Emerging Markets

After Early Skepticism, FDA Warms to At-Home Sample Collection for COVID-19 Testing

Even before the pandemic began, concerns over the marketing of fraudulent home testing kits had been a sore spot with the FDA. So, when the agency first began to roll out its liberalized clearance scheme for COVID-19 diagnostic testing, it didn’t apply to at-home testing. However, the agency has reversed that policy and recently broke new ground by authorizing coronavirus testing by multiple labs in nasal samples collected by consumers using an at-home kit.

The Rutgers & LabCorp Assays

At-home sample collection of COVID-19 test samples offers some obvious advantages over the standard method in which a qualified health care professional armed to the teeth in personal protective equipment inserts a swab into the nostrils to access and perform a tissue scrape of the nasopharynx at the back of the nasal cavity. On April 13, the FDA granted Emergency Use Authorization (EUA) to the Rutgers Clinical Genomics Laboratory TaqPath SARS-CoV-2 Assay, version of the Thermo Fisher Scientific Applied Biosystems TaqPath COVID-19 Combo Kit modified to allow for testing on saliva samples that can be collected at home. Just over a week later, the agency gave LabCorp the go-ahead for at-home sample collection.

However, these approvals of at-home sample collection had only marginal impact on overall COVID-19 testing capacity since in each case, the EUA was limited to testing at each approvee’s respective lab. As a result, neither Rutgers nor LabCorp are authorized to ship the at-home samples collected using their kits to third party labs for analysis.

The Everlywell At-Home Collection Kit

But on May 15, the FDA went to the next level by granting EUA clearance to a kit created by Austin, Texas-based Everlywell for COVID-19 testing by separate CLIA-certified labs using assays that also received EUA clearance that same day. Specifically, the Everlywell COVID-19 Test Home Collection Kit has now been cleared for self-collection of nasal samples and subsequent analysis by Fulgent Therapeutics using the Fulgent COVID-19 by RT-PCR Test and by Assurance Scientific Laboratories using the Assurance SARS-CoV-2 Panel.

The Everlywell EUA also includes language leaving open the possibility of authorizing other high complexity-certified CLIA labs to perform testing using the Everlywell kit, “provided that the data are submitted in an EUA request that demonstrate the accuracy of each test,”  according to the agency.

 The Quest Self-Collection Kit

The next step forward came on May 28, when Quest Diagnostics announced that it had received EUA for its own kit enabling individuals to self-collect nasal specimens at home for testing with the firm’s SARS-CoV-2 RT-PCR assay. For now, Quest will distribute the kits to providers and organizations running return-to-work testing programs but says it plans to give to their patients but says it plans to eventually make them directly available to patients via its QuestDirect platform.

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