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Search Publications

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Displaying 1 - 25 of 846

From Crisis to Routine - Standardization of SARS-CoV-2 Genome Detection by Enhanced EQA Schemes in a Scientific Pandemic Network

May 24, 2025
Author(s)
Martin Kammel, Hans-Peter Grunert, Anika Zimmerman, Annemarie Martin, Vanessa Lindig, Samuel Samuleit, Ulf Duehring, Mechthild Adams-Bagusche, Dirk Sander, Hannah Zeichhardt, Christian Drosten, Victor Corman, Daniela Niemeyer, Sandra Ciesek, Holger Rabenau, Martin Obermeier, Robert Ehret, Rolf Kaiser, Jim Huggett, Denise O'Sullivan, Peter Vallone, Megan Cleveland, Samreen Falak, Andreas Kummrow, Esmeralda Valiente, Rainer Macdonald, Mojca Milavec, Sabine Goseberg, Silke Kappler, Natalie Weiss, Laura Vierbaum, Patricia Kaiser, Ingo Schellenberg, Heinz Zeichhardt
The outbreak of the COVID-19 pandemic led to a crisis situation in which diagnostic methods for the genome detection of the emerging SARS-CoV-2 were urgently needed from the beginning of 2020 for patient diagnostics, detection of infection chains and

NIST Special Publication 260 NIST.SP.260-256 Certification of Standard Reference Material(R)s 3672a & 3673a: Organic Contaminants in Smokers' Urine (Frozen) & Organic Contaminants in Non-Smokers' Urine (Frozen)

May 14, 2025
Author(s)
Ashley Russell, Carolyn Burdette, Johanna Camara, Nathanael Heckert, Jennifer Hoguet, Kevin Huncik, Jared Ragland, Elena Wood
Standard Reference Material (SRM) 3672a Organic Contaminants in Smokers' Urine (Frozen) and SRM 3673a Organic Contaminants in Non-Smokers' Urine (Frozen) are intended for use in evaluating analytical methods for the determination of selected naturally

Interlaboratory Assessment of Candidate Reference Materials for Lentiviral Vector Copy Number and Integration Site Measurements

April 21, 2025
Author(s)
Hua-Jun He, Zhiyong He, Steven Lund, Barbara Paugh, Jennifer McDaniel, Justin Zook, Sierra Miller, Samantha Maragh, Simona Patange, Mahir Mohiuddin, Alessandro Tona, John Elliott, Kenneth Cole, Sheng Lin-Gibson
Reference materials are essential for accurately measuring integrated lentiviral vector (LV) copy number (VCN) and integration sites for the safety and efficacy of lentivirus-based gene therapy. We conducted an interlaboratory study on NIST candidate

Inhibition by 4-(4-Bromo-2-oxo-3H-benzimidazol-1-yl)-N-(4-iodophenyl)piperidine-1-carboxamide) (TH5487) of the Activity of Human 8-Oxoguanine DNA Glycosylase-1 (OGG1) for the Excision of 2,6-Diamino-4-hydroxy-5-formamidopyrimidine, 4,6-Diamino-5-formamido

April 3, 2025
Author(s)
Pawel Jaruga, R. Stephen Lloyd, Michael Luzadder, Istvan Boldogh, M Miral Dizdar
DNA glycosylases of the base excision repair pathway have become clinically validated drug targets for treatment of several diseases. Human OGG1 (hOGG1) is specific for the removal of the highly mutagenic 8-oxoguanine (8-oxo-Gua) and 2,6-diamino-4-hydroxy

CCQM-P199b: Interlaboratory comparability study of SARS-CoV-2 RNA copy number quantification

March 27, 2025
Author(s)
Alison Devonshire, Eloise Busby, Gerwyn Jones, Denise O'Sullivan, Ana Fernandez-Gonzalez, Laura Hernandez-Hernandez, Xinhua Dai, Lianhua Dong, Chunyan Niu, Jie Xie, Xia Wang, Xiaoting Qiao, Xiang Fang, Clare Morris, Neil Almond, Megan Cleveland, Peter Vallone, Esther Castro Galvan, Melina Perez Urquiza, Mercedes Guadalupe Herrera Lopez, Arifa Khan, Sandra Fuentes, Elsa Baumeister, John Emerson Leguizamon Guerrero, Sergio Luis Davila Gonzalez, Andres Felipe Leon Torres, Aurea Folgueras-Flatschart, Marcelo Neves de Medeiros, Antonio Marcos Saraiva, Roberto Becht Flatschart, Carla Divieto, Mattia Pegoraro, Massimo Zucco, Laura Revel, Marco Mazzara, Philippe Corbisier, Gerhard Buttinger, Young-Kyung Bae, Alexandra Bogozalec Kosir, Mojca Milavec, Malcolm Hawkins, A. Pia Sanzone, Phattarapornn Morris, Sasithon Temisak, David Lynch, Jacob McLaughlin, Michael Forbes-Smith, Felicity Hall, Daniel Burke, Sachie Shibayama, Shin-ichiro Fujii, Megumi Kato, Samreen Falak, Rainer Macdonald, Andreas Kummrow, Andrey Komissarov, Sema Akyurek, Muslum Akgoz, Maxim Vonsky, Andrey Runov, Elena Kulyabina, Denis Rebrikov, Jim Huggett
RNA is the analyte targeted by nucleic acid amplification tests for SARS-CoV-2 virus, the causative agent of the COVID-19 pandemic. RNA concentration measured in respiratory specimens can vary by over nine orders of magnitude (1, 2). While RNA abundances

METROLOGY FOR MRI: THE FIELD YOU'VE NEVER HEARD OF

March 19, 2025
Author(s)
Kathryn Keenan, Stephen Russek, Matt Hall
Quantitative MRI has been an active area of research for decades and has produced a huge range of approaches with enormous potential for patient benefit. In many cases, however, there are challenges with reproducibility which has hampered clinical

Certification of Standard Reference Material(R) 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 and plasma. A unit of SRM 965c consists of three ampoules each of four materials: Level 1, Level

Role of NEIL1 in genome maintenance

February 19, 2025
Author(s)
Amanda McCullough, Irina Minko, Michael Luzadder, Jamie Zuckerman, Pawel Jaruga, Vladimir Vartanian, M Miral Dizdar, R. Stephen Lloyd
Phylogenetic analyses of DNA glycosylases that function in the initiation step of base excision repair reveal a high degree of conservation within the genes encoding Nei-like DNA glycosylase 1 (NEIL1). In concert with other glycosylases, this enzyme is an

Impact of screening for HPV-positive oropharyngeal cancers: A microsimulation-based modeling study

February 6, 2025
Author(s)
Rebecca Landy, Gregory Haber, Barry Graubard, Carole Fakhry, Nicole Campos, Emily Burger, Li Cheung, Hormuzd Katki, Maura Gillison, Anil Chaturvedi
Purpose: We estimated the population-level impact of screening on morbidity and mortality of HPV16-positive oropharyngeal cancer among US men aged 45-79 years. Methods: We developed an individual-level, state-transition natural history microsimulation

Impacts of household water demands and water heater delivery temperatures on opportunistic premise plumbing pathogens (OPPPs) in a residential setting

February 1, 2025
Author(s)
Alshae Logan, Jumana Aljafari, Visesh Uppoor, Tania Ullah, Jennifer Dootz
Efforts aimed towards water and energy conservation within residential buildings may create enhanced conditions for Opportunistic Premise Plumbing Pathogens (OPPPs) growth. To investigate this issue, a study was conducted to assess the effect of water

Aflatoxin B1-induced DNA adduct formation in murine kidney and liver

January 31, 2025
Author(s)
Pawel Jaruga, Vladimir Vartanian, Irina Minko, M Miral Dizdar, Amanda McCullough, R. Stephen Lloyd
Aflatoxicosis is a life-threatening nephrotoxic condition arising from eating foods highly contaminated with aflatoxin-producing molds. Additionally, chronic aflatoxin exposures are linked to enhanced hepatocellular carcinomas. Using recent advances in

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 analyte measured using two or more measurement systems. Assessment of commutability is essential

Well characterized polyethyleneimine/carboxylated polyethylene glycol functionalized gold nanoparticles as prospective nanoscale control materials for in vitro cell viability assays: particle characterization and toxicity test in eight mammalian cell line

January 7, 2025
Author(s)
Vytas Reipa, Vincent Hackley, Alessandro Tona, Min Beom Heo, Ye Ryeong Lee, Tae Geol Lee, Aaron Johnston-Peck, Tae Joon Cho
Safety screening of manufactured nanomaterials (MNMs) is essential for their adoption by consumers and the marketplace. Lately, animal-based testing is replaced by mechanistically informative in vitro assays due to requirements of regulatory agencies. Cell

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

December 16, 2024
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 used in the medical laboratory. Therefore, sustainable availability of these CRMs is crucial to

Color-map recommendation for MR relaxometry maps

October 16, 2024
Author(s)
Miha Fuderer, Fabio Crameri, Nandita deSouza, Bettina Baessler, Vikas Gulani, Meiyun Wang, Ruud de Boer, Matt Cashmore, Wolter de Graaf, Kathryn Keenan, Dan Ma, Carolin Pirkl, Nico Sollmann, Sebastian Weingartner, Stefano Mandija, Xavier Golay

Multiplexed SERS Detection of Serum Cardiac Biomarkers Using Plasmonic Metasurfaces

October 15, 2024
Author(s)
Peng Zheng, Lintong Wu, Piyush Raj, Jeong Hee Kim, Santosh Paidi, Stephen Semancik, Ishan Barman
Surface-enhanced Raman spectroscopy (SERS) possesses exquisite molecular-specific properties with single-molecule sensitivity. Yet, translation of SERS into a quantitative analysis technique remains elusive owing to considerable fluctuation of the SERS

Feasibility of Metrological Traceability Implementation Using the Joint Committee on Traceability in Laboratory Medicine Database Entries Including the Fulfillment of "Fit-for-Purpose" Maximum Allowable Measurement Uncertainty

September 24, 2024
Author(s)
MAURO PANTEGHINI, Johanna Camara, VINCENT DELATOUR, Katleen Van Uytfanghe, Hubert Vesper, Tianjiao Zhang
Background: In previous publications, the Task Force on Reference Measurement System Implementation proposed a procedural approach combining a critical review of entries available in the Joint Committee on Traceability in Laboratory Medicine (JCTLM)

Cure probabilities and solid organ transplantation for patients with colorectal cancer

September 5, 2024
Author(s)
Eric Engels, Soutrik Mandal, Douglas Corley, Christopher Blosser, Allyson Hart, Charles Lynch, Baozhen Qiao, Karen Pawlish, Gregory Haber, Kelly Yu, Ruth Pfeiffer
A previous cancer diagnosis can preclude patients from consideration for solid organ transplantation. Statistical models may improve candidate selection. We fitted statistical cure models for colorectal cancer patients in the United States using registry

Bilirubin measurements in neonates: uniform neonatal treatment can only be achieved by improved standardization

July 26, 2024
Author(s)
Christian Hulzebos, Johanna Camara, Miranda van Berkel, VINCENT DELATOUR, Stanley Lo, Agnes Mailloux, Marcel Schmidt, Mercy Thomas, Lindsey Mackay, Ronda Greaves
Measurement of total serum bilirubin (TSB) concentration is the gold standard approach for diagnosing neonatal unconjugated hyperbilirubinemia. It is of utmost importance that the measured TSB concentration is sufficiently accurate to prevent

Morphologic alterations across three levels of biological organization following oral exposure to silver-polymer nanocomposites in Japanese medaka (Oryzias latipes)

July 5, 2024
Author(s)
Melissa Chernick, Alan Kennedy, Treye Thomas, Keana C. K. Scott, Joana Sipe, Christine Hendren, Mark Wiesner, David Hinton
Polymer nanocomposites have diverse industrial and commercial uses. While many toxicity studies have assessed the individual materials (e.g., polymer, nanomaterial) comprising nanocomposites, few have examined the potential toxicity of the nanocomposite as
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