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(edit) Um, I do NOT trust the CEO Berman like the SEC lawyers.
IF, IF the CEO Berman keeps what he has said in many Press Releases,
everything will be good for you.
About 3 months:
1. The CEO Berman has boasted about "unproven" test kits.
2.Berman has not completed the "FDA-mandated Testing" up to now.
You read the recent PRs on May 5, 12, 21.
Rember this:
If the DECN company can't obtain EUA from the FDA,
Berman can't sell the "Swift Kits" due to the FDA new rules.
Fortunately, the DECN company only has "demos."
You do remember this:
Unfortunately, the DECN company can't get the EUA.
(I wrote "why" yersterday.)
Has Keith Berman mentioned the "accuracy of sensitivity" before???
In the PRs?? Or on the company website??
He has not. -- Because the test kits made by the DECN company
can't prove the "high accuracy of sensitivity." --- This is the reason
why the DECN can't get the EUA.
You'd better read some papers on the SARS-COV-2 virus or antigens/
antibodies in the blood. If you don't have time, you read the posts by IPwatcher, rawman, et al.
Um, I really don't read your posts.
This is the only exception.
It should be noted that every test kit for COVID-19 requires the
ACCURACY of both 90% sensitivity and 95% specificity in order to obtain the EUA.
This is one reason why CEO Berman can't submit the Testing data to the FDA and mention the accuracy of sensitivity in the PRs and on the company's website.
Sensitivity (i.e. Positive rate) means a test kit's ability to detect antigens / antibodies to the SARS-COV-2 virus that causes COVID-19. Namely, a test's sensitivity is an ability to detect people with COVID-19.
Specificity (i.e. Negative rate) means a test's ability to determine a negative case.
Remember it is "impossible" to develop a test kit with the accuracy of 90% sensitivity from the finger prick blood with the technology used by the DECN company.
Once again, remember that the DECN CEO Berman has never mentioned the accuracy of sensitivity in any press releases and on the company website.
Why?? Because Berman can't prove the "high" accuracy of sensitivity in the finger prick blood with the DECN's test kits.
Read what CEO Berman said:
The SEC staff members are looking forward to CEO Berman
submitting the Testing data to the FDA more than you and
DECN shareholders.
Why?? That could be the most stark evidence of the CEO's falsehood
for nearly 3 months.
All tests for COVID-19 require "high accuracy" in both 90% sensitivity and 95% specificity to obtain the EUA. --- This is why Berman can't submit the Testing data to the FDA and mention the accuracy of sensitivity in the PRs and on the company's website.
If Berman had been confident in the accuracy of the "Swift kits," he would have "already" handed in the Testing data to the FDA.
Sensitivity (i.e. Positive rate) means a test kit's ability to detect antigens / antibodies to the SARS-COV-2 virus that causes COVID-19. Namely, a test's sensitivity is an ability to detect people with COVID-19.
Specificity (i.e. Negative rate) means a test's ability to determine a negative case.
It is "impossible" to develop a test kit with the accuracy of 90% sensitivity from the finger prick blood with the technology used by this company.
To sum up, Berman is in a dilema:
1. If he submits the Testing data to the FDA, all his hype and lies about the "Swift kits" will be revealed to the SEC.
2. If he doesn't submit the Testing data, the DECN stock price will plummet.
As a result, he can't make as much money as he expected by selling DECN shares.
Plus, DECN will be out of the spotlight for a long time from people with the right mindset.
Just to buy time, Berman has been making a lot of announcements but he has never told you the accuracy of sensitivity on the website.
The SEC's investigation into the DECN company & Berman will continue.
One example:
The CEO Berman can't submit the Testing data required by the FDA.
Here is a good reason:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=155804686
How can the DECN company submit the Testing data that
the accuracy of sensitivity is not high enough?
You make a lot of money, but please accept the fact:
The DECN test kits cannot get the EUA because the kits
cannot meet the FDA's standard -- accuracy of 90% sensitivity.
What did the SEC lawyers think after reading the news release
saying that the DECN company will update some of the recent data
on the COVID-19 test kits on the two websites in a few days??
Why can't Berman tell you the "accuracy of sensitivity"
even though he has spent about 50 days since he submitted the application in early April??
EUA: You should listen to this DECN shareholder.
This shareholder, JB180 tells you the truth.
Which planet have you lived on so far??
The posts by mretgnol will help,
if you own pre-lock shares.
Have a nice weekend!
Do you still want to say that in the situation that this BCIT company has been in so far???
So what can you do in this situation??
If you can't do anything for BCIT shareholders,
please don't mention the naked short selling any more.
Just wait like many other shareholders, please.
You mean the accuracy of 95% specificity??
Did you check the accuracy of sensitivity???
DECN cannot get the EUA because
neither kit has the accuracy of 90% sensitivity .
Let's forget the technique the DECN uses, and you think about "Berman"
based on all the exaggerated press relesses.
If Berman had confirmed the high sensitivity,
he wouldn't have had to drag his feet.
From May 4 to 21 yesterday, the FDA issued 23 EUAs:
-- 20 PCR tests / Molecular technology
-- 1 antigen test using swabs by Quidel ( NASDAQ: QDEL)
-- 1 Serology lgG antibody by EUROIMMUN US Inc. & PerkinElmer Inc.
EUROIMMUN US Inc. is a wholly owned subsidiary of
PerkinElmer (NYSE: PKI)
-- 1 Home collection kit using nasal swab specimens
I am also assured that DECN cannot receive EUA from the FDA.
Why? Because the DECN's test kits cannot have 90% sensitivity.
(DECN shareholders, you read the company's PRs yourself.)
To receive the EUA, the test kit MUST satisfy the accuracy of 90% of
sensitivity (i.e. positive rate) & 95% of specificity ( i.e. negative rate).
The Abbott test kits that have been controversial these days were approved
before the announcement of the FDA's new rules on May 4.
As the issues regarding the accuracy of COVID-19 tests were raised in April,
since May 4, the FDA has adhered to the new criteria for "Non-PCR" tests, which is bad newsfor the DECN company.
Knowing that my post on the DECN board was deleted by someone,
I PMed you and another moderator on the DD support group &
research team board at the same time on May 19.
The moderator explained something to me, and I was able to re-posted
my deleted post.
My premium membership here ends on June 10, but I prevented it
from automatically extending this time. Instead, I contacted UNICEF
to donate $20 more a month than before.
Have a nice day!!!
1. I've recently posted messages on the board in the hope that
even a few good people would not be deceived the CEO full of lies.
2. Even if you face a barrage of questions from BCIT shareholders,
I do hope you understand them and stay on this board as a moderator.
3. This is off-topic. So if anyone reports this posting, I'll take it this time.
In the situation where so many people lose their lives, lose jobs, and suffer,
Keith Berman has been exaggerating about the unproven kits since March 3
via so many PRs. --- This is why the SEC suspended DECN.
I aslo don't like Berman using this situation to make money for his own good.
FYI, here are some of the DECN's stock transactions:
Feb. 27, 2020: Volume- 1,351
Feb. 28, 2020: Volume- 981
March 2: Volume- 152
March 3: Volume- 180,023 -- the first PR on the COVID-19 kit on March 3
It is Keith Berman who hasn't been able to carry out what he said even though he has had enough time.
Considering all the news stories on the COVID-19 test kits, Berman is a big talker.
IF Berman had confirmed the high accuracy of the test kits, he would have published news releases before this stock was traded on the grey market on May 8.
I do think Berman has known that the test kits fall far short of the FDA standards.
The SEC lawyers and FDA researchers are not fools.
In the situation where so many people lose their lives, lose jobs, and suffer,
Keith Berman has been exaggerating about the unproven kits since March 3
via many PRs. --- This is the why the SEC suspended DECN.
I aslo don't like Berman using this situation to make money for his own good.
FYI, here are some of the DECN's stock transactions:
Feb. 27, 2020: Volume- 1,351
Feb. 28, 2020: Volume- 981
March 2: Volume- 152
March 3: Volume- 180,023 -- the first PR on the COVID-19 kit on March 3
It is Keith Berman who hasn't been able to carry out what he said
even though he has had enough time.
Considering all the news stories on the COVID-19 test kits, Berman is a big talker.
IF Berman had confirmed the high accuracy of the test kits, he would have published news releases before this stock was traded on the grey market on May 8.
I do think Berman has known that the test kits fall far short of the FDA standards.
The SEC lawyers and FDA researchers are not fools.
DECN: Berman faced "Alps on Alps."
(Apls on Alps is one of my favorite poems, written by Alexander Pope), but I meant an unexpected series of difficulties.)
As Pope said in the poem, "A little learning is dangerous thing."
The bottom line is that all Berman's plans came to nothing because of the FDA's new rules.
Until May 4, before the FDA changed its rules for COVID-19 tests, any company could sell test kits without the EUA as long as a company notified the FDA and included disclaimers.
I think if the DECN company/manufacturer submits "its lousy Testing data" on GenViro COVID-19 Swift kits," the SEC will ask the FDA for comments on the data. Why not??
The DECN company is currently under investigation by the SEC.
By "lousy testing data" I meant what Berman stated in the PRs.
Also, most importantly, such technology used by this company cannot improve the accuracy of "sensitivity" &""specificity."
DECN: Dream on!!!
No man or company is jealous of the test kits by the DECN company.
Once again, how simple, fast, and cheap DECN's GenViro COVID-19 Swift kits are,
they've haven't been proved by a "reliable laboratory on how accurate they work.
"They are simple, fast and affordable." "They work."
These words were only spoken by the CEO Berman without any "official proof."
The most important things are facts.
"DECN to Add 2nd Covid-19 Test Kit Using Antibody/Antigen Methodology as a Determination Test for Patients Who Previously Tested Positive for Covid-19"
(The title of the Press Release on March 25)
From May 4 the FDA's "new rules" (the accuracy of 90% sensitivity & 95% of specificity) do apply to ALL test kits: PCR tests (Molecular technology) and Non-PCR tests such as the DECN's two Swift kits.
The FDA issued 3 EUAs to Abbott:
March 18 (Molecular) - PCR
March 27 (Molecular) - PCR
April 26 (Serology lgG antibody only)
Abbott's three kits received the EUAs before May 4.
From May 4 to 15 the FDA granted 18 EUAs:
- 15 Molecular technology (PCR test)
- 1 Serology test on May 4
- 1 Antigen test on May 8: The FDA issued the first EUA to Quidel Corporation for a COVID-19 antigen test that quickly detect fragments of proteins found on or within the virus by testing samples collected from the nasal cavity using swabs.
(NASDAQ:QDEL -- Quidel Corporation, a major American manufacturer founded in 1979)
- 1 Home Collection Kit on May 15 by Everlywell Inc:
"For use by individuals to self-collect nasal swab specimens at home, when determined by a healthcare provider to be appropriate based on results of a COVID-19 questionnaire, and for use only with in vitro diagnostic (IVD) molecular tests for the detection of SARS-COV-2 RNA that are indicated for use with the Everlywell COVID-19 Home Collection Kit."
Thanks to Abbott, the FDA will abide by the new heightened standards, which is bad news for the DECN company.
Now, some of DECN shareholders inspire people to expect the EUA by JUNE?? Why not July, August... by the end of this year??
DECN will never get EUA from the FDA. -- I did explain the reason based on facts from the DECN's PRs and the "stricter rules" of FDA on May 4, etc.
The DECN has NEVER mentioned the accuracy of"Sensitivity" in so many press releases, which is the KEY to getting EUA from the FDA.
No matter how simple, fast, and cheap COVID-19 kits are, from May 4 no company is allowed to sell the kits that have not received EUA from the FDA.
Now, all test kits for COVID-19 must meet the FDA's criteria:
90% sensitivity & 95% specificity to obtain the EUA.
DECN announced they validated the accuracy of its kits in March.
But why hasn't the CEO Keith Berman submitted the Testing result data to the FDA yet??
If the DECN/manufacturer submits the Testing data to the FDA, it is likely that the SEC will "first" hear the FDA's end result; the DECN is currently "under investigation" by the SEC.
If I had developed such proud test kits for COVID-19, I would have already turned in the Testing Data in April and received the EUA.
"GenViro COVID-19 Switf Kits" by DECN & PharmaTech Solutions, Inc. can't get the EUA.
The COVID-19 Kits by DECN & PharmaTech Solutions, Inc. can't save people's lives.
Here is the reason for that:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=155682472
Hundreds of companies developing test kits for COVID-19 have stressed that
their products are accurate and work like.
Once again, the FDA does not grant EUA to "GenViro COVID-19 swift kits" because they are cheap.
The SEC is waiting for proof of the GenViro swift kits with perfect technology of the DECN company.
DECN PRs vs SEC & FINRA ....... and the EUA
"DECN to Add 2nd Covid-19 Test Kit Using Antibody/Antigen Methodology as a Determination Test for Patients Who Previously Tested Positive for Covid-19"
(The title of the Press Release on March 25)
Monday May 4:The FDA announced manufacturers of antibody tests MUST now apply for EUA within 10 business days after their products hit the market. If a test does not meet the FDA's 95% of specificity and the accuracy of 90% sensitivity criteria, its manufacturer must suspend distribution.
In other words, from May 4 the "new standards" (the accuracy of 90% sensitivity & 95% of specificity) do apply to ALL test kits: PCR tests (Molecular technology) and Non-PCR tests such as the DECN's two Swift kits.
The FDA issued 3 EUAs to ABBOTT:
March 18 (Molecular) - PCR
March 27 (Molecular) - PCR
April 26 (Serology lgG antibody only)
ABBOTT's three kits received the EUAs before May 4.
From May 4 to 15 the FDA granted 18 EUAs:
-- 15 Molecular technology (PCR test)
-- 1 Serology test on May 4
-- 1 Antigen test on May 8: The FDA issued the first EUA to Quidel Corporation for a COVID-19 antigen test that quickly detect fragments of proteins found on or within the virus by testing samples collected from the nasal cavity using swabs.
(NASDAQ:QDEL -- Quidel Corporation, a major American manufacturer founded in 1979)
-- 1 Home Collection Kit on May 15 by Evrlywell Inc:
"For use by individuals to self-collect nasal swab specimens at home, when determined by a healthcare provider to be appropriate based on results of a COVID-19 questionnaire, and for use only with in vitro diagnostic (IVD) molecular tests for the detection of SARS-COV-2 RNA that are indicated for use with the Everlywell COVID-19 Home Collection Kit."
Thanks to, Abbott, the FDA will abide by the new heightened standards, which is BAD news for the DECN company.
Now, some of DECN shareholders inspire people to expect the EUA by JUNE?? Why not July, August... by the end of this year??
DECN will never get EUA from the FDA. I did explain the reason based on facts from the DECN's PRs and the stricter rules of FDA on May 4, etc.
The DECN has NEVER mentioned the accuracy of "Sensitivity" in so many press releases, which is the KEY to getting EUA from the FDA.
That is why the FDA has been heavily criticized for allowing at least 160 antibody tests to be marketed by health experts and members of Congress.
On May 4, the FDA announced manufacturers of antibody tests MUST now apply for EUA within 10 business days after their products hit the market. If a test does not meet the FDA's 95% of specificity and the accuracy of 90% sensitivity criteria, its manufacturer must suspend distribution.
Then I bet DECN's test kits will show less than 30% Sensitivity.
The DECN company will not get the EUA.
The FDA has not issued EUA to any company that does not meet the standards: 90% Sensitivity & more than 95% Specificity.
DECN: Ignorance is nothing to boast of.
Prestigious institutes, big pharmaceutical companies and well-known companies that have been devoted to the development of blood diagnostic biosensors have obtained EUA from the FDA because of "very high accuracy."
The FDA issues EUA to a company that meets the following criteria:
90% Sensitivity & more than 95% Specificity
For instance, the FDA granted the EUA to Roche which proved
100% Sensitivity & 99.8% Specificity of its antibody kit.
Before submitting an application for EUA, every company finishes testing with many samples. So they do know the accuracy of their kits: both sensitivity & specificity.
Before submitting an application to the FDA, Roche had announced that its antibody test had more than 99% accuracy.
The DECN company has bragged about "Specificity" in the PR, but never mentioned "sensitivity."
If the DECN company had confirmed the kits' "high sensitivity" and had confidence, Berman would have published a news release every other day and had already handed in Testing result data in April.
The CEO/CFO will turn in Testing data to the FDA, but you do not expect the EUA.
1. The first kit called 'GenViro screening swift kit' can't prove 90% sensitivity. In other words, the kit made using such technology does not work. Berman has never mentioned its sensitivity either.
Berman must have thought at least he shouldn't lie about its "Sensitivity."
2. The second kit for at-home use is worse than the first kit, but there is not much difference between the first kit and second one. Both are xxxxxx Why??
The answer is in the PR: ...."with minor changes"
(You find the PR and read it yourself.)
I was speechless because of the PR yesterday.
What? CBS validated the test kits???
Berman seems to be out of his mind.
The worst wheel of the cart always creaks most.
Have a nice day!
In the post linked below, I wrote about the facts about the CBS local news on May 5.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=155515137
The CEO/CFO of DECN has been questioned by the SEC since March.
Nevertheless, he continued to publish news releases until the very day before the stock was suspended on Friday April 24. --- 13 PRs!
Thursday April 23: PR at 10:20 am
The stock started at 0.38.
It rose to 0.497.
It was closed 0.21 something.
(Thanks, Zarw)
Who has been extravagantly promoting this DECN??
Tuesday May 5: Berman even advertised unproven antibody test kits on the the CBS local news.
It was full of exaggerations (e.g. EUA, game changer, etc) and the insubstantial content (e.g. price, FEMA, large companies, numbers of kits to be produed in the future, etc).
And now?
PRs published by the DECN company & Revised FDA Rules on May 4 -- You read my previous posts on the amended Rules.
And some scientific knowledge.
The DECN company has to wait at least until May 22 to see the end result from the FDA.
---If the company manages to submit the Testing result data to the FDA by this Friday.
However, it is highly unlikely that this company will get EUA from the FDA .
Thanks! And.....
Even if the company submits the TESTING data/result to the FDA by next week (May 15), you have to wait another 7 to 10 days to get the end result from the FDA. --- At least until May 22 or 25.
There is no gurantee that the FDA will grant the EUA around May 22.
I think the DECN company has little chance of receiving the EUA.
(I posted the reason why this company will not get the EUA in the previous post today.
The unknown small Korean company called The BIO Limited Corporation and this company (DECN) have not produced antibody tests yet.
The two antibody tests shown on the local news on May 5 are demos, not for sale.
As long as a company notified the FDA and included disclaimers. any companies could sell antibody tests for COVID-19 without EUA from the FDA until May 3 when the FDA changed its rules.
IF they had made antibody tests in April, Berman would not have thought of applying for the FDA EUA. --- Without the EUA, he could have exported them to Europe.
Why waste his time knowing that the company (DECN) won't get the EUA?
In my opinion, in order to buy time, the CEO/CFO Keith Berman of DECN came up with the idea of obtaining the FDA EUA. It takes time to get the approval.
Once again, considering the CEO/CFO's problems with the SEC in the past and 13 press releases and the local news om May 5, Berman seems to have planned to make a lot of money by hype and false information, buying time to sell the company shares.
If the DECN company has the "perfect technology" as written in the PR, , it will receive EUA from the FDA within 7 days. -- The FDA did grant EUA for an antibody test to a company within 3 days.
Even if Keith Berman does not get the EUA from the FDA, he has nothing to lose. He has only the money left to sell his company shares.
No FDA EUA and .....
The following is the post I wrote on the DD board on May 6 (Post #171998):
DECN: As of May 4th, the FED enacted stricter rules for antibody tests thanks to members of Congress.
Decision Diagnostics corporation has more than 70 daysfrom March to the next week, maybe Friday May 15 when the testing requested by the FDA is completed.
1manband, sorry... I was mistaken.
Correction in the last part: (Post# 171998)
PR on April 7
News on May 5
.
.
Have a great day!!!
PS. I read your post a short time ago.
1manband and other iHubbers/iHubers, could you please report the Task Force team or the SEC about DECN? I haven't reported these agencies.
If yes, I'd like you to include my 2 posts on DECN: Post #171350 & #171998
In reality, the CEO/CFO has no patents. It is said the company bought old useless patents. --- Jhonny C and IPwatcher on the DECN mentioned the patents. One of them does know about Keith Berman very well for a long time. -- Keith Berman did have problems with the SEC before.
DECN: As of May 4th, the FED enacted stricter rules for antibody tests thanks to members of Congress.
Decision Diagnostics corporation has more than 70 daysfrom March to the next week, maybe Friday May 15 when the testing requested by the FDA is completed.
[t][/t]
DECN: Deceptive and Deceitful
After watching the New York CBS local news linked below, I really understood why a poster has called Keith Berman (DECN) a liar and fraud.
According to the poster who has known Berman for a long time, the CEO's history of running the company (DECN) is full of lies and deception.
May 5 at 3:44 pm
https://newyork.cbslocal.com/2020/05/05/coronavirus-covid-19-decision-diagnostics-testing/?_gl=1
The news reminds me of these proverbs, "The empty vessels make the most sound", "Don't count your chickens before they hatch".
I have to do something else right now. I will post tomorrow morning why the CEO/CFO Keith Berman is a very bad person.
I guess all the CEO wants is to buy time to sell off his stock. --- He has to prevent the company's stock price from plummeting this Friday.
The shareholders on the DECN board are excited and in a festive mood
because of the local news which means nothing. -- Even a broken clock is right twice a day.
FYI, the company (DECN) does not file with the SEC.
Have a good night!
I hope you, Mike and all the other BCIT shareholders stay healthy.
Have a nice day!!!
A moderator on the DECN board said to a basher: "None of the internal happenings makes a bit of difference to traders. The share price running is all anyone is concerned with."
I think this is the immutable truth in the OTC stock world.
I rarely visit stock boards, but I happened to visit the DECN board. Now, about three times a week since then. To put up with the hypothetical CEO is ........ I thought of this after reading the press releases.
In early April the company (DECN) filed its EUA application for a antibody test kit named 'Genviro COVID-19 Swift kit' used in professionally administered settings; results will be available in about 15 sconds using a finger prick sample.
They announced that as soon as they get the EUA from the FDA,the Genviro Swift test kit strip will go into production.
The CEO has made 12 press releases with certainty. He even boasted a high accuracy rate of the test kit for COVID-19. They use an odd diagnostic technique not validated by experts in the field. --- No matter how hard Mr. President has urged the FDA to relax the rules owing to the urgency of the situation, they should not do things that do more harm than good.
In the Tuesday April 21st PR, the CEO of DECN stated "Our Genviro COVID-19 test kit is currently in the FDA EUA review process. Our sister product, Genviro at-home use kit is now in the process of completing our FDA EUA application." -- Also he mentioned he would release another PR on Thursday April 23.
The CEO of DECN is deceiving shareholders.
The FDA has NOT granted the EUA for any 'at-home-finger prick blood test kit' for COVID-19 so far because of an accuracy issue.
Even though the CEO is well aware of the fact that the FDA will NOT approve the EUA for 'home-test kits', he re-released such absurd news this Tuesday. After submitting the application for 'at-home use kit, two more PRs will be released as usual. --- Maybe in order to buy time to sell off the over 50million shares he issued in March. According to a poster, the CEO said to him, "I am not issuing any new shares." Sounds like Greg Rotman (VYST).
Feb. 27, 2020: Volume- 1,351 / Closing price- 0.0175
Feb. 28, 2020: Volume- 981
March 2: Volume- 152
From March 3 to this Tuesday April 21, the CEO published 12 PRs on plans for antibody test kits for COVID-19.
March 3: Volume- 180,023 / Closing price- 0.0313
March 4, 3/11, 3/16, 3/17, 3/18, 3/20, 3/23, 3/25,
April 6, 4/7, 4/21 & Today 4/23
NB: The stock prices fell for two consecutive days because of the uncertainty, the anxiety about not getting the EUA approval.
So the CEO released insubstantial news again on Tuesday.
The initial immune response is characterized by the appearance of neutralizing antibodies of the lgM class. -- (lg is an abbreviation for immunoglobulin.) lgM antibodies appear earlier and decline more rapidly than lgG antibodies. Antibody tests, lgM tests are widely used for the diagnosis of acute infections. Can you still say that a 'Home test kit' using a finger prick is reliable?
Considering the CEO of DECN uses the odd diagnostic test for COVID-19, there is a possibility that the company will make "crappy" antibody test kits without the EUA from the FDA and sell them to poor countries. --- European countries will no longer be deceived.
Around 70 COVID-19 antibody tests had been developed in March all over the world. Now?? Even more.
Here is an example of error-prone antibody test kits: The British government imported 3.5 million antibody test kits, but they did not work, so they requested a refund.
https://www.theguardian.com/world/2020/apr/09/uk-government-urged-to-abandon-poor-finger-prick-antibody-tests-coronavirus
I think the CEO of DECN is really bad. To be honest with you, I hope ihub people make a lot money. Don't listen to the male cheerleaders, though.
Have a nice day!
An antibody test known as a serology test misses early infections of COVID-19, so that the results can be wrong.
However, I think antibody testing is useful for people who have recovered from COVID-19.
SARS-COV-2 causes COVID-19. When the novel coronavirus invades the body, the immune system produces different antibodies. The problem is that SARS-COV-2 has acquired mutations capable of substantially changing the pathogen. -- About 4,300 mutations worldwide so far. I think this will make it harder to develop treatments and vaccines for COVID-19.
Negative as it may sound, it is said that COVID-19 will "restart" this late fall with the flu.
An individual's immune status is different. If you have underlying diseases such as high blood pressure, diabetes, bronchial diseases, etc, you should be especially careful.
Viruses enter through the eyes, nose or mouth,so do not touch your face with your hands. Let's wash our hands well. Wear a face mask outside for me and others even if it is uncomfortable.
--- There are many people who are asymptomatic.
I expect effective treatments to be developed sooner or later.
I think the Nobel Prize in Medicine should go to those who have contributed the most to developing great vaccines.
A blood test for COVID-19 antibodies
I hope some shareholders do not exaggerate that the companies (OTC- Stocks) are developing a great blood test kit for COVID-19.
Making that kind of test kit does not take a lot of time; the test kit is not that much complicated, according to the experts in the field.
I wonder how people can believe the OTC-Stock CEO saying they are going to make it by the summer. Does he make a "groundbreaking" test kit for COVID-19?? I even doubt he has a U.S. manufacturer in South Korea.
Many companies in Asian countries had already developed blood test kits for COVID-19 in early March.
However, the governments in Asia have not allowed to sell them in the country due to the question of accuracy. Some "small companies" have still made the blood test kits to export to other countries. - This is a golden opportunity for them.
What is important is that blood tests for COVID-19 antibodies are not accurate enough compared to RT-PCR testing. --- This is a proven fact.
Since this novel virus is so contagious and paralyzes everything, the governments of the US, the UK, etc appeared to allow blood tests kits for COVID-19 in haste. I am afraid that test errors will keep people spreading COVID-19. I do hope reliable U.S. companies continue to develop 'Rapid' PCR test kits.
Due to an enormous economic downturn, it seems that the White House inevitably urged the the approval of "blood test kits" for COVID-19.
(ABC news on April 8)
"Could a simple blood test for COVID-19 antibodies help reopen the economy? "
Commercial labs are scrambling to develop and distribute serologic tests.
https://www.abcnews.go.com/Politics/simple-blood-test-covid-19-antibodies-reopen-economy/strong?id=
With a White House increasingly anxious to get the economy in gear and an approved vaccine for the novel coronavirus still months away at best, public health officials are hoping that tens of millions of Americans will have access to a simple blood test that can identify recovered patients who've developed some kind of immune response to the virus.
The idea behind the push is that people who have been exposed to the virus form antibodies in their bloodstream that may help them to fight off another infection. The hope is that the body's antibodies against COVID-19 can diminish the chances of re-infection. Theoretically, those found to have immunized antibodies could then return to work and help reignite the economy.
Commercial labs are scrambling to develop and distribute serologic tests, as they are known, in large quantities -- and the federal government is doing its best to expedite an approval process that is, under normal circumstances, lengthy and cumbersome.
Adm. Brett Giroir, tapped by President Donald Trump to lead testing efforts, said he is "very optimistic" that tens of millions of the tests will be available by May. And he says it could dramatically change what we know about the scope of infection inside the United States.
"That's really important as we think about re-opening the country and the economy because if you've had the virus and you've had an immune response to it, in all probability you are immune and safe from the virus," Giroir said on ABC's "Good Morning America" on Monday.
Others remain skeptical. Dr. Scott Gottlieb, the former head of U.S. Food and Drug Administration under President Trump, told ABC News he does not view the antibody test as a game-changer in the effort to reopen the economy. In reality, he said, relatively few people have been exposed to the virus.
"I think there's a perception that when we test the larger, general population that there's a lot of people out there who were exposed and have immunity," Gottlieb said. "But I think when we do these tests, we'll see it's actually much smaller."
Others on the White House coronavirus task force have put faith in antibodies as a way to reverse course in quick order. Dr. Anthony Fauci, director of the National Institute of Allergies and Infectious Diseases, has said he is "willing to bet anything that people who recover are really protected against reinfection," and Dr. Deborah Birx, the White House task force coordinator, said she has "called on every university and every state to develop [antibody test capabilities]."
<Testing troubles from the start>
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Now, health officials are urging Americans to reserve diagnostic tests for the active virus – a nasal swab – for health care workers and patients in hospitals.
In March the FDA allowed developers of the antibody test to market their antibody tests without FDA review as long as certain conditions were met.
"The important thing is for the people who have this test -- and I stress that some companies are developing them, and they're also being found in academic centers -- to work with the FDA so that this test can be done very rapidly," Casadevall said.
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(CNN April, 2, 2020) -If interested, read the rest in the news
https://www.cnn.com/2020/0402/health/fda-coronavirus-antobody-test-authorization/index.html
The US Food and Drug Administration has issued its first emergency use authorization for a coronavirus test that looks for antibodies in the blood.
That type of test, called a serology test, would be able to identify past coronavirus infections, although it may be less effective at identifying recent ones. -- By recent ones, they mean COVID-19 infections.
Because antibodies can take time to develop, the FDA has previously warned against using antibody tests to definitively diagnose coronavirus.
But in issuing what is known as an Emergency Use Authorization for the new test, the FDA signaled that the benefits of using the new blood test outweighed the risks.
"Based on the totality of scientific evidence available to FDA, it is reasonable to believe that your product may be effective in diagnosing COVID-19," said the agency, adding that "the known and potential benefits of your product when used for diagnosing COVID-19, outweigh the known and potential risks of your product."
Unlike most coronavirus tests, which generally require a swab and look for signs of the virus itself, antibody tests look instead for our body's response to a virus.
The FDA said in its letter that initial antibodies against coronavirus are "generally detectable in blood several days after initial infection," but the agency cautioned that "levels over the course of infection are not well characterized."
The US Centers for Disease Control and Prevention says it is also working to develop a serology test -- or blood test -- that could look for antibodies, which would develop even in people with mild or no symptoms.
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Have a nice day!
PS: A Chinese company that has been selling 'COVID-19 Home diagnostic kits' was caught by the LA prosecution on April 6th. They made false advertising that their products were approved by the FDA.
So sorry... A small screen... I've never used my computer when I visit iHub.
-the same
- the Department of Health and Welfare
- An 'Antibody' is an immune-related protein that is made in the body by stimulation of an antigen and binds the antigen to activate the antigen.
- Since a number of samples are sent to the labs and generate tens of thousands of tests results at research institutions.
- The experts in other countries like Germany, the UK, China, S. Korea, Taiwan, etc as well as the U.S. have recognized the accuracy of the RT-PCR / PCR testing , not Non-PCR testing using antibodies or antigens.
Have a nice day!
COVID-19 Testing: Beware of the companies (OTC Stocks) saying that we are working on the Rapid test kits, or we have already made them and are waiting for "emergency authorization" from the FDA.
https://www.nytimes.com/aponline/2020/04/05/health/bc-us-med-virus-outbreak-testing.html
On April 5, U.S. regulators says "Home testing for the new coronavirus may sound like a good idea, but it's still TOO RISKY."
RC-PCR testing (Real Time Polymerase Chain Reaction): genetic methods
In the case of RT-PCR tests, nucleic acid (RNA) is extracted from a patient's sample and reacted with a reagent exclusive for COVID-19.
This reagent serves to amplify by attaching to a specific gene of the virus called SAR-CoV-2. SAR-CoV-2 genes cause COVID-19. When the sample combined with the reagent is replaced in the PCR equipment, the temperature is raised and lowered repeatedly, and a
specific gene is amplified up to millions of times. The expert reads the results and determines whether the COVID-19 is infected. --- Even if there are not many viruses in the sample, it can be found. So RT-PCR is evaluated as the most accurate COVID-19 test, although it takes some time (usually 3 to 6 hours: time-consuming).
The news posted above says "Genetic tests are the gold stand for COVID-19 infections. New, quicker ones are replacing the original laboratory tests that have to be manually mixed and developed."
The new point-of-care test called 'ID NOW' developed by Abbott Labs received emergency use authorization (EUA) from the FDA. It is known that when a sample is put into the kit, the positive is determined in 5 minutes and the negative in 13 minutes.
The world's attention is focused on its diagnostic accuracy.
According to experts, 'ID Now' also uses PCR diagnostics to amplify the nucleic acid of the COVID-19 gene to check for an infections. However, it does not change the temperature when amplifying the nucleic acid. --- This is called 'isothermal amplication'. This method is known to be LESS sensitive if the number of viruses in the sample is small. As a result, experts say the sensitivity of the existing RT-PCR test is better than the 'ID Now'test method.
'GeneXpert' by Cepheid was approved by the FDA for emergency use on March 21, 2020. The diagnostic method is virtually the szme as that of RT-PCR. However, if a sample were put in the kit, nucleic acid extraction would proceed by itself and deliver results "in 45 minutes". --- In S. Korea, after taking a sample, it takes about 3 hours to produce a result IF travel time to the lab is reduced as much as possible. - It usually takes within 6 hours to get test results since samples are sent in large quantities to labs and generate research institutions.. There used to be tens of thousands of test results a day. The result of 'point-of-care testing by 'GeneXpert is delivered to patients in the patient care settings such as the hospitals, urgent centers and emergency room.
For this reason, it is reported that the S. Korean authorities of the Department of Halth and Welfare have recently entered into a detailed review for the approval of emergency use of 'GeneXpert'. Many of the devices have already been used for the purpose of TB (tuberculosis) diagnosis in S. Korean medical institutions. Therefore, it is possible to test immediately by simply importing a newly developed COVID-19 diagnostic reagent from the U.S. company.
Experts say that since the sensitivity may be slightly reduced, it will be used only in a limited range for the purpose of diagnosing emergency patients. It is said that the reagent is expensive.
On March 26, Bosch Healthcare Solutions announced that it had developed a COVID-19 test that can deliver results with an accuracy of over 95% in 2.5 hours and that the Bosch test meets the quality standards for the WHO.
NON-PCR testing: antibodies or antigens
The Immuninodiatic method that checks for COVID-19 infections through antibodies or antigens. Non-PCR testing is much faster and
simpler, resulting in around 10 minutes. HOWEVER, the testing has many limitations. The test does not detect the virus itself as PCR tests do, but analyzes the body's reaction to infection.
(An 'antibody' is an immune-related protein that is made in the by stimulation of an antigen and binds the antigen to inactivate the antigen.) - To put it more simply, 'antibodies' are substances that the body makes so as to fight viruses. They are usually detected at least 10 days after virus invason. That is, a person who is infected will deveop "antibodies" after 10 days. Therefore, in the early stages of COVID-19 infections, the test accuracy is greatly reduced. Non-PCR tests are of no use in the early infection phase, according to Christian Drosten, a German viologist whose research focus is on novel viruses.
It is reported that the RT-PCR test with throat swabs & nasopharyngeal swabs is only reliable in the first week of the COVID-19 because later on the virus can disappear in the throat, multiplying in the lungs. -- For infected people tested in the second week, sputum can be used. (Drosten, March 31, April 2)
Suppose a patient, who has been infected with COVID-19, but has not yet produced enough antibodies, went to a local hospital and had a negative antibody test. So he/she can continue to release the COVID-19 which is a big threat to the community.
Meanwhile, when an organism or a substance enters the body, it can be recognized by the immune system or interact with the immune system, which is called an antigen. An antigen can refer to the virus itself. When an antigen enters the body, an antibody against the antigen is produced. In order to confirm COVID-19 infection by antigens, the virus must be activated in the body and released in LARGE numbers. --- This is possible after after a certain period of time after the onset. It is evauated that it is NOT a suitable test for COVID-19, which is even causes an "asymptomatic infection." --- It is also pointed out that the sensitivity of the antigen test is only 50% to 70%. For this reason, countries with diagnostic infrastructure are cautious about using immunoassays. Who would buy this kind of Non-PCR test kits???
Once again, let us remember what the U.S. regulators said in the paper: No home testing for COVID-19. What they said also implies that Non-PCR tests are inaccurate and unreliable. The experts in
other countries like the UK, Germany, China, S. Korea, Taiwan, etc.
I really do hope that the government agencies in each country ban the test kits not received for emergency authorization by the FDA/FDS/... from importing them.
Yes, a crisis can be a chance, but bad people swindle miserable people and make money in times of emergency when many people lose their lives, crying out for more fraud.
In a situation where the number of COVID-19 cases increase expotentially, I hope that many other countries, especially in European countries can use the new,"Rapid" PCR test kits, not Non-PCR test kits.
Stay safe!!!
There are already several kinds of "rapid" COVID-19 test kits made by companies in China, S. Korea, and the U.S.
The biggest problem is they are not accurate enough. According to leading research institutes in Spain, China, and Korea etc, "rapid" test kits had an accuracy rate of less than 50% or 30%.
Antigen antibody diagnostic methods using "fast" test kits are NOT recommemded by the WHO, and all countries like the U.S., China, Korea,Japan, and so on have tested people for the COVID-19 through "RT-PCR"--- not antigen / antibody tests.
The antigen tests can return a test in 10 to 15 minutes. They, however, are dangerous due to the diagnostic reliability of the equipment. Patients who are supposed to be positive might not be detected and can spread the coronavirus to others.
Despite the fact that not all countries officially use the antigen tests because of the reliability, "unconscionable bosses" still say they will develop coronavirus test kits and produce medical supplies and hype them in order to make money by selling a considerable number of shares.
I read some PRs and posts on the DECN board for the first time yesterday. The CEO seems to be exploiting this serious emergency crisis and the situation of Daegu city in S. Korea.
In addition, some people also mislead naive people without even knowing the truth. A person posted a Korean News link on the DECN board. The news says "A total of 12 Korean test kit makers have applied for the pre-EUA approval and more companies are expected to gain the approval given the high demand for the devices amid the urgency of thd outbreak situation in the US."
As far as I know, only three manufacturers for the virus test kits which the Korean government has used were given the interim EUA approval. --- They are not Rapid test kits.
The CEO of Decision Diagnostics Corp (DECN) stated that they "WILL" develop coronavirus test kits, and it seems that the price of the stock has soared recently.
Ah, what on earth do people who sell off their conscience look like? Greg Rottman (VYST), Megas & Sytner (BCIT) and so many...
They must have looked normal people. I wonder if such people regret what they have done when they are near death.
FYI, I usually read posts on politics and some posts on the DD support~ board and VYST board when I visit this iHub.
Have a good night!
mretgnol, I think it is even better for you to to communicate now and then on the BCIT board for those who desperately want to hear "any news" from you.
Thanks a lot!!!
I am really sorry for my angry tone last time. I will assume no one knows about it but you.
There were clear reasons for me then, but I forgot all those trivial things. I do not hate anyone including R & J; I came to understood their personalities.
To the people who sent me a pm:
- There is nothing I can tell you right now.
- You read what mretgnol said. "One down, two more to go."
- Well, let's assume we'll get what we want, at least within the year.
Have a nice day!