The U.S. Food and Drug Administration on Monday authorized LabCorp's Pixel COVID-19 Test Home Collection Kit for use by any individual 18 years and older without a prescription. However, the user has to courier the samples for testing at labs and results will be informed by phone or email.
This product will be the first COVID-19 direct-to-consumer test system without any prescription and allows an individual to self-collect a nasal swab sample at home and then send it for testing to LabCorp, which will conduct the tests and inform them by a phone call from a health care provider. If the result is negative, it will be intimated via email.
But it is too late as Israeli researchers have found a way of testing the Covid-19 virus within 30 seconds. Unlike the swab sample collection method, for this test, people will have to blow into a breathalyser which will collect a sample for testing. Then, they want to use a technique called terahertz spectroscopy or isothermal test to compare and determine the Covid-19 virus. This test, once approved, is likely to make the Labcorp's Pixel outdated.
Pending Israeli testing instrument undergoing tests in India, the Pixel will be useful as it can be purchased online or in a store in the US without a prescription. The sample collection kit is likely to enable users to get information about their COVID-19 infection status that could help if self-isolation (quarantine) is appropriate and to assist with health care decisions after discussion with a health care professional, said a statement by FDA.
"This is the first kit for consumers to self-collect a nasal sample for COVID-19 in their home that does not require a prescription," said Jeff Shuren, director of FDA's Center for Devices and Radiological Health.
"While many home collection kits can be prescribed with a simple online questionnaire, this newly authorized direct-to-consumer collection kit removes that step from the process, allowing anyone to collect their sample and send it to the lab for processing," he said.
What is Pixel COVID-19 Test Home Collection Kit
Since the kit is not to provide instant results, it may fall short of expectations. Moreover, the kit available in the US requires the sample to be collected only from those aged above 18. Once the sample is received by the lab, it will take one to two days on an average to deliver results.
Further, the test does not detect antibodies or immunity as it is designed to determine active infection with the virus that causes COVID-19. The Pixel kit by LabCorp is for a molecular test, also known as a reverse polymerase chain reaction (RT-PCR) test or a nucleic acid amplification test (NAAT). This test detects the presence or absence of SARS-CoV-2, the virus that causes COVID-19.
