Author Topic: What Happened to Covid-19 Tests?!  (Read 1032 times)

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Online PeteS in CA

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What Happened to Covid-19 Tests?!
« on: August 29, 2020, 06:37:59 PM »
What Happened to Covid-19 Tests?!

Test development started when the CDC knew what a test had to detect, January 11th (the 12th on China's side of the International Dateline), https://www.who.int/csr/don/12-january-2020-novel-coronavirus-china/en/ . With that as the starting date the CDC started shipping its test in less than 4 weeks, not exactly a slow response. But a fateful decision had already been been made. Only the CDC-created test could be used and only processed by the CDC. If everything worked OK with the tests that began shipping on February 6th, the CDC would soon have become an awful bottleneck, though that may not have been realized in late January and early February.

But everything was not OK with those tests. Piecing together information from these articles, https://hotair.com/archives/john-s-2/2020/04/20/heres-didnt-coronavirus-testing-february/ , https://www.washingtonpost.com/investigations/contamination-at-cdc-lab-delayed-rollout-of-coronavirus-tests/2020/04/18/fd7d3824-7139-11ea-aa80-c2470c6b2034_story.html , and https://arstechnica.com/science/2020/04/cdcs-failed-coronavirus-tests-were-tainted-with-coronavirus-feds-confirm/ , when labs to whom early samples were shipped tried the tests they found the tests yielded false positives when highly purified water was tested. When this was verified and the cause investigated, it was found that there had been cross-contamination due to researchers working where the tests were being assembled not changing their lab coats when they went from one part of the lab to another, and by test components being assembled in an area shared with people handling samples containing the coronavirus.

Figuring out that the tests were defective and determining the cause consumed several weeks. Finally, at the end of February the FDA permitted use of other labs' tests that were still in the process of obtaining an Emergency Use Authorization, and then the testing ball got moving:

January 20, 2020 - First confirmed coronavirus case in the US announced; https://www.cdc.gov/media/releases/2020/p0121-novel-coronavirus-travel-case.html

January 23, 2020 - CDC sought “special emergency authorization” from FDA to allow states to use its coronavirus test; https://www.reuters.com/article/us-china-health-cdc-idUSKBN1ZM2XS

February 6, 2020 - Shipping of CDC 2019 coronavirus test kits begins; https://www.cdc.gov/media/releases/2020/p0206-coronavirus-diagnostic-test-kits.html

February 29, 2020 - Testing labs allowed to use tests whose FDA Emergency Use Authorization requests are still pending; https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-new-policy-help-expedite-availability-diagnostics

March 9, 2020 - HHS announced funding support to Hologic for the advanced development of a high-volume Covid-19 test; https://www.hhs.gov/about/news/2020/03/09/hhs-supports-development-of-first-high-throughput-covid-19-diagnostic-test.html

March 10, 2020 - Trump and VP Pence met with health insurance companies and secured commitment to waive co-pays for coronavirus testing; https://www.nbcnews.com/video/trump-pence-meet-with-insurance-executives-agree-to-waive-copays-extend-treatment-80407109506

March 13, 2020 - FDA granted emergency approval for faster coronavirus test; https://thehill.com/policy/healthcare/other/487393-fda-grants-emergency-approval-for-faster-coronavirus-test

March 13, 2020 - FDA emergency approval for Thermo-Fisher coronavirus test (within 24 hours of applying); https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-emergency-use-authorization-thermo-fisher

March 13, 2020 - Public-private partnerships allowed to open up drive-through testing collection sites; https://www.mercurynews.com/2020/03/13/in-declaring-national-emergency-trump-pledges-drive-thru-testing-greater-flexibility-for-doctors/

March 13, 2020 - FDA granted Roche AG an emergency approval for automated coronavirus testing kits; https://www.bloomberg.com/news/articles/2020-03-13/roche-gets-clearance-for-coronavirus-test-that-s-10-times-faster

March 13, 2020 - HHS announced funding support to DiaSorin Molecular and Qiagen for the development of a high-speed Covid-19 tests; https://www.hhs.gov/about/news/2020/03/13/hhs-funds-development-covid-19-diagnostic-tests.html

March 16, 2020 - FDA allowing states to authorize use of tests developed by labs in their states; https://seekingalpha.com/news/3552325-fda-to-allow-states-to-authorize-coronavirus-tests

March 18, 2020 - HHS announced funding support to Mesa Biotech for the advanced development of a high-speed point-of-care Covid-19 test; https://www.hhs.gov/about/news/2020/03/18/hhs-supports-mesa-biotech-develop-rapid-diagnostic-detect-novel-coronavirus-infections.html

March 20, 2020 - HHS, DOD, and Fedex coordinated an airlift from Copan Diagnostics in Italy of 500,000 swabs and sample kits used in the COVID-19 testing process; https://www.hhs.gov/about/news/2020/03/20/hhs-dod-coordinate-international-airlift-of-covid-19-supplies.html

April 2, 2020 - FDA issued Emergency Use Authorization for the first coronavirus antibody test, developed by Cellex; https://www.usatoday.com/story/news/2020/04/02/fda-oks-first-coronavirus-blood-test-track-immunity-test-vaccines/5116281002/

April 8, 2020 - HHS authorized pharmacists to order, administer coronavirus tests; https://www.hhs.gov/about/news/2020/04/08/hhs-statements-on-authorizing-licensed-pharmacists-to-order-and-administer-covid-19-tests.html

April 10, 2020 - Trump administration working to bring blood-based serology tests to market so Americans can determine if they have had the coronavirus; https://www.centerforhealthsecurity.org/resources/COVID-19/serology/Serology-based-tests-for-COVID-19.html

April 13, 2020 - FDA clears first saliva test to help diagnose new virus; https://abcnews.go.com/Health/wireStory/us-clears-saliva-test-diagnose-virus-70127442

April 21, 2020 - FDA has now authorized more than 50 coronavirus diagnostic tests and four antibody tests; https://abcnews.go.com/Health/wireStory/types-testing-covid-19-infections-70253488

April 21, 2020 - FDA authorized first at-home coronavirus test; https://www.cbsnews.com/news/coronavirus-test-pixel-fda-approval/

April 24, 2020 - To date, the FDA has issued 44 individual emergency use authorizations for test kit manufacturers and laboratories; https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-april-24-2020

April 27, 2020 - HHS Launches COVID-19 Uninsured Program Portal allowing health care providers who have conducted COVID-19 testing or provided treatment for uninsured individuals to submit claims for reimbursement; https://www.hhs.gov/about/news/2020/04/27/hhs-launches-covid19-uninsured-program-portal.html

April 29, 2020 - DOD will invest $75.5 million in DPA funding to increase swab production by 20 million per month starting in May; Puritan Medical Products was awarded the contract; https://www.defense.gov/Newsroom/Releases/Release/Article/2170355/dod-details-75-million-defense-production-act-title-3-puritan-contract/

May 6, 2020 - Coordinated through the DPA, Bath Iron Works finalized a contract with Puritan Medical Products to deliver 30 industrial machines to help meet demand for COVID-19 testing clinical swabs; https://www.mainebiz.biz/article/biw-signs-contract-to-build-swab-machines-for-puritan-medical-products

May 8, 2020 - To date, the FDA has issued 58 individual emergency use authorizations for test kit manufacturers and laboratories; https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-may-4-2020

May 8, 2020 - FDA issued an emergency use authorization (EUA) to Rutgers Clinical Genomics Laboratory for their COVID-19 laboratory developed test with the option of using home-collected saliva samples; https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-diagnostic-test-using-home-collection-saliva

June 1, 2020 - To date, the FDA has authorized 117 tests under EUAs, which include 101 molecular tests, 15 antibody tests, and 1 antigen test; https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-june-1-2020

June 10, 2020 - FDA issued an EUA to Illumina, Inc. for the first COVID-19 diagnostic test utilizing next generation sequence technology; https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-next-generation-sequence-test-diagnosing-covid-19

June 12, 2020 - FDA issued an EUA for Cue Health Inc.’s Cue COVID-19 Test for use at the Point of Care (sample not sent to lab); https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-june-12-2020

June 29, 2020 - FDA issued EUAs for SARS-CoV-2 molecular diagnostic tests from Inform Diagnostics, Inc. and Diagnostic Solutions Laboratory, LLC; https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-june-29-2020

June 30, 2020 - FDA issued an Emergency Use Authorization to LifeHope Labs for its molecular-based Covid-19 test; https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-june-30-2020

June 30, 2020 - To date, the FDA has authorized 157 tests under EUAs; these include 132 molecular tests, 24 antibody tests, and 1 antigen test; https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-june-30-2020

June 30, 2020 - HHS extends COVID-19 testing public-private partnership with CVS, Rite-Aid, Walgreens, Quest services at Walmart) and eTrueNorth services at Kroger, Health Mart, and Walmart); https://www.hhs.gov/about/news/2020/06/30/hhs-extends-covid-19-testing-public-private-partnership.html , https://www.hhs.gov/coronavirus/community-based-testing-sites/index.html

July 6, 2020 - FDA granted an EUA for the BD Veritor Plus System rapid, point-of-care, Covid-19 diagnostic test; https://www.hhs.gov/about/news/2020/07/06/ash-adm-brett-giroir-md-statement-on-fda-eua-approval-of-the-bd-veritor-portable.html

July 14, 2020 - HHS announced a large-scale procurement of FDA-authorized rapid point-of-care diagnostic test instruments and tests for nursing homes in COVID-19 hotspot geographic areas; https://www.hhs.gov/about/news/2020/07/14/trump-administration-announces-initiative-more-faster-covid-19-testing-nursing-homes.html

July 25, 2020 - Under the DPA, DOD in coordination with HHS signed a $7.6 million contract with Hologic, Inc. to increase domestic production of consumables for sample collection and testing for Covid-19;https://www.defense.gov/Newsroom/Releases/Release/Article/2288926/dod-hhs-award-76-million-contract-to-hologic-inc-to-expand-domestic-production/ , https://www.hhs.gov/about/news/2020/07/26/hhs-dod-invest-7-6m-hologic-expand-production-custom-sample-collection-processing-consumables-covid-19-tests.html

July 31, 2020 - To date, the FDA has currently authorized 194 tests under EUAs; these include 159 molecular tests, 33 antibody tests, and 2 antigen tests; https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-july-31-2020

August 10, 2020 - Under the DPA, DOD in support of HHS signed an agreement with BioFire Defense, LLC that will triple its Covid-19 test manufacturing capacity; https://www.defense.gov/Newsroom/Releases/Release/Article/2307721/dod-hhs-announce-dpa-title-iii-agreement-with-biofire-defense-llc-to-expand-dom/

August 13, 2020 - HHS announced combined investments of $6.5 million in Aegis Sciences Corporation and Sonic Healthcare USA to expand capacity to conduct up to 4 million additional Covid-19 tests per month; https://www.hhs.gov/about/news/2020/08/13/hhs-invests-in-diagnostic-labs-to-expand-covid-19-testing-capacity-in-the-united-states.html

August 20, 2020 - Under the DPA, HHS contracted with Becton Dickinson and Quidel Corporation through September to purchase diagnostic systems and assays for COVID-19 testing for ~14,000 nursing homes certified by the Centers for Medicare & Medicaid services; https://www.hhs.gov/about/news/2020/08/20/trump-administration-uses-defense-production-act-to-aid-our-most-vulnerable.html

August 26, 2020 - FDA issued an EUA for Abbott Laboratories' BinaxNOW COVID-19 Ag Card, which can give test results in 15 minutes on a small card and costs $5 each; https://www.fda.gov/news-events/press-announcements/covid-19-update-fda-authorizes-first-diagnostic-test-where-results-can-be-read-directly-testing-card

August 27, 2020 - The Trump administration purchased 150 million of Abbott Laboratories' newly approved BinaxNOW COVID-19 Ag Card tests; https://www.upi.com/Top_News/US/2020/08/27/Trump-administration-buys-150M-card-based-COVID-19-tests-authorized-by-FDA/6241598539001/ , https://www.hhs.gov/about/news/2020/08/27/trump-administration-will-deploy-150-million-rapid-tests-in-2020.html

August 27, 2020 - To date, the FDA has currently authorized 226 tests under EUAs, including 182 molecular tests, 40 antibody tests, and 4 antigen tests; https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-august-27-2020

Looking at it all from a level above the nutsy-boltsy details, the CDC lab in Atlanta made undergraduate-level mistakes that resulted in defective tests. This was something Trump could not have controlled or prevented, so his, "The Buck Stops Here" responsibility was to Oversee recovering from the problem. Having the FDA permit the use of tests still in the EUA process bypassed both the defective tests problem and the future problem of the CDC becoming a bottleneck in the processing of test samples.
« Last Edit: September 13, 2020, 10:11:34 AM by PeteS in CA »
Think of the Press as Democratic Operatives with Bylines and it All Makes Sense - Glenn Reynolds, Instapundit blog

Democracy is the theory that the common people know what they want, and deserve to get it good and hard. - H.L. Mencken

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Public opinion has most shallow eyes. - Euripides, "Medea"

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Online PeteS in CA

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« Last Edit: August 31, 2020, 09:24:25 AM by PeteS in CA »
Think of the Press as Democratic Operatives with Bylines and it All Makes Sense - Glenn Reynolds, Instapundit blog

Democracy is the theory that the common people know what they want, and deserve to get it good and hard. - H.L. Mencken

A government which robs Peter to pay Paul can always depend on the support of Paul. - George Bernard Shaw

Public opinion has most shallow eyes. - Euripides, "Medea"

All that is gold does not glitter,
Not all those who wander are lost; - J.R.R. Tolkien, The Fellowship of the Ring

Offline LadyLiberty

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Re: What Happened to Covid-19 Tests?!
« Reply #2 on: August 30, 2020, 02:38:51 PM »
Abbot Labs just announced a new antigen test.  $5, no testing equipment needed (like a pregnancy test). Results in 15 minutes.

Online PeteS in CA

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Re: What Happened to Covid-19 Tests?!
« Reply #3 on: August 30, 2020, 05:17:17 PM »
Abbot Labs just announced a new antigen test.  $5, no testing equipment needed (like a pregnancy test). Results in 15 minutes.

Thanks! I had that info, but lost it in the shuffle of the past couple of days' flurry of activity.
Think of the Press as Democratic Operatives with Bylines and it All Makes Sense - Glenn Reynolds, Instapundit blog

Democracy is the theory that the common people know what they want, and deserve to get it good and hard. - H.L. Mencken

A government which robs Peter to pay Paul can always depend on the support of Paul. - George Bernard Shaw

Public opinion has most shallow eyes. - Euripides, "Medea"

All that is gold does not glitter,
Not all those who wander are lost; - J.R.R. Tolkien, The Fellowship of the Ring

Online Hoodat

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Re: What Happened to Covid-19 Tests?!
« Reply #4 on: August 30, 2020, 05:25:17 PM »
Abbot Labs just announced a new antigen test.  $5, no testing equipment needed (like a pregnancy test). Results in 15 minutes.

I will be tested again on Wed.  I am so sick of the nose rape technique and am so looking forward to something better.
If a political party does not have its foundation in the determination to advance a cause that is right and that is moral, then it is not a political party; it is merely a conspiracy to seize power.

-Dwight Eisenhower-

Online PeteS in CA

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Re: What Happened to Covid-19 Tests?!
« Reply #5 on: August 30, 2020, 05:26:54 PM »
I will be tested again on Wed.  I am so sick of the nose rape technique and am so looking forward to something better.

My understanding is that the Abbott Labs test uses a nasal swab.
Think of the Press as Democratic Operatives with Bylines and it All Makes Sense - Glenn Reynolds, Instapundit blog

Democracy is the theory that the common people know what they want, and deserve to get it good and hard. - H.L. Mencken

A government which robs Peter to pay Paul can always depend on the support of Paul. - George Bernard Shaw

Public opinion has most shallow eyes. - Euripides, "Medea"

All that is gold does not glitter,
Not all those who wander are lost; - J.R.R. Tolkien, The Fellowship of the Ring

Offline Victoria33

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Re: What Happened to Covid-19 Tests?!
« Reply #6 on: August 30, 2020, 07:53:48 PM »
@PeteS in CA

Pete, talked to family members in Cardiff, Wales today.  Wales and England are pieces of the same land.

Here is a problem happening in both countries:
Young people, early twenties down through about 16, are using the internet to schedule large groups to meet at a certain spot to party - anyone can come from anyplace.  One just happened in Wales over the weekend.  Two thousand young people appeared in a scenic area and "partied" for hours.  Then they split and were gone, no way to trace.  Will COVID numbers go up in a week or two??  Two truths: Men and women will gather; where there are men and women, sex will happen.  Now we have third truth: in today's world, gathering may cause severe sickness and death.

Online Hoodat

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Re: What Happened to Covid-19 Tests?!
« Reply #7 on: August 30, 2020, 11:32:25 PM »
Now we have third truth: in today's world, gathering may cause severe sickness and death.

It may also bring them closer to herd immunity with minimal sickness and zero deaths.  The least vulnerable segment of the populations ventures to the front line and becomes a sizeable buffer protecting the rest of society.
If a political party does not have its foundation in the determination to advance a cause that is right and that is moral, then it is not a political party; it is merely a conspiracy to seize power.

-Dwight Eisenhower-