7 COVID-19 testing updates

The U.S. has made significant strides to expand COVID-19 testing since the pandemic began, and testing remains critical to tracking the spread of the virus. But the U.S. may face another shortage of tests if there is a second wave of the coronavirus in the fall. 

Seven testing updates: 

Editor's note: This is not a comprehensive list. Updates are listed in order of most to least recent. 

  1. The FDA is cracking down on sellers of at-home COVID-19 antibody tests. The agency has issued three warning letters in the last week to sellers of at-home COVID-19 antibody tests for marketing the tests without FDA approval, MedTech Dive reported.

  2. The U.S. is at major risk of not having enough COVID-19 testing in the fall if schools and businesses reopen, Politico reported. Some experts have said that safely reopening schools and businesses could require 30 million tests per week. The U.S. is currently conducting about 3 million tests per week.

  3. The FDA has revoked emergency use authorization for Chembio Diagnostics' COVID-19 antibody tests over concerns about its accuracy, MedTech Dive reported. It was one of the first antibody tests granted emergency authorization by the FDA during the COVID-19 pandemic.

  4. The National Institutes of Health is partnering with Quest Diagnostics to test antibodies from 10,000 people to see if they've had COVID-19, MedTech Dive reported. The agency is hoping to show the prevalence of exposure to the virus in the U.S.

  5. Some diagnostic labs are charging "egregious" prices for COVID-19 tests, Aetna said. The federal government doesn't regulate the amount labs charge for the tests, and a diagnostic lab in Texas has charged insurers as much as $2,315 for the same COVID-19 test that costs $100 elsewhere.

  6. Testing labs are urging the CDC to change its guidance on antibody testing, saying the current guidelines discourage them, MedTech Dive reported. The American Clinical Laboratory Association wrote to the CDC saying employers and providers have interpreted the guidelines to mean antibody tests "have no utility in the management of individuals and populations in the workplace and congregate settings."

  7. Amazon is building testing labs at its fulfillment centers with the goal of testing most of its warehouse workers for COVID-19 every two weeks. The company is planning to develop standalone diagnostic labs at several sites, starting in Sunnyvale, Calif., and Kentucky. It has reportedly built a team of research scientists, program managers, procurement specialists and software engineers to design the labs. 

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