Tags: Coronavirus | FDA | rapid COVID test

Dr. David Samadi: FDA Approves First Rapid Result Test for At-Home COVID-19 Diagnosis

a nasal swab covid test
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By    |   Wednesday, 25 November 2020 10:22 AM

The future of our nation gaining better control over coronavirus is continuing to improve. On Tuesday, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization for the first rapid result COVID-19 test that can be conducted from start to finish, in the comfort of your home.

Lucira Health, a California-based company, has developed a prescription-only COVID-19 All-in-One Test Kit for self-diagnosis providing results within 30 minutes. The test kit is approved for patients 14 and older who are suspected of having COVID-19 by their healthcare provider. This molecular single-use test is designed to detect SARS-CoV-2, the virus that causes COVID-19. The test kit is also authorized for use at doctor's offices, hospitals, urgent care centers and emergency rooms for all ages, including children under the age of 14. In these settings, the samples are required to be collected by a healthcare provider.

This is not the first COVID-19 at-home diagnostic test authorized by the FDA. Prior at-home collection tests require sample collections to be shipped to a lab for processing. However, Lucira's at-home test is the first that can be fully self-administered providing results at home without sending sample collections sent off to a lab, removing the need for an intermediary.

The actual at-home test is very user-friendly; It can be performed in about two minutes by simply swabbing the inside of both nostrils, swirling the self-collected nasal sample into a vial and then placing it in the kit's test unit. Within 30 minutes, the results will light up showing if a person is positive or negative for the virus, which is significantly faster than labs which currently take anywhere from two to seven days to generate tests results.

Whether a person tests positive or negative, federal guidelines state that healthcare providers who prescribe this test kit must report their patients' results to public health authorities. Reporting results of the tests allow better tracking of where and how fast the virus is spreading.

Anyone who tests positive for COVID-19 using Lucira's at-home test kit, are advised to self-quarantine for 10 days starting from the onset of symptoms or from the day they tested positive, which follow the guidelines from the Centers for Disease Control and Prevention. Even if a person tests negative, they should still practice safety measures such as frequent hand-washing, physical distancing and wearing a mask.

Other tests that send test samples to labs to be tested look for the coronavirus' genetic material using a technique called polymerase chain reaction or PCR. Lucira's at-home test uses a method called a loop-mediated isothermal amplification reaction, or LAMP, similar to PCR in that it repeatedly copies the virus's genetic material until it reaches detectable levels.

The CEO of Lucira Health, Erik Engelson, stated that there are two types of COVID-19 tests, antigen and molecular, used to detect whether a person is infected with the virus. The antigen test can detect viral proteins providing quick results. But they are more likely to miss active coronavirus infections. Lucira is a molecular test, which are 50 to 60 times more sensitive than antigen tests and are considered the "gold standard" for determining if a person is infected or not.

One caveat of Lucira's at-home test kit is that the accuracy rate of detecting COVID-19 was based on a small study, conducted by the company, and only included people who had symptoms of the virus and states it "has not been evaluated" in people without symptoms. But the study did find that it was able to accurately detect 94.1 percent of the infections found by a well-established PCR-based test.

Availability of Lucira's COVID-19 at-home test kit is expected to be widely available throughout the nation by early spring 2021 through healthcare providers.

The FDA granting emergency use authorization of an at-home test is an exciting move I fully support. This is a step in the right direction allowing Americans options of widespread testing outside of healthcare settings. Having results within minutes as opposed to waiting for days, improves our ability to immediately protect ourselves and others from spreading the virus.

The rapid response and impressive innovation by American biotechnology companies has been inspiring to witness. As we move forward in our fight against COVID-19, I'm cautiously optimistic we will win this battle sooner than later and regain normalcy.

Dr. David Samadi is the Director of Men's Health and Urologic Oncology at St. Francis Hospital in Long Island. He's a renowned and highly successful board certified Urologic Oncologist Expert and Robotic Surgeon in New York City, regarded as one of the leading prostate surgeons in the U.S., with a vast expertise in prostate cancer treatment and Robotic-Assisted Laparoscopic Prostatectomy. Dr. Samadi is a medical contributor to NewsMax TV and is also the author of The Ultimate MANual, Dr. Samadi's Guide to Men's Health and Wellness, available online both on Amazon and Barnes & Noble. Visit Dr. Samadi's websites at robotic oncology and prostate cancer 911. Read Dr. David Samadi's Reports – More Here.

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