nist-gov/www.nist.gov/topic-terms/clinical-diagnostics
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<h2 class="nist-block__title"> <div class="string">News and Updates</div>
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<div class="viewsreference"><div class="views-element-container"><div class="js-view-dom-id-fe3840acbd1dde3d84947c3c03044dd8b0519ab8e926eee2fb5a3b482457b866">
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<article
about="/news-events/news/2024/10/nist-scientists-use-dna-origami-chip-detect-biomolecules" typeof="schema:Article" class="nist-teaser"
>
<div class="nist-teaser__image">
<div class="entity-reference"> <a href="/news-events/news/2024/10/nist-scientists-use-dna-origami-chip-detect-biomolecules" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/thumbnail/public/images/2024/10/17/thumb%20%283%29.png?itok=QO61bjoF" width="100" height="100" alt="DNA hinge thumbnail" typeof="foaf:Image" />
</a>
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<header>
<h3 class="nist-teaser__title"><a href="/news-events/news/2024/10/nist-scientists-use-dna-origami-chip-detect-biomolecules"><span property="schema:name">NIST Scientists Use DNA Origami on a Chip to Detect Biomolecules</span>
</a></h3>
<div class="nist-teaser__date">
<div class="daterange"><time datetime="2024-10-17T12:00:00Z">October 17, 2024</time>
</div>
</div>
</header>
<div class="nist-teaser__content">
<div property="schema:text" class="text-with-summary"> 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
</div>
</div>
</div>
</article>
</div>
<div>
<article
about="/news-events/news/2024/10/nist-research-leader-featured-medical-iot-discussions" typeof="schema:Article" class="nist-teaser"
>
<div class="nist-teaser__image">
<div class="entity-reference"> <a href="/news-events/news/2024/10/nist-research-leader-featured-medical-iot-discussions" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/thumbnail/public/images/2024/11/29/NIST%20Research%20Leader%20Featured%20in%20Medical%20IoT%20Discussions.png?itok=cSHpnjGw" width="100" height="96" alt="NIST Research Leader Featured in Medical IoT Discussions" typeof="foaf:Image" />
</a>
</div>
</div>
<div class="nist-teaser__content-wrapper">
<header>
<h3 class="nist-teaser__title"><a href="/news-events/news/2024/10/nist-research-leader-featured-medical-iot-discussions"><span property="schema:name">NIST Research Leader Featured in Medical IoT Discussions</span>
</a></h3>
<div class="nist-teaser__date">
<div class="daterange"><time datetime="2024-10-01T12:00:00Z">October 1, 2024</time>
</div>
</div>
</header>
<div class="nist-teaser__content">
<div property="schema:text" class="text-with-summary"> NIST researcher Dr. Edward Griffor has contributed to recent dialogs on the role of Internet of Things technologies to advance future healthcare. For a podcast
</div>
</div>
</div>
</article>
</div>
<div>
<article
about="/news-events/news/2024/06/nist-partners-gates-foundation-develop-breathalyzers-malaria-and" typeof="schema:Article" class="nist-teaser"
>
<div class="nist-teaser__image">
<div class="entity-reference"> <a href="/news-events/news/2024/06/nist-partners-gates-foundation-develop-breathalyzers-malaria-and" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/thumbnail/public/images/2024/02/13/grantfund-graphic-v3.png?itok=amqd5dOg" width="100" height="67" alt="Illustration shows a breathalyzer device with a paper report and microscope slides. " typeof="foaf:Image" />
</a>
</div>
</div>
<div class="nist-teaser__content-wrapper">
<header>
<h3 class="nist-teaser__title"><a href="/news-events/news/2024/06/nist-partners-gates-foundation-develop-breathalyzers-malaria-and"><span property="schema:name">NIST Partners With the Gates Foundation to Develop Breathalyzers for Malaria and Tuberculosis</span>
</a></h3>
<div class="nist-teaser__date">
<div class="daterange"><time datetime="2024-06-26T12:00:00Z">June 26, 2024</time>
</div>
</div>
</header>
<div class="nist-teaser__content">
<div property="schema:text" class="text-with-summary"> NIST will create the standards and tools needed to ensure that the breathalyzers work.
</div>
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<h2 class="nist-block__title"> <div class="string">Events</div>
</h2>
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class="nist-block "
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<div class="viewsreference"><div class="views-element-container"><div class="js-view-dom-id-dfadc79e62b39440c5327e40c82f4e74ddd3717a7fb8db90150b26b9dbad7d5f">
<div>
<article
about="/news-events/events/2025/06/ai-and-flow-cytometry-workshop" class="nist-teaser"
>
<div class="nist-teaser__image">
<div class="entity-reference"> <a href="/news-events/events/2025/06/ai-and-flow-cytometry-workshop" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/thumbnail/public/images/2025/01/22/FlowCytometryConsortium_IdentifierGraphic_NIST_NIAIDlogos.png?itok=G6JfnpKd" width="100" height="66" alt="Conceptual illustration of cells, a flow cytometry stream, automation and collaboration with logos for NIST and NIAID underneath." typeof="foaf:Image" />
</a>
</div>
</div>
<div class="nist-teaser__content-wrapper">
<header>
<h3 class="nist-teaser__title"><a href="/news-events/events/2025/06/ai-and-flow-cytometry-workshop"><span>AI and Flow Cytometry Workshop</span>
</a></h3>
<div class="nist-teaser__date">
<div class="smartdate">Mon, Jun 9 - Tue, Jun 10 2025</div>
</div>
</header>
<div class="nist-teaser__content">
<div class="text-with-summary"> A NISTFDANIAID Co-Organized Workshop This workshop aims to advance AI/ML applications in flow cytometry and related
</div>
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<h2 class="nist-block__title"> <div class="string">Projects and Programs</div>
</h2>
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class="nist-block "
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<div class="viewsreference"><div class="views-element-container"><div class="js-view-dom-id-21d45bad2f27afbb2832a9f2861bd1775db6bfaed43c2bd83f724ee2690a3959">
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<article
about="/programs-projects/h5-influenza-positive-controls" class="nist-teaser"
>
<div class="nist-teaser__image">
<div class="entity-reference"> <a href="/programs-projects/h5-influenza-positive-controls" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/thumbnail/public/images/2024/11/01/RGTM10263_2.JPG?itok=Q7TAUNqL" width="100" height="58" alt="Unit of RGTM 10263 -- H5N1 Avian flu synthetic RNA fragments" typeof="foaf:Image" />
</a>
</div>
</div>
<div class="nist-teaser__content-wrapper">
<header>
<h3 class="nist-teaser__title"><a href="/programs-projects/h5-influenza-positive-controls"><span>H5 Influenza Positive Controls</span>
</a></h3>
<div class="nist-teaser__type">
<div class="nist-badge display-inline-block margin-y-1 nist-badge--blue boolean">Ongoing</div>
</div>
</header>
<div class="nist-teaser__content">
<div class="text-with-summary"> 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
</div>
</div>
</div>
</article>
</div>
<div>
<article
about="/programs-projects/standards-development-ensure-reliable-breath-analysis-field" class="nist-teaser"
>
<div class="nist-teaser__image">
<div class="entity-reference"> <a href="/programs-projects/standards-development-ensure-reliable-breath-analysis-field" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/thumbnail/public/images/2024/07/10/Picture1%20summary%20use.png?itok=SGOuNpgV" width="100" height="67" alt="Breathalyzer" typeof="foaf:Image" />
</a>
</div>
</div>
<div class="nist-teaser__content-wrapper">
<header>
<h3 class="nist-teaser__title"><a href="/programs-projects/standards-development-ensure-reliable-breath-analysis-field"><span>Standards Development to Ensure Reliable Breath Analysis in the Field</span>
</a></h3>
<div class="nist-teaser__type">
<div class="nist-badge display-inline-block margin-y-1 nist-badge--blue boolean">Ongoing</div>
</div>
</header>
<div class="nist-teaser__content">
<div class="text-with-summary"> 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
</div>
</div>
</div>
</article>
</div>
<div>
<article
about="/programs-projects/trusted-ai-framework-new-class-standard-reference-materials-and-data-exquisitely" class="nist-teaser"
>
<div class="nist-teaser__image">
<div class="entity-reference"> <a href="/programs-projects/trusted-ai-framework-new-class-standard-reference-materials-and-data-exquisitely" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/thumbnail/public/images/2021/04/14/AI%20for%20SRMs%20and%20SRD.png?itok=eCuT22c2" width="100" height="42" alt="AI for SRMs and SRD" typeof="foaf:Image" />
</a>
</div>
</div>
<div class="nist-teaser__content-wrapper">
<header>
<h3 class="nist-teaser__title"><a href="/programs-projects/trusted-ai-framework-new-class-standard-reference-materials-and-data-exquisitely"><span>Trusted AI framework for a new class of Standard Reference Materials and Data with exquisitely characterized uncertainty for billions of properties</span>
</a></h3>
<div class="nist-teaser__type">
<div class="nist-badge display-inline-block margin-y-1 nist-badge--blue boolean">Ongoing</div>
</div>
</header>
<div class="nist-teaser__content">
<div class="text-with-summary"> 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
</div>
</div>
</div>
</article>
</div>
<div>
<article
about="/programs-projects/genome-bottle" class="nist-teaser"
>
<div class="nist-teaser__image">
<div class="entity-reference"> <a href="/programs-projects/genome-bottle" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/thumbnail/public/images/2019/05/15/giab_logo_color.png?itok=KdsryiNW" width="72" height="100" alt="GIAB Logo" typeof="foaf:Image" />
</a>
</div>
</div>
<div class="nist-teaser__content-wrapper">
<header>
<h3 class="nist-teaser__title"><a href="/programs-projects/genome-bottle"><span>Genome in a Bottle</span>
</a></h3>
<div class="nist-teaser__type">
<div class="nist-badge display-inline-block margin-y-1 nist-badge--blue boolean">Ongoing</div>
</div>
</header>
<div class="nist-teaser__content">
<div class="text-with-summary"> 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
</div>
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<h2 class="nist-block__title"> <div class="string">Publications</div>
</h2>
<div
class="nist-block "
>
<div class="viewsreference"><div class="views-element-container"><div class="js-view-dom-id-ebf8634f423b0c1b9167210f5649cb3e2e46f19c49cf934c649cb0c6debe815a">
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<article
about="/publications/commutability-assessment-new-standard-reference-materials-srms-determining-serum-total" class="nist-teaser"
>
<div class="nist-teaser__content-wrapper">
<header>
<h3 class="nist-teaser__title"><a href="/publications/commutability-assessment-new-standard-reference-materials-srms-determining-serum-total"><span>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</span>
</a></h3>
<div class="nist-teaser__date">
<div class="daterange"><time datetime="2025-01-10T12:00:00Z">January 10, 2025</time>
</div>
</div>
<div class="nist-teaser__type">
<div class="nist-field nist-field--label-inline text-long">
<div class="nist-field__label">Author(s)</div>
<div class="nist-field__item">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, <span class="nist-author">Ashley Boggs-Russell</span>, <span class="nist-author">Carolyn Burdette</span>, Grace Hahm, Federica Nalin, <span class="nist-author">Johanna Camara</span></div>
</div>
</div>
</header>
<div class="nist-teaser__content">
<div class="text-with-summary"> 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
</div>
</div>
</div>
</article>
</div>
<div>
<article
about="/publications/application-digital-pcr-reference-measurement-procedure-support-accuracy-quality" class="nist-teaser"
>
<div class="nist-teaser__content-wrapper">
<header>
<h3 class="nist-teaser__title"><a href="/publications/application-digital-pcr-reference-measurement-procedure-support-accuracy-quality"><span>The Application of Digital PCR as a Reference Measurement Procedure to Support the Accuracy of Quality Assurance for Infectious Disease Molecular Diagnostic Testing</span>
</a></h3>
<div class="nist-teaser__date">
<div class="daterange"><time datetime="2024-12-26T12:00:00Z">December 26, 2024</time>
</div>
</div>
<div class="nist-teaser__type">
<div class="nist-field nist-field--label-inline text-long">
<div class="nist-field__label">Author(s)</div>
<div class="nist-field__item">Samreen Falak, Denise O'Sullivan, <span class="nist-author">Megan Cleveland</span>, Simon Cowen, Eloise Busby, Alison Devonshire, Esmeralda Valiente, Gerwyn Jones, Martin Kammel, Mojca Milavec, Laura Vierbaum, Ingo Schellenberg, Heinz Zeichhardt, Andreas Kummrow, <span class="nist-author">Peter Vallone</span>, Rainer Macdonald, Jim Huggett</div>
</div>
</div>
</header>
<div class="nist-teaser__content">
<div class="text-with-summary"> Background Nucleic Acid Amplification Tests (NAATs) are used to diagnose many infectious diseases. They are typically sensitive and specific and can be quickly
</div>
</div>
</div>
</article>
</div>
<div>
<article
about="/publications/recommendations-assessing-commutability-replacement-batch-secondary-calibrator" class="nist-teaser"
>
<div class="nist-teaser__content-wrapper">
<header>
<h3 class="nist-teaser__title"><a href="/publications/recommendations-assessing-commutability-replacement-batch-secondary-calibrator"><span>Recommendations for assessing commutability of a replacement batch of a secondary calibrator certified reference material</span>
</a></h3>
<div class="nist-teaser__date">
<div class="daterange"><time datetime="2024-12-16T12:00:00Z">December 16, 2024</time>
</div>
</div>
<div class="nist-teaser__type">
<div class="nist-field nist-field--label-inline text-long">
<div class="nist-field__label">Author(s)</div>
<div class="nist-field__item">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, <span class="nist-author">Johanna Camara</span>, Alicia Lyle, W. Greg Miller, VINCENT DELATOUR</div>
</div>
</div>
</header>
<div class="nist-teaser__content">
<div class="text-with-summary"> Commutable secondary certified reference materials (CRMs) play an essential role in the calibration hierarchy of many in-vitro diagnostic measurement procedures
</div>
</div>
</div>
</article>
</div>
<div>
<article
about="/publications/concordant-inter-laboratory-derived-concentrations-ceramides-human-plasma-reference" class="nist-teaser"
>
<div class="nist-teaser__content-wrapper">
<header>
<h3 class="nist-teaser__title"><a href="/publications/concordant-inter-laboratory-derived-concentrations-ceramides-human-plasma-reference"><span>Concordant inter-laboratory derived concentrations of ceramides in human plasma reference materials via authentic standards</span>
</a></h3>
<div class="nist-teaser__date">
<div class="daterange"><time datetime="2024-10-03T12:00:00Z">October 3, 2024</time>
</div>
</div>
<div class="nist-teaser__type">
<div class="nist-field nist-field--label-inline text-long">
<div class="nist-field__label">Author(s)</div>
<div class="nist-field__item"><span class="nist-author">Tracey Schock</span>, <span class="nist-author">Christina Jones</span>, 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</div>
</div>
</div>
</header>
<div class="nist-teaser__content">
<div class="text-with-summary"> In this community effort, we compared measurements between 34 laboratories from 19 countries, utilizing mixtures of authentic synthetic standards, to quantify
</div>
</div>
</div>
</article>
</div>
</div>
</div>
</div>
</div>
</div>
</div>
<div class="margin-y-4">
<div class="paragraph paragraph--type--dynamic-content-list-topic paragraph--view-mode--default">
<h2 class="nist-block__title"> <div class="string">Software</div>
</h2>
<div
class="nist-block "
>
<div class="viewsreference"><div class="views-element-container"><div class="js-view-dom-id-f9055770b7c858909ee3802ce97b73dcc1974fa69bff8759e358308e4a6ff47a">
<div>
<article
about="/services-resources/software/nists-integrated-colony-enumerator-nice" class="nist-teaser"
>
<div class="nist-teaser__image">
<div class="entity-reference"> <a href="/services-resources/software/nists-integrated-colony-enumerator-nice" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/thumbnail/public/images/2016/09/21/nicewindow.gif?itok=rZdnL2I_" width="100" height="75" alt="NICE screenshot" typeof="foaf:Image" />
</a>
</div>
</div>
<div class="nist-teaser__content-wrapper">
<header>
<h3 class="nist-teaser__title"><a href="/services-resources/software/nists-integrated-colony-enumerator-nice"><span>NIST&#039;s Integrated Colony Enumerator (NICE)</span>
</a></h3>
<div class="nist-teaser__date">
<div class="daterange"><time datetime="2021-01-04T12:00:00Z">January 4, 2021</time>
</div>
</div>
</header>
<div class="nist-teaser__content">
<div class="text-with-summary"> Enumeration of bacterial colonies on an agar plate is simple in concept, but automated colony counting is difficult due to variations in colony color, size
</div>
</div>
</div>
</article>
</div>
<div>
<article
about="/services-resources/software/curated-archive-covid-19-research-challenge-dataset-cord19-cdcs-nist" class="nist-teaser"
>
<div class="nist-teaser__image">
<div class="entity-reference"> <a href="/services-resources/software/curated-archive-covid-19-research-challenge-dataset-cord19-cdcs-nist" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/thumbnail/public/images/2020/04/17/cord19_snapshot.png?itok=iMMrP7lP" width="100" height="62" alt="cord19_snapshot" typeof="foaf:Image" />
</a>
</div>
</div>
<div class="nist-teaser__content-wrapper">
<header>
<h3 class="nist-teaser__title"><a href="/services-resources/software/curated-archive-covid-19-research-challenge-dataset-cord19-cdcs-nist"><span>Curated Archive for COVID-19 Research Challenge Dataset (cord19-cdcs-nist)</span>
</a></h3>
<div class="nist-teaser__date">
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