On Tuesday, the Food and Drug Administration conducted the first rapid, at-home coronavirus tests using Lucira’s Health’s “All-in-One” test kits. The single-use home test kit requires a doctor’s official prescription before using and expects to cost only $50 per material. The newly-crafted COVID-19 test kit was the California biotechnology corporation Lucira’s Health’s invention.
The creation of the previously mentioned test kit commenced addressing people’s concerns regarding getting tested in the United States. Several of these issues include waiting for many days to get test results and leaving quarantine to attend a medical appointment at the nearest hospital. Moreover, the “All-in-Test” Kits could help high-risk COVID-19 infected individuals to cancel any clinical or hospital visits to get tested for the virus. As of date, the coronavirus has potentially infected and killed more than 247,000 citizens residing in the United States.
The kit isn’t like the usual ones that many medical health professionals use to assess people’s susceptibility to the virus. Instead, the “All-in-One” testing kit aims to examine genetic material in a similar technique that present health officers are using for detecting COVID-19 positive results from laboratory evaluations. Home-testers can now have the ability to plug the vial into a portable, battery-operated device after mixing the prototype into a solution. Additionally, the kit uses light to generate the test results in under 30 minutes of processing. In less than 11 minutes, one could already determine a positive test outcome.
Soon, the test would then become available to both South Florida’s Cleveland Clinic and Northern California’s Sutter health patients. However, according to Lucira’s statement on Wednesday morning, the needed number of test kits would have to wait for its official lease until the early spring of 2021 due to the company’s production capacities.
Additionally, the company stated that the test’s results accurately correlated with that of the FDA’s most reliable authorized assessment tools. According to a California study of 100 people tested for the presence of COVID-19, at least 94.1% (positive) and 98% (negative) of the test results agreed with the results achieved by Lucira’s “All-in-One” testing kits. As of the present time, a clinical trial in Florida is still underway.
According to The Washington Post reporter William Wan, several kit retailers, including Costco, established ongoing sales of rapid-at-home test kits across the state. However, each testing material costs up to $130 and requires people to wait for at least two days after they mailed the samples to a laboratory. Until then, individuals can finally get their coronavirus results.
Wan also stated that the newly-constructed test kit would prove to be a great help for the upcoming winter season. He explained that with the emergence of the latest at-home-rapid test kit, people can now get tested in the comforts of their homes during the holiday season and help minimize the surge of coronavirus infections.
The Associated Press also reported that the federal agency had authorized at least over 300 coronavirus testing kits as of the latest news update. However, most of the permitted kits require the assistance of a medical expert to do a nasal swab test and aid in handling high-tech laboratory apparatus to generate test results.
Furthermore, the FDA granted the use of Lucira’s test kits for medical spots such as urgent care centers, doctor’s offices, and hospitals with their emergency powers. It requires the assistance of a health professional for patients with age ranges of 13 and below.
Despite the FDA’s authorization for Lucira’s test kits to aid in detecting traces of possible COVID-19 infections, the prerequisite to enable its full assessment is to obtain official prescriptions from medical experts to report test results from patients in accordance to the confederate, local, and state qualifications.