FDA approves first home self-testing kit

3 minute read


The first non-lab test for COVID-19 has been approved by the US Food and Drug Administration under its Emergency Use Authorisation program.


Welcome to The Medical Republic’s COVID Catch-Up.

It’s the day’s COVID-19 news in one convenient post. Email bianca@biancanogrady.com with any tips, comments or feedback.


19 November


  • The first home self-testing kit for COVID-19 has been approved by the US Food and Drug Administration under its Emergency Use Authorisation program.
    The Lucira COVID-19 All-In-One Test Kit is a single-use test that uses a real-time loop mediated amplification reaction to detect SARS-CoV-2 RNA in a nasal swab sample, and delivers a result within 30 minutes.
    “A test that can be fully administered entirely outside of a lab or healthcare setting has always been a major priority for the FDA to address the pandemic,” said Dr Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, in a statement.
  • First it was bats, then pangolins, and now mink are getting the side-eye as a possible animal vector for zoonotic transmission of SARS-CoV-2, and the crisis has claimed not only 2.85 million minks but also political scalps.
    The Washington Post reports that Denmark’s agricultural minister has resigned after apparently unlawfully ordering the killing of the country’s entire population of 15 million farmed mink over COVID-19 fears.
    The order for the mass cull was issued two weeks ago, and it was underway as the revelation came that the government did not in fact have the authority to order the slaughter in the first place. The plan is now on hold while the government tries to get that authority solidified.
    According to a report in Emerging Infectious Diseases, SARS-CoV-2 has spread rapidly among Denmark’s farmed mink. Researchers collected samples from apparently healthy mink at farms where there had been human cases of COVID-19, and found a seroprevalence as high as 95%. Sequencing the mink viral genomes found close relationship to human SARS-CoV-2 genomes.
    “The infections we describe here occurred with little clinical disease or increase in death, making it difficult to detect the spread of infection; thus, mink farms could represent a serious, unrecognized animal reservoir for SARS-CoV-2,” the authors wrote.
  • A Sydney man has been fined more than $10,000 for selling hydrogen peroxide for ‘internal therapeutic use’ against COVID-19 on his eBay store, along with Condy’s crystals (potassium permanganate), according to the Therapeutic Goods Administration.
    Donald Trump – is that you? I mean, I know you’re stuck for cash right now, but this is a little desperate.
  • As South Australia enters into a hopefully short hard lockdown, another six cases of COVID-19 were reported yesterday. Four of these cases are connected to the so-called Parafield cluster – which now numbers 23 people – and one is being investigated.
    The ACT has recorded its first new COVID-19 case in nearly one month, in a diplomat returning from overseas. The man has been in quarantine since his arrival. New South Wales has reported seven new cases and West Australia has six, all of which are returned travellers in hotel quarantine.
    Here are the latest confirmed COVID-19 infection numbers from around Australia to 9pm Wednesday:
    National – 27,777 with 907 deaths
    ACT – 115 (1)
    NSW – 4509 (7)
    NT – 46 (0)
    QLD – 1187 (1)
    SA – 551 (6)
    TAS – 230 (0)
    VIC – 20,345 (0)
    WA – 794 (6)

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