FDA Issues First At-Home COVID-19 Test, Done With a Saliva Sample
A drive-through COVID-19 testing sight at the Veterans Affairs Hospital in Los Angeles, California on Monday May 18, 2020. All residents of the city of Los Angeles are encouraged to get tested as the city starts phased reopening. (Maxim Elramsisy/The Corsair)
The U.S. Food and Drug Administration (FDA) issued its authorization for the first diagnostic test for Coronavirus (COVID-19) to be conducted at home. Those who have been recommended by a doctor to take the test may be examined for a qualitative finding of nucleic acid from Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2).
The discovery of certain genes from SARS-CoV-2, which causes COVID-19, can be found after a saliva sample provides the virus' genetic substance as it gets examined in a laboratory. If the virus’s genetic material is there, then the individual is positive for COVID-19.
Skander Zmerli, Santa Monica College (SMC) Director of Budget Management of Associated Students (A.S.) said, "I think it's a great alternative compared to the previous test. It means we no longer have to put health care professionals at risk for infection by performing nasopharyngeal or oropharyngeal collections through the swab test."
The Rutgers Clinical Genomics Laboratory developed the test at RUCDR Infinite Biologics, which is connected with Rutgers’ Human Genetics Institute of New Jersey. Rutgers’ RUCDR performs about 20,000 saliva tests per day, with the goal to increase that number to 50,000.
The tests have become available nationally, as people can get tested when prescribed by a physician or a telehealth provider. Vault Health is one of the online healthcare companies that is currently offering this test online. "Although it would be more ideal to have a doctor being physically present, it's better due to these uncertain times to have this virtual consultation to avoid any contamination," Zmerli said.
"I think that this is a great option for people who are afraid to leave their homes and want to have a process be as easy to administer at home as possible," said Joshua Elizondo, A.S. Student Trustee-elect. "I haven’t taken the COVID-19 active test, however, I have taken the antibody test through the LA County Research Participation Study, which was a quick and easy process - driving up, staying in car, finger prick and leaving."
According to the CEO of Vault Health Jason Feldman’s letter on the website, they have partnered with RUCDR in order to make the kit available to the public. Vault’s virtual approach to healthcare, focuses primarily on testosterone treatments available by conducting a telemedicine consultation, while the COVID-19 test is an addition to their services.
To order the COVID-19 test kit which is priced at $150, a photo ID is required, along with entering first and last name information, date of birth, a phone number, gender identification, race, and a choice if enrolled in Medicare or Medicaid. Thus, purchasing a test for someone else is prohibited. Vault is an out of network company and individuals might get reimbursed after they submit the receipt to their own insurance company, but the final decision will be made by the individual’s insurer.
"While not necessarily expensive per say, for the average American in economic hardship at this time, $150 is a lot of money," Elizondo said. "I understand that maybe this particular test, needs to cost because of the at home administration. However, in an ideal world, taking in consideration the people who cannot leave their house due to age, underlying condition; this test would also be free because it provides access to people who may not be getting it otherwise."
Forms of identification necessary to receive this test include a state issue driver’s license, a passport, or a state ID card. People who do not have a US ID are also able to get tested, as this test is available to all genders and at the age of 18 and above.
Individuals are required to be supervised virtually by a Vault healthcare provider through a Zoom video call, during the saliva sample collection. In addition, Vault highlights in their website that this is not an antibody test, but it is meant to diagnose if a person is currently infected with COVID-19 and if there is potential to infect others.
Elizondo did not express any concerns of having a healthcare provider monitor him live while taking the test, as long as he doesn't have to show his personal space and surroundings. "If anything, I would actually appreciate the live assistance because I would be paying $150 and would want to make sure it’s not going to go to waste with the test being done inaccurately, voiding my results," Elizondo said.
The results take about two to three days via email, after the sample is received by Vault’s lab. Shipment labels are provided and paid by the company. If the results return positive the individual is determined infected and may infect others, while if the results return negative, there is no infection. However, Vault’s website includes the possibility of unfounded test results.
In the case where the tests come back neither positive nor negative, they are determined inconclusive which means the results cannot be definitive and amounts to two percent of the cases, according to Vault. The accuracy of the test kit ranks at 98 percent of tests providing either a positive or a negative result according to their website.
While the testing kit is available for shipment currently to many states including California, however, it is not yet available in Alaska. Dr. Stephen M. Hahn, Commissioner of FDA tweeted that “FDA has authorized over 80 COVID-19 tests and adding more options for at-home sample collection is an important advancement in diagnostic testing during this public health emergency,” as their work for developing accurate and reliable tests continues.