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BioMedomics Launches COVID-19 IgM-IgG Rapid Test for Novel Coronavirus
HospiMedia Daily clinical news ^ | 14 March 2020 | HospiMedica International staff writers

Posted on 03/24/2020 12:14:41 PM PDT by Candor7

click here to read article


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To: dontreadthis
not sure if that’s accurate.

Here's a video that explains everything in detail with what they're doing:

MedCram

21 posted on 03/24/2020 1:16:36 PM PDT by politicket (Don't remove a Bernie Sanders bumper sticker. It's the only thing holding the car together!)
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To: Candor7

Awesome! So how soon before we can get WuFlu immunity IDs? With proof of immunity we will have a new class of privileged individuals who can come and go as they please, work, and even congregate with this their immune people.

You could even deliberately get infected, I would prefer one of the less virile strains, somas to get a head start on everyone else.


22 posted on 03/24/2020 1:31:58 PM PDT by FreedomNotSafety
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To: Candor7

Once the denominator gets large enough they death rate will be on par with the regular flu (23,000 deaths so far). So we cannot have that happen until the Progs have scared all the Chicken Freepers into giving up their freedom.


23 posted on 03/24/2020 1:34:21 PM PDT by FreedomNotSafety
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To: Candor7; null and void
BioMedomics, Inc. (Morrisville, NC, USA) has developed and launched one of the world’s first rapid point-of-care lateral flow immunoassays for the diagnosis of coronavirus infection. The new rapid IgM-IgG combined antibody test for COVID-19 is used to qualitatively detect IgG and IgM antibodies of the novel coronavirus in human serum, plasma or whole blood in vitro. These proteins indicate that a person’s immune system has responded to infection with the COVID-19 virus. It is one of the world’s first rapid tests for coronavirus utilizing this technology.

The way I know good things are happening in the country is the market's starting go up again. Things are happening. This might be one of 'em.

24 posted on 03/24/2020 1:39:52 PM PDT by GOPJ ( http://www.tinyurl.com/cvirusmap https://www.youtube.com/watch?v=OfeZlKu8M7A)
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To: Candor7; bitt; LucyT

Candor7 wrote:

“Biomedics, Inc. Link : https://www.biomedomics.com/

Thanks!!

Ping!


25 posted on 03/24/2020 1:58:41 PM PDT by WildHighlander57 ((WildHighlander57 returning after lurking since 2000)
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To: politicket

“This isn’t a test to see if one has the virus. This is a test to see if one used to have the virus and is now recovered.”

it does both ... when you test for IGM, you’re testing for an antibody that indicates a current infection, and when you test for IGG, you’re testing for an antibody produced when the body has fought off an infection and that confers immunity to future infections ... IGM is a very short lived antibody, while IGG is a very long lived antibody ...


26 posted on 03/24/2020 2:22:09 PM PDT by catnipman (Cat Nipman: Vote Republican in 2012 and only be called racist one more time!)
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To: Candor7

this is one of the tests that Dr. Barbara Brix has been alluding too, and she said she wants to get this type of test validated, approved, and distributed as soon as possible ... validation is what leads to approval, and what needs to be validated is the bounds for both false negative and false positive results, because if either is too large,then the test is virtually useless ...


27 posted on 03/24/2020 2:25:05 PM PDT by catnipman (Cat Nipman: Vote Republican in 2012 and only be called racist one more time!)
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To: CharlesWayneCT

That pooled sample testing is brilliant as long as a very small fraction of the population was infected. At some low point of infection, the benefit is gone as both pools will be positive for the disease.


28 posted on 03/24/2020 2:44:56 PM PDT by ProtectOurFreedom
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To: catnipman

she said she wants to get this type of test validated, approved, and distributed as soon as possible >>>>>>>>>>>>>>>>>>>>>>>>

Approval Already done. BUT PEOPLE NEED TO BE INFORMED. And it needs to be available over the counter to all Americans.That’s the point I am trying to make.

*********************************************************

“NOTE: Updated USFDA guidance issued on March 16, 2020, allows the distribution of this product for diagnostic use in laboratories or by healthcare workers at the point-of-care. The updated policy can be viewed by clicking here. Please see FAQ’s below for more detailed information.

This product has CE-IVD registration. You can download the Certificate of Conformity here.”

Link:

https://www.biomedomics.com/products/infectious-disease/covid-19-rt/

*********************************************


29 posted on 03/24/2020 3:20:39 PM PDT by Candor7 ((Obama Fascism)http://www.americanthinker.com/articles/2009/05/barack_obam_the_quintessentia_1.html))
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To: Candor7

NOT FDA-approved,however: they are simply allowed to distribute it and people can use it via this declaration:

“We herewith declare that the products listed above are in compliance with the requirements set out in the Council Directive on the harmonization of the Laws of the Member States concerning In-Vitro-Diagnostic Directive 98/79/EC.

The Declaration of Conformity is issued under the sole responsibility of the manufacturer.”

there are thousands of tests administered by various private labs, both large and small, that are NOT FDA approved; however, those tests are always self-paid as no insurance company, including Medicare and Medicaid will reimburse the end user ...

so, that means they have NOT submitted data to the FDA that demonstrates the degree of false positives and false negatives,where said data is generally obtained under rigorous clinical trial conditions and conducted on thousands of patients, including unknowns, folks known to have had the illness via other testing and folks known to NOT have the illness based on other testing, and therefore this test has yet to receive FDA approval, meaning labs can do the test, folks can take the test, but they have to pay for it AND, and this is a big AND, the validity of the results are unknown ... interestingly, New York state bans most non-FDA-approved tests ...


30 posted on 03/24/2020 4:20:30 PM PDT by catnipman (Cat Nipman: Vote Republican in 2012 and only be called racist one more time!)
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To: politicket

thanks


31 posted on 03/24/2020 4:28:38 PM PDT by dontreadthis (A TIMELINE OF TREASON on Profile Page)
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To: Candor7

It takes 12 to 15 days to develop antibodies for this test. But it’s a money maker I spoose. The gold standard for the earliest detection is nucleic acid.


32 posted on 03/24/2020 4:29:28 PM PDT by momincombatboots (Ephesians 6... who you are really at war with)
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To: catnipman

NOT FDA-approved>>>>>>>>>>>>>>>>>

Not true, its approved as much as it can be for emergency use. you are using prohibitive semantics, in this case where i CAN save lives...do you want to ensure MORE deaths?

It has been approved for use, like it or not, ITS BEING USED. Not only that, the US military ordered 100,000 units.

Link:

https://www.biomedomics.com/products/infectious-disease/covid-19-rt/

“NOTE: Updated USFDA guidance issued on March 16, 2020, allows the distribution of this product for diagnostic use in laboratories or by healthcare workers at the point-of-care. The updated policy can be viewed by clicking here. Please see FAQ’s below for more detailed information.

This product has CE-IVD registration. You can download the Certificate of Conformity here.”


33 posted on 03/24/2020 6:08:49 PM PDT by Candor7 ((Obama Fascism)http://www.americanthinker.com/articles/2009/05/barack_obam_the_quintessentia_1.html))
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To: GOPJ; Fred Nerks

The way I know good things are happening in the country is the market’s starting go up again. Things are happening. This might be one of ‘em.>>>>>>>>>>>>

Here is another ( though the Bolshevik Jews are trying to tear the Hasidim Doctor Zelenko down):

Successful therapy against Covid-19 virus from New York State:

Dr. Vladimir (Zev) Zelenko

Board Certified Family Practitioner

501 Rt 208, Monroe, NY 10950

845-238-0000

March 23, 2020

To all medical professionals around the world:

My name is Dr. Zev Zelenko and I practice medicine in Monroe, NY. For the last 16 years, I have cared for approximately 75% of the adult population of Kiryas Joel, which is a very close knit community of approximately 35,000 people in which the infection spread rapidly and unchecked prior to the imposition of social distancing.

As of today my team has tested approximately 200 people from this community for Covid-19, and 65% of the results have been positive. If extrapolated to the entire community, that means more than 20,000 people are infected at the present time. Of this group, I estimate that there are 1500 patients who are in the high-risk category (i.e. >60, immunocompromised, comorbidities, etc).

Given the urgency of the situation, I developed the following treatment protocol in the pre-hospital setting and have seen only positive results:

1. Any patient with shortness of breath regardless of age is treated.

2. Any patient in the high-risk category even with just mild symptoms is treated.

3. Young, healthy and low risk patients even with symptoms are not treated (unless their circumstances change and they fall into category 1 or 2).

My out-patient treatment regimen is as follows:

1. Hydroxychloroquine 200mg twice a day for 5 days

2. Azithromycin 500mg once a day for 5 days

3. Zinc sulfate 220mg once a day for 5 days

The rationale for my treatment plan is as follows. I combined the data available from China and South Korea with the recent study published from France (sites available on request). We know that hydroxychloroquine helps Zinc enter the cell. We know that Zinc slows viral replication within the cell. Regarding the use of azithromycin, I postulate it prevents secondary bacterial infections. These three drugs are well known and usually well tolerated, hence the risk to the patient is low.

Since last Thursday, my team has treated approximately 350 patients in Kiryas Joel and another 150 patients in other areas of New York with the above regimen.

Of this group and the information provided to me by affiliated medical teams, we have had ZERO deaths, ZERO hospitalizations, and ZERO intubations. In addition, I have not heard of any negative side effects other than approximately 10% of patients with temporary nausea and diarrhea.

In sum, my urgent recommendation is to initiate treatment in the outpatient setting as soon as possible in accordance with the above. Based on my direct experience, it prevents acute respiratory distress syndrome (ARDS), prevents the need for hospitalization and saves lives.

With much respect,

Dr. Zev Zelenko

cc: President Donald J. Trump; Mr. Mark Meadows, Chief of Staff

Video at Link

https://matzav.com/watch-kiryas-yoel-dr-zev-zelenko-to-trump-im-seeing-success-with-your-approved-drug/?fbclid=IwAR0gVHAW9kWF-JLRHjzQx9bSFx6jlRgTn9_PpAmaiykXhsVqTE7wJrddS4g


34 posted on 03/24/2020 6:27:34 PM PDT by Candor7 ((Obama Fascism)http://www.americanthinker.com/articles/2009/05/barack_obam_the_quintessentia_1.html))
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To: Candor7
From the Biomedics site... Accuracy
A total of 525 cases were tested: 397 (positive) clinically confirmed (including PCR test) SARS-CoV-2-infected patients and 128 non- SARS-CoV-2-infected patients (128 negative). Of the 397 blood sample from SARS-CoV-2-infected patients, 352 tested positive, resulting in a sensitivity of 88.66%. Twelve of the blood samples from the 128 non-SARS-CoV-2 infection patients tested positive, generating a specificity of 90.63%.

Sensitivity 88.66%
Specificity 90.63%

35 posted on 03/24/2020 7:15:12 PM PDT by ProtectOurFreedom
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To: ProtectOurFreedom

Sensitivity 88.66%
Specificity 90.63% >>>>>>

Should do in a pinch!


36 posted on 03/24/2020 7:20:19 PM PDT by Candor7 ((Obama Fascism)http://www.americanthinker.com/articles/2009/05/barack_obam_the_quintessentia_1.html))
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To: Candor7

“Not true”

nope. it IS true that test is NOT FDA-approved, for emergency use or for any other use ... it’s just some test whose company is hawking it without any clinical data to back up whether the test is valid or not ... there are tons of non-validated tests like that one which are being hawked like that ...


37 posted on 03/24/2020 9:13:39 PM PDT by catnipman (Cat Nipman: Vote Republican in 2012 and only be called racist one more time!)
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To: ProtectOurFreedom
That pooled sample testing is brilliant as long as a very small fraction of the population was infected. At some low point of infection, the benefit is gone as both pools will be positive for the disease.

Not only that....but on another thread today was a report (I think from Italy) on a modification to a ventilator that serviced multiple patients simultaneously.

38 posted on 03/24/2020 9:35:12 PM PDT by spokeshave (Trump:....Bernie Sanders is a communist. ...thats gonna leave a Marx.)
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To: Candor7

Saved, thank you.

Do you have a link to the text you posted?


39 posted on 03/24/2020 10:03:14 PM PDT by Fred Nerks (Fair Dinkum!)
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To: Candor7

It takes 12-15 days after infection to build detectable antibodies. For acute cases rna detection eliminates that gap. Of course there are lots of false negs with any nasopharyngeal test, rna mitigates that by increasing sensitivity.


40 posted on 03/25/2020 12:18:23 AM PDT by momincombatboots (Ephesians 6... who you are really at war with)
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