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Regulatory Focus™ > News Articles > 2020 > 5 > FDA issues EUA for saliva-based COVID-19 test, provides path for wider home sample collection

FDA issues EUA for saliva-based COVID-19 test, provides path for wider home sample collection

Posted 08 May 2020 | By Michael Mezher 

FDA issues EUA for saliva-based COVID-19 test, provides path for wider home sample collection

Credit: NIAID-Rocky Mountain Laboratories

The US Food and Drug Administration (FDA) on Friday granted the first emergency use authorization (EUA) allowing for at-home saliva sample collection for a coronavirus disease (COVID-19) diagnostic and opened the door to wider at-home sample collection.
 
EUA
 
The EUA allows Rutgers Clinical Genomics Laboratory to use its TaqPath SARS-CoV-2 Assay, which was previously covered under the umbrella EUA for laboratory developed tests (LDT) for COVID-19, to test home collected saliva samples using the Spectrum Solutions LLC SDNA-1000 saliva collection device.
 
While the test is authorized for at-home sample collection, a prescription is required, and the EUA limits testing to be performed only at Rutgers’ laboratory.
 
FDA says it issued a separate EUA authorizing the test for use with home collected saliva samples as the revised use is “beyond the scope” of the LDT umbrella EUA, which does not allow for home-based testing or at-home sample collection. (RELATED: FDA: Flexible COVID-19 testing policy doesn’t apply to at-home tests, Regulatory Focus 24 March 2020).
 
The test is the second authorized for at-home sample collection following LabCorp’s COVID-19 RT-PCR Test, which uses self-collected nasal swabs. (RELATED: FDA authorizes first COVID-19 test for at-home sample collection, Regulatory Focus 21 April 2020).
 
“Authorizing additional diagnostic tests with the option of at-home sample collection will continue to increase patient access to testing for COVID-19. This provides an additional option for the easy, safe and convenient collection of samples required for testing without traveling to a doctor’s office, hospital or testing site,” said FDA Commissioner Stephen Hahn.
 
The authorization comes two days after FDA issued an EUA to Sherlock BioSciences for its CRISPR-based test for SARS-CoV-2. FDA says the Sherlock test is the first ever authorized using CRISPR to diagnose an infectious disease.
 
Home testing and collection
 
This week, FDA updated its frequently asked questions page for SARS-CoV-2 to note that it supports the development of at-home testing and encourage test developers to reach out to the agency to discuss validating their tests for home use or home sample collection.
 
However, FDA notes there are multiple safety and reliability issues posed by home testing and sample collection, “including whether the lay user can safely and properly collect the specimen, whether the components of the specimen transport media are safe for use in the home environment (since some may be toxic), proper shipment, and adequate stability of the specimen given the time lapse between collection and testing and potential impact of shipping conditions.”
 
FDA says that some of the specimen collection issues may be addressed by having a physician watch the collection via telemedicine.
 
FDA also says that companies may leverage analytical validation data for swab stability during transport generated by Quantigen Biosciences, with support from the Bill and Melinda Gates Foundation and UnitedHealthGroup. “Quantigen Biosciences has granted a right of reference to any sponsor wishing to pursue an EUA to leverage their COVID-19 swab stability data as part of that sponsor's EUA request,” FDA says.
 
While the validation data can be used to support sample stability for foam and polyester nasal swabs shipped in a tube, either dry or in saline, FDA says it would need to see additional clinical data to authorize dry swab transport “to better understand its impact on test validity.”
 
FDA reminds sponsors that tests intended for at-home sample collection are not eligible for authorization under the umbrella EUA and adds that it is considering developing EUA templates for tests involving at-home sample collection.
 
FDA

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