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Health

Clinical diagnostics

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Displaying 51 - 75 of 165

Assessment of Serum Total 25-Hydroxyvitamin D Assays for Vitamin D External Quality Assessment Scheme (DEQAS) Materials Distributed at Ambient and Frozen Conditions

November 9, 2021
Author(s)
Johanna Camara, Christopher T. Sempos, Emma L. Williams, Graham D. Carter, Julia C. Jones, Carolyn Burdette, Grace Hahm, Federica Nalin, David L. Duewer, Adam J. Kuszak, J. M. Betz, Andrew Hoofnagle, Pierre Lukas, E. Cavalier, Ramon Durazo-Arvizu, P. M. Crump, Christian Popp, Christian Beckert, Glen Van Slooten, Patrick Gradon, Joelle Morgand, Sarah Paul, Bruno Emanuelli, Angelo Maggio, Fiona Ivison, Ralf Fischer, Jody M. van den Ouweland, Chung S. Ho, Emmett W. Law, Jean-Nicolas Simard, Renaud Gonthier, Brett Holmquist, Manisha S. Patwardhan, Marcelo C. Batista, Heather Pham, Sarah Meadows, Eugene Jansen, Dilshad A. Khan, Kimberly Robyak, Mark Kilbane, Neil Parker, Vincent Chen, Robert Fitzgerald, Sohail Mushtaq, Michael W. Clarke, Norma Breen, Christine Simpson, Stephen A. Wise
The Vitamin D External Quality Assessment Scheme (DEQAS) distributes human serum samples four times per year to over 1000 participants worldwide for the determination of total serum 25-hydroxyvitamin D [25(OH)D)]. These samples are stored at −40 °C prior

Optimizing Available Tools for Obtaining Result Standardization: A Joint Committee on Traceability in Laboratory Medicine (JCTLM) Project

October 12, 2021
Author(s)
Mauro Panteghini, Federica Braga, Johanna Camara, Vincent Delatour, Katleen Van Uytfanghe, Hubert Vesper, Tianjiao Zhang
BACKGROUND: The JCTLM created a Task Force on Reference Measurement System Implementation (TFRMSI) to provide guidance on metrological traceability implementation for the in vitro diagnostics (IVD) community. CONTENT: TF-RMSI investigated the reference

An assessment of US microbiome research

September 23, 2021
Author(s)
Scott Jackson
Genome-enabled technologies have supported a dramatic increase in our ability to study microbial communities in environments and hosts. Taking stock of previously funded microbiome research can help to identify common themes, under-represented areas and

Current Explorations of Nutrition and the Gut Microbiome: A Systematic Review

September 23, 2021
Author(s)
Scott Jackson, Leigh A. Frame, Elise Costas
Background The ability to measure and describe the microbiome has led to a surge in information about the gut microbiome and its role in health and disease. The relationship between nutrition and the gut microbiome is central, as the diet is a source of

Health Assessment Measurements Quality Assurance Program: Exercise 6 Final Report

September 20, 2021
Author(s)
Chuck Barber, Carolyn Burdette, Hugh Hayes, Monique Johnson, Shaun Kotoski, Jacolin Murray, Melissa M. Phillips, Kate Rimmer, Laura J. Wood, Andrea Yarberry
The Health Assessment Measurements Quality Assurance Program (HAMQAP) was launched in collaboration with the National Institutes of Health (NIH) Office of Dietary Supplements (ODS) in 2017. HAMQAP was established to enable laboratories to improve the

Certification of Standard Reference Materials(R) 2969 and 2970: Vitamin D Metabolites in Frozen Human Serum (Total 25-Hydroxyvitamin D Low Level) and (25-Hydroxyvitamin D2 High Level)

September 2, 2021
Author(s)
Grace Hahm, Michael Nelson, Johanna Camara, Blaza Toman
Standard Reference Materials (SRMs) 2969 and 2970 are intended for 1) use in validating methods for determining concentrations of 25-hydroxyvitamin D2 (25(OH)D2) and 25-hydroxyvitamin D3 (25(OH)D3) in human serum and plasma and 2) value assigning in house

Interlaboratory Comparison of 25-Hydroxyvitamin D Assays: Vitamin D Standardization Program (VDSP) Intercomparison Study 2 - Part 2 Immunoassays - Impact of 25 Hydroxyvitamin D2 and 24R,25-Dihydroxyvitamin D3 on Assay Performance

August 27, 2021
Author(s)
Stephen Wise, Johanna Camara, Carolyn Burdette, Grace Hahm, Federica Nalin, Adam Kuszak, Joyce Merkel, Ramon Durazo-Arvizu, Emma Williams, Christian Popp, Christian Beckert, Jan Schultess, Glen Van Slooten, Carole Tourneur, Camille Pease, Kavi Kaul, Alfredo Villarreal, Marcelo Batista, Heather Pham, Alex Bennett, Eugene Jansen, Dilshad Khan, Mark Kilbane, Patrick Twomey, James Freeman, Neil Parker, Sohail Mushtaq, Christine Simpson, Pierre Lukas, Etienne Cavalier, Christopher Sempos
An interlaboratory comparison study was conducted by the Vitamin D Standardization Program (VDSP) to assess the performance of immunoassays (Part 2) for the determination of serum total 25 hydroxyvitamin D [25(OH)D]. A set of 50 single-donor samples was

Interlaboratory Comparison of 25-Hydroxyvitamin D Assays: Vitamin D Standardization Program (VDSP) Intercomparison Study 2 - Part 1 Liquid Chromatography - Tandem Mass Spectrometry (LC-MS/MS) Assays - Impact of 3-epi-25-Hydroxyvitamin D3

August 27, 2021
Author(s)
Stephen Wise, Johanna Camara, Carolyn Burdette, Grace Hahm, Federica Nalin, Adam Kuszak, Joyce Merkel, Ramon Durazo-Arvizu, Emma Walker, Andrew Hoofnagle, Fiona Ivison, Ralf Fischer, Jody van den Ouweland, Chung Ho, Emmet Law, Jean-Nicolas Simard, Renaud Gonthier, Brett Holmquist, Sarah Meadows, Lorna Cox, Kimberly Robyak, Michael Creer, Robert Fitzgerald, Michael Clarke, Norma Breen, Pierre Lukas, Etienne Cavalier, Christopher Sempos
An interlaboratory comparison study was conducted by the Vitamin D Standardization Program (VDSP) to assess the performance of liquid chromatography – tandem mass spectrometry (LC-MS/MS) assays used for the determination of serum total 25-hydroxyvitamin D

Challenges of Accuracy in Germline Clinical Sequencing Data

July 20, 2021
Author(s)
Justin Zook, Ryan Poplin, Mark DePristo
Physicians are increasingly using clinical sequencing tests to establish diagnoses of patients who might have genetic disorders, which means that accuracy of sequencing and interpretation are important elements in ensuring the benefits of genetic testing

Assessment of Serum Total 25 Hydroxyvitamin D Assay Commutability of Standard Reference Materials and College of American Pathologists Accuracy Based Vitamin D (ABVD) Scheme and Vitamin D External Quality Assessment Scheme (DEQAS) Materials: Vitamin D Sta

July 1, 2021
Author(s)
Johanna Camara, Stephen A. Wise, Andrew Hoofnagle, Emma L. Williams, Graham D. Carter, Julia C. Jones, Carolyn Burdette, Grace Hahm, Federica Nalin, Adam J. Kuszak, Joyce M. Merkel, Ramon Durazo-Arvizu, Pierre Lukas, E. Cavalier, Christian Popp, Christian Beckert, Jan Schultess, Glen Van Slooten, Carole Tourneur, Camille Pease, Ravi Kaul, Alfredo Villarreal, Fiona Ivison, Ralf Fischer, Jody M. van den Ouweland, Chung S. Ho, Emmett W. Law, Jean-Nicolas Simard, Renaud Gonthier, Brett Holmquist, Marcelo C. Batista, Heather Pham, Alex Bennett, Sarah Meadows, Lorna Cox, Eugene Jansen, Dilshad A. Khan, Kimberly Robyak, Michael H. Creer, Mark Kilbane, Patrick J. Twomey, James Freeman, Neil Parker, Jinyun Yuan, Robert Fitzgerald, Sohail Mushtaq, Michael W. Clarke, Norma Breen, Christine Simpson, Christopher T. Sempos
An interlaboratory study was conducted through the Vitamin D Standardization Program (VDSP) to assess commutability of Standard Reference Materials® (SRMs) and proficiency testing/external quality assessment (PT/EQA) samples for determination of serum

Vitamin D Standardization Program (VDSP) intralaboratory study for the assessment of 25-hydroxyvitamin D assay variability and bias

May 17, 2021
Author(s)
Johanna Camara, Stephen Wise, Christopher T. Sempos, Pierre Lukas, Caroline LeGoff, Stephanie Peeters, Carolyn Burdette, Federica Nalin, Grace Hahm, Ramon Durazo-Arvizu, Adam J. Kuszak, Joyce M. Merkel, E. Cavalier
An intralaborabory comparison study to assess the performance of assays for the determination of serum total 25-hydroxyvitamin D [25(OH)D] was conducted in 2017 as part of the Vitamin D Standardization Program (VDSP). The intralaboratory study consisted of

Towards Quantitative and Standardized Serological and Neutralization Assays for COVID-19

March 8, 2021
Author(s)
Linhua Tian, Elzafir B. Elsheikh, Paul Patrone, Anthony Kearsley, adolfas Gaigalas, Sarah L. Inwood, Sheng Lin-Gibson, Dominic Esposito, Lili Wang
Quantitative and robust serology assays are critical measurements underpinning global COVID-19 response to diagnostic, surveillance, and vaccine development. Here, we report a proof-of-concept approach for the development of quantitative, multiplexed flow

Accelerating Innovation and Commercialization Through Standardization of Microfluidic-Based Medical Devices

January 5, 2021
Author(s)
Darwin R. Reyes-Hernandez, Henne van Heeren, Suvajyoti Guha, Luke Herbertson, Alexios P. Tzannis, Jens Ducr?e, Hugo Bissig, Holger Becker
The microfluidics industry has grown steadily over the last 5 years worldwide, with the market for microfluidic medical devices experiencing a compound growth rate of 18%. The number of submissions to regulatory agencies such as the U.S. Food & Drug

Chromosome-scale, haplotype-resolved assembly of human genomes

December 7, 2020
Author(s)
Justin Zook, Shilpa Garg, Heng Li
Haplotype-resolved or phased genome assembly provides a complete picture of genomes and their complex genetic variations. However, current algorithms for phased assembly either do not generate chromosome-scale phasing or require pedigree information, which

Development of a pregnancy-specific reference material for thyroid biomarkers, vitamin D, and nutritional trace elements in serum

October 24, 2020
Author(s)
Ashley Russell, Lisa Kilpatrick, Carolyn Burdette, Denise S. Tevis, Zachary A. Fultz, Michael Nelson, Jeff M. Jarrett, Stephen A. Wise, Brittany Kassim, Stephen E. Long
Background Concentrations of critical metabolites, hormones, and nutritional elements change significantly throughout pregnancy. Therefore, increased matrix complexity is a challenge for the measurement of these biomarkers. To provide a quality assurance

Certification of Standard Reference Material(R) 955d, Toxic Elements and Metabolites in Frozen Human Blood

October 15, 2020
Author(s)
Lee L. Yu, Karen E. Murphy, Colleen E. Bryan Sallee, Thomas W. Vetter, Robert C. Hagwood, George C. Caceres, Stephen E. Long, J M. Jarrett, M A. Franklin, J Castro Georgi, D M. Jones, Robert Jones, Z Li, Y L. Sommer, D S. Tevis, K Wallon, C D. Ward, M Maras, S Erdahl, C Gilmer, M Wermers, H Woldeysus, K F. Mehigan, M Morrissette, Christopher D. Palmer, Patrick J. Parsons
Standard Reference Material (SRM) 955d is intended for use in validating analytical methods for measuring toxic elements and mercury species in human blood, and in value assigning locally produced control materials analyzed using the validated methods. A

A Diploid Assembly-based Benchmark for Variants in The Major Histocompatibility Complex

September 22, 2020
Author(s)
Justin M. Zook, Justin M. Wagner, Chen-Shan Chin, Qiandong Zeng, Alexander Dilthey, Tobias Marschall, Mikko Rautiainen, Erik Garrison, Shilpa Garg
Most human genomes are characterized by aligning individual reads to the reference genome, but accurate long reads and linked reads now enable us to construct accurate, phased de novo assemblies. We focus on a medically important, highly variable, 5

NIST/NIH Vitamin D Metabolites Quality Assurance Program (VitDQAP): Final Report

September 16, 2020
Author(s)
Katrice A. Lippa, Mary Bedner, Susan Tai, Carolyn Q. Burdette
The National Institute of Standards and Technology (NIST) established a Vitamin D Metabolites Quality Assurance Program (VitDQAP) in collaboration with the National Institutes of Health Office of Dietary Supplements (NIH-ODS) in 2009. The VitDQAP at NIST

Expanding NIST's Calibration of Fluorescent Microspheres for Flow Cytometry to More Fluorescence Channels and Smaller Particles

September 15, 2020
Author(s)
Paul DeRose, Linhua Tian, Elzafir B. Elsheikh, Aaron Urbas, Yu-Zhong Zhang, Hao-Wei Wang
NIST, NIH and other industry stakeholders have been working together to enable fluorescence intensities of flow cytometer calibration beads to be assigned quantitative 'ERF' values with high accuracy and precision. The ultimate goal of this effort is to

Expression of a germline variant in the N-terminal domain of the human DNA glycosylase NTHL1 induces cellular transformation without impairing enzymatic function or substrate specificity

June 16, 2020
Author(s)
Carolyn G. Marsden, Pawel Jaruga, Erdem Coskun, Robyn L. Maher, David S. Pederson, Miral M. Dizdar, Joann B. Sweasy
Oxidatively-induced DNA damage, widely accepted as a key player in the onset of cancer, is predominantly repaired by base excision repair (BER). BER is initiated by DNA glycosylases, which locate and remove damaged bases from DNA. NTHL1 is a bifunctional
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