First Rapid Coronavirus Test Authorized by FDA

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Lucira Health's rapid coronavirus test receives emergency use authorization by the FDA
Source: Lucira Health
  • Last week, the FDA authorized the first rapid coronavirus test for at-home testing.
  • The test, designed by Lucira Health in California, can give results within 30 minutes.
  • According to Lucira, the test will be available nationwide by early spring 2021.

In the past, the U.S. Food and Drug Administration (FDA) has approved many COVID-19 diagnostic tests, including at-home ones. However, they either require sending of samples to a lab for analysis, or collection of samples by a health professional. Lucira Health’s rapid coronavirus test allows self-testing and provides results within 30 minutes. 

While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home

Dr. Stephen M. Hahn, MD, FDA Commissioner

On 17th November, the FDA issued an emergency use authorization for the company’s all-in-one test kit. However, the at-home kit is currently for prescription use only.

Swab, Stir and Detect

The single-use device initially started off as a flu test kit but, due to the pandemic, the company decided to redesign it for the detection of the SARS-CoV-2 virus.

The user-friendly kit includes a swab, sample vial, test device, and instruction cards for the user. Users follow three simple steps and obtain results within 30 minutes.

FDA authorises Lucira Health's Rapid Coronavirus Test for at-home testing
Source: Lucira Health

The first step involves the collection of the sample. The user rotates the swab five times within each nostril. After that, the swab is stirred inside the sample vial. The vial is placed in the battery-powered test unit of the device.

Lastly, the display light then confirms whether it’s a negative or positive result.

We believe this highly mobile test can make a big difference by providing lab-quality results expeditiously and conveniently. Early, accurate detection is vital to delivering appropriate care and controlling the pandemic.

Dr. John Chou, Principal Investigator on the Lucira Health Community Testing Study 

According to the instructions provided in the kit, the nasal swab should be conducted while tilting the head backward.

The molecular diagnostic test detects the virus through a loop-mediated amplification reaction (LAMP). This method extracts the viral genetic material and amplifies it. However, it can not detect viral proteins like COVID-19 antigen tests.

Compared to PCR, the gold standard of COVID-19 testing, the molecular method has a lower accuracy. But, it is more likely to detect an active infection.

Testing Lucira’s Rapid Coronavirus Test 

The FDA has authorized the kit for home use in individuals aged 14 years and above. And, in point-of-care settings such as emergency rooms, doctor’s offices, and hospitals. However, in children younger than 14 years, a healthcare provider must collect the samples.

According to Lucira, a community-based trial found that 100% of the participants could self-administer the test. Thus, confirming the device is user-friendly. In addition, when compared to current laboratory tests, Lucira’s test correctly identified 94% of people with the virus. While correctly identifying 98% of negative results.

The test will have an expected cost of $50. According to Lucira, it will be available nationwide by early spring 2021.

Reference:

Commissioner, O. (2020, November 17). Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test for Self-Testing at Home. Retrieved November 24, 2020, from https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-covid-19-test-self-testing-home

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