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Health

Clinical diagnostics

News and Updates

Events

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

AI and Flow Cytometry Workshop

Wed, Mar 26 - Thu, Mar 27 2025
A NIST–FDA–NIAID Co-Organized Workshop This workshop aims to advance AI/ML applications in flow cytometry and related

Projects and Programs

Unit of RGTM 10263 -- H5N1 Avian flu synthetic RNA fragments

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
GIAB Logo

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

Publications

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

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

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

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

Recommendations for assessing commutability of a replacement batch of a secondary calibrator certified reference material

Author(s)
Liesbet Deprez, Jesper Johansen, Thomas Keller, Jeffrey Budd, Neil Greenberg, Cas Weykamp, Sverre Sandberg, MAURO PANTEGHINI, Ferruccio Ceriotti, Elizabeth Barczak, Robert Rej, Pernille Kjeilen Fauskanger, Finlay MacKenzie, Johanna Camara, Alicia Lyle, W. Greg Miller, VINCENT DELATOUR
Commutable secondary certified reference materials (CRMs) play an essential role in the calibration hierarchy of many in-vitro diagnostic measurement procedures

Concordant inter-laboratory derived concentrations of ceramides in human plasma reference materials via authentic standards

Author(s)
Tracey Schock, Christina Jones, Federico Torta, Nils Hoffmann, Bo Burla, Irina Alecu, Makoto Arita, Takeshi Bamba, Steffany A.L. Bennett, Justine BERTRAND-MICHEL, Britta Brugger, Mónica Molina, María Dolores Camacho Muñoz, Antonio Checa, Michael Chen, Michelle Cinel, Benoit COLSCH, Cristina Coman, Bebiana Da Costa Sousa, Alex Dickens, Maria Maria, Finnur Freyr Eiríksson, Hector Gallart-Ayala, Mohan Ghorasaini, Martin Giera, Xue Guan, Mark Haid, Thomas Hankemeier, Amy Harms, Marcus Höring, Michal Holčapek, Thorsten Hornemann, Chunxiu Hu, Andreas Hülsmeier, Julijana Ivanisevic, Harald Köfeler, Sin Man Lam, Jong Cheol Lee, Gerhard Liebisch, Andrea F Lopez-Clavijo, Malena Manzi, Peter Meikle, Maria Monge, Sneha Muralidharan, Anna Nicolaou, Valerie O'Donnell, Matej Oresic, Arvind Ramanathan, Daisuke Saigusa, Heidi Schwartz-Zimmermann, Guanghou Shui, Masatomo Takahashi, Margrét Thorsteinsdóttir, Anthony Tournadre, Hiroshi Tsugawa, Victoria Tyrrell, Grace van der Gugten, Michael Wakelam, Craig Wheelock, Denise Wolrab, Guowang Xu, John Bowden, Kim Ekroos, Robert Ahrends, Markus Wenk
In this community effort, we compared measurements between 34 laboratories from 19 countries, utilizing mixtures of authentic synthetic standards, to quantify

Software

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