ABSTRACT
Lead exposure is toxic even at low levels, resulting in impairments that can affect a child's lifelong success. In North Carolina, testing for lead is encouraged for all children at ages 1 and 2 years and required for children covered by Medicaid; investigations are performed to identify potential exposure sources for children with blood lead levels (BLLs) ≥5 µg/dL. During June-August 2023, routine lead testing identified four asymptomatic North Carolina children with BLLs ≥5 µg/dL. Home investigations identified only WanaBana brand apple cinnamon fruit puree pouches as a potential exposure source; product samples contained 1.9-3.0 ppm of lead. An expanded nationwide investigation led to identification of approximately 500 cases of childhood lead exposure believed to be linked to consumption of apple cinnamon purees, including 22 cases in North Carolina. Fewer than one half (45%) of the 22 North Carolina cases were among children covered by Medicaid. A coordinated multiagency communication strategy was implemented in North Carolina to notify consumers of the hazard and provide recommendations for preventing further exposure. The Food and Drug Administration issued a nationwide public health advisory on October 28, 2023; 2 days later, the manufacturer issued a voluntary recall. Routine testing of young children for lead exposure, combined with thorough environmental investigations, can identify emerging sources of lead exposure and limit further harm.
Subject(s)
Lead Poisoning , Lead , Humans , North Carolina/epidemiology , Lead/blood , Lead/analysis , Infant , Child, Preschool , Lead Poisoning/epidemiology , Malus , Fruit/chemistry , Cinnamomum zeylanicum/chemistry , Food Contamination , Female , Food Packaging , Environmental Exposure/analysis , MaleABSTRACT
BACKGROUND: The ongoing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic posed an unpreceded threat to the management of other pandemics such as human immunodeficiency virus-1 (HIV-1) in the United States. The full impact of the SARS-CoV-2 pandemic on the HIV-1 pandemic needs to be evaluated. METHODS: All individuals with newly reported HIV-1 diagnoses from NC State Laboratory of Public Health were enrolled in this prospective observational study, 2018-2021. We used a sequencing-based recency assay to identify recent HIV-1 infections and to determine the days postinfection (DPI) for each person at the time of diagnosis. RESULTS: Sequencing used diagnostic serum samples from 814 individuals with new HIV-1 diagnoses spanning this 4-year period. Characteristics of individuals diagnosed in 2020 differed from those in other years. People of color diagnosed in 2021 were on average 6 months delayed in their diagnosis compared to those diagnosed in 2020. There was a trend that genetic networks were more known for individuals diagnosed in 2021. We observed no major integrase resistance mutations over the course of the study. CONCLUSIONS: SARS-CoV-2 pandemic may contribute to the spread of HIV-1. Public health resources need to focus on restoring HIV-1 testing and interrupting active, ongoing, transmission.
Subject(s)
COVID-19 , HIV-1 , Humans , United States/epidemiology , SARS-CoV-2/genetics , COVID-19/diagnosis , COVID-19/epidemiology , HIV-1/genetics , Pandemics , High-Throughput Nucleotide Sequencing , COVID-19 TestingABSTRACT
Prior to statewide newborn screening (NBS) for spinal muscular atrophy (SMA) in North Carolina, U.S.A., we offered voluntary screening through the Early Check (EC) research study. Here, we describe the EC experience from October 2018 through December 2020. We enrolled a total of 12,065 newborns and identified one newborn with 0 copies of SMN1 and two copies of SMN2, consistent with severe early onset of SMA. We also detected one false positive result, likely stemming from an unrelated blood disorder associated with a low white blood cell count. We evaluated the timing of NBS for babies enrolled prenatally (n = 932) and postnatally (n = 11,133) and reasons for delays in screening and reporting. Although prenatal enrollment led to faster return of results (median = 13 days after birth), results for babies enrolled postnatally were still available within a timeframe (median = 21 days after birth) that allowed the opportunity to receive essential treatment early in life. We evaluated an SMA q-PCR screening method at two separate time points, confirming the robustness of the assay. The pilot project provided important information about SMA screening in anticipation of forthcoming statewide expansion as part of regular NBS.
ABSTRACT
Meeting recruitment targets for clinical trials and health research studies is a notable challenge. Unsuccessful efforts to recruit participants from traditionally underserved populations can limit who benefits from scientific discovery, thus perpetuating inequities in health outcomes and access to care. In this study, we evaluated direct mail and email outreach campaigns designed to recruit women who gave birth in North Carolina for a statewide research study offering expanded newborn screening for a panel of rare health conditions. Of the 54,887 women who gave birth in North Carolina from September 28, 2018, through March 19, 2019, and were eligible to be included on the study's contact lists, we had access to a mailing address for 97.9% and an email address for 6.3%. Rural women were less likely to have sufficient contact information available, but this amounted to less than a one percentage point difference by urbanicity. Native American women were less likely to have an email address on record; however, we did not find a similar disparity when recruitment using direct-mail letters and postcards was concerned. Although we sent letters and emails in roughly equal proportion by urbanicity and race/ethnicity, we found significant differences in enrollment across demographic subgroups. Controlling for race/ethnicity and urbanicity, we found that direct-mail letters and emails were effective recruitment methods. The enrollment rate among women who were sent a recruitment letter was 4.1%, and this rate increased to 5.0% among women who were also sent an email invitation. Study Highlights WHAT IS THE CURRENT KNOWLEDGE ON THE TOPIC? Under-representation by traditionally underserved populations in clinical trials and health research is a challenge that may in part reflect inequitable opportunities to participate. WHAT QUESTION DID THIS STUDY ADDRESS? Are direct-mail and email outreach strategies effective for reaching and recruiting women from traditionally underserved and rural populations to participate in large-scale, population-based research? WHAT DOES THIS STUDY ADD TO OUR KNOWLEDGE? Despite sending recruitment letters and email invitations in roughly equal proportion by urbanicity and race/ethnicity, women living in rural areas were less likely to enroll (2.8%) than women from urban areas (4.2%). Additionally, enrollment rates decreased as the probability that women were members of a racial or ethnic minority group increased. HOW MIGHT THIS CHANGE CLINICAL PHARMACOLOGY OR TRANSLATIONAL SCIENCE? Results from this study might encourage researchers to take a holistic and participant-centered view of barriers to study enrollment that may disproportionately affect underserved communities, including differences in willingness to participate, trust, and access to resources needed for uptake.
Subject(s)
Clinical Trials as Topic/organization & administration , Electronic Mail/statistics & numerical data , Neonatal Screening/organization & administration , Patient Selection , Postal Service/statistics & numerical data , Clinical Trials as Topic/statistics & numerical data , Female , Humans , Infant, Newborn , Mothers/statistics & numerical data , North Carolina , Rural Population/statistics & numerical data , Vulnerable Populations/statistics & numerical dataABSTRACT
Newborn screening is designed for presymptomatic identification of serious conditions with effective early interventions. Clinical laboratories must perform prospective pilot studies to ensure that the analytical performance and workflow for a given screening test are appropriate. We assessed the potential to screen newborns for fragile X syndrome, a monogenic neurodevelopmental disorder, by establishing a customized, high-throughput PCR and analysis software system designed to detect fragile X mental retardation 1 gene repeat expansions from dried blood spots (DBSs). Assay precision, accuracy, sensitivity, and specificity were characterized across the categorical range of repeat expansions. The assay consistently resolved genotypes within three CGG repeats of reference values up to at least 137 repeats and within six repeats for larger expansions up to 200 repeats. Accuracy testing results were concordant with reference results. Full and premutation alleles were detected from subnanogram DNA inputs eluted from DBSs and from mixtures with down to 1% relative abundance of the respective expansion. Analysis of 963 deidentified newborn DBS samples identified 957 normal and 6 premutation specimens, consistent with previously published prevalence estimates. These studies demonstrate that the assay system can support high-throughput newborn screening programs.
Subject(s)
Fragile X Mental Retardation Protein/genetics , Fragile X Syndrome/diagnosis , Fragile X Syndrome/genetics , Genetic Testing , Neonatal Screening , Polymerase Chain Reaction , Alleles , Female , Genetic Testing/methods , High-Throughput Nucleotide Sequencing , Humans , Infant, Newborn , Male , Mosaicism , Mutation , Neonatal Screening/methods , Polymerase Chain Reaction/methods , Polymerase Chain Reaction/standards , Reproducibility of Results , Sensitivity and Specificity , Trinucleotide Repeat ExpansionABSTRACT
BACKGROUND: Newborn screening (NBS) occupies a unique space at the intersection of translational science and public health. As the only truly population-based public health program in the United States, NBS offers the promise of making the successes of translational medicine available to every infant with a rare disorder that is difficult to diagnose clinically, but for which strong evidence indicates that presymptomatic treatment will substantially improve outcomes. Realistic NBS policy requires data, but rare disorders face a special challenge: Screening cannot be done without supportive data, but adequate data cannot be collected in the absence of large-scale screening. The magnitude and scale of research to provide this expanse of data require working with public health programs, but most do not have the resources or mandate to conduct research. METHODS: To address this gap, we have established Early Check, a research program in partnership with a state NBS program. Early Check provides the infrastructure needed to identify conditions for which there have been significant advances in treatment potential, but require a large-scale, population-based study to test benefits and risks, demonstrate feasibility, and inform NBS policy. DISCUSSION: Our goal is to prove the benefits of a program that can, when compared with current models, accelerate understanding of diseases and treatments, reduce the time needed to consider inclusion of appropriate conditions in the standard NBS panel, and accelerate future research on new NBS conditions, including clinical trials for investigational interventions. TRIAL REGISTRATION: Clinicaltrials.gov registration # NCT03655223 . Registered on August 31, 2018.
Subject(s)
Fragile X Syndrome/diagnosis , Muscular Atrophy, Spinal/diagnosis , Neonatal Screening , Public Health , Translational Research, Biomedical , Early Diagnosis , Female , Follow-Up Studies , Fragile X Syndrome/epidemiology , Health Policy , Humans , Infant, Newborn , Informed Consent , Internet , Intersectoral Collaboration , Male , Muscular Atrophy, Spinal/epidemiology , North Carolina/epidemiology , Outcome Assessment, Health Care/methods , Patient Selection , Program Evaluation , Prospective Studies , Self-Help GroupsABSTRACT
OBJECTIVE: To evaluate the performance of a 2-tiered newborn screening method for mucopolysaccharidosis type I (MPS I) in North Carolina. STUDY DESIGN: The screening algorithm included a flow injection analysis-tandem mass spectrometry assay as a first-tier screening method to measure α-L-iduronidase (IDUA) enzyme activity and Sanger sequencing of the IDUA gene on dried blood spots as a second-tier assay. The screening algorithm was revised to incorporate the Collaborative Laboratory Integrated Reports, an analytical interpretive tool, to reduce the false-positive rate. A medical history, physical examination, IDUA activity, and urinary glycosaminoglycan (GAG) analysis were obtained on all screen-positive infants. RESULTS: A total of 62 734 specimens were screened with 54 screen-positive samples using a cut-off of 15% of daily mean IDUA activity. The implementation of Collaborative Laboratory Integrated Reports reduced the number of specimens that screened positive to 19 infants. Of the infants identified as screen-positive, 1 had elevated urinary GAGs and a homozygous pathogenic variant associated with the severe form of MPS I. All other screen-positive infants had normal urinary GAG analysis; 13 newborns had pseudodeficiency alleles, 3 newborns had variants of unknown significance, and 2 had heterozygous pathogenic variants. CONCLUSIONS: An infant with severe MPS I was identified and referred for a hematopoietic stem cell transplant. Newborn IDUA enzyme deficiency is common in North Carolina, but most are due to pseudodeficiency alleles in infants with normal urinary GAG analysis and no evidence of disease. The pilot study confirmed the need for second-tier testing to reduce the follow-up burden.
Subject(s)
Mucopolysaccharidosis I/diagnosis , Neonatal Screening , Algorithms , Dermatan Sulfate/urine , Genetic Testing , Genetic Variation , Glycosaminoglycans/urine , Heparitin Sulfate/urine , Humans , Iduronidase/blood , Iduronidase/genetics , Infant, Newborn , Mucopolysaccharidosis I/genetics , North Carolina , Referral and Consultation/statistics & numerical data , Sequence Analysis , Tandem Mass SpectrometryABSTRACT
Policy decisions about mandated newborn screening should be based on scientific evidence and incorporate expert opinion. At the national level, a systematic evidence review evaluates the benefit of screening for disorders that may be added to the Recommended Uniform Screening Panel, and ultimately considered by individual newborn screening programs. Recent changes in state laws, including in North Carolina, are intended to streamline the decision-making process for newborn screening policy changes.
Subject(s)
Health Policy , Neonatal Screening , Policy Making , Humans , Infant, Newborn , North CarolinaABSTRACT
Newborn screening is a process-based public health service. Newborn screening staff and families alike are essential to maintaining the timeliness of the screening process. Newborn screening education must be accurate and accessible. Past newborn screening conferences have highlighted gaps in best practice and evidence-based guidance on newborn screening education. Sharing successful strategies across programs mitigates the scarcity of resources by cutting costs and reducing the burden of work. These factors illustrate the need for an education framework to guide newborn screening education efforts. The Newborn Screening Education Best Practices Framework responds to these issues by outlining guidance for newborn screening education approaches. Experts in the fields of newborn screening, genetics, and bioethics as well as previous research on best practice guidelines have contributed to the development of this framework. The framework outlines a process for users to evaluate newborn screening education approaches as best practices. This framework reviews best practices using a two-step approach, looking at guiding questions, implementation of the newborn screening issue, and evaluation. The framework helps the user define the characteristics of the newborn screening issue, intended audience, and practical steps to implementation, and then decide whether or not it can be used as a best practice.
ABSTRACT
Newborn screening is a public health program facilitated by state public health departments with the goal of improving the health of affected newborns throughout the country. Experts in the newborn screening community established a panel of eight quality indicators (QIs) to track quality practices within and across the United States newborn screening system. The indicators were developed following iterative refinement, consensus building, and evaluation. The Newborn Screening Technical assistance and Evaluation Program (NewSTEPs) implemented a national data repository in 2013 that captures the quality improvement metrics from each state. The QIs span the newborn screening process from collection of a dried blood spot through medical intervention for a screened condition. These data are collected and analyzed to support data-driven outcome assessments and tracking performance to improve the quality of the newborn screening system.
ABSTRACT
The identification of ticks using morphological characters is a well-established practice, however specimens that are small or damaged are often difficult to speciate. A novel, rapid real-time PCR assay, which targets the second internal transcribed spacer (ITS2) region in the nuclear ribosomal DNA gene, was developed for identification of four tick species of utmost medical importance in the United States: Ixodes scapularis, I. pacificus, Dermacentor variabilis, and Amblyomma americanum. Computational analyses of public databases and DNA sequencing studies revealed regions that could be specifically targeted with oligonucleotides optimized for TaqMan chemistry. The oligonucleotide sets designed in this study are specific at both the genus and species levels, and are sensitive at 0.1-1 pg of total tick DNA.
Subject(s)
Arachnid Vectors/classification , Phylogeny , Polymerase Chain Reaction/veterinary , Ticks/classification , Animals , Arachnid Vectors/genetics , Base Sequence , DNA, Intergenic , DNA, Ribosomal Spacer , Dermacentor/classification , Ixodes/classification , Nucleic Acid Amplification Techniques/veterinary , Polymerase Chain Reaction/methods , Sensitivity and Specificity , Species Specificity , Ticks/geneticsABSTRACT
Most adult mosquito surveillance in Maryland is performed using dry ice-baited or unbaited Centers for Disease Control (CDC) miniature light traps suspended approximately 1.5 m above the ground. However, standardized trapping methods may miss mosquito species involved in disease transmission cycles. During a 2-yr study, the effectiveness of the olfactory attractant 1-octen-3-ol alone and in combination with carbon dioxide was evaluated for collecting mosquito vector species. In addition, trap heights were examined to determine the optimal vertical placement to target various species. We evaluated the results during the second year by targeting selected species by using various habitat- height-bait combinations. Although Culex erraticus Dyar & Knab and Anopheles quadrimaculatus Say were not successfully targeted, Culex salinarius Coquillett, Aedes vexans Meigen, Anopheles bradleyi/crucians King, Coquillettidia perturbans Walker, Aedes sollicitans Walker, and Aedes taeniorhynchus Wiedemann were preferentially captured using targeted trapping schemes.
Subject(s)
Culicidae/physiology , Ecosystem , Insect Vectors/physiology , Animals , Carbon Dioxide/pharmacology , Culicidae/classification , Culicidae/drug effects , Female , Insect Vectors/classification , Insect Vectors/drug effects , Maryland , Mosquito Control/methods , Octanols/pharmacology , Odds Ratio , SeasonsABSTRACT
Numerous studies have investigated the role of weather on insect species. For mosquitoes, these studies have yielded mixed results. Although it is clear that weather impacts mosquito population dynamics, these investigations have failed to accurately characterize their fluctuations. We use a novel graphical method to examine large numbers of meteorological aggregations of varying lengths and lags simultaneously to establish relationships between these summary variables and mosquito counts, to gain a better understanding of the weather effects. Poisson regression models were developed to characterize the population dynamics of Aedes sollicitans (Walker) by using meteorological data and a 34-yr set of daily mosquito count data. The models accurately characterize mosquito dynamics over time and space. The aggregated meteorological variables included in the model were lowest minimum tides between days 27 and 14 before trapping, total precipitation between days 22 and 9, total precipitation on day 1 and the day of trapping, cooling degree-days on day 0, average minimum relative humidity between days 28 and 9, lowest stream flow from day 11 to day 0, and lowest minimum temperature between days 28 and 13.
Subject(s)
Aedes/physiology , Insect Vectors/physiology , Meteorological Concepts , Models, Biological , Animals , Female , Humidity , Population Dynamics , Rain , Regression Analysis , Temperature , Time Factors , Water MovementsABSTRACT
It has long been recognized that arthropod populations fluctuate with changes in environmental conditions and these changes occur at various spatial and temporal scales. Empirical studies that have explored associations between vector abundance and the environment often considered meterological events as leading indicators with their effects traditionally restricted to single points in time, such as precipitation 12 days prior to trapping. Field experience, however, suggests that the duration of these environmental effects on vectors often extends over a range or interval of time. Such a scenario is not directly interpretable from cross correlation plots routinely employed to visualize and identify time lag associations. Cross correlation maps are introduced as a way to generalize cross correlation plots and to visualize the effects of environmental conditions over intervals of time. This graphical method is flexible and can include different characterizations of environmental effects, as well as interactions among environmental variables. A time series of daily trapped female Ochlerotatus sollicitans mosquitos and leading meterologic conditions were used for demonstration. Associations shown in cross correlation maps were consistent with the arthropod biology and trapping efficacy and were also stronger than those identified at single time points using cross correlation plots. Poisson regression models for vector abundance built using meterological variables with both single and interval based leading time lags were compared. The approach based on the leading meterological events allowed to extend over time intervals reproduced the Oc. sollicitans daily population dynamics better than the traditional approach.
Subject(s)
Arthropod Vectors/growth & development , Arthropods/growth & development , Weather , Animals , Arthropod Vectors/physiology , Arthropods/physiology , Culicidae/growth & development , Culicidae/physiology , Environment , Female , Male , Maryland , Models, Biological , Population Dynamics , Population Surveillance , Regression Analysis , Seasons , Time FactorsABSTRACT
In rodent populations, males are more likely to be infected with hantaviruses and to engage in aggression than are females. To assess the relationship between aggression and Seoul virus infection, Norway rats were trapped in Baltimore, Maryland and wounding, infection status, and steroid hormone concentrations were examined. Older males and males with high-grade wounds were more likely to have IgG antibody to Seoul, to shed virus in saliva, urine, and feces, and to have viral RNA in organs than either juveniles or adult males with less severe wounds. In contrast, neither age nor wounding predicted virus shedding among females. Although viral antigen was not identified in the brain, viral protein was detected in the gonads and adrenal glands of adult males. Males with more severe wounds had higher testosterone concentrations than males with no or low-grade wounds. Because wounding, testosterone, and virus shedding are associated among males, aggression may be the primary mode of Seoul virus transmission among male, but not female, Norway rats.
Subject(s)
Aggression , Hemorrhagic Fever with Renal Syndrome/transmission , Seoul virus , Wounds and Injuries/virology , Animals , Antibodies, Viral/blood , Female , Immunoglobulin G/blood , Male , RNA, Viral/analysis , Rats , Sex FactorsABSTRACT
During the summer of 2001, field studies were performed to evaluate the effects of carbon dioxide (CO2) and 1-octen-3-ol (octenol) on the ability to collect Aedes albopictus with Centers for Disease Control (CDC) Fay-Prince traps. Results from these studies indicated that Ae. albopictus is significantly more attracted to CO2- or CO2 + octenol-baited CDC Fay-Prince traps than unbaited or octenol-baited traps. However, the difference between the responses to CO2 and CO2 + octenol was not statistically different, indicating that CO2 is driving the response of Ae. albopictus to CDC Fay-Prince traps.