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Health

Clinical diagnostics

Projects/Programs

Keyword

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RM 8376 Microbial Pathogen DNA Standards for Detection and Identification

Ongoing

RM 8376 consists of 20 individual gDNA components from 19 bacterial strains and 1 human reference genome. Its purpose is to enable developers and regulators to evaluate the analytical performance of metagenomic next generation sequencing (mNGS) tools. The material is certified for chromosomal copy

Broadband Coherent Anti-Stokes Raman Scattering (BCARS) Microscopy

Ongoing

Impact There is a need for label-free chemical microscopy in medicine, biology and materials science. Most of the current methods use chemical labels that often disturb the distribution and nature of chemical components being investigated. The method we are developing enables noninvasive and rapid

Building Measurement Confidence for Cell Characterization

Ongoing

NIST collaborates with key stakeholders in industry, other government agencies, and academia to develop measurement assurance strategies and advanced measurement capabilities for cell characterization. Data and concepts developed through workshops and laboratory programs inform the development of

Cancer Genome in a Bottle

Ongoing

Goals: This project is an extension of the Genome in a Bottle Consortium to develop the technical infrastructure (reference standards, reference methods, and reference data) to enable translation of cancer genome sequencing to clinical practice and innovations in technologies. The priority of GIAB

Clinical and Forensic Reference Materials

Ongoing

Below is a listing of the reference materials currently produced by the Applied Genetics group. Clinical Diagnostics SRM 2393 - CAG Repeat Length Mutation in Huntington`s Disease SRM 2365 - BK Virus DNA Quantitative Standard SRM 2366a - Cytomegalovirus DNA (Towne Δ147 BAC) for DNA SRM 2367 - JC

Clinical Measurements Quality Assurance Program

Ongoing

The National Institute of Standards and Technology (NIST) established the Clinical Measurements Quality Assurance Program (ClinQAP) to support the measurement needs of the clinical community. Participants measure concentrations of marker compounds, contaminants, metabolites in clinical samples (e.g

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

Human Vitamin D Binding Protein in complex with 25-hydroxyvitamin D3

Development of Reference Materials and Methods for Vitamin D Binding Protein

Ongoing

Vitamin D is essential for bone health, and vitamin D deficiency can lead to rickets in children and osteomalacia (soft bones) in adults. Vitamin D status is typically monitored through measurement of the metabolite 25-hydroxyvitamin D [25(OH)D] in serum. Most 25(OH)D is tightly bound to its

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

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 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)

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

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

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

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

Genome in a Bottle Workshops

Ongoing

GIAB has held 1-2 workshops each year since being formed in 2012. These workshops include progress updates, presentations about related work, and planning for new samples and analyses. Following are links to agendas, reports, and presentations from past workshops. Workshop Reports APRIL 2020

Health Assessment Measurements Quality Assurance Program (HAMQAP)

Completed

Participants in the HAMQAP measured concentrations of nutritional and toxic elements, fat- and water-soluble vitamins, fatty acids, active and/or marker compounds, and contaminants in samples distributed by NIST.   Samples that represent human intake (e.g., foods, dietary supplements, tobacco) were

Human Gut Microbiome Reference Material

Ongoing

The most common measurements currently being used to describe these complex microbial communities are: NGS-based metagenomics Mass spectrometry-based metabolomics In either case, no fit-for-purpose standards exist that enable researchers to compare results generated across different laboratories and

H5 Influenza Positive Controls

Ongoing

In response to the current H5N1 avian influenza outbreak, NIST has developed a research grade test material (RGTM) for PCR-based assays. This material contains 3 vials with RNA fragments for HA (Part A), NA (Part B), and MP (Part C). A NIST Reference Material is also under development. The guidance

Methods to Quantify Microbial Viability

Ongoing

Validating DNA-based methods to quantify viable bacteria ( S. Da Silva , G. Pinheiro) Microbial detection technologies based on nucleic acid measurements, such as polymerase chain reaction (PCR), are powerful detection tools that can provide relatively rapid results as compared to traditional

Microbial Cell Quantification Methods – Toward Whole Cell Reference Materials

Ongoing

Bacterial disaggregation as a strategy to improve cell counting ( S. Servetas, S. Da Silva) Counting bacterial cells is challenging enough when they are single, individual cells. It can be further complicated by the various bacterial morphologies (e.g., chains, clusters, etc.), which interfere with

Micronutrients Measurement Quality Assurance Program (MMQAP)

Completed

The MMQAP supported the long-term (months to years) reliability of selected fat- or water-soluble vitamin measurements in human serum and plasma. Results from the comparison studies helped participants to make accurate clinical and health-care decisions as well as to maintain and improve their

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