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
in English
| MEDLINE | ID: covidwho-1253367
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.
Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Clinical Laboratory Techniques
/
Reverse Transcriptase Polymerase Chain Reaction
/
Multiplex Polymerase Chain Reaction
/
COVID-19 Testing
/
SARS-CoV-2
/
COVID-19
Type of study:
Cohort study
/
Diagnostic study
/
Observational study
/
Prognostic study
Topics:
Variants
Limits:
Humans
Language:
English
Journal:
Mol Cell Probes
Journal subject:
Molecular Biology
/
Biotechnology
Year:
2021
Document Type:
Article
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