Clinical diagnostics

News and Updates

NIST Releases Reference Material to Aid Gut Microbiome Research

March 17, 2025

Researchers hope this material will help usher in a new era of diagnostics and treatments involving the gut microbiome.

This AAV vector is a bumpy sphere that looks like it's made up of tiny crumpled black and white tubes.

Study Highlights Need for Standardized Measurement Methods in Gene Therapy

January 6, 2025

Scientists looked at multiple techniques used to measure the modified viruses deployed in some gene therapy research and treatments.

NIST Scientists Use DNA Origami on a Chip to Detect Biomolecules

October 17, 2024

Using strands of DNA to create miniature hinges that pop open or shut when binding to specific molecules, researchers at the National Institute of Standards and

Blog Posts

A medical worker wears gloves as she prepares to swab the nose of a female patient.

Measuring the Accuracy of PCR Tests Can Improve Health Care Beyond COVID-19

To See Life in a Drop of Blood

Working to Improve Small-Scale MRIs: My Summer as a SURF Student at NIST

Events

2025 NIST Workshop on Rapid Microbial Testing Methods

Tue, Apr 8 2025, 11:00am - 5:00pm EDT

Workshop Overview The NIST-led Rapid Microbial Testing Methods (RMTM) Consortium launched in 2020 to develop standards

Conceptual illustration of cells, a flow cytometry stream, automation and collaboration with logos for NIST and NIAID underneath.

AI and Flow Cytometry Workshop

Mon, Jun 9 - Tue, Jun 10 2025

A NIST–FDA–NIAID Co-Organized Workshop This workshop aims to advance AI/ML applications in flow cytometry and related

Projects and Programs

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

Standards Development to Ensure Reliable Breath Analysis in the Field

Ongoing

Numerous volatile organic compounds (VOCs) have been identified in human breath. These compounds can be produced by the body or by organisms in the body (e.g., bacteria or viruses) and provide a non-invasive window into human health. Inexpensive point-of-care devices are being developed to diagnose

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

Trusted AI framework for a new class of Standard Reference Materials and Data with exquisitely characterized uncertainty for billions of properties

Ongoing

The measurement of diverse molecular classes in biospecimens containing millions of molecules, known as omics, is increasingly important in the life sciences and medicine, and used to find novel cancer therapeutics, discover COVID-19 infection pathways, and diagnose diseases. NIST RMs and SRDs for

Publications

Certification of Standard Reference Material® 965c Glucose in Frozen Human Serum

March 13, 2025

Author(s)

Amanda Bayless, William Davis, Elena Wood, Abraham Kuri Cruz, Johanna Camara, Blaza Toman, Komal Dahya, Katherine Earl, Chui Tse, Uliana Danilenko, Hubert Vesper

Standard Reference Material (SRM) 965c Glucose in Frozen Human Serum is intended for use in validating methods for the determination of glucose in human serum

Commutability Assessment of New Standard Reference Materials (SRMs) for Determining Serum Total 25-Hydroxyvitamin D using Ligand Binding and Liquid Chromatography – Tandem Mass Spectrometry (LC-MS/MS) Assays

January 10, 2025

Author(s)

Stephen Wise, Etienne Cavalier, Pierre LUKAS, Stephanie Peeters, caroline Le Goff, Laura Briggs, Emma Williams, Ekaterina Mineva, Christine Pfeiffer, Hubert Vesper, Christian Popp, Christian Beckert, Jan Schultess, Kevin Wang, Carole Tourneur, Camille Pease, Dominik Osterritter, Ralf Fischer, Ben Saida, Chao Dou, Satoshi Kojima, Hope Weiler, Agnieszka Bielecki, Heather Pham, Alexandra Bennett, Shawn You, Amit Ghoshal, Chistian Vogl, James Freeman, Neil Parker, Samantha Pagliaro, Jennifer Cheek, Jie Li, Hisao Tsukamoto, Karen Galvin, Kevin Cashman, Hsuan-Chieh Liao, Andrew Norbert Hoofnagle, Jeffery Budd, Adam Kuszak, Ashley Boggs-Russell, Carolyn Burdette, Grace Hahm, Federica Nalin, Johanna Camara

Commutability is where the measurement response for a reference material (RM) is the same as for an individual patient sample with the same concentration of

Small variant benchmark from a complete assembly of X and Y chromosomes

January 8, 2025

Author(s)

Justin Wagner, Nathanael Olson, Jennifer McDaniel, Lindsay Harris, Chunlin Xiao, Fritz Sedlazeck, Kishwar Shafin, Andrew Carroll, Justin Zook

The sex chromosomes contain complex, important genes impacting medical phenotypes, but differ from the autosomes in their ploidy and large repetitive regions

The Application of Digital PCR as a Reference Measurement Procedure to Support the Accuracy of Quality Assurance for Infectious Disease Molecular Diagnostic Testing

December 26, 2024

Author(s)

Samreen Falak, Denise O'Sullivan, Megan Cleveland, Simon Cowen, Eloise Busby, Alison Devonshire, Esmeralda Valiente, Gerwyn Jones, Martin Kammel, Mojca Milavec, Laura Vierbaum, Ingo Schellenberg, Heinz Zeichhardt, Andreas Kummrow, Peter Vallone, Rainer Macdonald, Jim Huggett

Background Nucleic Acid Amplification Tests (NAATs) are used to diagnose many infectious diseases. They are typically sensitive and specific and can be quickly

Clinical diagnostics

News and Updates

NIST Releases Reference Material to Aid Gut Microbiome Research

Study Highlights Need for Standardized Measurement Methods in Gene Therapy

NIST Scientists Use DNA Origami on a Chip to Detect Biomolecules

Blog Posts

Measuring the Accuracy of PCR Tests Can Improve Health Care Beyond COVID-19

To See Life in a Drop of Blood

Working to Improve Small-Scale MRIs: My Summer as a SURF Student at NIST

Events

2025 NIST Workshop on Rapid Microbial Testing Methods

AI and Flow Cytometry Workshop

Projects and Programs

H5 Influenza Positive Controls

Standards Development to Ensure Reliable Breath Analysis in the Field

Cancer Genome in a Bottle

Trusted AI framework for a new class of Standard Reference Materials and Data with exquisitely characterized uncertainty for billions of properties

Publications

Certification of Standard Reference Material® 965c Glucose in Frozen Human Serum

Commutability Assessment of New Standard Reference Materials (SRMs) for Determining Serum Total 25-Hydroxyvitamin D using Ligand Binding and Liquid Chromatography – Tandem Mass Spectrometry (LC-MS/MS) Assays

Small variant benchmark from a complete assembly of X and Y chromosomes

The Application of Digital PCR as a Reference Measurement Procedure to Support the Accuracy of Quality Assurance for Infectious Disease Molecular Diagnostic Testing

Software

NIST's Integrated Colony Enumerator (NICE)

AutoDimer

Curated Archive for COVID-19 Research Challenge Dataset (cord19-cdcs-nist)