Optimization and clinical validation of dual-target RT-LAMP for SARS-CoV-2.
J Virol Methods
; 286: 113972, 2020 12.
Article
in English
| MEDLINE | ID: covidwho-759120
ABSTRACT
A novel reverse-transcriptase loop mediated amplification (RT-LAMP) method targeting genes encoding the Spike (S) protein and RNA-dependent RNA polymerase (RdRP) of SARS-CoV-2 has been developed. The LAMP assay achieves a comparable limit of detection (25-50 copies per reaction) to commonly used RT-PCR protocols using clinical samples quantified by digital droplet PCR. Precision, cross-reactivity, inclusivity, and limit of detection studies were performed according to regulatory standards. Clinical validation of dual-target RT-LAMP (S and RdRP gene) achieved a PPA of 98.48 % (95 % CI 91.84%-99.96%) and NPA 100.00 % (95 % CI 93.84%-100.00%) based on the E gene and N2 gene reference RT-PCR methods. The method has implications for development of point of care technology using isothermal amplification.
Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Pneumonia, Viral
/
RNA, Viral
/
Coronavirus Infections
/
Clinical Laboratory Techniques
/
Nucleic Acid Amplification Techniques
/
Molecular Diagnostic Techniques
/
Betacoronavirus
Type of study:
Diagnostic study
/
Prognostic study
/
Randomized controlled trials
Limits:
Humans
Language:
English
Journal:
J Virol Methods
Year:
2020
Document Type:
Article
Affiliation country:
J.jviromet.2020.113972
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