May 14, 2020 | By Rachel Sandler | Forbes.com |
“The Food and Drug Administration issued an alert Thursday warning that Abbott Laboratories’ rapid COVID-19 tests may deliver inaccurate results, a major setback for the testing system commonly used around the U.S. as the country looks to ramp up its testing capacity.
In this April 10, 2020, file image made from video, a lab technician dips a sample into the Abbott … [+]AP PHOTO/CARLOS OSORIO, FILE
KEY FACTS
The FDA said it received 15 reports indicating Abbott’s ID NOW test produced false negative results, meaning that patients were told they were not infected when they actually had the disease.
The agency is investigating whether the false negatives were a result of the types of swabs used or the material used to transport the patient’s specimen rather than a problem with Abbott’s machine.
The alert comes after multiple studies have raised questions about the test’s accuracy, including an NYU study released Wednesday, which hasn’t yet been peer reviewed, that found the company’s tests missed diagnosing up to half of known positive cases.
The test can still be used, the FDA said, but negative results may need to be confirmed with a separate molecular test.
The Wall Street Journal reported that Abbot is changing its instructions and telling healthcare providers to verify negative results with another test for patients with symptoms, possibly adding more time to the test that was lauded for producing results in under 15 minutes.
Abbott spokesman Scott Stoffel emphasized that only 15 inaccurate events were reported to the FDA out of the 1.8 million tests the company has shipped. He also pointed to additional studies showing the tests were accurate more than 90% of the time.
Abbott shares dropped 3.5% in after hours trading.
CRUCIAL QUOTE
“We are still evaluating the information about inaccurate results and are in direct communications with Abbott about this important issue. We will continue to study the data available and are working with the company to create additional mechanisms for studying the test,” said Tim Stenzel, , director of the FDA’s Office of In Vitro Diagnostics and Radiological Health.
KEY BACKGROUND
Abbot has previously said that false negatives could arise because samples were being stored in a solution instead of being put directly into the company’s testing machine, according to NPR, causing the company change its instructions in April by telling users to not use the solution. Abbott’s tests are used by the White House to test members of the administration, including President Donald Trump himself.”
Link To Full Article @ Source
“U.S. to ship millions of tests in push to reopen K-12 schools”
October 1, 2020 | By Associated Press | Honolulu Star Advertiser |
“WASHINGTON >> President Donald Trump planned to announce today that the federal government will begin distributing millions of rapid coronavirus tests to states this week and urging governors to use them to reopen schools for students in kindergarten through 12th grade.
The move to vastly expand U.S. testing comes as confirmed new COVID-19 cases remain elevated at more than 40,000 per day and experts warn of a likely surge in infections during the colder months ahead. It also comes just five weeks before the November election, with Trump facing continued criticism for his handling of the crisis.
The tests will go out to states based on their population and can be used as governors see fit, but the administration encourages states to place a priority on schools. A senior administration official with knowledge of the plans told The Associated Press that 6.5 million tests will go out this week and that a total of 100 million tests will be distributed to governors over the next several weeks.
The official spoke on the condition of anonymity so as not to get ahead of the president’s announcement.
The official said the administration is emphasizing testing in schools because it’s important to the physical, social and emotional development of students to be back in classrooms to the degree that’s possible. The Abbott Laboratories tests would allow teachers, for example, to be tested on a weekly basis, or for parents to know whether their symptomatic child has COVID-19, the official said. In some cases, states could undertake some baseline surveillance, like testing a proportion of students per week or per month to make sure that the incidence of COVID-19 is low.
The tests will come from a previously announced supply of 150 million ordered from Abbott. The company’s rapid test, the size of a credit card, is the first that does not require specialty computer equipment to process. It delivers results in about 15 minutes.
Rapid, convenient testing is considered essential to reopening the U.S. economy. But the effort has been plagued by problems since the earliest days of the outbreak.
First, the government lost pivotal weeks distributing, then correcting a flawed test developed by U.S. scientists. Then, for months private labs and hospitals struggled to ramp up testing capacity due to shortages of key supplies, including testing chemicals.”
Link To Read Full Article @ Source
August 22, 2020 | Del Bigtree’s The Highwire | Andrew Kaufman, MD
BOMBSHELL: WHO Coronavirus PCR Test Primer Sequence is Found in All Human DNA https://pieceofmindful.com/2020/04/06…
Kary Mullis quote about the PCR test: http://www.virusmyth.org/aids/hiv/jlp…
(archived link: https://archive.is/onUc7)
W.H.O PCR Test Coronavirus Primer Sequence is Found in All Human DNA (Chromosome 8)
“Dr. Reiner Fuellmich is a consumer protection trial lawyer in Germany and California. He is one of four members of the German Corona Investigative Committee. In this video he is describing how there is no legal doubt about the possibility of a class action lawsuit against those responsible for the lockdowns. From the local level all the way to the WHO and many pharma companies in between. Please take a look as he is working very hard to end the insanity and make those responsible financially liable.”
“Though the whole world relies on RT-PCR to “diagnose” Sars-Cov-2 infection, the science is clear: they are not fit for purpose”
From Torsten Engelbrecht and Konstantin Demeter
Bulgarian Pathology Association Says COVID-19 PCR Tests Are Scientifically Meaningless
“Lockdowns and hygienic measures around the world are based on numbers of cases and mortality rates created by the so-called SARS-CoV-2 RT-PCR tests used to identify “positive” patients, whereby “positive” is usually equated with “infected.”
But looking closely at the facts, the conclusion is that these PCR tests are meaningless as a diagnostic tool to determine an alleged infection by a supposedly new virus called SARS-CoV-2.”
“Faulty Coronavirus kits suspected as goat and fruit test positive in Tanzania” New York Post Link
