Reference material development for detection of human respiratory syncytial virus using digital PCR.
Anal Bioanal Chem
; 415(16): 3131-3135, 2023 Jul.
Article
em En
| MEDLINE
| ID: mdl-37160423
ABSTRACT
Nucleic acid testing is a powerful tool for the detection of various pathogens. Respiratory syncytial virus (RSV) is a major cause of acute respiratory infection, especially in young children and infants. To improve the confidence and reliability of nucleic acid testing results for RSV, reference materials (RMs) of both type A and B of RSV were developed by the National Institute of Metrology, China, code numbers NIM-RM 4057 and 4058. The reference material was composed of in vitro transcribed RNA containing the nucleocapsid (N) gene, matrix (M) gene, and partial polymerase (L) gene of RSV. A duplex reverse transcription digital PCR method was established with limit of blank (LoB), limit of detection (LoD) and limit of quantification (LoQ) of 2, 5, and 23 copies per reaction for RSV-A and 4, 8, and 20 copies per reaction for RSV-B. The certified value and expanded uncertainty (U, k = 2) of the two RMs were determined to be (6.1 ± 1.4) × 104 copies/µL for RSV-A and (5.3 ± 1.2) × 104 copies/µL for RSV-B. The developed RMs can be used as standards to evaluate the performance of RSV detection assays.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Vírus Sincicial Respiratório Humano
/
Infecções por Vírus Respiratório Sincicial
Tipo de estudo:
Diagnostic_studies
Limite:
Child
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Child, preschool
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Humans
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Infant
Idioma:
En
Ano de publicação:
2023
Tipo de documento:
Article