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Multi-Laboratory Evaluation of Prototype Dried Blood Spot Quality Control Materials for Creatine Kinase-MM Newborn Screening Assays

Pilot studies to detect newborns with Duchenne Muscular Dystrophy (DMD) by newborn bloodspot screening (NBS) have been conducted under the New York State Newborn Screening Program (NYS) and are currently in progress as part of the Early Check Program at Research Triangle Institute (RTI) Internationa...

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Autores principales: Dantonio, Paul, Tavakoli, Norma P., Migliore, Brooke, McCown, Elizabeth, Lim, Timothy, Park, Sunju, Caggana, Michele, Kucera, Katerina S., Phan, Han, Street, Natalie, Petritis, Konstantinos, Vogt, Robert F.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10053407/
https://www.ncbi.nlm.nih.gov/pubmed/36975851
http://dx.doi.org/10.3390/ijns9010013
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author Dantonio, Paul
Tavakoli, Norma P.
Migliore, Brooke
McCown, Elizabeth
Lim, Timothy
Park, Sunju
Caggana, Michele
Kucera, Katerina S.
Phan, Han
Street, Natalie
Petritis, Konstantinos
Vogt, Robert F.
author_facet Dantonio, Paul
Tavakoli, Norma P.
Migliore, Brooke
McCown, Elizabeth
Lim, Timothy
Park, Sunju
Caggana, Michele
Kucera, Katerina S.
Phan, Han
Street, Natalie
Petritis, Konstantinos
Vogt, Robert F.
author_sort Dantonio, Paul
collection PubMed
description Pilot studies to detect newborns with Duchenne Muscular Dystrophy (DMD) by newborn bloodspot screening (NBS) have been conducted under the New York State Newborn Screening Program (NYS) and are currently in progress as part of the Early Check Program at Research Triangle Institute (RTI) International. The Newborn Screening Quality Assurance Program (NSQAP) at the U.S. Centers for Disease Control and Prevention (CDC) produced a set of seven prototype dried blood spot (DBS) reference materials spiked with varying levels of creatine kinase MM isoform (CK-MM). These DBS were evaluated over a 3-week period by CDC, NYS, and RTI, all using the same CK-MM isoform-specific fluoroimmunoassay. Results from each laboratory were highly correlated with the relative proportion of CK-MM added to each of the six spiked pools. Based on reference ranges established by NYS and RTI for their pilot studies, these contrived DBS collectively spanned the CK-MM ranges found in typical newborns and the elevated ranges associated with DMD. This set allows quality assessment over the wide range of fluctuating CK-MM levels in typical and DMD-affected newborns.
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spelling pubmed-100534072023-03-30 Multi-Laboratory Evaluation of Prototype Dried Blood Spot Quality Control Materials for Creatine Kinase-MM Newborn Screening Assays Dantonio, Paul Tavakoli, Norma P. Migliore, Brooke McCown, Elizabeth Lim, Timothy Park, Sunju Caggana, Michele Kucera, Katerina S. Phan, Han Street, Natalie Petritis, Konstantinos Vogt, Robert F. Int J Neonatal Screen Article Pilot studies to detect newborns with Duchenne Muscular Dystrophy (DMD) by newborn bloodspot screening (NBS) have been conducted under the New York State Newborn Screening Program (NYS) and are currently in progress as part of the Early Check Program at Research Triangle Institute (RTI) International. The Newborn Screening Quality Assurance Program (NSQAP) at the U.S. Centers for Disease Control and Prevention (CDC) produced a set of seven prototype dried blood spot (DBS) reference materials spiked with varying levels of creatine kinase MM isoform (CK-MM). These DBS were evaluated over a 3-week period by CDC, NYS, and RTI, all using the same CK-MM isoform-specific fluoroimmunoassay. Results from each laboratory were highly correlated with the relative proportion of CK-MM added to each of the six spiked pools. Based on reference ranges established by NYS and RTI for their pilot studies, these contrived DBS collectively spanned the CK-MM ranges found in typical newborns and the elevated ranges associated with DMD. This set allows quality assessment over the wide range of fluctuating CK-MM levels in typical and DMD-affected newborns. MDPI 2023-02-28 /pmc/articles/PMC10053407/ /pubmed/36975851 http://dx.doi.org/10.3390/ijns9010013 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Dantonio, Paul
Tavakoli, Norma P.
Migliore, Brooke
McCown, Elizabeth
Lim, Timothy
Park, Sunju
Caggana, Michele
Kucera, Katerina S.
Phan, Han
Street, Natalie
Petritis, Konstantinos
Vogt, Robert F.
Multi-Laboratory Evaluation of Prototype Dried Blood Spot Quality Control Materials for Creatine Kinase-MM Newborn Screening Assays
title Multi-Laboratory Evaluation of Prototype Dried Blood Spot Quality Control Materials for Creatine Kinase-MM Newborn Screening Assays
title_full Multi-Laboratory Evaluation of Prototype Dried Blood Spot Quality Control Materials for Creatine Kinase-MM Newborn Screening Assays
title_fullStr Multi-Laboratory Evaluation of Prototype Dried Blood Spot Quality Control Materials for Creatine Kinase-MM Newborn Screening Assays
title_full_unstemmed Multi-Laboratory Evaluation of Prototype Dried Blood Spot Quality Control Materials for Creatine Kinase-MM Newborn Screening Assays
title_short Multi-Laboratory Evaluation of Prototype Dried Blood Spot Quality Control Materials for Creatine Kinase-MM Newborn Screening Assays
title_sort multi-laboratory evaluation of prototype dried blood spot quality control materials for creatine kinase-mm newborn screening assays
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10053407/
https://www.ncbi.nlm.nih.gov/pubmed/36975851
http://dx.doi.org/10.3390/ijns9010013
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