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Health

Clinical diagnostics

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Displaying 1 - 25 of 155

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

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

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

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

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. To enable technology developers along with research and clinical laboratories to evaluate variant

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 developed and adapted. It is more challenging to develop standards to ensure NAATs perform

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

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

October 3, 2024
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, Monica Molina, Maria Dolores Camacho Munoz, Antonio Checa, Michael Chen, Michelle Cinel, Benoit COLSCH, Cristina Coman, Bebiana Da Costa Sousa, Alex Dickens, Maria Maria, Finnur Freyr Eiriksson, Hector Gallart-Ayala, Mohan Ghorasaini, Martin Giera, Xue Guan, Mark Haid, Thomas Hankemeier, Amy Harms, Marcus Horing, Michal Holcapek, Thorsten Hornemann, Chunxiu Hu, Andreas Hulsmeier, Julijana Ivanisevic, Harald Kofeler, 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, Margret Thorsteinsdottir, 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 by mass spectrometry four ceramide species in the NIST human blood plasma Standard Reference

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)

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

Ensuring accuracy in the development and application of nucleic acid amplification tests (NAATs) for infectious disease

May 20, 2024
Author(s)
Jim Huggett, Denise O'Sullivan, Simon Cowen, Megan Cleveland, Jacob Moran-Gilad, Amanda Winter, Michael Messenger, Julian Braybrook
Diagnostic tests were heralded as crucial during the COVID-19 pandemic with most of the key methods using bioanalytical approaches. Bioanalytical techniques can be loosely described as methods that identify and quantify larger molecules (than conventional

Certification of Standard Reference Material(R) 1595a Tripalmitin

March 1, 2024
Author(s)
Michael Nelson, Jerome Mulloor, Brian Lang, Blaza Toman, Antonio Possolo, William Perry, Alicia Lyle
Standard Reference Material (SRM) 1595a Tripalmitin is a high purity chemical substance having a certified value for purity, expressed as a mass fraction. It is intended for use in preparing calibrants for measurement of total glyceride in clinical samples

From animal testing to in vitro systems: advancing standardization in microphysiological systems

February 15, 2024
Author(s)
Darwin Reyes-Hernandez, Mandy Esch, Lorna Ewart, Rohollah Nasiri, Anna Herland, Carolina Lucchesi, Kyung Sung, MONICA PIERGIOVANNI, Jelena Vukasinovic, James Shoemaker, Nureddin Ashammakhi
Limitations with cell cultures and experimental animal-based studies have had the scientific and industrial communities searching for new approaches that can provide reliable human models for applications such as drug development, toxicological assessment

Digital PCR for the Characterization of Reference Materials

February 14, 2024
Author(s)
Megan Cleveland, Hua-Jun He, Mojca Milavec, Young-Kyung Bae, Peter Vallone, Jim Huggett
Well characterized reference materials are essential to ensuring the harmonization and accuracy of nucleic acid-based tests (such as qPCR); digital PCR (dPCR) can measure the absolute concentration of a specific nucleic acid sequence in a background of non

Recommendations for setting a criterion and assessing commutability of sample materials used in external quality assessment/proficiency testing schemes

November 2, 2023
Author(s)
Sverre Sandberg, Pernille Fauskanger, Jesper Johansen, Thomas Keller, Jeffrey Budd, Neil Greenberg, robert rej, MAURO PANTEGHINI, VINCENT DELATOUR, Ferruccio Ceriotti, Liesbet Deprez, Johanna Camara, Finlay MacKenzie, Alicia Lyle, Eline van der Hagen, Chris Burns, W. Greg Miller
It is important for external quality assessment materials (EQAMs) to be commutable with clinical samples; i.e., they should behave like clinical samples when measured using end-user clinical laboratory in vitro diagnostic medical devices (IVD-MDs). Using

Results of German external quality assessment schemes for SARS-CoV-2 antigen detection

August 14, 2023
Author(s)
Laura Vierbaum, Nathalie Wojtalewicz, Peter Grunert, Anika Zimmerman, Annemarie Scholz, Sabine Goseberg, Patricia Kaiser, Ulf Duehring, Christian Drosten, Victor Max Corman, Daniela Niemeyer, Holger F. Rabenau, Martin Obermeier, Andreas Nitsche, Janine Michel, Jim Huggett, Denise O'Sullivan, Simon Cowen, Peter Vallone, Megan Cleveland, Samreen Falak, Andreas Kummrow, Ingo Schellenberg, Heinz Zeichhardt, Martin Kammel
The COVID-19 pandemic illustrated the important role of diagnostic tests, including lateral flow tests (LFTs), in identifying patients and their contacts to slow the spread of infections. INSTAND performed external quality assessments (EQA) for SARS-CoV-2

Recommendations for Setting a Criterion for Assessing Commutability of Secondary Calibrator Certified Reference Materials

August 11, 2023
Author(s)
W. Greg Miller, Thomas Keller, Jeffrey Budd, Jesper Johansen, Mauro Panteghini, Neil Greenberg, Vincent Delatour, Ferruccio Ceriotti, Robert Rej, Johanna Camara, Liesbet Deprez, Finlay MacKenzie, Alicia Lyle, Eline van der Hagen, Chris Burns, Pernille Fauskanger, Sverre Sandberg
A secondary higher-order calibrator is required to be commutable with clinical samples to be suitable for use in the calibration hierarchy of an end-user clinical laboratory in vitro diagnostic medical device (IVD-MD). Commutability is a property of a
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