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Health

Projects/Programs

Keyword

Organizational Unit

Consistency Analysis and Uncertainty in ‘omic Data

Ongoing

‘Omics is increasingly moving out of the laboratory and towards use in industrial and commercial applications. For instance, in biomanufacturing, there is a need for quality control when developing biotherapeutics, which will almost certainly require a machine-learning classifier to separate

Data Infrastructure for Biomanufacturing Process Control

Ongoing

Objective The objective of this project is to develop measurement science that includes ontology models, ontology expression (axiomatic) patterns, guidelines for qualifying those ontologies, and distributed ontology development software that will allow U.S. manufacturers to have better access to

Development of Biomarker-based Systems for Cancer Detection and Therapy

Completed

Intended impact Although significant progress has been made in both the understanding and treatment of cancer during the last thirty years, it remains the second leading cause of death in the US. The cancer community has set a goal to eliminate cancer-related suffering and death by 2015. To achieve

Development of a Collagen Fibril Reference Material for Reproducible Cell Response

Ongoing

Research is ongoing to assess what information is required to validate films of collagen as reference extracellular matrix. During the first portion of this work we will develop protocols for characterizing the prototype collagen reference material with various instrumental techniques to develop

Development of Enhanced mRNA Amplification Using Microfluidics

Completed

Intended Impact Tissue samples frequently contain multiple cell types. New methods (e.g. laser capture microdissection) enable the segregation of small quantities of individual cells and cell types, but the current methods to analyze global gene expression do not provide highly efficient profiling

Figure contains text “Omics Data Quality” and human outline with arrows pointing from the human to the following specimen types: liver, serum, stool, plasma, urine. On either side of the human are analytical spectra and everything is surrounded by a decorative molecule structure circular border.

Development of NIST Reference Materials for Untargeted Metabolomics, Lipidomics and Proteomics

Ongoing

There is a significant need for tools to increase harmonization, comparability, and reproducibility between laboratories and/or studies, and to provide quality control of sample preparation and data analysis protocols utilized in untargeted omics analysis. Reference materials are being developed to

Development of Reference Measurement Procedures and Reference Materials for Creatinine

Ongoing

Kidney function can be evaluated by determining the glomerular filtration rate (GFR), which provides an estimate of how well the kidneys are removing waste and excess fluid from the blood. The GFR is not measured directly. Instead, a measurement of serum creatinine is performed, and this value is

Photograph of several clinical Standard Reference Materials showing labeled boxes, bottles, vials, ampoules and printed certificates.

Development of Reference Methods and Reference Materials for Clinical Diagnostic Markers

Ongoing

Reference measurement procedures and standard reference materials help ensure accuracy and comparability of routine clinical assays. In addition, this work allows U.S. clinical diagnostic manufacturers to comply with the European Union directive regarding in-vitro diagnostic medical devices (IVD MD)

NIST researcher pipetting solutions into 96-well plate for analysis

Development of Reference Methods and Reference Materials for Protein Biomarkers

Ongoing

Accuracy and reliability of clinical assays is essential for timely and accurate medical interventions. However, studies have shown that large variations in results can occur among routine clinical assays. In one example, a clinical comparison among 13 commercial cardiac troponin I assay platforms

Photograph of SRM 2669 Arsenic Species in Frozen Human Urine, with vials and desiccant packs, and labeled mylar bag.

Development of SRM 2669 for Accurate Assessment of Arsenic Exposure

Ongoing

Arsenic exposure in the U.S. population is an important part of the NHANES program conducted by CDC because dietary exposure to arsenic can cause serious health effects. A major challenge in the arsenic exposure assessment is that arsenic exists as various species in nature, and the toxicity of

Development of SRMs 2668 and 3668 for Accurate Assessment of Exposure to Toxic Elements and Anions

Completed

Toxic elements in the environment are a threat to public health and safety. Federal and state regulations have been issued to limit and abate the presence of toxic elements in the environment. The levels of toxic elements in the U.S. population are carefully monitored. NHANES is one of the federal

Dietary Supplement Laboratory Quality Assurance Program (DSQAP) Consortium

Ongoing

The objective of the DSQAP Consortium is to develop and evaluate measurement methods and standards to support quality and safety for the dietary supplement testing community. Approximately 75% of the U.S. population takes dietary supplements, including vitamins and mineral supplements, representing

Dietary Supplement Laboratory Quality Assurance Program (DSQAP)

Ongoing

Approximately 75% of the U.S. population takes dietary supplements, including vitamins and mineral supplements, representing an annual expenditure of more than $20 billion. Regulations, driven by reported cases of inaccurate labeling, adulteration, contamination (with pesticides, heavy metals, or

Digital PCR

Ongoing

With appropriately validated assays, digital polymerase chain reaction (dPCR) determines the number of DNA targets (copies) per reaction partition, without the need for a standard curve. Reaction partitions can be in the form of fixed chambers in a microfluidic device, referred to as chamber digital

ERCC 2.0: Developing a New Suite of RNA Controls

Completed

Requested RNA Control products include: Transcript isoforms; New and improved messenger RNA mimics and mixture formulations; microRNA and other small RNA molecules; and Cancer fusion transcripts. ERCC technical working groups are developing design specifications, RNA control products, and analysis

Evaluating Measurement Quality of Microfluidic Cell-based Assays

Completed

Impact and Customers Our work establishes metrics for measurement quality and reproducibility for cell-based assays within microfluidic devices. Many novel microfluidic devices are being created that permit new measurements or enable new biological functions to be tested; however, characterizations

Evaluating the Quality of Cell Counting Methods: Experimental Design and Statistical Analysis

Ongoing

Related Standards/Tools ISO 20391-2:2019 Biotechnology — Cell counting — Part 2: Experimental design and statistical analysis to quantify counting method performance COMET (Counting Method Evaluation Tool) A Shiny Application that executes the statistical analysis and reporting outlined in ISO 20391

External RNA Controls Consortium

Completed

While early gene expression measurements with DNA microarrays were groundbreaking in their ability to reveal biological activity, the results were irreconcilable and irreproducible. Industry leaders approached the National Institute of Standards and Technology (NIST) in 2003 for help with addressing

FAQs - Genome in a Bottle

Ongoing

Photograph of SRM 2378 Fatty Acids in Human Serum showing three vials labeled Serum 1, Serum 2, and Serum 3.

Fatty Acids in Human Serum and Plasma Quality Assurance Program (FAQAP)

Completed

Interlaboratory comparison studies of the FAQAP focused on the measurement of 24 fatty acids in selected serum and plasma matrices. Frozen or freeze-dried serum or plasma samples were sent to laboratories for analysis together with control materials. Results were returned to NIST for data evaluation

Flow Cytometry Lab

Ongoing

Current Capabilities ERF value assignment measurement service for traceable ERF value assignment to microparticles, Aseptic sorting of cell lines, and primary cells Quantitative measurements of cell surface and intracellular biomarkers by estimating antibody bound per cell Accurate enumeration of

Food Nutrition and Safety Measurements Quality Assurance Program (FNSQAP)

Ongoing

As part of a revamp of QAPs in 2021, NIST established the FNSQAP to support the NIST Food Safety Program and Measurements and Standards to Support Nutrition Labeling. Participants measure nutrient components (e.g., minerals, vitamins, fatty acids, dietary fiber) and contaminants (e.g., toxic

viral vector illustration with RNA seen within the capsid

Gene Delivery Particle Analysis with High-Throughput Light Scattering Microscopy

Ongoing

This project aims to develop light-scattering microscopy methods for rapid, multi-attribute characterization of gene therapy particles at the single particle level. Emerging gene therapy treatments use gene delivery particles, such as viral vectors and non-viral carriers, to cure intractable

Gene Delivery Systems

Ongoing

Viral Vectors Viral vectors are a critical tool for delivering DNA or RNA into patient’s cells. Common viral vectors for gene therapy include adenovirus, lentivirus, and adeno associated virus. Administration of viral vectors can occur in vivo or ex vivo , such as for adeno associated virus or

Genome in a Bottle

Ongoing

Consortium goals: The Genome in a Bottle Consortium is a public-private-academic consortium hosted by NIST to develop the technical infrastructure (reference standards, reference methods, and reference data) to enable translation of whole human genome sequencing to clinical practice and innovations

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