Authorized by Congress as part of the Children’s Health Act of 2000, the National Children’s Study (NCS) is a planned nationwide longitudinal study of 100,000 children. The study will enroll expectant women or mothers of newly born infants across the country and will follow their children to age 21, collecting survey data and biological and environmental samples. The mission of the NCS is to improve the health and well-being of children and contribute to understanding of the role that various environmental and genetic factors have on health and disease.
The NCS is divided into two phases. The NCS Vanguard Phase pilot study was launched in 2009 and has enrolled several thousand participants. It is evaluating and optimizing various strategies for recruitment as well as methods and procedures under consideration for incorporation into the Main Study. The Main Study will apply the findings of the Vanguard pilot across a much larger study population. Both phases of the NCS will operate in parallel and will follow participants to age 21. Throughout the course of the NCS, a variety of biological samples will be collected from child and parent participants. To date, the NCS Vanguard pilot has evaluated collection of urine, blood, mucosal swabs, placenta, umbilical cord, umbilical cord blood, meconium, newborn filter paper adsorbed dried blood spots, breast milk, saliva, hair, and nail clippings, plus environmental samples of air, dust, and water from participant homes, together with physical, cognitive, and behavioral assessments and environmental observations.
Collected materials are stored in the NCS Biological and Environmental Sample Repository, where they are carefully managed to preserve biochemical integrity. The NCS approach to biological and environmental sample management aims to preserve integrity for a wide variety of potential future analytes by reducing variability in specimen handling through centralized and automated processing and storage. One critical advantage of centralized biobanking is the ability to ensure that all materials are managed according to standardized procedures and best practices. This helps assure sample integrity and minimize pre-analytical variability that could influence results of future laboratory analysis. Evaluating the effects of sample handling and storage on short-term and long-term stability is an important part of the development and evaluation of NCS procedures.
Data from the NCS will provide insights and information about health and disease. By examining how events and exposures from before birth to adulthood may be associated with specific outcomes, the NCS can provide information to help develop strategies to promote health, prevent disease, and guide future research.
Materials stored in the NCS Biological and Environmental Sample Repository are used by NCS investigators and other qualified researchers in current Supplemental Methodologic Studies and will be used in future Adjunct Studies. Supplemental Methodologic Studies are intended to address methodological, logistical, or operational questions, while Adjunct Studies will evaluate genetic influences and effects of physical, biological, chemical, and psychosocial exposures on health and developmental outcomes. As with other biobanks, whether population-based or disease-oriented, the products of the research made possible from use of stored samples and data are unknown but unlimited.
For the latest updates and information about the NCS, visit the National Children’s Study website.
Millions of Samples, Abundant Data
The millions of samples to be collected during the NCS, together with the other information collected in the study, will allow researchers to identify interactions between the environment and the individual that may influence health. Biobanks like those established by the NCS are changing the face of medical research by making available a wealth of material needed to investigate these correlations, allowing identification of important associations that in turn may lead to development of measures to promote health and prevent disease.
Given the large quantity and variety of samples that will be collected over the course of the NCS, maximizing efficiencies in sample handling, processing, and storage is critical. Sample repositories that support such large-scale research, in addition to meeting standards for sample and data quality and integrity, will need to rely on automation to achieve the high throughput required. However, automation of processes specific to biobanking must be done strategically.
Laboratory Automation for Biobanking
Sample processing and repository services for the NCS Biological and Environmental Sample Repository are provided by Fisher BioServices. For the NCS repository, robotic sample processing and storage were carefully investigated to ensure that biobanking best practices were preserved and even enhanced by the automation selected. For instance, as part of quality assessment of samples collected during the NCS Vanguard pilot, buffy coat fractions from 704 blood samples were tested for DNA yield and purity. Armed with this baseline data, automated DNA extraction systems were investigated, leading to selection of the Chemagen instrument for automated extraction of DNA from NCS samples, based on its versatility in extracting DNA from different sample types and from different volumes of material. Fisher BioServices also uses an automated tube labeler as part of its NCS sample processing to improve efficiency in labeling derivative aliquot vials.
In addition to extracting DNA, the Fisher BioServices laboratory aliquots specimens such as urine, blood, saliva, and breast milk for the NCS. Robotic liquid handling systems (Hamilton STAR) were selected for NCS specimen processing, with integration of the robotic equipment into a Laboratory Information Management System (LIMS) selected specifically for the NCS. The LIMS will provide not only complete sample processing workflows, but also inventory tracking and management functions, so that laboratory and biorepository data are fully integrated.
Biobank Storage Systems for Automation and Risk Mitigation
Once NCS samples are processed in the laboratory, they are placed in long-term storage. Maintaining correct and consistent temperatures for multiple sample storage conditions is critical to the long-term success of the NCS. Exposure to incorrect temperatures, excessive handling, and other deviations from optimal storage conditions could lead to degradation or destruction of irreplaceable samples.
NCS DNA samples will constitute a critical collection within the larger collection. For the large numbers of DNA aliquots to be generated, the NCS and Fisher BioServices will use a dedicated, high-capacity, ultralow-temperature (-80°C) automated robotic storage unit (Brooks BioStore). Technicians can queue up thousands of vials at a time for the robotic storage system to load into the unit, which later can pick and pull individual vials for shipping to NCS researchers, assuring temperature homogeneity and stability during storage and related handling.
NCS sample types that do not require processing by the laboratory are shipped directly to the repository for inventory and storage of the primary sample. NCS samples are stored by Fisher BioServices under a variety of conditions, including controlled ambient, refrigerated, frozen (-20°C and -80°C), and cryogenic (liquid nitrogen) conditions. The NCS environmental and biological sample collections are stored separately within Fisher BioServices facilities to avoid potential cross-contamination, and the overall NCS collection is divided between Fisher BioServices facilities located in different geographic regions to reduce the risk of loss in the event of natural or man-made disaster.
As the NCS moves into its Main Study phase, increasing reliance on automation is expected in order to maintain quick and efficient processing and storage of these irreplaceable specimens. For related information about biobanking automation, click here to download our eBook on "Automating Your Sample Collection for Biobanking: 10 Things to Consider" by Kathleen Groover, Ph.D.
Click on NCS poster below to download PDF.
To go to the National Children’s Study website, click here.
To learn more about how biobanking is changing the future of medical and public health research, and how the National Children's Study is on the forefront of these changes, download the poster recently presented at a recent NCS Expanded Steering Committee Meeting and the official NCS overview presentation.
Mechanic L, Mendez A, Merrill L, Rogers J, Layton M, Todd D, Varanasi A, O'Brien B, Meyer III WA, Zhang M, Schleicher RL, Moye J. Planned variation in preanalytical conditions to evaluate biospecimen stability in the National Children's Study (NCS). ClinChem Lab Med. 2013 Dec 1;51(12):2287-94.