Monday, February 17, 2020

#CORONAVIRUS, USA--Lab Testing Procedure---NV HEALTH LAB DIR INTERVIEW


JOUR107.1104; Lab//James L'Angelle//University of Nevada, Reno//18 Feb 2020


Lab#3B: Interview: Initial Draft Transcription

    Topic of this interview is the coronavirus epidemic and it was held at the Nevada State Health Laboratory on the UNR campus in the office of the Director, Dr. Mark Pandori, on Friday, 14 February, 2020 at 09:00.

(tape on)--

LANGELLE
OK, anyway, I'm here to interview Dr. Mark Pantori, Pandori, excuse me, Pandori, at the Health Department regarding the coronavirus outbreak which hasn't happened in the United States yet but the CDC, I believe, may have just come up with a warning that it could. And, uh, so I have a couple of questions I would like to ask Dr. Pandori.
First of all, would be the test kits, how does that work?

PANDORI
How does what work, getting the test kits or having the test work?

LANGELLE
Well, we can start with getting the test kits, sure.

PANDORI
Sure, the test kits, first of all, it is important to say that this is not unprecedented but it was impressive to see how quickly the CDC would get a test up and running so, this, just building a lab test in just a few weeks from absolutely not knowing that this thing existed from having a lab test in a few weeks is a pretty huge accomplishment so I think we should start with that. And so after the test was developed at CDC, they were the ones running it for a few weeks but of course with so many specimens coming into one place, it's hard for the CDC to have what we call the turnaround time when they're short-staffed for the tests and of course they want their public health partners at the state level and it's what we call  (...) level  to support them testing.
So they gave the test that they developed available to all the public health labs in the United States, and, the way that worked, was, they would improve the existing way of ordering influenza test kits ....extensive amounts of influenza surveillance as you might imagine on an annual basis and the labs should be able to support that surveillance. There's a website and a methodology that allows us to order reagents and test kits for free. So what the CDC did was to utilize that existing infrastructure so that the public health labs could order the coronavirus test kits through that same mechanism. And when they did, they ordered and they came in by FedEx in just a few days. And that's how we got the test kits.

LANGELLE
Uh, that's great. So it's similar to other test kits where it's ... or how does that work?

PANDORI
It's similar that they both utilize the same diagnostic mechanism which we call (...) chain reaction. So these are tests that test what we call the genome of the organ, the RNA, you have a DNA genome as human beings, these viruses, the coronaviruses have what we call an RNA genome and what the test does is to look for that genome, to look for, specifically three parts in the genome and in that way it is similar to influenza which is also a PCR or.......   chain reaction

LANGELLE
I see. So the virus is already in the cell when that happens, is that what you're saying?

PANDORI
When what happens?

LANGELLE
When you do the testing...

PANDORI
Well, so the test would be done on a specimen so that could be a swab of the throat   (stop ....02:57.729)---or what we call an mt swab or sputum, something that comes out of the human being. In that specimen there could be what we call free virus which are the virus particles that could be  floating around in the specimen or there could be what we call cell associated virus which are cells that you've accidentally coughed up or swept off constantly shedding dead cells when you cough or in your bowel, all the time dead cells coming off your skin and, so, this virus might actually be in cells that have sloughed off and we would call that cell associated virus but the test would not discriminate necessarily between cell associated and cell free virus.

LANGELLE
Oh, OK

PANDORI
And it's not a distinction that's relevant from a diagnostic perspective.

LANGELLE
That's real interesting, so I noticed on a lot of the websites they have this little vial with stuff in it . What is that, is that the reagent, or whatever you call it?

PANDORI
We call them reagents and if you want to get real down in the diagnostic...we call those analyze specific reagents which is to say that in those tubes are the chemicals that will only react with coronavirus.

LANGELLE
Oh, OK

PANDORI
And it's those analyze specific reagents that form the heart of a diagnostic test and so they will only see this particular organism or agent and not others.

LANGELLE
I see. Now each test kit has a different number in there so you can only use one for each test or is it, each little vial ...........

PANDORI
....if you were to hold the box in your hand and read it, it would say there's a thousand reactions in there but because we have to run what we call controls every time we run a diagnostic test, controls would be known positive and known negative samples along with the test specimen that we have interest, that means we might only get a few hundred tests out of that kit, but of course right now we are in such early stages, we are not anticipating more than one or two cases, that means we would consume a hundred then of course that would be in a thousand....bigger situation...

LANGELLE
And so, the test takes place here, so if somebody isolates themself, how does that happen, they go to the hospital and they bring the swab or whatever over to you to test here or do they come in here to be tested?

PANDORI
It's a good question, So, a person, right now testing is regulated and this test exists through what is called an emergency use authorization. Normally, tests need to be vetted very carefully before they're offered to be  used diagnostically in a medical environment. In this particular case, the FDA went ahead and said "Go for it," and use this now but only under certain conditions and those conditions are that the test is run on a patient that meets a very specific definition, that means that they are what;s called a person under investigation, or a patient under investigation. That criteria is set by the CDC and that criteria in this case is would be someone who is symptomatic with a respiratory ailment and has recent travel to China or contacted someone that did recent travel to China. That, of course, could be a moving target, those base definitions have changed as time goes by especially as more cases have started to occur outside of China. But at the moment the emergency use authorization  is specific in that regard so to answer your question, if there was a symptomatic individual, symptomatic means coughing, feverish, respiratory or down with a cold or the flu. If this were to occur at a clinic or a hospital, and during interview it was discovered that they...the ...definition, then the health department would be brought in and the health department and the CDC would communicate and decide whether  testing was warranted in that case, put another way, they would decide together whether or not that person meets the...definition of somebody that should be tested by the ...and then, and only then would we run the test.

LANGELLE
OK, then that whole process takes what, pretty quick, or the...

PANDORI
Faster than you realize. Public health departments and clinics, public health are good at this. We do this, this isn't our first rodeo, so to speak. You know we have a lot of scary creatures out there and so, occasionally, they pop up in clinical environments and in this case the public health departments are brought in you could have an answer in a couple of hours, and when you consider the federal and state and local authorities involved then that's impressive. It could take a few hours to discern whether testing is needed.

LANGELLE
So, pretty much, do you feel you've got it under control already, ahead of the game? Because the way it looks.....you're a little bit more aware of the symptoms...you don't expect it to get out of control...is what I'm asking.

PANDORI
Well of course China was caught off guard by this. You know, the thing about new infectious agents is, they're new and they're miserable and you don't see 'em until people are sick with them. Generally when you are already sick people around, you're not seeing the first infected individual that means there's already other infected people. Now being in the United States and overseas, here we are at the advantage of being able to react to what was happening in China, so we were able to establish at certain airports fever screens for example and we were able to get these tests unrolled very quickly so, are we ahead of this?
I've learned in my time of studying infectious disease is that you are never ahead of these agents. But when you're in such the early stages of something like this it's an opportunity, for public health. You know it's sort of no different if there was a fire at your house. If the fire started in your kitchen and the fire department was called and they were a few blocks away and they got there in a few minutes, it's very likely they could save your house from burning down. But are we in that similar situation from keeping your place from burning down, you never really know.

LANGELLE
OK, I won't take any more of your time ...I wanted to hear how these test kits work, ...I haven't been able to find a lot of stuff on. But other than that, thank you very much.

PANDORI
Sure, James .  (tape off)


Further Reading:

How the New Coronavirus Spreads and Progresses - And Why One Test May Not Be Enough

UCSF infectious disease expert Charles Chiu, MD, PhD, has been following the disease since its outbreak and provided the latest updates on what science has revealed about how the coronavirus is transmitted, what happens to someone who's infected, and why a single diagnostic test may not be enough.




Test Kit Image 001: https://futurism.com/neoscope/coronavirus-covid19-test-kits-broken-america-scarce-china
Test Kit Image 002: https://www.livescience.com/coronavirus-testing-kits-flawed.html
Dr. Pandori photo: Eyeless on Campus..



JOUR107.1104; Lab//James L'Angelle//University of Nevada, Reno//18 Feb 2020