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Search Publications by: Megan Cleveland (Fed)

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Displaying 1 - 25 of 31

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

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

Standards and Metrology for Viral Vectors as Molecular Tools: Outcomes from a CCQM Workshop

May 24, 2024
Author(s)
Janathan Campbell, Neil Almond, Y Bae, Ravneet Bhuller, Andrea Briones, S-Y CHO, Megan Cleveland, Thomas Cleveland, Francis Galaway, Hua-Jun He, U Herbrand, Jim Huggett, Sarah Kempster, Ibolya Kepiro, Afifa Khan, Edward Kwee, Wilson Li, Sheng Lin-Gibson, Luise Luckau, Caterina Minelli, M Ryadnov, I Searing, Lili Wang, Alexandra Whale, Julian Braybrook
Viral vectors are agents enabling gene transfer and genome editing and have widespread utility across the healthcare and biotechnology sectors. In January 2023, the International Bureau for Weights and Measures' Consultative Committee for Amount of

NIST's Engagement with CCQM Studies from 1992 to 2023: History and Performance

May 21, 2024
Author(s)
David L. Duewer, Christina Cecelski, Megan Cleveland, Nancy Lin, Katrice Lippa, Jacqueline L. Mann, John L. Molloy, Michael Nelson, James E. Norris, Kenneth W. Pratt, Sumona Sarkar, Hratch G. Semerjian, Robert L. Watters
This report documents the engagement and measurement performance of the National Institute of Standards and Technology (NIST) in studies coordinated by the Consultative Committee for Amount of Substance: Metrology in Chemistry and Biology (CCQM) from 1992

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

CCQM-P199: Interlaboratory comparability study of HIV-1 RNA copy number quantification

April 13, 2024
Author(s)
Alison Devonshire, Eloise Busby, Gerwyn Jones, Denise O'Sullivan, Ana Fernandez-Gonzalez, Sachie Shibayama, Shin-ichiro Fujii, Megumi Kato, John Emerson Leguizamon Guerrero, Claudia Patricia Tere Pena, Maria Mercedes Arias Cortes, Roberto Becht Flatschart, Marcelo Neves de Medeiros, Antonio Marcos Saraiva, Young-Kyung Bae, Inchul Yang, Hee-Bong Yoo, Alexandra Bogozalec Kosir, Mojca Milavec, Lianhua Dong, Chunyan Niu, Xia Wang, Phattaraporn Morris, Sasithon Temisak, Megan Cleveland, Peter Vallone, Daniel Burke, Michael Forbes-Smith, Jacob McLaughlin, Samreen Falak, Martin Hussels, Rainer Macdonald, Andreas Kummrow, Burhanettin Yalcinkaya, Sema Akyurek, Muslum Akgoz, Maxim Vonsky, Andrey Runov, Simon Cowen, Stephen Nyangoma, Stephen Ellison, Clare Morris, Neil Almond, Jim Huggett
RNA is measured for a range of applications including clinical virology, disease-related gene expression biomarkers, biotechnology, cell therapy (viral vectors) and vaccines. For applications measuring viruses with RNA genomes, such as clinical viral load

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

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

Deep Sequencing and Molecular Characterisation of BK Virus and JC Virus WHO International Reference Materials for Clinical Diagnostic Use

May 30, 2023
Author(s)
Sheila Govind, Martin Fritzsche, Adrian Jenkins, Megan Cleveland, Peter Vallone, Neil Almond, Clare Morris, Neil Berry
Reactivation of JC and BK polyomaviruses during immunosuppressive transplantation procedures can lead to adverse clinical outcomes. In renal transplant recipients BKV-associated nephropathy can result in graft loss, while prolonged immunomodulatory drug

Rapid Production and Free Distribution of a Synthetic RNA Material to Support SARS-CoV-2 Molecular Diagnostic Testing

May 3, 2023
Author(s)
Megan Cleveland, Erica Romsos, Becky Steffen, Nathanael David Olson, Stephanie Servetas, William Valiant, Peter Vallone
In response to the COVID-19 pandemic, the National Institute of Standards and Technology released a synthetic RNA material for SARS-CoV-2 in June 2020. The goal was to rapidly produce a material to support molecular diagnostic testing applications. This

RNA reference materials with defined viral RNA loads of SARS-CoV-2 - A useful tool towards a better PCR assay harmonization

January 20, 2022
Author(s)
Laura Vierbaum, Nathalie Wojtalewicz, Vanessa Lindig, Ulf Duhring, Hans-Peter Grunert, Christian Drosten, Victor Corman, Daniela Niemeyer, Sandra Ciesek, Holger Rabenau, Annemarie Berger, Martin Obermeier, Andreas Nitsche, Janine Michel, Martin Mielke, Jim Huggett, Denise O'Sullivan, Simon Cowen, Megan Cleveland, Peter Vallone, Samreen Falak, Andreas Kummrow, Thomas Keller, Ingo Schellenberg, Heinz Zeichhardt, Martin Kammel
The outbreak and pandemic spread of SARS-CoV-2, the cause of the novel coronavirus disease (COVID-19), led to the need for a reliable detection method to track the circulation of this virus. After introducing PCR methods for genome detection of SARS-CoV-2

One in seven pathogenic variants can be challenging to detect by NGS: an analysis of 450,000 patients with implications for clinical sensitivity and genetic test implementation

May 18, 2021
Author(s)
Stephen Lincoln, Tina Hambuch, Justin Zook, Sara Bristow, Kathryn Hatchell, Rebecca Truty, Michael Kennemer, Brian Shirts, Andrew Fellowes, Shimul Chowdhury, Eric Klee, Shazia Mahamdallie, Megan Cleveland, Peter Vallone, Yan Ding, Sheila Seal, Wasanthi DeSilva, Farol Tomson, Catherine Huang Huang, Russell Garlick, Nazneen Rahman, Marc L. Salit, Stephen Kingsmore, Matthew Ferber, Swaroop Aradhya, Robert Nussbaum
Next-generation sequencing (NGS) is widely used and cost-effective. However, depending on the specific methods used, NGS can have limitations with certain technically challenging variant types. These types are poorly represented in some validation studies

Report of the 2019 NIST-FDA Workshop on Standards for Next Generation Sequencing Detection of Viral Adventitious Agents in Biologics and Biomanufacturing

February 22, 2021
Author(s)
Megan Cleveland, Bharathi Anekella, Mike Brewer, Pei-Ju Chin, Heather Couch, Eric Delwart, Jim Huggett, Scott Jackson, Javier Martin, Serge Monpoeho, Tom Morrison, Siemon Ng, David Ussery, Arifa Khan
Adventitious virus testing assures product safety by demonstrating the absence of viruses that may have been unintentionally introduced during the manufacturing process. The capabilities of next-generation or high-throughput sequencing (NGS/HTS) for broad