Construction of a reference material panel for detecting
Adult
Beijing
Biomarkers, Tumor
/ blood
Carcinoma, Non-Small-Cell Lung
/ blood
Cell Line, Tumor
Circulating Tumor DNA
/ blood
DNA Mutational Analysis
/ standards
ErbB Receptors
/ blood
Female
GTP Phosphohydrolases
/ blood
High-Throughput Nucleotide Sequencing
/ standards
Humans
Liquid Biopsy
/ standards
Lung Neoplasms
/ blood
Male
Membrane Proteins
/ blood
Middle Aged
Mutation
Predictive Value of Tests
Proto-Oncogene Proteins B-raf
/ blood
Proto-Oncogene Proteins c-met
/ blood
Proto-Oncogene Proteins p21(ras)
/ blood
Reference Standards
Young Adult
lung
molecular biology
pathology, molecular
Journal
Journal of clinical pathology
ISSN: 1472-4146
Titre abrégé: J Clin Pathol
Pays: England
ID NLM: 0376601
Informations de publication
Date de publication:
May 2021
May 2021
Historique:
received:
22
05
2020
revised:
28
06
2020
accepted:
02
07
2020
pubmed:
21
8
2020
medline:
27
4
2021
entrez:
21
8
2020
Statut:
ppublish
Résumé
The absence of high-quality next-generation sequencing (NGS) reference material (RM) has impeded the clinical use of liquid biopsies with plasma cell-free DNA (cfDNA) in China. This study aimed to develop a national RM panel for external quality assessment and performance evaluation during kit registration of non-small-cell lung cancer (NSCLC)-related Kirsten rat sarcoma viral oncogene ( Mutation cell lines detected by NGS and validated by Sanger sequencing were selected to establish the RM. Cell line genomic DNA was sheared and used to spike basal plasma cfDNA at 10% concentration. Then, the calibration accuracy was determined by four sequencing platforms. Average values were adopted and diluted to 0.1%, 0.3%, 1% and 3% concentrations with basal plasma as the RM panel. Then, five manufacturers were invited to evaluate the performance of the RM panel. 20 cell lines with 23 clinically important mutations were selected, including six mutations in RM for a
Sections du résumé
BACKGROUND
BACKGROUND
The absence of high-quality next-generation sequencing (NGS) reference material (RM) has impeded the clinical use of liquid biopsies with plasma cell-free DNA (cfDNA) in China.
OBJECTIVE
OBJECTIVE
This study aimed to develop a national RM panel for external quality assessment and performance evaluation during kit registration of non-small-cell lung cancer (NSCLC)-related Kirsten rat sarcoma viral oncogene (
METHODS
METHODS
Mutation cell lines detected by NGS and validated by Sanger sequencing were selected to establish the RM. Cell line genomic DNA was sheared and used to spike basal plasma cfDNA at 10% concentration. Then, the calibration accuracy was determined by four sequencing platforms. Average values were adopted and diluted to 0.1%, 0.3%, 1% and 3% concentrations with basal plasma as the RM panel. Then, five manufacturers were invited to evaluate the performance of the RM panel.
RESULTS
RESULTS
20 cell lines with 23 clinically important mutations were selected, including six mutations in
CONCLUSION
CONCLUSIONS
RM for a
Identifiants
pubmed: 32817175
pii: jclinpath-2020-206745
doi: 10.1136/jclinpath-2020-206745
pmc: PMC8070650
doi:
Substances chimiques
Biomarkers, Tumor
0
Circulating Tumor DNA
0
KRAS protein, human
0
Membrane Proteins
0
EGFR protein, human
EC 2.7.10.1
ErbB Receptors
EC 2.7.10.1
MET protein, human
EC 2.7.10.1
Proto-Oncogene Proteins c-met
EC 2.7.10.1
BRAF protein, human
EC 2.7.11.1
Proto-Oncogene Proteins B-raf
EC 2.7.11.1
GTP Phosphohydrolases
EC 3.6.1.-
NRAS protein, human
EC 3.6.1.-
Proto-Oncogene Proteins p21(ras)
EC 3.6.5.2
Types de publication
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
314-320Informations de copyright
© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.
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