Less than a month after the first instance of COVID-19 was announced, the state has surpassed 1,300 cases. Testing has ramped up including the addition of private labs like, Quest and LabCorp, on top of two state labs in Northern and Southern Nevada.
Mark Pandori is the director of the Nevada State Public Health Lab located at the University of Nevada, Reno. He has regularly been talking to The Nevada Independent about the novel coronavirus and the state’s testing efforts, and this week we talked to him once again as Nevada begins to create its own tests and collection kits as the national supply runs dry.
This interview has been edited for length and clarity.
Q: You guys are developing your own tests now. Can you explain that to me?
A: Well, back [on March] 16, the FDA allowed states to create their own systems for analyzing the quality of lab-developed tests or test components. And so rather than waiting for the FDA to clear new tests or the use of certain test components, we wrote a system here in Nevada so that we could evaluate the quality of novel test components on the market.
We knew that there were far more test components that were usable for the test on the market, but we weren't able to use them unless we waited for FDA to release authorization on them. So instead of waiting for the FDA to authorize all of these other products, Nevada can take responsibility for that now. And so we have a system in place where we worked with the Department of Public and Behavioral Health in Nevada to create our own system to evaluate quality.
So it's not like we can develop our own tests now. We could always develop our own tests. It's just that Nevada decides now whether that goes live, not the FDA. So, huge advantages.
Q: And you don't have a shortage of the testing kit, then you just have this shortage of collection kits, right?
A: Well, because of the regulatory change that the FDA made that we talked about in the first part of the call, we’ve been able to evaluate some other brands of testing kit components here in the lab, and we've found some that work really well, so we're not too worried anymore about test kits in the lab. Where the shortages nationally are is in collection kits. In order to quell that, we manufacture our own collection kits here at the Nevada State Public Health Lab, and we distribute them.
Q: What are the advantages to making the test kits?
A: Yeah, number one [is] time. So you don't have to wait for the FDA, which is overwhelmed right now. Now the process through Nevada is a much shorter time because Nevada is only concerned about what goes on in Nevada labs.
Number two, the advantage is that we can now look at test components that are not on the FDA cleared list. What that allows Nevada labs to do is to possibly utilize components that might work great, but aren't being used by other states or other tests, so that we can actually go after vendors of products that everyone isn't going after.
Kind of like the store shelves these days. Everybody's running in buying toilet paper, right? Because there's only a few brands of toilet paper on the shelves, the shelves are empty of toilet paper you really needed. Now in Nevada, we can go and buy toilet paper from anywhere we want — if we can find it.
Q: You explained to me earlier that you are developing the actual collection kits too, not the actual tests, what does that mean?
A: Yes…the other component to getting a test run is you need to collect a specimen, and that's done by what are called collection kits. And there's no collection kits available in the United States. So what we decided to do at the Nevada State Public Health Lab is to construct collection kits. We are constructing about a thousand a day. It's not super fast because we have to do quality control on them.
And once we do quality control, if they look like they're clean and effective, then we distribute them to anybody that runs a health care operation in Nevada that needs test collection kits.
Q: What is in a collection kit?
A: The collection kit is a tube that has fluid in it that, like some preservatives…and then a swab. So with the collection kit, a clinician a nurse or a doctor can swab your throat or your nose or whatever, and then take that swab and put it into a tube and seal it, and then that tube goes to the lab for transport and testing. The test kit in the lab, that's like a bunch of chemical components that are specific to the detection of COVID-19 virus or SARS or COV-2.
A lot of politicians out there talking about problems with inventory conflate test kits with collection kits and they call collection kits test kits, but lab people and medical people don't think that way.
We know that we call one a collection kit and one a test kit. The test kit being what's used to do the actual testing. The collection kit is just collecting a specimen that would be tested.
Q: Are you distributing them to Southern Nevada and the private labs as well?
A: Well, we haven't fielded any requests from private labs yet, but we are shipping some to Southern Nevada and to many clinics around Nevada and hospitals.
Q: Do you have any communication with the private labs?
A: No, not with the private labs.
Q: What specimens are being sent to you guys compared to the private labs? Who's deciding that?
A: Any private doctor in Nevada can decide to send to us or they can send to private labs.
Now, these private labs process a lot of medical testing for these private doctors during the let's call it peacetime, for lack of a better word. So it's very comfortable and easy for private doctors to just continue to use those contracts that they have with private labs and send their COVID-19 stuff to them.
And when they do that, the private labs are reporting their results to the state of Nevada Health and Human Services. So you can go to the dashboard that Health and Human Services for Nevada maintains and you can see the numbers that the private labs are running, and you can compare those to ours if you like.
Now there's no particular reason that we here at the Nevada State Public Health Lab [have] to know what they're doing. What's really important is that the health department knows what they're doing.
Of course, we have a very close relationship with the health department because we're the public health lab. We tell them every day what we do and what we see. The public health departments have to hope that the private labs comply with that. Now, I think in the good nature of things, private labs are probably doing a pretty good job of reporting that intelligence to the Health and Human Services division. But you can't be sure 100 percent.
Q: Are you still sending materials down to the Southern Nevada Health District?
A: Yeah. We're sending 500 collection kits right now and we're sending 500 more next week or late this week.
Q: Are you testing people that you know have been in contact with COVID-19 or are you just testing generally whatever the hospitals are sending you?
A: So we're testing whatever the hospital sends to us and not asking any questions. And then we're testing whatever the health districts send to us. That means the state and that means Carson and that means Washoe. We assume that the health districts are screening patients using some criteria that is reasonable.
Q: Is testing still kind of hard to come by for a generic person? If I felt like I had a cough, and I wanted to be sure I didn’t have COVID-19, I couldn't just go get tested, though?
A: Right. So Nevada is one of the states, and most states are like this, where in order to get a test ordered, you have two options. A clinician that is your doctor or an emergency room doctor can order a lab test for you. The other way you can get a lab test in the state of Nevada is a health district person can ascertain that you need a lab test.
If you can convince a doctor or a health district employee to order a test for you, we would run that test.
In a lab, we can't order the test for you.
Q: I want to move back to the making of the collection kits just a little bit here. Do you know if other states are making collection kits?
A: No, I'm not aware of any other effort to do this. We'd had the idea several weeks ago and started assembling the components to do this. And then about a week and a half after we got the idea and started doing it. I did notice the CDC sending the ingredients out and sending information to labs that they could build their own kits.
I think we had a head start. We also have our school of medicine here. One of the cool things about being on a school of medicine campus is I've got people here now in the microbiology division and biology campus here at UNR that are helping to build collection kits.
Q: Is it a complicated process to make these kits?
A: So, it's easy to build a collection kit. The difficult parts are as follows: number one, the caps have to be put on all the tubes, and that's a thousand. People get repetitive motion injuries pretty quickly. So, you know, you have to share that task and get the kits physically assembled. And then the other thing is that we need to perform quality control on these kits when they've been completed. Quality control means we need to establish three things about them. Number one, we test samples of the kits that we build for sterility. So we take the kit that we build and we swab it to make sure that there's no microorganisms growing in there that we don't want.
Number two, we test all the fluid in the kit to make sure there's no contamination of COVID-19 virus DNA or RNA in them. And then the third thing we do is we spike the sample. We spike them with positive COVID-19 samples and then test those samples to see if they retained stability… we know that they're not digesting or degrading the specimen. And number three, that they're not full of bacteria and junk.
Q: Do you guys have a backlog or are you still getting through all of the tests every day when you get them?
A: No. By about 10 PM every night, we have basically everything done… [We have] a new extraction method for RNA on the front end of the test. Before we could only extract 40 at a time. Now we can extract 94 at a time.
Q: How's morale doing? Are you guys still doing all right?
A: They're strong. Yeah. Everybody's doing real well and hanging in there real tight.