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Test Warning

The US Food and Drug Administration in a new report warns people against using the rapid COVID-19 test from the California-based Innova Medical Group, the Guardian reports. The test, it notes, forms the basis of the mass testing program in the UK.

The test, a lateral flow immunochromatographic assay, is designed to quickly detect viral nucleocapsid protein antigens from nasal swab samples and the company says it has 97.0 percent sensitivity and 99.9 percent specificity in detecting infected individuals, according to 360Dx. But, it adds, the FDA says the test may not perform as thought. "The FDA has significant concerns that the performance of the test has not been adequately established, presenting a risk to health," the agency says in a statement.

Additionally, the FDA says the company was selling the test in the US despite not having marketing approval, clearance, or authorization and tells healthcare providers and others to return their tests to the company or destroy them. Innova tells 360Dx that it issued a voluntary recall of certain lots of the test in April, that the FDA noted that it had taken some corrective actions, and that "none of the inspectional observations concern the performance of the test."

The Guardian notes that the tests have also faced criticism in the UK about their accuracy and ability to detect lower viral loads. It adds that the UK's Medicines and Healthcare products Regulatory Agency is scheduled to review its special authorization of the test later this month.

The Scan

Not as High as Hoped

The Associated Press says initial results from a trial of CureVac's SARS-CoV-2 vaccine suggests low effectiveness in preventing COVID-19.

Finding Freshwater DNA

A new research project plans to use eDNA sampling to analyze freshwater rivers across the world, the Guardian reports.

Rise in Payments

Kaiser Health News investigates the rise of payments made by medical device companies to surgeons that could be in violation of anti-kickback laws.

Nature Papers Present Ginkgo Biloba Genome Assembly, Collection of Polygenic Indexes, More

In Nature this week: a nearly complete Ginkgo biloba genome assembly, polygenic indexes for dozens of phenotypes, and more.