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Even once a test is working beautifully in the lab, it still faces an — COVID-19 testing

"Even once a test is working beautifully in the lab, it still faces an arduous journey to mass usage. The first challenge is to verify performance, because quality can vary. “It’s a Wild West out there for assay development,” says Catharina Boehme, chief executive officer of the Foundation for Innovative New Diagnostics (FIND), a non-profit group in Geneva that is collaborating with the World Health Organization and the University Hospitals of Geneva to assess hundreds of SARS-CoV-2 testing options. Most RT-PCR-based tests that FIND has evaluated perform just as well as the gold standard does, whereas antigen tests have so far fallen short of expectations, Boehme says. Another hurdle is scaling up the assays for mass production. Given this constraint, Boehme thinks it is unrealistic that all the new tests will be deployed before the end of the year — although a small number might be. But once they are available, they could work alongside the gold standard to push countries closer to the target of millions of tests per week — and prepare the world for the next pandemic."
COVID-19 testing
COVID-19 testing
COVID-19 testing
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COVID-19 testing involves analyzing samples to assess the current or past presence of SARS-CoV-2, the virus that causes COVID-19 and is responsible for the COVID-19 pandemic. The two main types of tests detect either the presence of the virus or antibodies produced in response to infection. Molecular tests for viral presence through its molecular components are used to diagnose individual cases an

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"Another way researchers are trying to bring testing to the masses is to devise assays that could be used in temporary testing facilities, drive-through testing centres and even in people’s homes. At least two teams are taking advantage of the gene-editing technology CRISPR to power such tests. For example, researchers led by Zhang have developed a coronavirus assay that can be run in a single test tube in about an hour4. But it still requires heating the sample to about 65 °C, and it’s not as sensitive as a PCR-based assay. “That’s okay, because it’s much easier to use,” Zhang says. When tested multiple times on samples from 12 people infected with coronavirus, the assay detected the virus on nearly every occasion. The test builds on an approach that Zhang co-developed in 2017, called SHERLOCK5, which relies on the ability of the CRISPR machinery to home in on specific genetic sequences. Researchers program a guide molecule to latch on to a particular stretch of the SARS-CoV-2 genome. If the guide molecule finds a match, a CRISPR enzyme generates a signal that can be detected either as a fluorescent glow or as a dark band on a paper dipstick (see ‘Cut and detect’). On 6 May, the US Food and Drug Administration (FDA) authorized a SHERLOCK coronavirus assay for emergency use. The test is made by biotechnology firm Sherlock BioSciences in Cambridge, Massachusetts (of which Zhang is a co-founder), and the company has partnered with a manufacturer to mass-produce the kits. (See also ‘Coronavirus assays assessed’.)"
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"For some US allies, the fixation on words at a time when the international order was arguably facing its greatest challenge since the second world war encapsulated the glaring absence of US leadership. And that absence was illustrated just as vividly by news coverage of planes full of medical supplies from China arriving in Italy, at a time when the US was quietly flying in half a million Italian-made diagnostic swabs for use in its own under-equipped health system and Donald Trump was on the phone to the South Korean president pressing him to send test kits."
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