New Lab Matters: Sharing the value of public health laboratories

New Lab Matters: Sharing the value of public health laboratories |

The need for a laboratory voice in budgetary discussions has become more urgent recently, and “human-to-human relationships” are as critical as technical knowledge. So how does a public health laboratory raise its profile within the community? By telling a good story…over and over again.

In the summer issue of Lab Matters, our feature article examines how laboratories are sharing their value, one interview, photo or outreach moment at a time.

Here are just a few of this issue’s highlights:

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The post New Lab Matters: Sharing the value of public health laboratories appeared first on APHL Lab Blog.

NCBI’s Virus Variation Resource Enhancements Include Standardized Search Criteria

NCBI’s Virus Variation resource makes it easy to find genome and protein sequences for a number of viruses – no more stumbling through multiple synonyms to find what you need. Now you can search using standardized biological criteria and intuitive … Continue reading

Sensitive CRISPR diagnostics using RNA targeting CRISPR enzyme

0000-0002-8715-28960000-0003-0319-5416 I was recently involved in a collaboration between the Zhang and Collins labs at MIT to use the RNA-targeting CRISPR protein Cas13a/C2c2 to detect either DNA or RNA from pathogens. By combining the use of Cas13a/C2c2

10 Years of PLOS Neglected Tropical Diseases

0000-0002-8715-2896 10 Years of PLOS Neglected Tropical Diseases   post-info AddThis Sharing Buttons above Publications Manager Charlotte Bhaskar celebrates PLOS Neglected Tropical Diseases 10 year anniversary and looks forward to upcoming events and initiatives for

Battling Biting Mosquitoes and Jumping Genes in 2016

NCEZID microbiologist Jane Basile shows how to use the new yellow fever test kit that in less than 4 hours yields results that are as accurate as the older 2-day test.

Last year, an expert from the CDC National Center for Emerging and Zoonotic Diseases (NCEZID) found himself in an unlikely position: guest starring on a popular Navajo language radio program to field questions about hantavirus infection. Hantavirus is caused by contact with mouse droppings and can sometimes be fatal.

This is just one example of how NCEZID has worked over the past year to confront a wide range of infectious disease concerns. From antibiotic resistance to Zika, last year’s threats required rapid and innovative responses, and CDC experts stepped up to the plate. Below are just a few of highlights from 2016.

Fighting the bite

In 2016, the mosquito was a major culprit. Zika virus became the first known mosquito-borne virus that can cause major birth defects, and we continue to learn about Zika virus every day. The Zika virus outbreaks in the Americas and other parts of the globe required a massive response, which is hands-down a top accomplishment for 2016. The consequences of Zika can be devastating, and stopping the epidemic has been anything but simple. It has involved expertise from many fields, including mosquito control, pregnancy and birth defects, laboratory, epidemiology, blood safety, communication, and the list goes on. NCEZID led that effort and, by the end of the year, more than 2,000 CDC staff members had been part of the Zika response.

Confronting an imminent threat

Imagine a post-antibiotic world where bacteria no longer respond to the drugs designed to kill them. It’s a real threat, and many consider it the most concerning challenge to our country’s health. CDC has made the fight against antibiotic resistance a priority, and our transformative investments nationwide can be seen using the interactive AR Investment Map. This work includes establishing a new lab network in 2016 with expanded lab capacity in all 50 states.

Tackling illnesses caused by food

What do packaged salads and raw flour have in common? In 2016, both made dozens of people sick. For the first time, NCEZID experts conclusively showed that these foods were linked to specific bacteria that caused outbreaks. Whole genome sequencing helped connect the dots by showing that flour was the cause of an E. coli outbreak that made 60 people in 24 states sick, a third of whom were hospitalized. Some reported eating raw dough or raw batter. Whole genome sequencing also helped determine that an outbreak of listeriosis, which resulted in at least one death and 30 hospitalizations in the United States and Canada, was caused by eating packaged salads. As a result, the company that produced the salads recalled all brands produced at a single US facility.

Responding to rare infections

The jumping gene. A fungus that can cause bloodstream infections. A rare bacteria found in water. These are brief descriptions of three new or rarely seen emerging infectious threats that caused heightened concern in 2016. We worked to identify and contain the mcr-1 – or “jumping” – gene, which can make bacteria resistant to an antibiotic that is a last resort for some infections. A report by our experts also detailed the first US cases of Candida auris, an emerging fungus that is resistant to drugs and can cause serious – and sometimes deadly – blood infections. And, after the first cases of the rare Elizabethkingia infection were reported in Wisconsin, our scientists assisted the Wisconsin and Michigan state health laboratories in investigating the outbreak that would sicken almost 60 people and cause 20 deaths.

Assisting the response to hantavirus in Navajo Nation

NCEZID’s Craig Manning (left) fields a question about hantavirus from KTNN-AM radio host Navajo Bob during the live call-in program.

When a young woman from Navajo Nation in western United States died from an uncommon respiratory infection in early 2016, CDC experts stepped in to help. The problem was hantavirus which is spread by deer mice and causes a serious, sometimes lethal, respiratory infection. NCEZID experts worked with Navajo leaders to share information about hantavirus and create messages on preventing infection, including messages broadcast on a popular Navajo language radio station.

For more on the top infectious threats of 2016 and how we confronted them, please see the NCEZID 2016 Accomplishments.

10 Ways CDC Gets Ready For Emergencies

Dr. Stephen Redd, Director, Office of Public Health Preparedness and Response
Dr. Stephen Redd, Director, Office of Public Health Preparedness and Response

One of the best parts of my job is the opportunity to learn from a wide range of experiences. We have an obligation to not only respond to emergencies today, but to prepare for tomorrow by learning from the past. Our work extends to households affected by disease, communities ravaged by disasters, and U.S. territories battling new and changing threats. In fact, all over the world – we try to get ahead of, and manage, complex responses that touch many lives through ever changing circumstances. In an ideal world the health in every community would be at a level that would make recovery and reliance easier. The reality is that emergencies happen in all kinds of environments and populations.

The Public Health Preparedness and Response National Snapshot is our annual report that gives us an opportunity to showcase the work that we and our state partners do. The report reminds us that no matter how big the emergency, we need to work together to respond to the best of our ability—with the cards we are dealt.

Here are 10 ways CDC’s Office of Public Health Preparedness and Emergency Response worked to keep people safer in 2016 that can inform our work going forward.

1) Four Responses at Once: An Unprecedented Challenge

CDC experts continue to provide 24/7 monitoring, staffing, resources, and coordination in response to natural disasters, terrorist attacks, and infectious disease threats. In early 2016, CDC managed four public health emergencies at the same time through our Emergency Operations Center :

  • Ebola
  • Flint, Michigan, Water Quality
  • Zika Virus
  • Polio Eradication

See us in action:

2) A Complex Threat: Zika Hits the U.S.

CDC scientists and responders were activated in CDC’s Emergency Operations Center, where they combed through research, developed and distributed diagnostic tests, and provided on-the-ground mosquito control and education to protect people at higher risk for the virus, including pregnant women and infants.

3) Right Resources, Right Place, Right Time

CDC’s Strategic National Stockpile is ready to send critical medical supplies quickly to where they are needed most to save lives. The stockpile is the nation’s largest supply of life-saving pharmaceuticals and medical supplies that can be used in a public health emergency if local supplies run out.

Last year, we helped conduct 18 full-scale exercises and provided training for 2,232 federal and state, local, tribal, and territorial emergency responders to ensure that systems for delivering medicines are functioning well before they are needed in an actual emergency. We continue to work with our federal, state, local, and commercial partners to make sure every step of the medical supply chain – from manufacture to delivery – is coordinated.

4) State and Local Readiness

CDC connects with state and local partners to provide support and guidance, helping every community get ready to handle emergencies like floods, hurricanes, wildfires, or disease outbreaks.

This year, we created a new process to evaluate how well state and local jurisdictions can plan and execute a large-scale response requiring the rapid distribution of critical medicines and supplies. Through this program, we conducted assessments of 487 state and local public health departments. The information from these assessments will be used to help improve the ability to get emergency supplies quickly to those who need them most.

5) Cutting-Edge Science to Find and Stop Disease

To protect lifesaving research, CDC experts in biosafety and biosecurity conducted approximately 200 laboratory inspections and thousands of assessments of those who handle dangerous select agents and toxins like anthrax, plague, and ricin to keep these materials safe, secure, and out of the hands of those who might misuse them.

CDC’s Laboratory Response Network (LRN)l also develops and deploys tests to combat our country’s most pressing infectious and non-infectious health issues, from Ebola to Zika virus to opioid overdose. The network connects over 150 labs to respond quickly to high priority public health emergencies.

6) Protecting Our Most Vulnerable

CDC supports efforts all across the country to help those who may not be able to help themselves when a crisis strikes. Some populations, like children, older adults, and others with functional and access needs may need extra help during and after an emergency.

From planning for the 69 million children who may be in school when disaster strikes to the millions of Americans who need to make sure prescriptions are filled, medical equipment is working, and help arrives even if power is out and roads are blocked, it’s up to us to protect our most vulnerable in emergencies.

7) Emergency Leaders: The Future of Incident Response

When every minute counts, we need people who have the knowledge to step in and take immediate action. Learning and using a common framework like the CDC Incident Management System helps responders “speak the same language” during an event and work more seamlessly together.

CDC experts train leaders from around the world—25 countries in 2016—through an innovative, four-month fellowship based at our Atlanta headquarters. Lessons learned from this course were put to work immediately to head off an outbreak of H5N1 influenza in Cameroon.

8) The Power of Preparedness: National Preparedness Month

Throughout September, CDC and more than 3,000 organizations—national, regional, and local governments, as well as private and public organizations— supported emergency preparedness efforts and encouraged Americans to take action.

The theme for National Preparedness Month 2016 was “The Power of Preparedness.” During our 2016 campaign , we recognized the successes of countries and cities who have seen the direct benefits of being prepared, looked at innovative programs to help children and people with disabilities get ready for emergencies, and provided tips for home and family on making emergency kits.

9) Health Security: How is the U.S. Doing?

As part of the Global Health Security Agenda, teams of international experts travel to countries to report on how well public health systems are working to prevent, detect, and respond to outbreaks. In May, a team made a five-day visit to the U.S. to look at how well we’re doing.

In the final report, the assessment team concluded that, “the U.S. has extensive and effective systems to reduce the risks and impacts of major public health emergencies, and actively participates in the global health security system.” They recognized the high level of scientific expertise within CDC and other federal agencies, and the excellent reporting mechanisms managed by the federal government.

10) Helping YOU Make a Difference

Get a flu shot. Wash your hands. Make a kit. Be careful in winter weather. Prepare for your holidays. Be aware of natural disasters or circulating illnesses that may affect you or those you care about. There are many ways to prepare, and in 2016 we provided the latest science and information to empower every one of us to take action.

Every person needs knowledge to prepare their home, family, and community against disease or disaster before an emergency strikes. Whether it’s how to clean mold from a flooded home, how to wash your hands the right way, or how to use your brain in emergencies, our timely tips and advice put the power of preparedness in your hands. From the hidden dangers of hurricanes to the heartbreaking dangers of flu, there are steps we can all take to stay safe every day as we work toward a healthy and protected future.

For more ways we are helping protect America’s health, check out the new National Preparedness Snapshot.

To find out more about the issues and why this work matters, visit our website.


Leading the Zika relay race and other presidential priorities for 2017

Leading the Zika Relay Race and other Presidential Priorities for 2017 |

By A. Christian Whelen, PhD, D(ABMM), laboratory director, Hawaii Department of Health State Laboratories; president, APHL Board of Directors

Hau`oli Makahiki Hou (“Happy New Year” in Hawaiian)! In 2017, APHL and its members face some significant undertakings. From Zika to superbugs, public health laboratories can and should utilize their extensive experience and knowledge coupled with new approaches to tackle these pressing issues.

As APHL’s president, these are my top three priorities for 2017:

Coordinated & Integrated Zika Testing

We’ve been here before. Specimens flood into our public health laboratories because of a new threat, and we work with local and national partners to establish algorithms, activate our response and continuity plans, and do what it takes to stop it. The Zika virus outbreak has been unique in its own right. Most of the people infected don’t get sick, yet it causes potentially life-threatening birth defects. It’s mosquito-borne AND sexually-transmitted. Cross-reactivity in serological tests with other flaviviruses like dengue disrupts screening and confuses confirmation. We clearly had our work cut out for us from the beginning, and the problem wasn’t going away anytime soon. Consequently, a successful and sustained response to this threat is going to require corporate, clinical and public health coordination and integration.

Coordination: Public health laboratory leaders need to reach out and bring together stakeholders. We need to identify barriers to timely case identification and specimen transport (pre-analytic) as well as meaningful results delivery (post-analytic). We need to continue to improve Zika algorithms, and keep everyone informed of those changes. We need to convene the meetings today that will outline our activities month and years from now.

Integration: We need to help corporate test developers understand testing demands and requirements so they can leverage their strengths to make new tests available to our clinical partners. We need to work with developers, regulators and clinical partners to ensure that we maintain continuity if/when transitioning testing to non-public health labs. We need to ensure reporting to public health is not overlooked and that access to confirmatory services are available.

So, the Zika response is a bit like a relay race. We have the baton now, but we also need to make sure it is firmly in the hands of another “runner” before we let go. APHL is committed to helping with this; I certainly am as president.

Learn more about Zika testing

Smarter Antimicrobic Therapy

Speaking of races, the bugs seem to be beating the drugs. Alarming resistance mechanisms have (finally) gotten enough attention for us to witness significant funding for public health efforts to combat the antimicrobial resistance epidemic. Lab folks may not control prescriptions, but we need to get in the game with providers, epidemiologists, pharmacists, clinical labs and manufacturers to reassert our collective dominance over the single cell super bugs. We need to get advanced detection and characterization methodologies validated and available to improve antibiotic awareness that can lead to better decisions for individuals (e.g., detection of Tamiflu-resistant influenza A, confirmation of carbapenemase-resistant Enterobacteriaceae, etc.) and populations (e.g., high-quality antibiograms, etc.) In 2017, the Antimicrobial Resistance Laboratory Network will begin providing services, and the new APHL/CDC Antimicrobial Resistance Fellowship, which offers master’s and doctoral level graduates the chance to explore related topics, will welcome its first cohort. Hard work at multiple levels is needed to reverse losses in the efficacy of life-saving therapeutics.

Learn more about antimicrobial resistance

Laboratory Science Leadership

Whether we like it or not, our communities look to public health laboratory scientists for leadership. This role extends far beyond the position description we read before getting hired for our jobs. It’s more than managing the people we directly supervise. It’s influencing people, policy and procedures throughout our sphere of influence. APHL’s vision is a healthier world through quality laboratory systems, so we cannot limit ourselves to those resources we control directly. We need to provide leadership throughout our sphere of influence. That can be as big as testifying on Capitol Hill, or as (seemingly) small as encouraging a student on his or her science project. The opportunities are TNTC*, however in the two subjects I outline above, the emphasis is on initiating and leading cross-cutting collaborations that strengthen laboratory systems and make the world a safer place.

Hmmm, not a bad thing to list as an accomplishment to get your boss’ attention during your next performance evaluation…am I right?

*TNTC – Too numerous to count; an amusing reference to the acronym used in microbial quantitative plate counting.

The post Leading the Zika relay race and other presidential priorities for 2017 appeared first on APHL Lab Blog.

APHL’s top 10 blog posts of 2016

APHL's top 10 blog posts of 2016 |

There is never a dull year in public health, but 2016 seemed particularly eventful. From Zika to the twentieth anniversary of PulseNet, APHL’s top blog posts reflect the ups and downs of the year. Even if it was tumultuous at times, we are extremely proud of the work done by our members, partners and staff to protect the public’s health and safety. You are all truly heroes in our book!

10. APHL: US needs an environmental health surveillance system to prevent crises like Flint

9. One Team, One Purpose: The Role of USDA’s Food Safety and Inspection Service in Keeping Food Safe

8. Virginia: PFGE and whole genome sequencing show Salmonella outbreak who’s boss

7. Random dog food sample proved critical in solving human illness outbreak

6. Addition of lysosomal storage disorders to newborn screening panels is complex and highly emotional

5. Inside the public health lab Zika response: ‘It’s the great unknown as to how much longer this will go on’

4. Everything you need for Lab Week 2016

3. 3 Zika tests explained

2. Zika: Old virus, new challenges

The top blog post for 2016 was…

1. Sprouts: Just say no?

The post APHL’s top 10 blog posts of 2016 appeared first on APHL Lab Blog.

Looking Back: 5 Big Lessons from 2016

Looking through the rearview mirror while driving in the planes

Dr. Stephen Redd, Director, Office of Public Health Preparedness and Response
Dr. Stephen Redd, Director, Office of Public Health Preparedness and Response

CDC is always there – before, during, and after emergencies – and 2016 was no exception. Through it all, we’ve brought you the best and latest science-based information on being prepared and staying safe. Here’s a look back at 5 big lessons from a very eventful year. Follow the links to discover the full stories!

1. Expect the unexpected

Emergencies can devastate a single area, as we saw with Hurricane Matthew, or span the globe, like Zika virus. This year has shown us, once again, that we can’t predict the next disaster.

Zika virus was one of the top public health stories of 2016, and will continue to make headlines in 2017. CDC has worked hard since the start of the outbreak to make sure that people know how Zika is spread and how to protect themselves and their neighbors from the virus, including how to control mosquitos inside and outside the home.

This year, our Strategic National Stockpile was called on to locate and purchase the products to assemble ~25,000 Zika Prevention Kits for pregnant women in the U.S. territories. CDC also issued 180 Zika virus import permits so scientists could conduct research to develop better diagnostic tests, vaccine, and medicines. In any developing crisis, our mission is always to “conduct critical science to inform and communicate health information that protects our nation” against public health threats.

2. A health threat anywhere is a threat everywhereAbout 2/3 of the world remains unprepared to handle a public health emergency.

Diseases like SARS and Ebola – and now Zika – compel us to focus on stopping outbreaks early and close to the source. As part of the Global Health Security Agenda, teams of international experts travel to countries, including the U.S., to report on how well their public health systems are working to prevent, detect, and respond to outbreaks. This assessment process is called the Joint External Evaluation.

In 2016, we worked at home and around the world to use the law to prepare for global health emergencies, train leaders from 25 countries in public health emergency management, and protect the health of those affected by humanitarian crises.

3. Kids and communities matter

Fred in bathtub

There’s a saying in emergency management that goes something like, “emergencies begin and end locally.” Truer words were never spoken. The minutes, hours, and days immediately following a disaster are the most critical for saving lives, and local communities are our first responders. Every community needs to be resilient and prepared to handle the unexpected.

Prepared communities look like the Georgia Department of Public Health, which conducted a statewide exercise to practice their response to a bioterrorist attack of plague, and New York City, which used lessons learned from West Nile virus to prepare for Zika.

Children are a particularly vulnerable part of our communities, and they have different needs than adults. Children need to be included and involved in planning and preparing for emergencies.

Fred the Preparedness Dog sets a great example by visiting schools across Kansas to teach kids to get a kit, make a plan, and be informed. Parents should also take steps to prepare themselves and their child in case they get separated during or after an emergency.

4. Words save lives

7 Things to Consider When Communicating About Health

In an emergency, the right message at the right time from the right person can save lives. When a crisis hits, communicators need to quickly and clearly inform people about health and safety threats. Communication is especially critical when disaster strikes suddenly and people need to take action right away, as in a flood or hurricane, or when we may not yet have all the answers, as happened with Zika virus.

To make sure people know what to do to protect their health, our trained communicators learn how to put themselves in others’ shoes: Who are the people receiving the message, what do they need to know, and how do they get information? We apply the principles of Crisis and Emergency Risk Communication in every emergency response.

5. Preparedness starts with you


Get a flu shotWash your handsMake a kit. Be careful in winter weather. Prepare for your holidays. Be aware of natural disasters or circulating illnesses that may affect you or those you care about.

There are many ways to prepare, and in 2016 we provided the latest science and information to empower every one of us to take action. Whether we talked about how to clean mold from a flooded home, how to wash your hands the right way, or how to use your brain in emergencies, our timely tips and advice put the power of preparedness in your hands. What you do with it is up to you. Our hope is that you’ll resolve to be better prepared in 2017.

Inside the public health lab Zika response: ‘It’s the great unknown as to how much longer this will go on’

Inside the public health lab Zika response |

By Kim Krisberg

Public health laboratory scientists are well used to the preparations and demands that come with emerging disease threats. But Zika virus is different.

“With SARS, West Nile virus, H1N1 flu, mumps outbreaks — those came and were gone in a few months,” said Michael Pentella, PhD, director of the state public health laboratory at the Massachusetts Department of Public Health. “We’ve been ramping up and dealing with Zika for a long period of time now and there’s no end in sight.”

While the Aedes aegypti mosquito — the species by which Zika is most commonly spread — is not found in Massachusetts, the state’s public health lab began preparing for the disease in late 2015. At first, the pace of testing was fairly slow, Pentella said, with the lab receiving less than 20 specimens a week as of January. The weekly volume quickly ramped up to about 150 a week in February, then slowed around the time that officials began warning at-risk populations to avoid travel to high-transmission regions. As of early September, volume was back up, with about 130 specimens arriving at the Massachusetts state lab every week. Most of those specimens are coming from Massachusetts residents, but the lab is also providing testing for a handful of other states where Zika testing is not yet fully operational.

At the moment, Pentella said Zika testing is “by no means overwhelming” the lab’s capacity, though he said it is adding significantly to staff workload. He is worried, however, that if another health threat arises on top of Zika, it could quickly push the lab to capacity. For example, the same personnel who conduct Zika testing also perform influenza testing. So if the upcoming flu season is particularly bad or a new flu strain emerges as Zika demands continue inching upward, “I’m very worried about our ability to handle both at the same time,” Pentella said.

Public health systems, including labs, continually prepare and practice for the possibility of outbreaks and disasters, and staff are ready for the additional duties that come with understanding, monitoring and containing a dangerous pathogen. Still, effective and sustained response requires sufficient funding. And in the case of Zika — a complicated disease with multiple modes of transmission and the potential for devastating birth defects — that funding has hardly been forthcoming. As of Sept. 20, with more than 20,000 Zika cases confirmed in U.S. states and territories, including 43 locally acquired cases in U.S. states, Congress had yet to authorize emergency funding for Zika response.

The White House first submitted its request for $1.9 billion in emergency Zika funds back in February based on recommendations from the scientific and public health community. But instead of acting quickly on those recommendations, Congress deadlocked on the issue. To make matters worse, that inaction comes on top of years of declining public health preparedness funding at the federal level as well as declining state and local public health budgets. Inside a public health lab, that funding inaction can have an acute effect. The equipment and its maintenance are expensive, the training is complex and the skill set is competitive. Yet, public health labs are indispensable to combating a disease like Zika. They provide the data that shape and drive effective interventions and provide testing services for all residents, regardless of their ability to pay.

And even though the U.S. is well into mosquito season, public health officials like Pentella say federal emergency funding is still needed — urgently.

“We need to take the broader perspective and look longer term so we’re not constantly on this yo-yo of ramping up and ramping down because funding goes away,” he said. “[Federal Zika funding] is becoming more urgent every day. I see the possibility of us falling behind and it will limit our capacity to respond. It really is tying our hands when we need to have all hands on deck.”

Zika lab response: ‘We’re in a very tenuous place’

Today, thankfully, there is nationwide coverage for the three tests used to screen for Zika virus, with public health labs bearing the majority of the testing burden but some commercial and clinical labs receiving authorization from the Centers for Disease Control and Prevention (CDC) to test as well. What’s unique about Zika, however, is that it requires both molecular and serological diagnostics.

Inside the public health lab Zika response | www.APHLblog.orgOn the molecular side, nearly every public health lab in the country has been confirmed to screen for Zika via polymerase chain reaction (PCR) testing, which CDC recommends for symptomatic patients tested less than 14 days after the initial onset of symptoms as well as for asymptomatic pregnant women who may have been exposed to the mosquito-borne virus. A positive PCR requires no follow-up. If the result is negative, however, the next step is serological testing using the IgM Antibody Capture Enzyme-Linked Immunosorbent Assay (MAC-ELISA), which detects the antibodies the body uses to fend off Zika infection.

In addition to confirming a negative PCR result, the serological test is recommended for asymptomatic pregnant women tested 14 or more days after potential virus exposure as well as for symptomatic patients beyond the 14-day window from initial onset. The challenge is that the MAC-ELISA is incredibly complicated, the throughput takes days longer than PCR, and, in general, serological testing isn’t a typical component of a lab’s surge response.

Plus, many public health labs have either cut back or stopped ELISA testing altogether because of previous funding cuts, said Chris Mangal, director of public health preparedness and response at APHL. Those funding cuts meant many labs have had to spend valuable time and resources bringing their serological capacity back to the frontline. As of late summer, 43 public health labs could test for Zika using the MAC-ELISA.

“When Congress opts to not provide resources for these emerging threats, it has a big effect,” Mangal said. “Yes, they’re prepared by virtue of their membership in the [CDC Laboratory Response Network (LRN)], but you still have to keep replacing the gas in the gas tank, if you will. That one tank of gas won’t get you across the country.”

The MAC-ELISA may be the best way to identify Zika in asymptomatic patients, but it’s also incredibly nonspecific, said Kelly Wroblewski, director of infectious diseases at APHL. In other words, the ELISA can also pick up antibodies to dengue and West Nile virus, which are in the same genus of viruses as Zika, and that means a positive ELISA for Zika has to be confirmed with yet another highly complex test — the plaque reduction neutralization test (PRNT) — that only a small number of public health labs and CDC have the capacity to perform.

Fortunately, Wroblewski said, most labs are currently able to handle the volume of specimens coming their way, with the exception of Florida, which is being bombarded with testing demands in the wake of local mosquito transmission.

As of September 20, the Florida Department of Health reported nearly 700 travel-related Zika cases and 89 non-travel-related cases, 87 of which involved pregnant women. It also reported that the department had conducted Zika testing for more than 7,815 people so far, noting that it only has the capacity to test 4,930 people for active Zika (PCR) and 8,364 for Zika antibodies (ELISA). Florida is home to both mosquito species that carry Zika and mosquito season in the Sunshine State is pretty much year-round.

“I think we’re in a very tenuous place,” Wroblewski said. “This isn’t going to be something that goes away after mosquito season is over. The public health system has done an amazing job responding without congressional support…but once the immediate danger is over, we’re very likely going to be in the same position rolling into next mosquito season.”

Labs in action: High-risk to Big Apple

Texas is considered a high-risk state for Zika, as it shares a border with Mexico and is home to both mosquito species that transmit the virus. As of September 20, Texas had 195 reported cases of Zika, all travel-related or transmitted via sexual contact.

At the state public health lab in the capital of Austin, Grace Kubin, PhD, director of the Laboratory Services Section at the Texas Department of State Health Services, said the volume of Zika-related specimens arriving at the Austin lab every day has doubled since February — as of early September, the volume was about 50 a day. However, that number would be a good bit larger if Texas wasn’t able to spread its Zika testing demands across its network of state and local public health labs. Kubin said almost all LRN public health labs in Texas can perform the more rapid PCR test, while Austin- and Dallas-based public health labs can perform serological testing, with labs in Houston and San Antonio working to bring serological capacity online as well.

“I’m happy to report that of the specimens coming in, we seem to be keeping up,” Kubin said. “We don’t have a backlog for either PCR or serology. We’ve gotten to a comfortable place right now, where we’re able to test whatever comes our way.”

Bringing testing capacity online had its challenges, Kubin reported. While the PCR process was fairly typical, the serological response, i.e. MAC-ELISA, was much more difficult. The MAC-ELISA, which received emergency use authorization in February, came with very specific biosafety guidelines that apply to serious or potentially lethal agents and complying with those guidelines is no easy task, Kubin said. Another challenge for labs is simply the time it takes to run a MAC-ELISA. For example, for the PCR test, the Austin lab can process a plate of 38 specimens in just a few hours. Serology also runs on a plate, but it holds just eight specimens and takes three days to process. To speed things up, the Austin lab set up a new system that allows it to process multiple serology plates each day.

“We have a little bit of extra room that maybe other labs don’t have,” Kubin said, noting that the Austin-based lab is one of the largest public health labs in the country. “Being such a large lab with a lot of testing divided out as far as molecular techniques being done in different areas…it allows us the ability to ask for additional help.”

Of course, once a local mosquito-transmitted Zika case is detected in Texas, testing demands will likely surge — a turn of events the Austin lab is preparing for at the same time it responds to daily Zika needs. Kubin said the Iowa state public health lab has already offered its assistance to Texas in case Zika demands begin to overwhelm the Lone Star state.

“Zika will continue to be the next new thing,” she said.

Inside the public health lab Zika response | www.APHLblog.orgThe Aedes aegypti mosquito doesn’t travel as far north as New York City, but its relative and potential Zika vector, the Aedes albopictus, does. According to the New York City Department of Health and Mental Hygiene as of Sept. 9, the city was home to 568 Zika cases, all travel-associated. Scott Hughes, PhD, associate director of environmental sciences at the New York City Public Health Laboratory, said the lab is receiving Zika-related specimens from about 50 patients every day. As of early September, the lab had performed testing for about 7,500 patients and received about 12,000 specimens. It began serological testing about two months ago.

In addition to human testing, the New York City lab is testing mosquitoes too, screening about 200 pools of trapped mosquitoes every week. Like other lab officials, Hughes said he is also concerned about the lab hitting capacity if another outbreak happens in the midst of Zika response.

“We really went from zero to 60 in a very short time,” Hughes said. An agency graphic shows that Zika testing requests for pregnant women went from zero in late March to nearly 2,500 in mid-July. “It’s the great unknown as to how much longer this will go on or whether this will become part of the everyday menu of tests we perform.”

Another Zika challenge both Hughes and Kubin mentioned was working with local obstetric/gynecology providers to receive specimens for testing, as such practices don’t typically work with public health labs. In New York City, the health department established a call center where providers can get more information; in Texas, public health officials partnered with professional pediatric and medical associations to disseminate information, among other measures. Out in California, Neil Silverman, MD, said educating medical providers is a “critical component” of Zika response.

A high-risk pregnancy specialist, Silverman is an obstetrician at the Center for Fetal Medicine & Women’s Ultrasound in Los Angeles and since February, has been serving as a perinatal consultant on Zika for the California Department of Public Health. In his consulting role, he helped craft messaging for obstetricians that not only educated on the nature and epidemiology of Zika, but on who should be tested and how to go about accessing testing. To paint a clearer picture of the process, Silverman pointed to his own experience.

Since the end of January, his practice has seen more than 200 pregnant women for Zika-related travel risks. At first, patient specimens were collected at the practice, then couriered to a nearby hospital lab, which then facilitated shipment to the county public health lab and on to CDC. Fortunately, the Los Angeles County public health lab now has Zika testing capability, but provider specimens are still couriered through a hospital lab. In particular, Silverman said, providers needed to know that any specimens sent to public health labs have to be accompanied with the proper epidemiologic paperwork; without it, testing can’t proceed.

“I get questions about Zika every single day,” he said about his practice. “The anxiety level is high and I think it’s only a matter of time before we start seeing some local cases.” As of September 16, California had no locally acquired Zika cases.

Silverman noted that as commercial labs have come online, it’s lessened the burden on California’s public health labs. But he also said that public health labs still offer one big advantage: they serve as a buffer against testing people who don’t need to be tested, making it easier for those truly at risk to access timely screening. Also, public health labs provide Zika testing for all those who need it, regardless of income or payer status, Silverman said, noting that one of the commercial labs his practice works with charges $165 upfront for Zika PCR testing.

“Our public health department and public health labs really are the boots on the ground,” he said. “They’re the sentinels when outbreaks occur, and it really is unfortunate that people don’t think of everything they do until there’s no money to fund them.”

Emergency funds still critically necessary  

Unfortunately, dealing with severe funding cuts and budget shortfalls while still maintaining core public health functions has become a mainstay of public health practice. However, in the face of a threat like Zika and its potential consequences for newborns and families, one would think emergency funding would be a slam-dunk.

Inside the public health lab Zika response | www.APHLblog.orgBut despite the concerted efforts of public health advocates, Congress has yet to authorize any emergency funding. In the face of such inaction, the White House redirected about $600 million away from Ebola response to fight Zika, and CDC was forced to redirect more than $44 million in Public Health Emergency Preparedness (PHEP) funds away from state and local health departments and toward national Zika response, though some of those funds returned to at-risk states and localities via CDC’s Epidemiology and Laboratory Capacity (ELC) program. The U.S. Department of Health and Human Services (HHS) redirected hundreds of millions of funds to domestic response as well, including $222 million that went to CDC.

But those are only stop-gap measures. In an August letter to key members of Congress, HHS Secretary Sylvia Burwell wrote that “CDC is on pace to virtually exhaust all of its domestic response funding by the end of the fiscal year.” Without additional funds, Burwell stated that CDC will have “severely limited” capacity to support mosquito control and surveillance and improve diagnostic Zika testing.

“Labs, like the rest of public health, are barely funded and because of that, they’re able to do a terrific job on a finite set of activities,” said Peter Kyriacopoulos, senior director of public policy at APHL. “For instance, they can do standard flu testing, but when there’s a pandemic flu outbreak they need additional resources because they’re working additional hours, using additional materials, using their machines more often, which leads to more maintenance…and all of that burden comes on top of their daily work. When you layer on top of that something like Ebola or Zika, that’s when the system begins to fray.”

In turn, federal emergency funding is still desperately needed, said Kyriacopoulos, who noted that APHL has had more meetings with congressional offices on Zika than it has on all other outbreaks combined. In particular, Kyriacopoulos worries that the inaction on Zika funding and resulting reprogramming of funds away from other public health priorities could set a dangerous precedent.

“Right now, we’re just kicking the can down the road,” he said. “This is not the way to effectively handle a public health crisis.”

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