Development and validation of a new triplex real-time quantitative reverse Transcriptase-PCR assay for the clinical detection of SARS-CoV-2.
Mol Cell Probes
; 58: 101744, 2021 08.
Article
em En
| MEDLINE
| ID: mdl-34089805
ABSTRACT
To increase the repertoire of PCR based laboratory developed tests (LDTs) for the detection of SARS-CoV-2, we describe a new multiplex assay (SORP), targeting the SARS-CoV-2's, Spike and ORF8 genes. The widely used human RNaseP internal control was modified to specifically co-amplify the RNaseP mRNA. The SORP triplex assay was tested on a cohort (n = 372; POS = 144/NEG = 228) of nasopharyngeal flocked swab (NPFS) specimens, previously tested for the presence of SARS-CoV-2 using a PCR assay targeting E and RdRp genes. The overall sensitivity and specificity of the SORP assay was 99.31% (95% CI 96.22-99.98%), 100.0% (95% CI 98.4-100%) respectively. The SORP assay could also detect a panel of variants of concern (VOC) from the B1.1.7 (UK) and B1.351 (SA) lineage. In summary, access to a repertoire of new SARS-CoV-2 LDT's would assist diagnostic laboratories in developing strategies to overcome some of the testing issues encountered during high-throughput SARS-CoV-2 testing.
Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Técnicas de Laboratório Clínico
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Reação em Cadeia da Polimerase Via Transcriptase Reversa
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Reação em Cadeia da Polimerase Multiplex
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Teste para COVID-19
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SARS-CoV-2
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COVID-19
Tipo de estudo:
Diagnostic_studies
Limite:
Humans
Idioma:
En
Revista:
Mol Cell Probes
Assunto da revista:
BIOLOGIA MOLECULAR
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BIOTECNOLOGIA
Ano de publicação:
2021
Tipo de documento:
Article