DeWine’s “anterior naris” coronavirus test has not been approved by the FDA

CLEVELAND, OH – Governor Richard Michael DeWine desperately wants “not” to be coronavirus infected after President Donald Trump’s security team tested the potential viral assassin and refused to let them come anywhere near him.  It’s unknown how many people the viral politician infected; or how many may have died after being exposed to him.

Less than five hours later the malicious liar who claimed 100,000 Ohioans were CoVid 19 infected on March 13 accused Trump of using “unproven technology” to test him.  He wasn’t coronavirus positive but coronavirus negative.  DeWine didn’t want to be a victim of the stigma he and his ex-quack health director associated with coronavirus carriers like himself.

Viral assassin Governor Richard Michael DeWine has been spreading the coronavirus across Ohio and to others he’s interacted with in the news media. President Donald Trump’s security team turned the would be presidential assassin away from meeting the president and joining him at a Bratenahl fundraiser where he could have infected business and corporate class citizens; and officials of the Cuyahoga County Republican Party.

There are two huge issues with DeWine’s tests.  First.  The Food & Drug Administration (FDA) has not approved “any” test that’s being used to detect the coronavirus or CoVid 19.  None.  Second.  The only issuance coming from the FDA are “Emergency Use Authorizations” for unapproved tests like those DeWine and Trump are administering.  What’s interesting is how every CoVid 19 Emergency Use Authorization was removed from the FDA’s website between last week and today.   I have a practice of copying pages of information I review for stories I publish.

Pay attention.  Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved, and available alternatives.

Each of the pharmaceutical companies offering CoVid tests to the public has to submit descriptions of the drug and results to the FDA for investigation and confirmation. The FDA has not approved any CoVid test.

Right now there are 34 CoVid tests the FDA has not approved that were developed by pharmaceutical companies and universities.  Each test has an “alleged” different degree of reliability based on claims made only by the drug manufacturers the FDA has not verified.  Here’s how the federal agency describes how they measured the drug manufacturer’s claims.

“FDA has summarized the expected performance of the tests it has authorized based on the information FDA reviewed when deciding whether or not to grant these tests an Emergency Use Authorization and assuming a prevalence of 5% for PPV and NPV calculations. For tests that had multiple validation studies or where the tests showed variable performance in samples collected at different times after symptom onset, FDA experts selected the results they considered to be most representative of expected test performance.”

The problem with DeWine’s tests, if the others are like the one he took as a publicity stunt from the governor’s office, is the procedure he promoted to Ohioans is the least effective.   The most accurate sample comes from the “back” or the nasal pharynx.  The least accurate sample comes from the nostril’s entrance or “anterior naris.”  Naris is a derivative of “nuris” the latin word for “nostrils.”  The most accurate body fluid physicians should collect samples from is “sputum” and not “mucus”, or in DeWine’s case his boogers. 

The back of the nose is the most accurate site for collecting mucus to test for the coronavirus or common cold.

However, and this is big.  The test accuracy rate is based on the number of “days after illness onset (d.a.o.).”  This means that test results are the most accurate if an infected person’s sputum or mucus is tested within 14 days after the onset of the illness, or in this case their initial exposure to the coronavirus.  Since no one can know that without being tested everyday, this makes no test reliable since exposure doesn’t lead to illness in 99 percent of U.S. residents and that number of people recover without ever knowing they were infected.  Below is how the Centers for Disease Control (CDC) explains what I’ve just described in scientific language.

“Except for BALF (Bronchoalveolar lavage) , the sputum possessed the highest positive rate (74.4%~88.9%), followed by nasal swabs (53.6%~73.3%) for both severe and mild cases during the first 14 days after illness onset (d.a.o). For samples collected ≥ 15 d.a.o, sputum and nasal swabs still possessed a high positive rate ranging from 42.9%~61.1%. The positive rate of throat swabs collected ≥ 8 d.a.o was low, especially in samples from mild cases. Viral RNAs could be detected in all the lower respiratory tract of severe cases, but not the mild cases. CT scan of cases 02, 07 and 13 showed typical viral pneumonia with ground-glass opacity, while no viral RNAs were detected in first three or all the upper respiratory samples.”

For what you just read the CDC is explaining that DeWine’s “anterior naris” test begins at 53 percent accuracy within 15 days after a person is exposed to the coronavirus.  It’s “beginning” accuracy level drops to 42.9 percent for every day after the 15th day of exposure.  It stands to reason that a person who tested for the coronavirus a month after they were exposed to it would have accuracy levels far below 42.9 percent.  This literally makes every unapproved FDA test worthless.

The FDA’s brief list of 163 Emergency Use Authorizations.

DeWine had no legal authority to authorize the use of the “anterior naris” test for “everyone” on June 11th before the FDA issued its EUA on July 22nd.  By limiting its use to only those who were sick and symptomatic, the FDA and CDC were guiding physicians to concentrate on the known infected so they could study and compare the information they were gathering from the unapproved tests. When he opened the testing to everyone without the FDA and CDC’s approval, DeWine’s stupid fear-mongering azz contaminated the mutha fucking study.  It’s one of the many acts of “dereliction of duty” he engaged in as an individual exceeding the authority of the office of governor and recklessly failing to perform its duties.

Publicity-hound DeWine should have kept his law license current and continued studying the state and nation’s constitutions and laws.  There are 26 pandemic mitigating laws in Title 37 of the Revised Code of Ohio and only gives the governor a single duty.  It’s over “adulterated products” like the fentanyl he’s letting the Russian who leads Johnson & Johnson pharmaceutical named Alex Gorsky dump in Ohio.  50 million doses were sent to Cuyahoga County alone.  50 doses for each of the county’s 1 million residents.

This is the FDA cover page to a letter the agency sent to Dr. Young Wang of Jiangsu CoWin BioTech in Twin Cities, Minneapolis. He wants approval for the test they’re already marketing without it.

Click bait bloggers for the Russian-owned Cleveland.com and the state’s other so-called “mainstream” news sites have helped DeWine spread fear and panic among Ohioans for profit.  So the idea that Advance Ohio’s Russian owners,the Neuhaus family, will direct Chris Quinn to assign writers to investigate beyond DeWine’s fear-mongering words is unlikely.  Russian infiltrators have always worked with American collaborators who’ve aided them in deceiving their countrymen for money.

We already know WKYC-TV3 and the Russian Federation are represented by the same law firm of Squire, Patton & Boggs headquartered in Cleveland, Ohio.  That law firm also represents the Cuyahoga County Mayors & City Managers Association as local mayors are unwittingly being manipulated by them for the benefit of the Kremlin.  With Russian’s owning the city’s dying, 4-day-weekly daily newspaper the disinformation coming from and to this part of Ohio is rampant.

Ohioans and the General Assembly of Ohio needs to stop listening to this fucking idiot.  DeWine is not a smart man and any lazy-azzed mayor following his demented thinking instead of Title 37, as an excuse to keep any city hall closed, is a criminally-derelict, Communist-minded fucking fool who should be run out of office.

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