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Center for Public Health Preparedness

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University at Albany Center for Public Health Preparedness

THE NEW YORK STATE PUBLIC HEALTH LABORATORY AND NATIONAL SECURITY

Original Satellite Broadcast: 12/2/04

MODERATOR: Hello, and welcome to the University at Albany Center for Public Health Preparedness Grand Round Series. I'm Peter Slocum, and I'll be your moderator today. Before we begin, I'd like to remind you that we'll take your questions and calls later in the hour. The toll-free number is 800-452-0662. You may also send your questions by fax at 518-426-0696. We'd also like to remind you to please take a moment after the broadcast to fill out online evaluation forms. Your feedback is very important to use in deciding the future of this series.

Today's program is on how the New York State Public Health Laboratory and National Security System work together. Dr. Nick Cirino is the Director of the Biodefense Laboratory at the Wadsworth Center in Albany, New York. And Dr. Christina Egan is the Deputy Director. Both have considerable experience in infectious disease and in developing educational materials for the Department of Health, for first responders, law enforcement officials, healthcare providers, scientists, and students. They also contribute to coursework at the University at Albany School of Public Health. Welcome, and thank you both for joining us today.

EGAN, C.: Thank you, Peter.

CIRINO, N: Thank you.

MODERATOR: We'd like to start by talking a little bit about the laboratory work and there's certainly an awful lot going on in the world today in the whole field of bioterrorism and public health and newly emerging infectious disease. Could you tell us how this affects your laboratory?

EGAN, C.: Certainly. And as shown on this slide, there are an ever-growing number of both newly emerging infectious diseases as well as reoccurring infectious diseases in the world. The Wadsworth Center has always provided laboratory diagnostic capabilities in New York State. We have provided testing for naturally occurring outbreaks as well as intentional releases of bioterrorism agents, such as occurred in 2001.

We are currently preparing by developing diagnostic testing assays for these agents and also using our experiences with West Nile, monkey pox, and SARS virus. And we must remain diligent and be prepared for these types of unknown agents in order to protect the public health of our citizens.

MODERATOR: I see. Well, Dr. Cirino, perhaps you could fill us in a little bit on the role of the Wadsworth Public Health Laboratory. You and your stuff seem to spend an awful lot of time behind the scenes on these major issues.

CIRINO, N: Yeah, we do. As you can see from this slide, prior to the '01 events where we had anthrax in the mail, there were two camps. There was the public health infrastructure, which was focused on natural hazards like infectious diseases and environmental hazards. And there was the federal government and the military camp, which was focused on manmade hazards, weapons of mass destruction be they biochemical, radiological, nuclear. And they realized after the fall of '01 there was significant overlap between these two and so that a unified approach should be pulled together. And that was health security. And so this is a mechanisms now by which diagnostics and mitigation of these hazards can be addressed.

MODERATOR: So it's a coming together in effect of this overlapping.

CIRINO, N: Yes.

MODERATOR: So you're saying that when we're talking about biosecurity, we're talking about many areas, not just the white powder in the mail.

CIRINO, N: Correct. Public health is just a narrow scope of health security. Besides public health there's also food protection, veterinary protection, companion animals, protection of livestock, economically important animals like race horses, and also protecting the food supply and cash crops. Tobacco is a big industry that is at risk. And there's also protecting the environment. Our food and water supplies are critical infrastructures that we need to protect.

MODERATOR: I see. So the lab is really a part of several diagnostic and safety systems to protect the citizens of the state. And Chris, how does the Wadsworth Laboratory relate to other activities around New York State and to the country's security system as a whole?

EGAN, C.: Well, Wadsworth Center is an active participant in several of these national health laboratory systems. And initially, we joined the laboratory response network, which was established by the Centers for Disease Control, the Association of Public Health Laboratories, and the FBI to provide an effective laboratory response as well as increase the public health infrastructure to respond to these sorts of incidents.

This laboratory response network, the labs that are enrolled in this network, test both clinical and environmental samples for bioterrorism agents as well as newly emerging infections. The National Animal Health Laboratory System has been designed to improve surveillance of BT agents in animals. And while the Wadsworth Center doesn't participate in this network, we have active surveillance and diagnostic capabilities for BT agents in animals as well.

The other two networks that are shown on this slide are the FERN network, which is the food emergency response network. And that's established by the FDA and USDA to provide surveillance for radiological, chemical, and biological testing capabilities in food.

MODERATOR: Uh-huh (affirmative).

EGAN, C.: And the environmental laboratory network, which is established by the EPA, the emergency laboratory response network, is designed to detect agents in air and water.

MODERATOR: I see. Well, focusing on New York, can you describe the public health laboratory system that we deal with here?

EGAN, C.: Certainly. So if you look at the northeast laboratory map and especially at New York State, you can see that we have several participating laboratories. Along with the Wadsworth Center and the New York City Department of Health and Mental Hygiene, there are two other laboratory response networks. And we were fortunate to be able to increase our public health infrastructure for testing for bioterrorism agents. These laboratories are located in Erie County Public Health Lab and also down in Westchester at the Westchester County Department of Health Division of Labs and Research.

Also, we have a national animal health laboratory network facility at Cornell University. The Wadsworth Center also has one of the five chemical testing laboratories with advanced capabilities. And you'll hear more about that from Dr. George Eden next month.

MODERATOR: Okay. And then how does this integrate with the rest of the Northeast?

EGAN, C.: Well, as you can see from the map, there are a number of different laboratories throughout the Northeast.

MODERATOR: Uh-huh (affirmative).

EGAN, C.: And these networks are designed to improve communication and to utilize other laboratories for search capacity. And we've recently with the New York State laboratory response network have held a meeting of all of the public health laboratories in the Northeast region to increase communication in this area.

MODERATOR: I see. And then how many laboratory centers like Wadsworth are there in the rest of the United States, and how do they stay interconnected with each other?

EGAN, C.: So there are 120 laboratories throughout the United States and actually internationally, even in Canada and Australia.

MODERATOR: Uh-huh (affirmative).

EGAN, C.: In the United States, there are at least one LRN confirbontory (phonetic sp.) laboratory in each state, and several states have multiple laboratories such as ours.

MODERATOR: Uh-huh (affirmative).

EGAN, C.: The LRN, the laboratory response network, is coordinated through CDC. And they interconnect all the laboratories through national phone conferences, e-mails, through training sessions, as well as a secure network in which the laboratories receive up to date information and are connected with each other.

MODERATOR: Dr. Cirino, perhaps you can take us through behind the scenes here. And given the large number of labs around the country and all the current concerns, how does this all fit together? Is there a top down hierarchy of some kind?

CIRINO, N:Yes. There's a very well-defined hierarchy to the LRN. At the top of a pyramid would be the national laboratories. These are the Centers for Disease Control and Prevention and the U.S. Army Medical Research Institute for Infectious Diseases down in Washington. And these are the national laboratories with high-containment labs. They have the highest level, which is biosafety level four. So they can work with unknown agents or very infectious agents like ebola virus.

The next level down would be the reference laboratories. Wadsworth Center is an example as is the New York City Department of Health and Mental Hygiene as are the two new laboratories that will be coming online in Erie and Westchester Counties. These are reference level laboratories, which have biosafety level three, so not quite as sophisticated as the CDC in USAMRIID. But we have high testing capability. We have access to very sophisticated reagents and technologies so that we can do very definitive rule in testing for a lot of these different agents.

And at the bottom of the pyramid, the backbone or the base of the period if you will, are the sentinel laboratories. And these are clinical testing laboratories in hospitals or contract labs, which do the brunt of the testing in New York State. And these laboratories typically when they get a sample, would do a rule-in, if you will. They would do testing for things that people normally show up to the hospitals for. So if someone shows up to the hospital with a respiratory disease, and they show up with respiratory sensishal (phonetic sp.) virus, it's identified. It's ruled in as that agent, and so we can rule-out things like SARS or anthrax.

MODERATOR: I see.

CIRINO, N: So there's this rule-in, rule-out level that the sentinel labs can do.

MODERATOR: Okay.

CIRINO, N: If they cannot rule-out a select agent, they must refer it up to a reference laboratory.

MODERATOR: And the reference lab has the more sophisticated equipment, which can definitively rule something out.

CIRINO, N: Correct. And so if we can rule in the select agent, then it can stop there. If we can't identify it, then it gets kicked up to the national laboratories who can do even more sophisticated testing.

MODERATOR: I see. Well, how are samples sent between the laboratories? This is a fascinating sounding network here, but how does it actually work if somebody is ruling something in and then they need to rule it out and send it to you or the comparable elsewhere in the country?

CIRINO, N: The clinical samples come through our courier system as diagnostic specimens. Typically, they're packaged there in an appropriate way so they can be shipped through Department of Transportation or air transportation regulations. And if something is a high risk, the Centers for Disease Control would come up and take control of that specimen and take it down for testing.

MODERATOR: I see. I see. Can you tell us in somewhat simplified terms about some of the diagnostic methods you use in your laboratory?

CIRINO, N: Sure. We have basically four categories of testing. The routine culture we do is the gold standard (Indiscernible). We like to see stuff growing on a plate.

MODERATOR: Okay.

CIRINO, N: Still old school. We also do nucleic acid testing. So we look for the DNA or RNA that's present in living cells. And we can also do immuno acids. These are antibody-based methods, which look for surface epitopes on different bacteria or viruses. And we can do imaging like microscopy or electron microscopy.

Each of the method categories has different advantages. While culture is the gold standard because you can look for multiple things on a plate, it's relatively slow. We can't make the bacteria grow any faster. So it takes 24 to 48 hours typically.

MODERATOR: So if you're after an immediate answer in a crisis situation.

CIRINO, N: Exactly. After the fall of '01, we realized 24 hours is too long. So the nucleic acid we do based on polymerase chain reaction can be done much quicker. We can have a preliminary result in about six hours.

MODERATOR: I see.

CIRINO, N: And so it's much more rapid. It's still very specific, but we can't tell if something's infectious or not by PCR.

MODERATOR: Okay.

CIRINO, N: So there's advantages and disadvantage to each of the methods.

MODERATOR: I understand we have a video, which we can show now which shows the research scientists working on some of these methods in a secure laboratory setting.

CIRINO, N: Yes.

MODERATOR: Maybe you can talk us with that a little bit here.

[video begins]

CIRINO, N: These research scientists are working in a biosafety cabinet as a team. One person is handing in the equipment and the needed reagents, and the other person is processing in a clean area. They're going to be taking some isolettes from one plate and transferring it over to another plate containing different growth media. Note the slow movement of the person working in the cabinet, keeping the hands inside the air barrier. She's taking a loop from a slant now. She's going to transfer the bacteria onto the different culture media plates.

The bacteria on the slants are isolated from other plates, and these are for more definitive identification of the bacterial organisms. This would be something we might do if we were trying to rule-in a sample for anthrax or another select agent. Cassandra is taking another loop and putting it on another type of media. The different growth medias will foster the growth of different bacteria.

Now she's doing a motility test. So she put some of the bacteria in the agar. And if the bacteria are motile, which means they move, we'll see diffusion in that agar. We just passed in a biosafety carrier. So any samples that come out of that biosafety cabinet will be put into that container. So that if they're spilled in transport to an incubator or a refrigerator, the samples are contained. So that transport carrier is gasketed (phonetic sp.). It can be dropped from a fairly high height and not spill any of the contents onto the floor.

So Cassandra will now decontaminate the outside of that container with a 20 percent bleach solution. Both Maureen and Cassandra, the research scientists in this video, have been vaccinated and trained extensively in the testing for select agents.

Now Maureen is passing in some biochemicals, which we use to identify different bacteria. And again, we'll put the bacteria in those different chemicals. And the patterns we see on those different media and dyes will help us determine what bacteria is growing on that plate.

In each of those tubes are different growth media with different dyes. And so if the bacteria express certain enzymes, it'll change the color of the dyes in those media. While we haven't seen any anthrax since the '01 event, the Wadsworth Center did process positive samples from New York City during the '01.

And you can see that the processing is not a simple task. Working as a team and in a biosafety cabinet to maintain separation from the highly infectious organisms is a very slow and precise job.

[video ends]

MODERATOR: Wow. Fascinating.

CIRINO, N: Well, thank you. I just wanted to remind everybody that that video was actually shot in our biosafety level two laboratory, which was mocked up to be a biosafety level three. We put on the personal protective equipment and such. We can't take cameras into our high-containment laboratory obviously.

MODERATOR: For security reasons.

CIRINO, N: For security reasons.

MODERATOR: Well, Dr. Cirino, can you talk to us a little bit about what you consider the most serious bioterrorism threat that the laboratories in the United States have to prepare for today?

CIRINO, N: Personally I wouldn't say any is more of a threat than any other. The CDC has developed a list of what they call category A select agents. And these agents are shown on a list here. And these are the agents thought to be most likely to be weaponized and used by terrorists or Rogue Nations. As you can see, things for example, anthrax, botulinum toxin, tularemia, things that our zoonotic diseases typically and which have been weaponized in the past.

MODERATOR: Uh-huh (affirmative).

CIRINO, N: Also on the list is ricin, which is a category B select agent. It's not quite as toxic as botulinum toxin. But the Wadsworth Center can do service diagnostic for all of these agents except ebola virus. Eventually, we hope to have diagnostics for ebola here at Wadsworth. For things like ebola and smallpox, which are defined as category four select agents. So you have to work in a biosafety level four. We couldn't do anything that would propagate the viruses.

MODERATOR: I see.

CIRINO, N: We are one of 26 laboratories approved to do high-risk smallpox testing though, as long as our diagnostics don't propagate the virus and we have vaccinated staff in the laboratory and we have the methods to do definitive rule-in for smallpox, we can do that.

MODERATOR: So no culture growing.

CIRINO, N:No culture growing of those viruses. Correct.

MODERATOR: Okay. Let's talk for a moment if you can about some of the other purposes and objectives of the laboratory.

CIRINO, N: Well, most state public health laboratories have a very strong service component. Wadsworth is fairly unique in that we have enough facilities and staffing and expertise and support from the people of New York State to do other things. To do education and outreach not only of the public but to first responders, law enforcement, students. We also do a lot of research at the Wadsworth Center, obviously. We have several hundred research scientists at the Wadsworth Center actively working on basic science, pathogenesis, therapeutics.

And because of our unique facilities and staff, we're often approached by government agencies or businesses to do validation research. So someone may have a new test for anthrax, but they can't work with anthrax. They're not permitted to by the government.

MODERATOR: I see.

CIRINO, N:And so they would give us their assay to validate or valuate and see whether it would work in the field.

MODERATOR: Okay. I could see how all this outreach and networking is so much more important after the fall of 2001.

CIRINO, N: Yes. Our best defense against terrorism is education.

MODERATOR: Dr. Egan, can you tell us a little bit about what sort of services the lab does provide? And can I bring in an envelope with white powder in it that I think is anthrax?

EGAN, C.: Well, actually, we only accept samples from law enforcement. And to analyze these samples, we utilize specific diagnostic testing protocols and reagents from the laboratory response network as well as the FERN network. And we use these to test both clinical and environmental specimens. And it's very important that we utilize these consensus protocols and reagents so that we can have high confidence that a test result that we obtain at the Wadsworth Center will be just as efficacious as a result that is obtained in another LRN testing laboratory, say on the west coast of our nation.

MODERATOR: So it's a standardization of the methods across the country.

EGAN, C.: Correct. And that really is critical for high-confidence testing, which is what we're after. Some other service activities that we participate in are, as Dr. Cirino mentioned, suspect smallpox testing. We're one of several laboratories that can perform moderate and high-risk testing for smallpox.

MODERATOR: Uh-huh (affirmative).

EGAN, C.: And with the smallpox vaccination campaign 2002-2003, we also developed adverse event monitoring for this initiative. We also participate in emerging disease monitoring. And we participate through CDC in several different programs where we're looking at food-born illness as well as nosocomial infections and newly emerging diseases such as SARS and monkey pox.

And finally another type of service activity that we are involved with is the biohazard detection system, which we'll refer to as the BDS.

MODERATOR: Okay.

EGAN, C.: And this is an automated detection system for anthrax. And we'll talk about this in a little bit of detail in a few minutes.

MODERATOR: Okay. Good. Before we get there, can you give us a few examples of some of the select agents that your laboratory has provided testing for in the recent past?

EGAN, C.: Yes. Well, we had tested in the 2001 anthrax events. We tested over a thousand samples, 23 of which were positive for anthrax. We have also been involved for a number of years in testing samples for botulism. And we test both infant samples as well as adults and infants and children for food-born related botulism.

In New York State, we also test quite a number of samples every year for environmental outbreaks involving wildlife for botulism. Again, we test samples for vaccine adverse events. And we were able to identify laboratory confirm two adverse events, a generalized vaccinia as well as an inadvertent inoculation, which was important. Also, we have testing capabilities at the Wadsworth Center for testing clinical samples for SARS as well as animal and clinical samples for monkey pox.

And then in the past year, we have become very involved in testing environmental samples for rison.

MODERATOR: I see. Well, that's good. Brought us quite a gamut there.

EGAN, C.: It certainly does.

MODERATOR: Dr. Cirino, there are many different select agents in infectious diseases that you obviously much be concerned with. How is a laboratory like yours preparing for these eventualities?

CIRINO, N: Well, there is a long list of agents that we're looking for. And we're realizing quickly that we can't test for everything all at once. So independently and in collaboration with the Centers for Disease Control, we're developing what we call multiplex assays. So these are assays that can look for multiple things like anthrax and botulism and rison all in one reaction well. And this way, that expedites our testing. It reduces the cost of our testing. And this way when we run a sample -- Currently, we run samples just for anthrax typically. If it's not anthrax, well, then the next question is what is it? What can you do? What can you define?

And so developing these multiplex assays is critical. And so we're currently in the process of developing and validating several different panels for doing rapid screening. One would be a biothreat panel, which could rule in several different select agents that are on this list. And we have gotten to a fourplex at this point, which can rule in anthrax, plague, small pox, and rison toxin. And we're going to add other agents to the list soon. We're in the validation process for that.

MODERATOR: Are there laboratories around the country using the same sort of thing?

CIRINO, N: That's a Wadsworth Center assay so far.

MODERATOR: Okay.

CIRINO, N: But with the CDC, we are developing other multiplex assays that are similar. We've also, in collaboration with the clinical birology (phonetic sp.) lab, helped developed multiplex assays for pulmonary diseases, which every winter there's a large outbreak of some pulmonary disease. And it's hard to differentiate the pulmonary infections. Everything has flu-like symptoms.

MODERATOR: Right.

CIRINO, N: And so again, having a multiplex assay, which can rule-in flu and rule-out one of the select agents, would be good for biodefense purposes.

MODERATOR: I see. Yeah. I could understand.

CIRINO, N: And the last thing we've been working on is a multiplex assay for the pox viruses. Again, we were involved with the smallpox vaccination program and monitoring for adverse events. The virus that's used for the vaccine for smallpox, it's a live virus. So it can be transmitted as well. So we need to be able to discriminate between the virus that's the vaccine, the smallpox virus itself, and the things that look like smallpox, which would be like chicken pox. And so we've developed a multiplex assay, which can discriminate those pathogens as well.

MODERATOR: So a more fine-toothed comb, so to speak.

CIRINO, N: We can do one test and figure out what it was.

MODERATOR: Right. Well, Dr. Egan, let's talk about the research aspects of the work. We've heard some examples already of the way you've developed new assays and new ways of looking for these agents. What kind of research goes on and why is it important to do that? It's not something that maybe the public often thinks of as the public health laboratory function.

EGAN, C.: True. And in support of our service activities, it's really critical to have the research going on to develop improved diagnostics and optimize our protocols. And we perform a variety of research, again aimed at developing better diagnostics. We have published several papers, one of which was a assay to detect campylobacter species, which is a common food-born related illness in clinical specimens. And shown on this slide are two recent -- or one recent publication for one of the vaccine adverse events that I talked about.

In addition to these publications, the Wadsworth Center has produced guidelines based on CDC recommendations for the submission of smallpox and adverse event monitoring. And we also developed collection protocols. Because as well as getting better diagnostic tests, we also need to get appropriate samples and high-quality samples. And this is really critical in a testing laboratory.

And we have created smallpox collection kits in order to assure that we will get high-quality samples. And I think we have a video of one such collection kit.

MODERATOR: Oh, good. Let's run that now then.

[video begins]

EGAN, C.: Here we have an example of our New York State smallpox collection kit. These kits were designed in response to the smallpox vaccination program. In this kit, we have supplies to collect three different specimen types. We have slides to collect vesicular fluid. We have microcentrifuge tubes to collect scabs, and we have swabs, which are also used to collect vesicular fluid.

Also included in these collection kits are the associated supplies that you would need to assist in the collection. We have waste containers. We also have plastic forceps for removal of the lesion or the scab. We also have rulers, which are really important for getting an approximate size of the lesion material. We also have our antiseptic antimicrobial wipes, hand cleanser as well as retractable scalpels.

These smallpox collection kits have been distributed to local health departments as well as regional resource centers. In order to comply with IADA and DOT regulations, these specimens have to be specifically packed in IADA approved containers, which can be found here.

[video ends]

MODERATOR: All right. I see. A complicated process there.

EGAN, C.: It certainly is.

MODERATOR: Now I'd like to move to another part of this collection business. Dr. Cirino, an awful lot has been written lately about some of these highly sophisticated detection devices or systems that are placed on buildings in large cities. And many of them apparently are installed on post offices or in post offices around the country. Can you explain a little bit about how they work?

CIRINO, N: Yes. I think Christina mentioned the biohazard detection system, or BDS.

MODERATOR: Yes.

CIRINO, N: And this is an automated polymerus chain reaction-based detection system developed for the federal government, which can detect anthrax. So it's a real time testing machine. There's an aerosol collector above a pinch point in the mail processing system. And those aerosols are then automatically extracted and analyzed for several targets from bacillus anthracis. And if the nucleic acids from anthrax is detected, an alarm will go off immediately. The facility would be shut down, and an emergency response plan will be initiated.

MODERATOR: It sounds sort of like a sophisticated vacuum cleaner sucking the air in and then running it across the testing sample device.

CIRINO, N: That's a good analogy. It's very good.

MODERATOR: Do we have any of those biodetection systems here in New York State?

CIRINO, N: Actually, yes. They're in several counties across New York State. Actually, every mail facility in the state will have them by the end of next year. They're very -- They're in the high through put mail sorting facilities throughout the state. And the locations are shown on the map here. I'm sure that all the county health departments where these are located have already been brought into the process of getting these installed and developing response plans. It's very complex, because HAZMAT and first responders and law enforcement are all integrated into this as well as local and state health departments.

MODERATOR: And I assume if they have not already heard about it then anybody in our audience should contact the post office in their region to make sure they understand what's going on if they are installing one of these.

CIRINO, N: Yes. It's a very robust system that is going to greatly improve the health security in New York State.

MODERATOR: And I trust around the country, since this developed for the federal government.

CIRINO, N: Around the country as well. It's already been implemented in a lot of mailrooms across the country.

MODERATOR: Okay. Which I know the postal worker's union was understandably very concerned after the first outbreaks of the first anthrax mailings.

CIRINO, N: Yes.

MODERATOR: Dr. Egan, back to you for a second. The lab plays an important role in educating our local public health officials about all of these issues. What other educational activities have you been involved in at that laboratory?

EGAN, C.: Well, as Nick mentioned, education is really our primary defense against bioterrorism. And we have spent a significant amount of time working with our law enforcement and first responders in educating them around issues surrounding sampling for BT agents. In New York State, we have worked with several groups. We have worked with the police, fire, HAZMAT, as well as a specific New York State police response team, a contaminated crime scene emergency response team, which responds to hazardous scenes.

We work very closely with our National Guard civil support team and provide training and education. And we serve as a confirmatory lab for them as well. Critical to the bioterrorism response in our state and around the nation is our LRN sentinel clinical hospital labs and our reference laboratories. In order to provide early detection and early response, it's critical that these laboratorians (phonetic sp.) know the proper procedures and protocols for ruling out these select agents. And we have spent time with our New York State laboratory response system preparing outreach programs for those purposes.

We also spend a great deal of time with our department of health epidemiologists at the county, regional, and state level. And we have given training session as part of bioterrorism courses to our county epidemiologists that are newly hired to be a part of bioterrorism response in New York State. Several regional and state epidemiologists across the country also attend our training sessions with law enforcement and with our clinical laboratorians so we have a cohesive system in New York State.

We finally spend time with postal workers, with students and the general public trying to inform them and alleviate some of the confusion that arose in 2001 over several issues around anthrax.

MODERATOR: Well, I assume that this is sort of a whole new way of looking at the world for clinical laboratorians who never thought they would be dealing as part of the front line of a biodefense or bioterrorism defense system.

EGAN, C.: And really, they are the first responders in our laboratory system. So it is critical that they receive the proper education.

MODERATOR: Dr. Cirino, I read a few months ago that the Wadsworth Center was one of the few centers in the country to receive a special award for -- to develop a center of excellence. Could you tell us about that a little bit?

CIRINO, N: Yes. Wadsworth Center in collaboration with Columbia University last year received funding for a research center of excellence in the northeast. And specifically focusing on biodefense and emerging infectious diseases. And I think they'll show the list here. We're in very good company. Harvard medical school is on here. Duke University. The funding is meant to provide seed money, if you will, to established as well as young investigators to do basic research in development of therapeutics, which could eventually be used in the biodefense area.

MODERATOR: What does this resource do to assist other laboratories and the whole defense system in the northeast?

CIRINO, N: Well, while Columbia and the Wadsworth Center were the primary people on the grant, it's a whole regional center of excellence. So that the laboratories in the northeast can all apply to get funding through this regional center of excellence, our regional center of excellence is called the Northeast Biodefense Center, NBC. And so other members who have been funded this year are listed here on this slide. And there again, there are principle investigators doing basic research into various select agents on the category A list.

MODERATOR: They make up part of the newly defined health security system for the entire northeast.

CIRINO, N: Yes. The basic research feeds right into the clinical diagnostics that we would need and will eventually help out in health security.

MODERATOR: Okay. Can you please tell us a little bit about the emerging infections training conducted out of here?

CIRINO, N: Yes. Well, as I indicated, the regional center of excellence money funding was for established or junior PhD level researchers. The NIH realized there was a gap. That there weren't enough researchers in the field of biodefense and emerging diseases. And so they put out a proposal for universities to fund training of graduate level students and post docs in biodefense and emerging diseases. And the Wadsworth Center was with Suny (phonetic sp.) Albany Department of Biomedical Sciences was funded as one of these national training centers.

MODERATOR: Back in the fall of 2001 just after the initial 9-11 attacks and the anthrax mailings, there were thousands of false alarms regarding these unknown white powders that people found in their houses or mailboxes in some cases. Dr. Egan, supposedly there was a lot of confusion in communications about that and thousand and millions of people were effected or were concerned they might have been effected. What did we learn from this series of incidents?

EGAN, C.: Well, our laboratory, as did many others in the country, had several critical lessons that were learned from the 2001 incidents. And one of which was a gap that was identified between the laboratories and first responders. And this led to laboratories around the nation being overwhelmed with samples that were of a low credible threat and a delayed testing for the more highly suspect samples.

And so our laboratory in collaboration with several groups within the Department of Health as well as several state agencies have held training presentations for law enforcement through counter terrorism zones, which have been set up through the Department of Justice. And there are approximately 16 zones set up in New York State. And we, also after going out on several initial visits to these counter terrorism zones, rolled out a presentation series called forensic epidemiology, which was established by the CDC and the FBI. And we received a lot of feedback from these presentations. And the primary message that we got back to us was that first responders would like all the information that we gave them during these presentations into a pocket card that they could carry with them so that they would be able to refer to this pocket tri-fold so that they could have the proper and adequate information to determine if a sample should be collected and how to properly collect a sample.

MODERATOR: I see. So you've responded to that with a card. I understand we have a picture of the card on the screen or available to us here.

EGAN, C.: Yes, we do. And we call this card the code red card. And code red is an acronym, which stands for controlling a scene and an investigation, opening dialogs between the laboratory, between the criminal investigation officers, as well as the county public health departments. This -- D stands for determined biohazard credibility, which is really critical in avoiding all these low credible samples.

We next have employ the collection protocol, which we have a detailed protocol in the code red cards. Remove contamination, and that's important so that we can have decontaminated samples as well as personnel. And turning information refers to filling out the proper chain of custody so that we can use this information in a prosecution.

And finally, dispatch the specimen. And a specimen is brought to the laboratory by a law enforcement officer.

MODERATOR: So you've given the local first responders some clues as to how to determine the credibility of a threat. I mean, how serious or how likely is it to be a real biohazard threat.

EGAN, C.: Correct.

MODERATOR: Okay. And if there are people who are watching us who want to get a hold of these cards and they don't have them already, how can they get those?

EGAN, C.: They can get the code red cards by contacting our laboratory, and you will have that information at the end of the broadcast.

MODERATOR: Okay. I think we'll put the number up on the screen. Okay. Dr. Egan, you mentioned risk assessment. Can you tell us a little bit more about that in the context of these biothreat criteria?

EGAN, C.: In 2001 and still presently, we have a problem in the laboratory where we're still receiving these low credible threat samples.

MODERATOR: In other words, not likely to be a threat.

EGAN, C.: Correct. They tax the laboratory, and again, they can also delay testing for highly suspect samples. And so what we have done is developed criteria for first responders to use so that they can make an adequate risk assessment in the field without having to transport the sample to the laboratory. And the criteria that have been developed are listed on this slide. And they are, was there an overt threat? Is there a visible material to test? Was their an exposure? Or is there an uncertain or threatening origin?

MODERATOR: Have people started to work through this and find themselves comfortable with that ladder of criteria?

EGAN, C.: Yes. And it really is useful for the first responders to have something in hand and something that they can refer to rather than trying to recall presentations that we have given, you know, a year, a year and a half ago.

MODERATOR: Indeed. Well, part of this, of course as you mentioned, is -- I can't remember which letter in code red, but part of it is collecting the sample carefully and securely so that you and the laboratory are going to be able to get the best result. What's the safest way for first responders to collect the samples and transport them to the laboratory?

EGAN, C.: Well, the safest way is to follow the code red card strictly. And samples should be transported to the laboratory again by law enforcement. We only accept samples by law enforcement. These samples should be triple contained. And samples that are large, such as office chairs, couches, other things that people try to bring to the laboratory in 2001 can't be tested in our lab. And we showed you earlier in the video that we do all of our processing in a biosafety cabinet. So in order to address these large items, we have developed sampling kits. And they're collection kits that we have.

MODERATOR: And you have -- I understand you have a video that shows that.

EGAN, C.: Yes, we do.

MODERATOR: Okay. Let's play that now.

[video begins]

MALE: These are the components for the code red biothreat collection kits that we'll be distributing through New York State in the next few months. These are for unknown white powders, and the kits will be distributed through state police, law enforcement, and HAZMAT teams. And they're meant for collection and transport of unknown white powders and specimens known not to contain chemical hazards. So the code red cards are included in each kit, and those will give you the protocol for collecting the samples, who to contact, and how to transport things.

Code red card has everything you need to do a safe collection of an unknown white powder. Besides the contact information, it also has a credibility assessment with four questions that first responders can use to assess whether it is a high-risk or a low-risk biothreat.

The hypoid bags contain chemical decontamination towels, which are for decontamination of the bags and surfaces. The surrey gauze pads are included so that if there is a large abundance of white powder, you can wet the gauze pads with the water contained in the glass vials and take a sub sample of the powder and package it into one of the zip lock baggies.

Again, the complete protocol is in the code red card. Eventually, you'll put the bags, which have been decontaminated, in the bucket and transport the bucket through law enforcement to the Wadsworth Center for testing.

[video ends]

MODERATOR: So I understand in one of the early times, you had samples that someone thought might be anthrax come to you in a wad of duct tape bigger than a softball. And it was hard to get it apart to work on it, right?

EGAN, C.: Sure. And we were going to show that slide, but we always use it when we talk to law enforcement, and it was very interesting. That was the first sample that the biodefense laboratory, at Wadsworth Center at that time was a terrorism response team, received.

MODERATOR: Uh-huh (affirmative)

.

EGAN, C.: And the FBI was bringing it in, and it was the first sample they were going to bring to the laboratory. So everyone was very excited, and they called up and said, "What should we do? How should we get the sample to you?" And we said, "Triple contain it and get it to the laboratory." And when the laboratorians were in a high containment laboratory and they opened up the outer package, they realized it was triple contained. And it was triple contained in duct tape.

MODERATOR: I see.

EGAN, C.: And so we don't like to use sharp objects in a high containment lab, so it took about four to five hours just to get into the package, which was a mailed piece of -- It was a mailed item with powder contained in it.

MODERATOR: Right. Oh, wonderful.

CIRINO, N: And again, appropriate packaging expedites testing.

MODERATOR: Right

.

CIRINO, N: So it's very important when we say we can have rapid testing done or preliminary test done in six hours. That assumes that we can go upstairs and open the package immediately and start processing.

MODERATOR: I see.

CIRINO, N: It doesn't build in the time for unwrapping duct tape. [laughter]

MODERATOR: Okay. Alright. Well, we're all learning as we go along here. There's been some controversy over the use of some testing in the field. And I wanted to know what the health departments and laboratory view is on that question.

CIRINO, N: Be very careful.

MODERATOR: Okay.

CIRINO, N: That's the simplest term. Both the Centers for Disease Control and the FBI have done evaluations of various field tests. And none of the field tests give field responders sufficient confidence to make the decisions in the field.

MODERATOR: Uh-huh (affirmative).

CIRINO, N: All of them have non-negligible false positive and false positive rates, which could cause your response to be inappropriate. And when you're talking about a high-impact decision being made like shutting down a building or quarantining an airplane, you need to have high confidence that the field test you ran was going to give you the correct result. Many of the tests are good lab tests. The PCR-based systems are excellent for lab use, because we can control things. PCR is very sensitive, and so we have to watch out for false positives. You could have the same issue in the field.

MODERATOR: In the field you can control that sensitivity much less effectively.

CIRINO, N: Correct. And so you could have more false positives by field PCR. The most utilized field test is lateral flow tickets or -- They're essentially pregnancy test strips for things like anthrax

.

MODERATOR: Okay.

CIRINO, N: And there was a picture of one on the slide.

MODERATOR: We can go back to that. There we go.

CIRINO, N: If you show -- And down at the bottom of the slide there you can see one of the test strips for anthrax. If two pink lines show up, anthrax is present in the sample. The problem is if you look at the data on the slide, this data was compiled by the Centers for Disease Control and the FBI back in 2002. These were an example of four of these lateral flow tests. And if you look at the sensitivity, so a clean spike of anthrax spore is put on the test ticket. Wouldn't show positive until you had a hundred thousand to a million spores. The lethal dose of anthrax is probably less than ten thousand spores. And so you're looking -- It took that first responder a hundred lethal doses to see a positive. He was exposed to a hundred lethal doses to get that result.

MODERATOR: Not terribly useful from a biodefense.

CIRINO, N: Not very useful. And besides that, there were non-negligible false negative rates as well. The assays could fail a significant amount of the time.

MODERATOR: Uh-huh (affirmative).

CIRINO, N: And so you're not -- If you're close to an LRN laboratory, it just makes more sense to get it to the lab. You'll have high-confidence results, preliminary results in about six hours. And so you're only saving a few hours for something that could cost you your job. So we strongly recommend not running these tests.

MODERATOR: Right. Not just your job, but cause you a serious health threat.

CIRINO, N: Correct. And public panic.

MODERATOR: Right. And that -- We had to go over that slide fairly quickly, but that's available on our website ultimately as the entire presentation will be. And people can download that and look at it.

CIRINO, N: And that data is taken right out of the Department of Justice, Department of Health and Human Services report that was released in '02 from the Centers for Disease Control. There's a new study I understand that defined one test, the ramp test. Is that right? That is lab appropriate but not yet ready for the field. Some people may have heard about that.

CIRINO, N: Yes. The AOAC is a quality assurance group that commissioned a new test, basically to repeat the test that the CDC and FBI ran two years ago.

MODERATOR: Okay.

CIRINO, N: And they wanted to reevaluate. Because we all realize first responders need something to give them a feeling for what level gear they should go in, how much decontamination they need to do, should they shut down a building or not. We all realize that they need something. And so a reevaluation of these field tests was performed. They were all the lateral flow tests, assays again.

MODERATOR: Uh-huh (affirmative).

CIRINO, N: And the ramp assay was approved as an official OAC method for use in a lab. It's still not approved for use in the field. They have to do further evaluation. But the test strip itself was found to have sufficient sensitivity and specificity to be used in a laboratory. And now they're going to do the evaluation for first responders.

MODERATOR: And the aim is to see if you can make it effective in the field and that this is okay.

CIRINO, N: Yeah. So that we can have confidence.

MODERATOR: Right. Right. What progress is being made in terms of research on handling threats of bioterrorism agents, and where do you see things going in the next few years?

CIRINO, N: Well, research into diagnostics and basic science into select agents is being performed at the Wadsworth Center on an ongoing basis. We also do additional research into therapies. We have the research center of excellence, as I indicated, and the training grant. So biodefense, we're trying to build a focus on biodefense here in Albany at the Wadsworth Center.

In addition to these things, we're developing and evaluating test systems. We have brought in researchers who have novel detection systems, and we're trying to move those into the biodefense area so they can be used against things like anthrax.

I think we have a video coming up, which shows some of the technologies that we're evaluating. Real time PCR is a method we routinely use in the laboratory, which can give us results in six hours. It can do a definitive preliminary rule-in in about six hours.

MODERATOR: Right.

CIRINO, N: And it's a polymerus chain reaction based method. Very robust, very sensitive, and we use it routinely. The other method we're going to talk about is FTRI. It's Fourier transformed infrared microscopy. And it's a way of characterizing white powders.

MODERATOR: Okay.

CIRINO, N: And so we use that after we rule-out anthrax. We can do a definitive rule-in. Again, I use that word a lot.

MODERATOR: Right.

CIRINO, N: Rule-out, rule-in. We can rule-in the different chemicals using this FTIR system.

MODERATOR: Right. Alright, well then let's show that video then.

[video begins]

CIRINO, N: Dr. Egan's using an FTIR microscope, which stands for foriay transformed infrared microscopy. And she's analyzing an unknown white powder. And it has an infrared spectra, which we compare to a database of different powders. And this powder is coming up as a known sample of talc, which is pretty common for some of the white powders we get. Talc, flour, baby powder. There's a diamond on the end of the microscope, and it comes in contact with the white powder. And the infrared light shines up through it and takes a spectra. And then we compare that spectra to different spectra in the database.

This cannot rule in a biological agent, but what it can do is it can tell you if it's a hoax. It can tell you if it's a common chemical that we might find.

Real time PCR is a way of amplifying and detecting the DNA that's present in the different bacteria that we're looking for. So as you can see on this screen, we've done dilutions of a known positive sample. And you can see here we had a high concentration. And every time we made a dilution, we detected less and less. It shows that we're getting simultaneous amplification and detention of these nucleic acids in a real time PCR machine.

MODERATOR: So not a simple process, right?

CIRINO, N: No.

MODERATOR: But a lot of talc. [laughter]

EGAN, C.: A lot of white powder.

MODERATOR: A lot of white powder. In your SERVE acronym that we've shown a couple of times. The last two letters stand for validation and evaluation.

CIRINO, N: Uh-huh (affirmative).

MODERATOR: Do you want to give us a little fill in on that?

CIRINO, N: As I said, the Wadsworth Center has very unique capabilities. Not only facilities but staffing, education, collaboration, integration with other scientific expertise, chemistry, physics. And so we do a lot of validation and evaluation. As I said, companies who develop an assay for e-coli, which is a pretty common bacterial pathogen, may want to try to break into the select agent market. And they want to look at anthrax or plague and see if their system will work on those organisms.

And so they would ask us to use their system against these agents. And so we've worked with various government and corporate agencies to validate methods. And some of these methods are used in health security. We worked with one company to validate a method, which has now been FDA approved, to do clinical rule-in of anthrax.

MODERATOR: I see.

CIRINO, N: And so it's been very useful. And we use that material now. But we were involved in early stage of evaluation, and so this type of -- It is research. But this type of contract research, if you will, allows us to stay on the cutting edge of technology and see where the technology is going. So we're constantly improving our capabilities at the Wadsworth Center so we can detect these things.

MODERATOR: And I've got to assume that there's a tremendous investment in this kind of looking for this new technology in the last three or four years, both in the private sector and by the government, of course.

CIRINO, N: Yes.

MODERATOR: We've talked about some of the tests that we're trying to develop now.

CIRINO, N: Yes. The Federal Government has invested a lot of money to buy defense. And that money is co-utilized for infectious diseases. We would not have been able to respond as quickly as we did to SARS or monkey pox if we did not have this biodefense money. As I said, it's becoming an integrated network. It's health security. It's not just public health. It's a network where we can co-utilize biodefense funds for emerging diseases to help the public.

MODERATOR: Well, regrettably, we probably need to all become familiar with the term health security in a new way, right? I'm not sure that we have time for questions to be phoned in, but we do have a couple that have already been faxed in. And I'd like to pose them to you, because I think we have a couple of minutes here.

Number one question that came in, how does the Wadsworth Lab collaborate with hospital labs? I know hospital labs would fit in the first level of clinical --

CIRINO, N: Sentinel laboratories.

MODERATOR: Sentinel laboratories, yeah.

EGAN, C.: Well, there's several ways. There are several researchers and are also in our service laboratories that collaborate on research projects for various diagnostic testing capabilities. And we also collaborate, if you will, in a sense by performing outreach to these clinical laboratories. And we are always available at is our New York State laboratory response network for answering any types of questions they have, especially with the new regulations now since the select agent rule has been passed.

CIRINO, N: Last year we went out to five sites across New York State to talk to sentinel laboratories, and we gave them information on the select agents and rule-in and rule-out regulations and biosecurity and biosafety. And it was very well received. And we plan on going out in the next year again.

MODERATOR: Okay. I assume there's a lot of telephone traffic, too, between laboratories all the time, right?

EGAN, C.: Absolutely.

CIRINO, N: Yes.

MODERATOR: There is a fax number on the screen there. If people have questions they would like to fax in now, please go ahead. We have a couple more, and we'll see what we have time for. Stepping back from the sentinel system of the laboratories and the professionals, what steps should a member of the public take if he or she may find an unknown substance, the baby powder fear?

CIRINO, N: The first step is always contact law enforcement. All of these are considered crimes. We have worked hoaxes with state police, local law enforcement, and the FBI. And law enforcement should be called in. If law enforcement deems that it is a credible threat, they will call in HAZMAT, typically to collect the sample if they feel uncomfortable. And then HAZMAT and law enforcement in collaboration will get the sample to an LRN testing facility.

MODERATOR: I see. Then it plugs into the system we've talked about already in terms of law enforcement getting (Indiscernible).

CIRINO, N: Correct.

EGAN, C.: Correct.

CIRINO, N: The public should not try to collect the sample. The public cannot submit samples.

MODERATOR: Right.

CIRINO, N: They should contact law enforcement who can do the credibility assessment. And again, during our outreach, the first responders needed criteria, because powder in the donut box is not a credible threat.

MODERATOR: Right.

CIRINO, N: Although people may think it is because there was powder and it wasn't there two minutes ago, it just probably meant you didn't notice it two minutes ago.

MODERATOR: Right.

CIRINO, N: And we need to give law enforcement and first responders a means to say this is not a credible threat. We'll dispose of it for you, but it's not being submitted for testing. And we need to do this training now in a time when we're only getting a few samples a week so that when or if the next bioterrorist event occurs, law enforcement has the confidence to say this is a credible threat. This is a non-credible threat.

MODERATOR: Right. And I remember many clinic staff getting upset. Any closing remarks you'd like to make before we wrap up here?

CIRINO, N: I just want to thank you for the opportunity to talk to your audience and wish you well on the next talks.

MODERATOR: Alright. Aware and prepare is the code word.

EGAN, C.: That's the New York State logo for biodefense, bioterrorism preparedness.

MODERATOR: Alright. Now if viewers have questions after they may view this presentation on the website, but if they have any direct questions for you at the Wadsworth Lab, what's the best way to contact Wadsworth?

EGAN, C.: Well, they can call us directly at the number on the slide, 518-474-4177. And if there are any questions or people want some more information on the research that's going on at the Wadsworth Center, you can visit our website at www.wadsworth.org.

MODERATOR: Alright. Well, I'm afraid that's all the time we have. It's been a fascinating hour. I thank you very much. And I'd like to -- I'm sure the audience thanks you both, too, for joining us today and sharing all this wealth of information.

Before we close, I'd like all of you in the audience to take a moment to please fill out your evaluations either online or by sending a printed copy to us at the University at Albany Center for Public Health Preparedness. We appreciate your feedback.

This program will be available online, as I've said. Please check our website for more details. Thank you very much for joining us, and we hope you'll tune in again next month on January 6th for our program entitled, Accessing Chemical Exposure, a Different Approach, with Dr. George Eden, Director of the Division for Environmental Disease Prevention at the New York State Department of Health.

Until then, we hope you have a happy and safe holiday season and a wonderful start to the new year. I'm Peter Slocum. See you next time at the University at Albany Center for Public Health Preparedness Grand Rounds series. Thank you.

CIRINO, N: Thank you.

EGAN, C.: Thank you.

(END OF AUDIO)

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