Global at-home health testing and insights company, LetsGetChecked, a global at-home health testing and insights company, launched in the United States the world's first two-stage coronavirus (COVID-19) testing kit.

As a way to support the most at-risk population, and healthcare professionals, the company began production of their own Coronavirus (COVID-19) testing kits in early March. The tests, which are available now to frontline healthcare workers, are being manufactured at LetsGetChecked's state-of-the-art production facility in Dublin, Ireland, where the staff has been working around the clock. According to the company they are aiming to scale up production to 100,000 tests a day by the end of April.

The company informed that over the last five years, they have developed an end-to-end infrastructure that "supports in-home testing for a variety of important clinical indications," adding that "during this critical period, the platform is being leveraged to provide crucial testing to healthcare and frontline workers integral to the fight against the global pandemic."

The test is broken down into two parts: a rapid test which gives results within 15 minutes, followed by an oral and nasal swab which will be analyzed in LetsGetChecked's high-complexity CLIA laboratory. To ensure proper sampling for accurate results, it is designed to be administered by healthcare professionals in patients' homes and other locations where testing is required. This will allow the population to be tested in a safe place to minimize the exposure to critical care facilities.

"I don't mind saying there was a lump in my throat seeing the first 10,000 kits roll off the production line," said Peter Foley, CEO, and Founder of LetsGetChecked. "Seeing the tests being boxed-up and put on pallets in the back of UPS trucks ready for distribution to what is now the global epicenter of the pandemic, was incredibly emotional. Knowing that these tests will save lives and that we are producing tens of thousands each day, gives me hope that we will win this battle."

"We set up this company to help people by providing diagnostics and medical care in the home. We have been developing our platform for years around this core concept and have delivered hundreds of thousands of tests to patients remotely. I am absolutely committed to diverting all resources to this fight so that we can be part of the solution," he continued. "With a severe lack of testing capacity in U.S. laboratories, we have turned over our high complexity CLIA certified laboratory to screen thousands of samples per day This is critical to improving our understanding of what levels of the virus exist within the population."

The breakdown of the testing process is as follows:

Part 1 is a rapid blood test that identifies an active SARS-CoV-2 infection within 15 minutes of testing using an easy-to-read POC device, similar to a pregnancy test strip. The device detects the presence or absence of SARS-CoV-2 antibodies, proteins the body produces to fight off the viral infection, which develops several days after experiencing symptoms. The test will give individuals an immediate indication as to whether they have contracted the virus and should begin self-quarantine. Individuals will also have access to a resource page available via an iOS app or online via mobile device and desktop and can request a call from a LetsGetChecked nurse to discuss the next steps.

Part 2 involves a laboratory-based confirmation test using swab samples collected from both the throat and nasal cavity (step-by-step instructions are provided). Swabs are placed into a sealed transport buffer that kills the virus, but preserves the RNA for transport to the LetsGetChecked laboratory (return prepaid shipping labels included). Our CLIA certified lab then analyzes the sample using the gold standard for SARS-CoV-2 virus confirmation testing, Real-Time (RT) PCR.

According to the company, the two tests offer a unique and comprehensive approach to coronavirus testing, and they are also working on an Emergency Use Authorization (EUA) with the FDA, which would see people test themselves in the home. When approved, the home-testing kit will initially be available only in the U.S.

Dr. Robert Mordkin, Chief Medical Officer for LetsGetChecked said: "We are in the midst of a global pandemic, the magnitude of which we are still trying to understand. The best way to contain it is through sensible steps to stop the spread. The introduction of at-home testing will be a game-changer in the ability to detect the infection and support those healthcare workers on the frontline," adding that "LetsGetChecked's tried and tested logistics infrastructure is designed for getting at-home screening kits into the hands of patients and then back into our lab for analysis in the most efficient and safest way possible."