor's order to get them. There are currently two types of tests available for home use: swab tests and saliva tests.Saliva tests are less invasive, less uncomfortable and pose less risk for healthcare providers. How saliva tests perform compared to nasal swabs, the research is promising.

In order to slow the spread of the coronavirus, we need widespread testing. The US has been facing a shortage of test kits and the supplies needed to perform these tests, but the advent of at-home testing is trying to address that need. The newest coronavirus home test kit was authorized by the FDA in May and only requires a saliva sample, rather than an often-uncomfortable swab test. It also eliminates the need for someone who is feeling sick to go to a testing site, which in turn means that fewer people are exposed to the virus.

Testing is crucial to slow the spread of the coronavirus because it identifies people who are carrying the virus, both those who are ill and those who aren't exhibiting any symptoms. Once people are aware that they are infected, they can take the proper measures to avoid others to prevent exposure.

Medical testing companies started developing coronavirus home test kits back in March, but the FDA has been slow to authorize them. As of May 2020, there are a few kits that have the FDA's blessing for at-home testing, but you'll still need a doctor's order to get them. 

Here's what to know about the at-home test kits, the FDA's stance and how to get tested if you have symptoms of COVID-19 or think you've been exposed. 

At-home tests available now

There are currently two types of tests available for home use: swab tests and saliva tests.

Swab tests

The Food and Drug Administration authorized first at-home test kit, Pixel by LabCorp, on April 21, 2020. The FDA worked with LabCorp to develop the test, and said it's as accurate as a sample taken by a doctor. The test is performed with a special swab enclosed in the kit that the patient uses to take a sample from the nasal passage, and then you mail your sample back to LabCorp. The test does require a doctor's order first and you can't buy it without one.

"Specifically, for tests that include home sample collection, we worked with LabCorp to ensure the data demonstrated from at-home patient sample collection is as safe and accurate as sample collection at a doctor's office, hospital or other testing site. With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home," FDA Commissioner Dr. Stephen Hahn said in a statement.

Saliva tests

The Spectrum Solutions saliva collection device used for at-home saliva tests.

Spectrum Solutions

On April 13, the FDA granted Rutgers University's RUCDR Infinite Biologics biorepository emergency authorization for a new method it developed to test saliva samples for the coronavirus. Rutgers says that saliva testing allows patients to self-collect samples at home, which helps protect health care professionals from being exposed to the coronavirus at testing sites, and helps reduce the demand for personal protective equipment, which is already hard to come by. 

Following that authorization from the FDA, two companies, Vault Health and 1Health.io, announced plans to sell the saliva tests for at-home use under supervision from a doctor through telemedicine. 

It wasn't until May 8 that the FDA authorized Rutgers Clinical Genomics Laboratory to actually start testing samples of saliva collected at home for the coronavirus, using collection kits from Spectrum Solutions. This is the first at-home diagnostic test using saliva samples, and it can only be obtained with a prescription from a doctor. The test must also be returned to the Rutgers Clinical Genomics Lab for processing.

Saliva tests are much less invasive, less uncomfortable and pose less risk for healthcare providers -- so why did it take so long to approve them? The FDA needed to make sure the samples could provide the same level of accuracy as nasal swabs. When it comes to concerns over how the saliva tests perform compared to nasal swabs, the research is promising. 

Yale Public Health researchers did a small study and found the saliva tests were as dependable -- and sometimes even more accurate -- than nasal swab tests. It's important to know this study is only preliminary and not peer-reviewed. Because of this, the findings are not considered sound until a formal peer review can be completed.

The FDA's stance on other at-home tests

As coronavirus began to spread rapidly in the US in early March, companies began developing at-home testing kits to screen for it. EverlyWell, Scanwell and Nurx all announced that they would make and distribute at-home tests directly to consumers. The companies, at the time each announced its testing kits, 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 these 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 that time, there were no home tests that are authorized by the FDA.

Most companies paused orders for the testing in the wake of the FDA warning, but EverlyWell is still making its test kits available to medical professionals.

How to get tested in person

For many people, the only way to obtain a test is with a doctor's consent. That includes people who think they have been exposed but have no symptoms. You can try to contact a testing center in your area for a test, but the availability and eligibility depends on where you live.

The best action to take if you or someone you know is feeling sick is first to call your doctor so they can determine if you have symptoms of COVID-19. If your doctor decides you need to be tested, they will order a test and you'll be able to go to a drive-through testing center to receive it. A doctor can also order an at-home test for you, which will be shipped to you. In that case, you will collect the sample and be responsible for sending it back to the lab.

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. 

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 bluish lips or face. If you are able to call the hospital to tell them you are coming, try to do that so they can prepare appropriately.