The Observatory

Dec. 22, 2016

5 µg/dL
(micrograms per deciliter) of lead in blood is cause for concern.

45 µg/dL
of lead in blood recommends chelation therapy.

If you live in a home built this year or earlier, your home should be tested for lead contamination.

24 million
is the number of homes contaminated with lead.

4 million
is the number of households contaminated with lead that house children.

is the number of U.S. children ages one to five years who have blood lead levels high enough to damage their health.

is the number of preventable cases of blood lead poisoning.


Zika Virus

Patient blood management (PBM) is proposed as an approach to reduce the risk of Zika transmission through blood transfusion. As the Zika epidemic spreads in the U.S., the potential for contracting the disease via blood transfusion has emerged as a serious concern. The risk of transfusion-related ZIKV transmission, and recommended strategies to reduce that risk, were outlined recently in a special article in Anesthesia & Analgesia.

In addition to blood screening tests,  PBM can provide further protection by reducing the need for blood transfusion during surgery, according to the article by Drs. Lawrence Tim Goodnough of Stanford University and Marisa B. Marques of The University of Alabama at Birmingham. They write, “The principles and practices of perioperative PBM will reduce the risks from not only known but unknown risks of blood transfusion for our patients.”

“Blood centers have been bracing for the arrival of the virus in the United States’ blood supply since the beginning of 2016,” Goodnough and Marques write. Several approaches have been suggested, but all have limitations. For example, potential donors could be asked about recent travel to areas of active Zika infection—but they could still potentially be infected by sexual contact with an individual at risk. And because up to 80 percent of Zika infections cause no symptoms, simply asking blood donors if they are sick won’t prevent infected people from donating. For this reason, the FDA has recommended screening of donor blood using a nucleic acid test (NAT).

However, the NAT is still investigational. As the blood donor test for ZIKV was rolled out nationally in the fourth quarter of 2016, blood banks were faced with the challenge of managing two inventories: tested (labeled) blood units and untested units.

Goodnough and Marques suggest that PBM can also reduce the risk of transfusion-related Zika transmission. PBM seeks to reduce the need for blood transfusion by “consistently and rigorously” following steps to ensure that patients don’t have anemia before surgery; to reduce blood loss during surgery; and to use alternatives to transfusion, when possible.

Infectious Diseases

NIH-led effort examines use of big data for infectious disease surveillance. Big data derived from electronic health records, social media, the Internet, and other digital sources have the potential to provide more timely and detailed information on infectious disease threats or outbreaks than traditional surveillance methods. A team of scientists led by the NIH reviewed the growing body of research on the subject and has published its analyses in a special issue of The Journal of Infectious Diseases.

Traditional infectious disease surveillance—typically based on laboratory tests and other data collected by public health institutions—is the standard. However, the authors note, it can have time lags, is expensive to produce, and typically lacks the local resolution needed for accurate monitoring. Further, it can be cost-prohibitive in low-income countries. In contrast, big data streams from internet queries, for example, are available in real time and can track disease activity locally—though they have their own biases. Hybrid tools that combine traditional surveillance and big data sets may provide a way forward, the scientists suggest, serving to complement, rather than replace, existing methods.

“The ultimate goal is to be able to forecast the size, peak, or trajectory of an outbreak weeks or months in advance in order to better respond to infectious disease threats. Integrating big data in surveillance is a first step toward this long-term goal,” says Cecile Viboud, PhD, co-editor of the supplement and a senior scientist at the NIH’s Fogarty International Center. “Now that we have demonstrated proof of concept by comparing data sets in high-income countries, we can examine these models in low-resource settings where traditional surveillance is sparse.”

Experts in epidemiology, computer science, and modeling collaborated on the supplement’s 10 articles. They report on the opportunities and challenges associated with three types of data: medical encounter files, such as records from healthcare facilities and insurance claim forms; crowdsourced data collected from volunteers who self-report symptoms in near-real time; and data generated by the use of social media, the Internet, and mobile phones, which may include self-reporting of health, behavior, and travel information to help elucidate disease transmission.

But big data’s potential must be tempered with caution. Non-traditional data streams may lack key demographic identifiers such as age and sex, or provide information that under-represents infants, children, the elderly, and developing countries. Social media outlets may not be stable sources of data, as they can disappear if there is a loss of interest or financing. Most important, any novel data stream must be validated against established infectious disease surveillance data and systems, the authors said.

New Assays

Saliva test may predict future onset of Alzheimer’s disease. Aurin Biotech has announced that it has developed a simple saliva test that, the company asserts, can diagnose Alzheimer’s disease, as well as predict its future onset, allowing individuals to take possibly preventive measures before the disease takes hold.

The test is based on measuring the concentration of amyloid beta protein 42 (Abeta42) secreted in saliva. Abeta42 is the material which accumulates in the brain of Alzheimer disease cases and causes neuroinflammation which kills brain neurons.

“The number of cases studied is small, but our results are so remarkable, we felt they should be made widely available,” explains Dr. Pat McGeer, President and CEO of Aurin Biotech. “If individuals know they are destined to develop Alzheimer’s disease, they can initiate preventive measures. These might include taking over-the-counter non-steroidal anti-inflammatory drugs such as ibuprofen, drinking coffee, and a Mediterranean diet.”

In the Aurin Biotech study, 25 controls, ranging in age from 15 to 92 years, had Abeta 42 levels in their saliva averaging 23.34 picograms per ml (mean ± SEM: 23.34 ± 1.50). Six Alzheimer’s disease cases had values more than twice as high, ranging from 41.58 to 75.20 picograms per ml (mean ± SEM: 57.89 ± 6.53). A 51-year-old presenilin 1 mutation case, who was cognitively normal but destined to develop Alzheimer’s disease, had a value of 60.9, slightly higher than the average for Alzheimer’s disease cases. Two other cases, aged 52 and 60, who were also cognitively normal but were known from their family histories to be at high risk for Alzheimer’s disease, had values of 47.96 and 59.57 picograms per ml.

The study appears to show that nature tightly controls Abeta42 production in every organ of the body and keeps it at the same production rate throughout life. In normal individuals, this rate is almost exactly the same regardless of sex or age. However, for those destined to develop Alzheimer’s disease the rate is two to three times higher.

Urine test for fatigue could help prevent accidents. Doctors, pilots, air traffic controllers, and bus drivers have at least one thing in common: if they’re exhausted at work, they could be putting lives at risk. But the development of a new urine test, reported in the journal Analytical Chemistry, could help monitor just how weary they are. The results could potentially reduce fatigue-related mistakes by allowing workers to recognize when they should take a break.

The effects of fatigue have long been recognized and studied as a problem in the transportation and healthcare industries. In the early 2000s, studies published in scientific journals reported that fatigue-related mistakes were linked to thousands of vehicular crashes every year, and were a major concern in patient safety. Weariness can cause anyone on or off the job to lose motivation and focus, and become drowsy. Although very common, these symptoms come with biochemical changes that are not well understood. Zhenling Chen, Xianfa Xu, and colleagues set out to determine whether a urine test could detect these changes.

The researchers analyzed urine samples from dozens of air traffic controllers working in civil aviation before and after an eight-hour shift on the job. Out of the thousands of metabolites detected, the study identified three that could serve as indicators of fatigue. Further work is needed to validate what they found, the researchers say, but their initial results represent a new way to investigate and monitor fatigue and help prevent worn-out workers from making potentially dangerous errors.

New Study

Even low-intensity smokers are at increased risk of earlier death. People who consistently smoked an average of less than one cigarette per day over their lifetime had a 64 percent higher risk of earlier death than never smokers, and those who smoked between one and 10 cigarettes a day had an 87 percent higher risk of earlier death than never smokers, according to a new study conducted by researchers at the National Cancer Institute (NCI).

Risks were lower among former low-intensity smokers compared to those who were still smokers, and risk fell with earlier age at quitting. The results of the study were reported in JAMA Internal Medicine.

When researchers looked at specific causes of death among study participants, a particularly strong association was observed for lung cancer mortality. Those who consistently averaged less than one cigarette per day over their lifetime had nine times the risk of dying from lung cancer than never smokers. Among people who smoked between one and 10 cigarettes per day, the risk of dying from lung cancer was nearly 12 times higher than that of never smokers.

The researchers looked at the risk of death from respiratory disease, such as emphysema, as well as the risk of death from cardiovascular disease. People who smoked between one and 10 cigarettes a day had more than six times the risk of dying from respiratory diseases than never smokers and about one-and-one-half times the risk of dying of cardiovascular disease than never smokers.

To better understand the effects of low-intensity smoking on mortality from all causes and for specific causes of death, the scientists analyzed data on more than 290,000 adults in the NIH-AARP Diet and Health Study. Low-intensity smoking was defined as 10 or fewer cigarettes per day. All participants were age 59 to age 82 at the start of the study.

Industry News

First director named for Africa Centers for Disease Control and Prevention. Dr. John Nkengasong, PhD, MSc, an experienced virologist and chief of the International Laboratory Branch at the U.S. Centers for Disease Control and Prevention (CDC) in Atlanta, has been named as the first Director of the Africa Centers for Disease Control and Prevention (Africa CDC), effective Jan. 1, 2017.  The announcement was made by the Governing Board of the Africa CDC. The appointment was hailed by many healthcare professionals and groups, including the American Society for Clinical Pathology (ASCP).

“ASCP has had a long relationship with Dr. Nkengasong through his leadership of the President’s Emergency Plan for AIDS Relief (PEPFAR) at the U.S. CDC’s Center for Global Health,” says E. Blair Holladay, PhD, SCT(ASCP)CM, ASCP Chief Executive Officer. “Over the years, he has worked tirelessly to improve laboratory infrastructure on the continent of Africa. ASCP looks forward to supporting his future endeavors as a change agent for patient care.”

Dr. Nkengasong is currently the Associate Director for Laboratory Science and Chief of the International Laboratory Branch at the Division of HIV & TB, Center for Global Health at the U.S. CDC. In addition, he co-chairs the U.S. PEPFAR Laboratory Technical Working Group and serves as the founding chair of the Board of Directors for the African Society for Laboratory Medicine (ASLM).

Beckman Coulter launches annual CARES award to help people living with HIV/AIDS. Beckman Coulter Life Sciences launched an international HIV/AIDS award at the 2016 conference for the African Society for Laboratory Medicine (ASLM) that was held in Cape Town, South Africa, in December.

The annual award will be part of the company’s global CARES Initiative dedicated to helping people who are living with HIV/AIDS. The award is designed to recognize individuals who have shown “care, dedication and commitment” in their communities as part of the fight against HIV/AIDS. The winner will receive a $5,000 donation in his or her name to one of the selected causes, with the three individual stories that receive the most nominations publicized around the world on the CARES Initiative website.

Potential winners can be nurses, healthcare workers, national coordinators, lab scientists, and clinicians, or lay people who are active in community outreach work. This could include social workers providing AIDS counselling.

CARES supports the UNAIDS 90-90-90 target to ensure that by the year 2020, 90 percent of people living with HIV will know their status, 90 percent of those with diagnosed HIV infection will receive sustained antiretroviral therapy, and 90 percent of all people receiving antiretroviral therapy will have viral suppression.

The Initiative focuses on providing innovative solutions for the monitoring of HIV and AIDS treatment. CARES was inspired by the work of Professor Debbie Glencross, a South African laboratory pathologist, who found a different and less expensive way to measure a patient’s CD4 count.

While this is intended as an international award, in its first year, the award will focus on recognizing the dedication of people in Africa.