FDA Authorizes First Self-Diagnosis Kit for Covid-19

One of the primary strategies for combatting the novel coronavirus responsible for the 2020 pandemic is quick diagnosis. This allows for early treatment, appropriate isolation, and a better dampening of the spread of the virus.

At the onset of the pandemic, this meant only those displaying symptoms were eligible for the limited available tests. They would also have to travel to their nearest testing location to receive a professionally administered test.

As tests became more readily available, more people could be tested, including those who may have been exposed to the virus but were not displaying symptoms. This helped further blunt the spread of the virus.

To truly be most effective, though, testing needs to be available on an at-home basis. This allows potentially compromised individuals ages 14 and up to self-test and limit the number of people they expose to the virus. It also vastly increases the number of tests that can be performed since a medical worker does not have to administer every test.

Companies have been working around the clock to create a viable option for at-home testing, and recently, the FDA authorized the use of the first self-diagnosis kit for Covid-19. This is a major step toward more successfully combatting the virus!

Emergency Authorization

Under normal circumstances, new medical advancements, including testing kits, take a significant amount of time to receive approval. In fact, many drugs take approximately 15 years of development and testing to receive approval, and medical devices take an average of three to seven years.

In other words, the rate at which the self-diagnosis kit for Covid-19 was developed and approved is not just unusual, it is practically unheard of! The rapidity of this process was possible thanks to emergency authorization granted by the FDA.

Because Covid-19 has proven to be a dangerous illness and accurate, fast testing is a necessity, emergency use of the best available option, the Lucira Covid-19 All-in-One Test Kit, was quickly granted by the FDA.

How the Test Works

This molecular single-use test provides the patient with a nasal swab. The patient uses the nasal swab to collect a sample from the nasal passage, which is then inserted into a sample vial. A test unit is used to analyze the sample, and results are displayed via colored LED indicators. Each test includes detailed instructions to ensure the patient performs the test correctly.

The results of the test are available in 30 minutes, a drastic improvement from earlier professionally administered tests. With the data collected from these tests, researchers and doctors alike hope that a higher level of containment can be reached and treatment can be given in a more timely manner.