EmpowerDX, a Eurofins subsidiary, just launched its direct-to-consumer COVID-19 Home Collection Kit in the U.S. through Amazon, making it one of a miniscule number of at-home and over-the-counter kits that are putting detection of the SARS-CoV-2 virus in the hands of patients.
EmpowerDX, a Eurofins subsidiary, just launched its direct-to-consumer COVID-19 Home Collection Kit in the U.S. through Amazon, making it one of a miniscule number of at-home and over-the-counter kits that are putting detection of the SARS-CoV-2 virus in the hands of patients.
Over-the-counter (OTC) COVID-19 diagnostics kits are rare. The U.S. Food & Drug Administration’s (FDA) latest report shows it has issued emergency use authorizations (EUAs) for only one OTC antigen test and one OTC molecular test. All others require prescriptions.
Specifically, of the 340 tests and sample collection devices the FDA has authorized for the SARS-CoV-2 virus, only one molecular prescription at-home test and two antigen prescription-based at-home tests have EUAs. That said, the FDA has authorized 38 molecular tests that may be used with home-collected samples.
The FDA-authorized empowerDX COVID-19 Home Collection Kit can detect nucleic acid from the SARS-CoV-2 virus in both symptomatic and asymptomatic patients, using a nasal swab for shallow sample collection. It is airline-approved for pre-flight COVID-19 tests and can be purchased without a prescription for $99 either singly or in packages of 10.
Designed for average consumers without medical training, the kit includes step-by-step instructions, a shallow nasal swab, test tube, and a pre-paid FedEx package for easy sample returns. Users need only to activate their kits at empowerdxlab.com, take the test, and send it in.
Results are delivered to the secure patient portal within 48 hours (but only Monday through Friday) after the sample is received at one of the company’s 800 CLIA-certified laboratories in more than 50 countries, including 7 in the U.S. Such broad coverage makes it easy for consumers to be tested throughout the world, even while travelling, and to social distance while avoiding the long lines and deep (and some say painful) pharyngeal sample collection common at testing centers.
The consumer’s nasal swab is analyzed using reverse transcriptase polymerase chain reaction (RT-PCR) technology to detect the presence or absence of the SARS-CoV-2 RNA, thus determining whether the user has COVID-19.
The empowerDX COVID-19 Home Collection Kit is based on the FDA-authorized SARS-CoV-2 RT-PCR assay developed by Eurofins Viracor, an infectious disease testing laboratory with more than 35 years’ experience. The company says its lab test is 100% accurate for both sensitivity and specificity, able to distinguish between the SARS-CoV-2 virus and the common corona and other respiratory viruses in the population.
That accuracy, however, is based on the analytical validation used for EUA rather than the clinical validation used for full FDA approval. Real-world specificity and sensitivity are likely to be lower.
Analytical validations use precise virus additions to negative residual clinical samples, the company explained, so does not deal with such variables as virus shedding or the quality or sample collection. As such, diagnostic tests based on analytical analysis typically report higher sensitivity and specificity outcomes that are higher than those of clinical studies.
Another kit, by Cue Health, Inc., a few days ago, became the first molecular test for COVID-19 to receive an FDA EUA for COVID 19. The Cue COVID-19 Test for Home and Over The Counter Use does not require a prescription.
This molecular test uses a smartphone and downloadable app, which provides testing instructions. The kit works with the reuseable Cue Cartridge Reader and the Cue testing cartridge, and delivers results in about 20 minutes to the patient’s smartphone.
As the FDA authorization noted, “Positive results indicate the presence of viral RNA, but clinical correlation with past medical history and other diagnostic information is necessary to determine infection status.” In clinical studies, the Cue Health test exhibited nearly 99% sensitivity and 98% specificity, and can detect as few as 20 genome copies of the virus.
There is no word yet on the cost of the Cue test or how or where it can be purchased.
The growing availability of OTC COVID-19 testing will help contain the spread of this virus by alerting symptomatic and asymptomatic people to their actual disease status. As such, it is an important step in returning to normalcy.
