(CNN)Contamination in manufacturing the Centers for Disease Control and Prevention test for the coronavirus caused weeks of delays that slowed the US response to the pandemic, multiple health officials have told CNN, a problem that stemmed in part from the CDC not adhering to its own protocols, according to a US Food and Drug Administration spokesperson.
"CDC made its test in one of its laboratories, rather than in its manufacturing facilities," the FDA spokesperson told CNN on Saturday. "CDC did not manufacture its test consistent with its own protocol." The government has never fully explained what stalled the rollout of a crucial test needed to begin measuring the extent of the spread of Covid-19. It would take until the end of February to correct and the US continues to lack extensive testing capability even as some states prepare ease up on restriction and reopen to a degree.
Shortcomings with the tests were first noticed in late January, after the CDC sent an initial batch to 26 public health labs across the country. According to those with knowledge of what unfolded, false-positive reactions emerged at 24 of the 26 labs that first tried out the kits in advance of analyzing samples gathered from patients.
“Only two of them got it right,’’ said a senior federal scientist who reviewed the development of the kits and internal test documentation, and who concluded that the false positives were caused by contamination that occurred at the CDC.
“Either the CDC didn’t know it was a crisis or they should have pulled the plug on that faster,’’ said Paul Keim, a Northern Arizona University geneticist whose institute is testing for the virus. “They didn’t have a test that worked.”
On Jan. 17, five days after the Chinese made public the genetic sequence, Nancy Messonnier, director of CDC’s National Center for Immunization and Respiratory Diseases, said in a news briefing that agency counterparts in Japan and Thailand had already used DNA testing to detect coronavirus cases.
“We at CDC also have the ability to do that today, but we are working on a more specific diagnostic,” she added.
The tests used in Japan and Thailand had been developed by the WHO without the third component. A growing number of countries were turning to that test without difficulties.
While human-to-human spread had been confirmed in China, Messonnier said, “we continue to believe the risk of this novel coronavirus to the American public at large remains low at this time.’’
Microbiologist Xiugen Zhang runs a polymerase chain reaction (PCR) test at the Connecticut State Public Health Laboratory on March 2 in Rocky Hill, Conn. (Jessica Hill/AP)
Hired in August 2018 as director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, Stenzel was trained as both a physician and a Ph.D. microbiologist/immunologist. He had founded a molecular diagnostics lab at Duke University and, during 15 years as an industry executive, helped develop dozens of sophisticated tests, including an FDA- approved assay for detecting pancreatic cancer.
During his visit in Atlanta, Stenzel determined that the problems with the coronavirus test were caused by the CDC’s manufacturing, not the design, according to the FDA. The shortcomings with the test kits were attributable to what the FDA described as a “manufacturing issue.’’
Stenzel advised CDC officials to stop making the kits in-house.
On Feb. 28 — 47 days after the Chinese distributed the virus’s genetic sequence — Messonnier announced that “labs can start testing with existing CDC test kits.”
“They just kept doubling down on what they knew was a poor performing assay, and that has really bit us in the butt,’’ said James Lawler, a physician at the University of Nebraska Medical Center who has treated covid-19 patients.
Facts: 1. The United States is a member of the World Health Organization. 2. The W.H.O offered Germany's test kits and protocols to members. 3. Trump chose instead to order the CDC to develop his own test kits. 4. Trump refused the test kits from Germany. 5. Trump refused to approve states to use their own test kits. 6. Trump is $clear$, he wants nothing to do with the W.H.O.
Conclusion: Trump dropped the ball. You are cherry-picking the information, rather than considering the Trump fiasco as a whole. All things considered . . . Trump is one big FAIL -- to whit . . .
Contamination at CDC lab was likely cause of critical early delays in
rolling out coronavirus testing
https://www.cnn.com/2020/04/18/politics/cdc-coronavirus-testing-
contamination/index.html
(CNN)Contamination in manufacturing the Centers for Disease Control and
Prevention test for the coronavirus caused weeks of delays that slowed the
US response to the pandemic, multiple health officials have told CNN, a
problem that stemmed in part from the CDC not adhering to its own protocols, according to a US Food and Drug Administration spokesperson.
"CDC made its test in one of its laboratories, rather than in its
manufacturing facilities," the FDA spokesperson told CNN on Saturday. "CDC
did not manufacture its test consistent with its own protocol."
The government has never fully explained what stalled the rollout of a
crucial test needed to begin measuring the extent of the spread of Covid-19. It would take until the end of February to correct and the US continues to lack extensive testing capability even as some states prepare ease up on
restriction and reopen to a degree.
Contamination at CDC lab delayed rollout of coronavirus tests
https://www.washingtonpost.com/investigations/contamination-at-cdc-lab-
delayed-rollout-of-coronavirus-tests/2020/04/18/fd7d3824-7139-11ea-aa80-
c2470c6b2034_story.html
都心照不宣嘛
Shortcomings with the tests were first noticed in late January, after the
CDC sent an initial batch to 26 public health labs across the country.
According to those with knowledge of what unfolded, false-positive reactions emerged at 24 of the 26 labs that first tried out the kits in advance of
analyzing samples gathered from patients.
“Only two of them got it right,’’ said a senior federal scientist who
reviewed the development of the kits and internal test documentation, and
who concluded that the false positives were caused by contamination that
occurred at the CDC.
For reasons that have remained unexplained publicly, the CDC scientists
chose complexity over simplicity in the test’s design.
“Either the CDC didn’t know it was a crisis or they should have pulled the plug on that faster,’’ said Paul Keim, a Northern Arizona University
geneticist whose institute is testing for the virus. “They didn’t have a
test that worked.”
【 在 Justin3 (赵飞燕*采易百合*赵真*杨戬*苏明明*牡丹花�) 的大作中提到: 】
: 都心照不宣嘛
On Jan. 17, five days after the Chinese made public the genetic sequence,
Nancy Messonnier, director of CDC’s National Center for Immunization and
Respiratory Diseases, said in a news briefing that agency counterparts in
Japan and Thailand had already used DNA testing to detect coronavirus cases.
“We at CDC also have the ability to do that today, but we are working on a more specific diagnostic,” she added.
The tests used in Japan and Thailand had been developed by the WHO without
the third component. A growing number of countries were turning to that test without difficulties.
While human-to-human spread had been confirmed in China, Messonnier said, “we continue to believe the risk of this novel coronavirus to the American
public at large remains low at this time.’’
Microbiologist Xiugen Zhang runs a polymerase chain reaction (PCR) test at
the Connecticut State Public Health Laboratory on March 2 in Rocky Hill,
Conn. (Jessica Hill/AP)
https://www.ctpost.com/news/coronavirus/article/Connecticut-gets-second-
coronavirus-test-kit-from-15116828.php#photo-19142848
【 在 Justin3 (赵飞燕*采易百合*赵真*杨戬*苏明明*牡丹花�) 的大作中提到: 】
: 都心照不宣嘛
Hired in August 2018 as director of the FDA’s Office of In Vitro
Diagnostics and Radiological Health, Stenzel was trained as both a physician and a Ph.D. microbiologist/immunologist. He had founded a molecular
diagnostics lab at Duke University and, during 15 years as an industry
executive, helped develop dozens of sophisticated tests, including an FDA-
approved assay for detecting pancreatic cancer.
During his visit in Atlanta, Stenzel determined that the problems with the
coronavirus test were caused by the CDC’s manufacturing, not the design,
according to the FDA. The shortcomings with the test kits were attributable to what the FDA described as a “manufacturing issue.’’
Stenzel advised CDC officials to stop making the kits in-house.
On Feb. 28 — 47 days after the Chinese distributed the virus’s genetic
sequence — Messonnier announced that “labs can start testing with existing CDC test kits.”
“They just kept doubling down on what they knew was a poor performing assay, and that has really bit us in the butt,’’ said James Lawler, a physician at the University of Nebraska Medical Center who has treated covid-19
patients.
Facts:
1. The United States is a member of the World Health Organization.
2. The W.H.O offered Germany's test kits and protocols to members.
3. Trump chose instead to order the CDC to develop his own test kits.
4. Trump refused the test kits from Germany.
5. Trump refused to approve states to use their own test kits.
6. Trump is $clear$, he wants nothing to do with the W.H.O.
Conclusion: Trump dropped the ball. You are cherry-picking the information, rather than considering the Trump fiasco as a whole. All things considered . . . Trump is one big FAIL -- to whit . . .
Jan 17th Berlin-- test kit protocols Trump ordered the CDC not to usehttps://www.who.int/docs/default-source/coronaviruse/protocol-v2-1.pdf?
sfvrsn=a9ef618c_2
Jan. 21st- The CDC confirmed the first case -- Using a TEST KIT - see above. Trump finds out and shuts that down, insisting that the CDC develop a US
test kit.https://www.cdc.gov/media/releases/2020/p0121-novel-coronavirus-travel-case.html
Feb. 4th- CDC Ships the first faulty US created test kits to the stateshttps://www.bloomberg.com/news/articles/2020-02-04/china-will-soon-find-out-if-mass-quarantine-worked-virus-update
Feb. 28th- still no working tests to ship to the stateshttps://www.reuters.com/article/us-china-health-usa-testing/new-york-
scrambles-to-replace-u-s-governments-faulty-coronavirus-test-kits-
idUSKCN20N00J
Discussion or not-- Trump would not and did not approve of -- the use of
other test kits. It was his way or nothing.https://www.msn.com/en-us/news/us/coronavirus-testing-who-and-cdc-never-
discussed-providing-test-kits-to-the-us-global-health-agency-says/ar-
BB11lnrz
NY, waiting for approval, and waiting and waiting.https://www.axios.com/coronavirus-state-testing-fda-approval-831a1a2a-4a80-
47fa-a88b-983a81756bc3.html
https://www.bloomberg.com/news/articles/2020-02-04/china-will-soon-find-out-if-mass-quarantine-worked-virus-update
Trump supporters have a very limited capacity to understand the whole thing.
这个找得好，给加个鸡腿
帝国老了，喝水都呛到
随便一个本科生俩小时能干的活儿给搞成这样，美国丢人丢大发了。
美国这几万人死得真他妈冤枉。