2019-nCoV Coronovirus (COVID-19]

soulcompromise · Mar 12, 2020

SuzanneAU1977 said: ↑

Because it's just an international cold.
People need to realise that anyone can get this especially if they have been flying overseas and then bringing it back home with them.
They don't use test kits they have fever clinics.
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I think what it says is that we aren't prepared.

It's not that isn't serious enough, it's just that some department is underfunded and we're not being told the whole story.

Irminsul · Mar 12, 2020

soulcompromise · Mar 12, 2020

Irminsul said: ↑

View attachment 231483
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Coronavirus vs. swine flu (H1N1) – 2009-2010
Swine flu is the same strain of flu that wiped out 1.7% of the global population in 1918. It was declared a pandemic again in June 2009, and an estimated 11-21% of the world population contracted it.

Fortunately, the CFR is considerably lower than in the previous pandemic, with 0.1-0.5% of cases resulting in death. 18,500 of these deaths were laboratory-confirmed, but estimates are as high as 151,700-575,400 globally.

50-80% of severe cases were found in people who had underlying conditions such as pregnancy, asthma, diabetes, and cardiovascular disorders.

Compared to swine flu, coronavirus:

is less widespread

has caused fewer deaths

has a higher CFR

has a longer incubation period

affects young people less

Click to expand...

EDIT: How Does Coronavirus Compare to Other Outbreaks? - Blog - FutureLearn

soulcompromise · Mar 12, 2020

you gotta give it a minute

Irminsul · Mar 12, 2020

And also stop voting Boomers into power.

Vanilla Gorilla · Mar 12, 2020

Irminsul said: ↑

And it's not like we don't know it's contageuous, we're just in our 30s and know we won't even die from it.

There should just be a curfew for all the Boomers and they aren't allowed to go anywhere for a few months until all blows over. But noooo they gotta ruin it for everyone, I bet there was a lot 30 years olds looking forward to sporting events.
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I 2nd that motion. Lock up the Boomers so we can live our lives

deleted · Mar 12, 2020

soulcompromise · Mar 12, 2020

U.S. Food and Drug Administration
FAQs on Diagnostic Testing for SARS-CoV-2

The FDA intends to update this page regularly.

Q: Are two or more viral targets needed to validate an RT-PCR SARS-CoV-2 assay?

A: Based on evidence that has become recently available, and with the increased spread of COVID-19, FDA believes an appropriately validated single viral target SARS-CoV-2 assay could provide acceptable performance. Please refer to the policy outlined in Immediately in Effect Guidance for Clinical Laboratories and Food and Drug Administration Staff: Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency, which includes recommendations regarding the minimum testing to be performed to ensure analytical and clinical validity for COVID-19 diagnostic assays, as well as the templates for EUA submissions provided on FDA’s website.

Q: I am offering my own test under the new policy outlined in Immediately in Effect Guidance for Clinical Laboratories and Food and Drug Administration Staff: Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency. Do I have to report all my results as presumptive?

A: Under the policy outlined in Immediately in Effect Guidance for Clinical Laboratories and Food and Drug Administration Staff: Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency, the first five positive and first five negative results should be reported as presumptive and confirmed by an EUA authorized test. If all ten of these results are confirmed by an EUA authorized test, confirmatory testing for subsequent results is not recommended in the guidance.

Q: What happens if I do not have the instruments referenced in the authorization of CDC's EUA-authorized test?

A: FDA believes that the CDC's EUA-authorized test could be performed on the following instruments designed to detect RNA viruses, and which were FDA cleared in K190302 for CDC's RNA-based influenza panel:

Applied Biosystems™ 7500 Fast Dx Real-Time PCR Instrument with SDS software version 1.4

Applied Biosystems™ QuantStudio™ Dx with version 1.0.3 software

QIAGEN Rotor-Gene Q MDx with AssayManager version 1.0.4.1 and Epsilon version 1.0.1 software

Q: What happens if I do not have the extraction platform referenced in the authorization of CDC's EUA-authorized test?

A: FDA believes that the CDC's EUA-authorized test could be used with the following extraction platforms:

Roche MagNA Pure LC
Kit: Roche MagNA Pure Total Nucleic Acid Kit
Protocol: Total NA External_lysis
Recommendation(s): Add 100 μL of sample to 300 μL of pre-aliquoted TNA isolation kit lysis buffer (total input sample volume is 400 μL). Elution volume is 100 μL.

Roche MagNA Pure Compact
Kit: Roche MagNA Pure Nucleic Acid Isolation Kit I
Protocol: Total_NA_Plasma100_400
Recommendation(s): Add 100 μL of sample to 300 μL of pre-aliquoted TNA isolation kit lysis buffer (total input sample volume is 400 μL). Elution volume is 100 μL.

Roche MagNA Pure 96
Kit: Roche MagNA Pure 96 DNA and Viral NA Small Volume Kit
Protocol: Viral NA Plasma Ext Lys SV Protocol
Recommendation(s): Add 100 μL of sample to 350 μL of pre-aliquoted External Lysis Buffer (supplied separately) (total input sample volume is 450 μL). Proceed with the extraction on the MagNA Pure 96. (Note: Internal Control = None). Elution volume is 100 μL.

QIAGEN QIAcube
Kit: QIAGEN QIAamp® DSP Viral RNA Mini Kit or QIAamp® Viral RNA Mini Kit
Recommendations: Utilize 140 μL of sample and elute with 100 μL of buffer.

QIAGEN
Kit: QIAGEN QIAamp® DSP Viral RNA Mini Kit or QIAamp® Viral RNA Mini Kit
Recommendations: Utilize 100 μL of sample and elute with 100 μL of buffer or utilize 140 μL of sample and elute with 140 μL of buffer.

QIAGEN EZ1 Advanced XL
Kit: QIAGEN EZ1 DSP Virus Kit and Buffer AVL (supplied separately) for offboard lysis
Card: EZ1 Advanced XL DSP Virus Card
Recommendations: Add 120 μL of sample to 280 μL of pre-aliquoted Buffer AVL (total input sample volume is 400 μL). Proceed with the extraction on the EZ1 Advanced XL. Elution volume is 120 μL.

QIAGEN EZ1 Advanced XL
Kit: QIAGEN EZ1 Virus Mini Kit v2.0 and Buffer AVL (supplied separately) for offboard lysis
Card: EZ1 Advanced XL Virus Card v2.0
Recommendations: Add 120 μL of sample to 280 μL of pre-aliquoted Buffer AVL (total input sample volume is 400 μL). Proceed with the extraction on the EZ1 Advanced XL. Elution volume is 120 μL.

Q: If I do not have assay positive control material, how can I obtain it?

A: If you do not have assay positive control material:

Obtaining N1/N2 Positive Controls, for the CDC EUA design:

Novel Coronavirus extracted RNA is available from BEI. To create N1/N2 positive controls from BEI's concentrated RNA, dilute the concentrated RNA into extracted nucleic acid to approximately 2 to 3 times the assay LOD per reaction.

or

IDT sells a plasmid control (2019-nCoV_N_Positive Control #10006625). To create N1/N2 positive controls from IDT's plasmid control, dilute the plasmid into extracted nucleic acid to approximately 2 to 3 times the assay LOD per reaction.

Obtaining RNase P (RP) Control, for the CDC EUA design:

Human RNA can be extracted from human specimens or cultured human cells and used directly as the RP positive control.

or

IDT sells a plasmid control (Hs_RPP30 Positive Control #10006626). Dilute the plasmid into extracted nucleic acid to approximately 2 to 3 times the assay LOD per reaction.

These FAQs will be updated as warranted.

Q: If I do not have assay human extraction control material, how can I obtain it?

A: Human RNA can be extracted from human specimens or cultured human cells and used directly as the HSC control which is used as an RNA extraction procedural control to demonstrate successful recovery of RNA as well as extraction reagent integrity. The HSC should yield a positive result with the RP primer and probe set and negative results with all 2019-nCoV markers.

Q: I am developing a SARS-CoV-2 test kit and want to pursue an EUA. Do I need to have all of my validation and documentation completed and submitted in an EUA request to FDA before engaging with FDA?

A: No. The FDA is interested in early interactions with test developers and will review data on a rolling basis. We encourage you to reach out to us at Immediately in Effect Guidance for Clinical Laboratories and Food and Drug Administration Staff: Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency.

Q: I am a clinical laboratory certified to perform high-complexity testing under CLIA. I have developed a SARS-CoV-2 test and want to begin accepting patient samples. What should I do?

A: Please refer to the FDA's February 29, 2020, guidance document, Immediately in Effect Guidance for Clinical Laboratories and Food and Drug Administration Staff: Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency.

FDA encourages such laboratories developing tests to consider the validation recommendations in the guidance as they seek to validate their tests. If you pursue an alternate approach, we recommend discussing plans with us early, through the pre-EUA program. Please contact us at: 2019-nCoV coronavirus reagents - qPCR assays and genes | IDT External Link Disclaimer

Biosearch Technologies: 2019-nCoV CDC-qualified Probe and Primer Kits for SARS-CoV-2 | LGC Biosearch Technologies External Link Disclaimer

Q: I am a clinical laboratory certified to perform high-complexity testing under CLIA. Do I need an EUA if I purchase a CDC qualified lot of SARS-CoV-2 test kit reagents and develop my own protocol?

A: Yes. Laboratories that wish to develop their own protocol should refer to the streamlined EUA policy outlined in the February 29, 2020 guidance, Immediately in Effect Guidance for Clinical Laboratories and Food and Drug Administration Staff: Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency.

FDA encourages laboratories to discuss their plans with us early, through the pre-EUA program. Please contact us at: 2019 SARS-CoV-2 and currently available Coronaviruses strains and reagents External Link Disclaimer information box from the home page. You will be asked to register or log in, and then you may request reagent NR-52285 External Link Disclaimer.

Q: I am a clinical laboratory certified to perform high-complexity testing under CLIA and am interested in developing a SARS-CoV-2 test. What do I need to do if I make my own primers/probes or order the individual components?

A: Please refer to the FDA's February 29, 2020, guidance document, Immediately in Effect Guidance for Clinical Laboratories and Food and Drug Administration Staff: Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency.

FDA encourages such laboratories developing tests, whether using purchased components or making their own primers/probes, to consider the validation recommendations in the guidance as they seek to validate their tests. If you pursue an alternate approach, we recommend discussing plans with us early, through the pre-EUA program. Please contact us at: "Accelerated" EUA template that was posted online with the new policy guidance?

A: The "accelerated" EUA template is specific to the policy outlined in the February 29, 2020 guidance and is intended for laboratories certified to perform high-complexity testing under CLIA that are offering tests as set forth in the guidance. We have a separate EUA template for manufacturers, now also posted online, to use which includes the same clinical validation information and also addresses information regarding manufacturing, distribution, and stability, which are relevant only to distributed kits.

Q: What are the current minimum requirements for demonstrating performance of a new COVID-19 assay?

A: Please refer to the FDA's February 29, 2020, guidance document, Immediately in Effect Guidance for Clinical Laboratories and Food and Drug Administration Staff: Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency where we have provided recommendations regarding the minimum testing to be performed to ensure analytical and clinical validity of these tests. We recommend consulting with us as soon as possible if you pursue a different approach to validation or to discuss any additional questions regarding performance and validation issues.

Q: I requested and received an EUA template prior to the February 29, 2020 policy which was accompanied by a posting on the web of the EUA template for clinical laboratories. The first version references testing 50 clinical specimens and the version on the web references testing 30 clinical specimens. Which is accurate?

A. Due to the limited availability of reagents for the detection of SARS-CoV-2 and the growing need for testing suspected cases of the COVID-19, the FDA revised the EUA templates for both clinical laboratories and manufacturers with regard to EUA submissions for tests intended for the detection of SARS-CoV-2. As set forth in the guidance, FDA recommends clinical evaluation should include 30 contrived clinical specimens.

Additional Information
If you need additional information completing the EUA template, would like to know how to submit your Pre-EUA/EUA submission to FDA or wish to consider use an alternative specimen type, please contact the Division of Microbiology devices at (301) 348-1778 or email Emergency Situations (Medical Devices)

Contact Number 1-888-INFO-FDA (1-888-463-6332)
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tralala...

Deleted member 313194 · Mar 12, 2020

Irminsul said: ↑

And also stop voting Boomers into power.
Click to expand...

Grow up

GLENGLEN · Mar 12, 2020

Vanilla Gorilla said: ↑

I 2nd that motion. Lock up the Boomers so we can live our lives
Click to expand...

BOO......HISS.....

Sneers Glen.

Irminsul · Mar 12, 2020

SuzanneAU1977 said: ↑

Grow up
Click to expand...

No you grow up. When will you stop being so ignorant and realising every single one of our problems is boomer related?

All we have to answer for is jeans around knees and cellphones. I estimate maybe... 300 people a year trip on their jeans and split their skulls and a further 300 more people hit by cars and stuff looking at their phones. 600 millennials.

Boomers infect more than 600 people a day.

GLENGLEN · Mar 12, 2020

Irminsul said: ↑

No you grow up. When will you stop being so ignorant and realising every single one of our problems is boomer related?

All we have to answer for is jeans around knees and cellphones. I estimate maybe... 300 people a year trip on their jeans and split their skulls and a further 300 more people hit by cars and stuff looking at their phones. 600 millennials.

Boomers infect more than 600 people a day.
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I'm Sitting Here LOL ing When I Should Be Snapping Back At You......

Cheers Glen.

Deleted member 309004 · Mar 12, 2020

SuzanneAU1977 said: ↑

I wouldn't be surprised if the NRL gets cancelled. Then @GLENGLEN won't be happy.
@Mustard Tiger won't be happy if any of the combat sports get cancelled.
Oh and i'm sure @Napoleon Hill’s Spectre won't be able to see his hawks play come round 1 in the AFL
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?? I think it all should be suspended but I don't even like combat sports or football

Vanilla Gorilla · Mar 12, 2020

GLENGLEN said: ↑

BOO......HISS.....

Sneers Glen.
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Well, in the cities, you are ok, no need to quarantine Bathurst

soulcompromise · Mar 12, 2020

feels like i'm trying to convince people coronavirus is real...

& it isn't that I don't care because I do. I care that it will spread if people don't take it seriously at the very least. But on some level I consider all of you friends to some degree. I don't want you to get sick. & I don't want to get sick.

Things I'm doing: wearing latex gloves, using hand sanitizer, washing my hands for 20 seconds with soap (including my idiotic thumbs).

Napoleon Hill’s Spectre · Mar 12, 2020

SuzanneAU1977 said: ↑

Fucking hell you are so ignorant.
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North Melbourne should just be given the flag!

Irminsul · Mar 12, 2020

This. Fucking this!

Napoleon Hill’s Spectre · Mar 12, 2020

Rick to be the vaccine human guinea pig along with his family?

Irminsul · Mar 12, 2020

I don't know who it is but it rings of truth even if you don't want to believe it, that's exactly what happened. Every. Single. Word. of that. Truth. Argue all you want, the fact is that's what happened.

Deleted member 313194 · Mar 12, 2020

Irminsul said: ↑

This. Fucking this!

View attachment 231493
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yeah and because it's on social media it must be true.

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2019-nCoV Coronovirus (COVID-19]

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