[82lsju]

The U.S. government has come under severe criticism for not providing nearly enough tests needed to understand the extent of spread in the population. A test kit produced and distributed by the U.S. Centers for Disease Control and Prevention (CDC) was shelved after state and local lab trying it out discovered that it contained a faulty reagent. As a result, many labs that have the capability to test themselves have not been allowed to do so.

The new recommendations focus on “high-complexity testing laboratories” that are certified under federal rules known as Clinical Laboratory Improvement Amendments. This group of facilities includes many hospital labs, like the one that epidemiologist Michael Mina works at Brigham and Women’s Hospital in Boston. “Essentially it’s opening up a clear and concise avenue for labs like the one at Brigham and Women’s,” says Mina. “It’s what I’ve been advocating for a month now.”

If these labs want to make and use their own tests, FDA says, they should send five positive and five negative samples, as determined by their protocols, to another qualified lab for confirmation. The FDA still requires labs to submit what’s known as an emergency use authorization (EUA) application to the agency. “For a reasonable period of time after validation and while they are preparing their EUA requests, FDA does not intend to object to the use of these tests for specimen testing,” the recommendations state.
...
the agency’s [the CDC's] Nancy Messonnier said new manufactured testing kits have been provided to the International Reagent Resource, a clearinghouse of sorts established by CDC. She said these kits can test 75,000 people.

https://www.sciencemag.org/news/2020/02/...nges-rules

[82lsju]

The U.S. government has come under severe criticism for not providing nearly enough tests needed to understand the extent of spread in the population. A test kit produced and distributed by the U.S. Centers for Disease Control and Prevention (CDC) was shelved after state and local lab trying it out discovered that it contained a faulty reagent. As a result, many labs that have the capability to test themselves have not been allowed to do so.

The new recommendations focus on “high-complexity testing laboratories” that are certified under federal rules known as Clinical Laboratory Improvement Amendments. This group of facilities includes many hospital labs, like the one that epidemiologist Michael Mina works at Brigham and Women’s Hospital in Boston. “Essentially it’s opening up a clear and concise avenue for labs like the one at Brigham and Women’s,” says Mina. “It’s what I’ve been advocating for a month now.”

If these labs want to make and use their own tests, FDA says, they should send five positive and five negative samples, as determined by their protocols, to another qualified lab for confirmation. The FDA still requires labs to submit what’s known as an emergency use authorization (EUA) application to the agency. “For a reasonable period of time after validation and while they are preparing their EUA requests, FDA does not intend to object to the use of these tests for specimen testing,” the recommendations state.
...
the agency’s [the CDC's] Nancy Messonnier said new manufactured testing kits have been provided to the International Reagent Resource, a clearinghouse of sorts established by CDC. She said these kits can test 75,000 people.

https://www.sciencemag.org/news/2020/02/...nges-rules