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First at-home Covid test gets approval — what this means, its impact & if it’s good news

USFDA Tuesday issued an emergency use authorisation to Lucira Health Inc.’s rapid-result Covid test, the first that can be used at home. Here's all you'd like to know about it.

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Max Nisen, who covers the pharmaceutical industry for Bloomberg Opinion, answered questions about the Food and Drug Administration’s authorized on Tuesday of the first at-home testing kit for Covid-19. The conversation has been edited and condensed.

So the FDA just authorized the first Covid-19 testing kit for home use. While it sounds like a fantastic development in theory, what does it mean in practice?

Max Nisen: The test, which is made by California-based Lucira Health, is promising for a few reasons. There are other testing solutions that will send you a swab, but require you to send the sample back to a lab. This test can be done start-to-finish at home. It’s a convenient new option that should be very helpful in certain settings where you need a quick and accurate test or when labs are overwhelmed. But the broader public health impact may not be enormous. At around $50, it’s not cheap enough to provide the broad, repeated testing many public health experts are calling for. And it will only be available narrowly at first, with a national rollout expected by spring of 2021. There will only be about 50,000 to 100,000 assays available per month initially — New York routinely reports more tests in a day — and it requires a prescription from a doctor, which will limit uptake.

How hopeful are you for a cheaper at-home test that might have a broader impact?

Max Nisen: I am hopeful that this means the FDA is warming up to the idea of at-home tests. U.S. regulators have been somewhat reluctant to embrace the idea because of the possibility of human error and unreported cases. The real game changer would be broad authorization and manufacturing of rapid, easy and inexpensive at-home antigen tests that experts such as Harvard epidemiologist Michael Mina suggest could help the country get back to normal. Some of these tests could be faster and cheaper than Lucira’s. There’s been some concern that this category of test is less accurate. But the leading tests are quite good, and are very likely to detect people who are highly infectious. It’s that last feature that would help broad and frequent use contain outbreaks. The FDA may remain skeptical about those sorts of tests, however; Lucira’s test uses a molecular approach that tends to be more sensitive.

Can you dig a little deeper into the accuracy of the Lucira test? Is it as good at detecting asymptomatic cases as symptomatic cases?

Max Nisen: There’s not a ton of information on this yet. The study that validated the test detected 94% of the infections identified with a leading PCR test, which is the gold standard for molecular tests. Lucira’s test, which uses a different approach called a loop mediated amplification reaction, or LAMP, matched 98% of the negative results from the other test. I haven’t seen specific data about its performance in asymptomatic cases, and it’s only authorized for people with symptoms.

Everyone’s amazed at the recent Covid-19 vaccine breakthroughs. Is there anything similar happening on the testing side of things?

Max Nisen: It’s arguably already here in the form of rapid antigen tests that can be used at home, some of which are authorized outside the U.S. The breakthrough that’s needed is the political willingness and funding to get them into homes around the country and break as many chains of transmission as possible, even though they’re not perfect.

Do you think Operation Warp Speed would’ve been wise to aggressively target testing as well?

Max Nisen: Absolutely, you need both! The failure of Warp Speed to spend more time on testing and its choice to focus monomaniacally on vaccines has made the wait for shots much more painful than it needed to be.

Now that test-and-trace seems to be impossible to pull off in most of America, what is the primary purpose of testing?

Max Nisen: I’m not sure I agree with the premise! While it’s true that testing and tracing every case is not feasible, attempting to do so to the greatest extent possible is still arguably the best tool. We have to contain the virus short of unpopular restrictions on movement. It’s going to remain so for a long time to come, because vaccines won’t be widely available for months. Every unidentified infected individual is another opportunity for a potential superspreading event. Just because you can’t catch them all doesn’t mean you shouldn’t try to catch as many as possible.

So what’s your advice for those who were eager to add at-home testing kits to their anti-Covid arsenal but are maybe a little disappointed after digging into the Lucira news. What’s the best way for them to feel fully protected right now?

Max Nisen: Absent a much more dramatic change in the availability and use of rapid tests — I’m talking a Slovakia-style national effort with tens of millions of repeated tests — the answers are the same as they’ve been for months. Wear a mask and avoid indoor spaces when possible, especially those that are crowded and poorly ventilated. If you’re planning a big Thanksgiving gathering with out-of-state guests, reconsider it. Large swaths of the country are experiencing uncontrolled outbreaks. –Bloomberg

Also read: USFDA approves first at-home test kit for detecting Covid


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