FDA Watch

Agency Authorizes First OTC All-in-One At-Home COVID-19 Testing Kit

Since the pandemic began, the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for more than 225 COVID-19 diagnostic tests. Among these, 25 have been cleared for home collection of samples. On Nov. 17, the agency broke new ground by clearing Lucira Health’s COVID-19 All-in-One Test Kit, the first all-in-one COVID-19 diagnostic enabling people to test themselves in their own home to receive EUA. On Dec. 15, the agency went one step further by issuing EUA for a full at-home testing kit for the virus that does not require a prescription.

The Ellume COVID-19 Home Test

The distinction of being the first went to the Ellume COVID-19 Home Test, is a rapid antigen test capable of detecting fragments of the SARS-CoV-2 virus. Although the assay is performed on samples taken from nasal swabs, it is a nasal mid-turbinate (NMT) test, which makes it less invasive than tests performed on samples taken using the much longer nasopharyngeal (NP) swabs that require a trained a health care provider to administer.

More significantly, it is an over-the-counter rather than a prescription test. Accordingly, FDA Commissioner Stephen M. Hahn, MD, hailed the approval as “a major milestone” in COVID-19 testing. “By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test, and find out their results in as little as 20 minutes,” Hahn suggests.

Costing about $30, the Ellume test kit includes a sterile nasal swab, dropper, processing fluid, and a Bluetooth-connected “Analyzer,” that pairs with an app providing step-by-step video instructions that users can upload to their smartphone. Step-by-step video instructions for taking the test are provided on the app. After the sample is analyzed, results are delivered to the user’s smartphone via Bluetooth in 15 minutes or less.

The test is pretty accurate, having correctly identified 96 percent of positive samples and 100 percent of negative samples in individuals with symptoms, according to the FDA. The test also correctly identified 91 percent of positive samples and 96 percent of negative samples in asymptomatic persons.

However, because antigen tests are generally prone to both false negative and positive results, the FDA recommends that patients who are not displaying COVID-19 symptoms treat positive results as “presumptively positive until confirmed by another test as soon as possible.” This is likely to be particularly relevant for communities with fewer infections, because false positive results can be more common when antigen tests are used in populations where there is low prevalence of COVID-19.

Here are the other key new FDA EUAs and clearances announced in December:

New FDA Emergency Use Authorizations (EUAs) & Approvals

Manufacturer(s) Product
Abbott EUA for BinaxNow COVID-19 Ag Card rapid test
Quidel EUA for QuickVue SARS Antigen test for COVID-19
MatMaCorp. EUA for MatMaCorp COVID-19 2SF Test run on firm’s Solas 8 portable nucleic acid analysis system
Acon Laboratories EUA for Aptima SARS-CoV-2/Flu RT PCR assay
Hologic Clearance for HIV-1 viral load monitoring Aptima HIV-1 Quant Dx assay, first dual-claim assay for diagnosis and viral load monitoring in U.S.
Hologic Clearance for HIV-1 viral load monitoring Aptima HIV-1 Quant Dx assay, first dual-claim assay for diagnosis and viral load monitoring in U.S.
Genetworx EUA for Genetworx Covid-19 Nasal Swab Test including self-collection kit materials
PacificDx EUA for COVID-19 Test including use with nasal swab specimens self-collected at home using RapidRona’s self-collection kit
Ellume COVID-19 Home Test, first EUA for emergency COVID-19 test that can be completed at home without a prescription
Horiba Medical Clearance for Yumizen C1200 next-generation clinical chemistry system
Applied BioCode EUA for SARS-CoV-2 Assay expanded to include use with pooled samples
Siemens Healthineers EUA for over-the-counter version of firm’s Pixel by LabCorp COVID-19 Test Home Collection Kit
LabCorp EUA for over-the-counter version of firm’s Pixel by LabCorp COVID-19 Test Home Collection Kit
Mesa Biotech 510(k) clearance and CLIA waiver for Accula Strep A molecular test
Luminostics EUA for SARS-CoV-2 assay expanded to allow use with pooled samples
BioFire Defense EUA for SARS-CoV-2 assay expanded to allow use with pooled samples
Quest EUA for RC COVID-19 +Flu RT-PCR test for use with firm’s Self-Collection Kit for COVID-19 +Flu
Quest EUA for RC SARS-CoV-2 Assay, which is performed using Roche’s authorized Cobas SARS-CoV-2 RT-PCR test, expanded to include use with pooled samples
Rheonix EUA for SARS-CoV-2 assay expanded to include use on saliva samples
CDC EUA for CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel expanded to include use with pooled samples
Innovita Biological Technology EUA for Innovita 2019-nCoV Ab Test (Colloidal Gold) serology test
Cepheid EUA for Elecsys Anti-SARS-CoV-2 S electrochemiluminescence immunoassay run on firm’s Cobas E analyzers
Roche EUA for Elecsys Anti-SARS-CoV-2 S electrochemiluminescence immunoassay run on firm’s Cobas E analyzers
Lucira Health EUA for Lucira COVID-19 All-in-One Test Kit, first fully at-home test authorized for COVID-19
GenScript Biotech EUA for cPass SARS-CoV-2 Neutralization Antibody Detection Kit, first SARS-CoV-2 neutralizing antibody test to receive EUA
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