Development and validation of a 4-color multiplexing spinal muscular atrophy (SMA) genotyping assay on a novel integrated digital PCR instrument.


Journal

Scientific reports
ISSN: 2045-2322
Titre abrégé: Sci Rep
Pays: England
ID NLM: 101563288

Informations de publication

Date de publication:
16 11 2020
Historique:
received: 05 09 2020
accepted: 02 11 2020
entrez: 17 11 2020
pubmed: 18 11 2020
medline: 12 3 2021
Statut: epublish

Résumé

Digital PCR (dPCR) technology has been proven to be highly sensitive and accurate in detecting copy number variations (CNV). However, a higher-order multiplexing dPCR assay for measuring SMN1 and SMN2 copy numbers in spinal muscular atrophy (SMA) samples has not been reported. Described here is a rapid multiplex SMA dPCR genotyping assay run on a fully integrated dPCR instrument with five optical channels. The hydrolysis probe-based multiplex dPCR assay quantifies SMN1, SMN2, and the total SMN (SMN1 + SMN2) while using RPPH1 gene as an internal reference control. The quadruplex assay was evaluated with characterized control DNA samples and validated with 15 blinded clinical samples from a previously published study. SMN1 and SMN2 copy numbers were completely concordant with previous results for both the control and blinded samples. The dPCR-based SMA copy number determination was accomplished in 90 min with a walk-away workflow identical to real-time quantitative PCR (qPCR). In summary, presented here is a simple higher-order multiplexing solution on a novel digital PCR platform to meet the growing demand for SMA genotyping and prognostics.

Identifiants

pubmed: 33199817
doi: 10.1038/s41598-020-76893-7
pii: 10.1038/s41598-020-76893-7
pmc: PMC7670453
doi:

Substances chimiques

SMN1 protein, human 0
SMN2 protein, human 0
Survival of Motor Neuron 1 Protein 0
Survival of Motor Neuron 2 Protein 0

Types de publication

Journal Article Research Support, N.I.H., Extramural Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

19892

Subventions

Organisme : NIH HHS
ID : R44OD023028
Pays : United States
Organisme : NIH HHS
ID : P20GM103464
Pays : United States

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Auteurs

Lingxia Jiang (L)

Combinati Inc., 2450 Embarcadero Way, Palo Alto, CA, 94303, USA. lingxia@combinati.com.

Robert Lin (R)

Combinati Inc., 2450 Embarcadero Way, Palo Alto, CA, 94303, USA.

Steve Gallagher (S)

Combinati Inc., 2450 Embarcadero Way, Palo Alto, CA, 94303, USA.

Andrew Zayac (A)

Combinati Inc., 2450 Embarcadero Way, Palo Alto, CA, 94303, USA.

Matthew E R Butchbach (MER)

Center for Applied Clinical Genomics, Nemours Biomedical Research, Nemours Alfred I. duPont Hospital for Children, Wilmington, DE, USA.
Center for Pediatric Research, Nemours Biomedical Research, Nemours Alfred I. duPont Hospital for Children, Wilmington, DE, USA.
Department of Pediatrics, Sidney Kimmel College of Medicine, Thomas Jefferson University, Philadelphia, PA, USA.
Department of Biological Sciences, University of Delaware, Newark, DE, USA.

Paul Hung (P)

Combinati Inc., 2450 Embarcadero Way, Palo Alto, CA, 94303, USA.

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Classifications MeSH