Clinical evaluation of the GSD NovaPrime® SARS-CoV-2 RTq-PCR assay.
Diagn Microbiol Infect Dis
; 103(3): 115718, 2022 Jul.
Article
in English
| MEDLINE | ID: covidwho-2000368
ABSTRACT
Faced with the emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), high-throughput respiratory tests are in high demand. We evaluated the clinical performance of the GSD NovaPrime® SARS-CoV-2 RTq-PCR assay, a new assay that detects 2 specific RNA sequences of the nucleocapsid (N) gene. It was assessed using 99 nasopharyngeal samples and compared in parallel with the Allplex® assay. Among those samples, 72 and 27 were included in the positive (PPA) and negative (NPA) percent agreement analyses, respectively. In case of discordance, samples were reanalyzed with another amplification technique, the Aptima® SARS-CoV-2 assay. Cross-reactivity, including specimens positive for another respiratory virus and collected before the COVID-19 outbreak, was also evaluated (n = 32). Based on the patients' clinical history, the Ct (cycle threshold) values obtained, and the results of the Aptima® assay, the clinical performances were deemed satisfactory, with the PPA reaching a minimum percentage of 87.5% and the NPA reaching 100%. No cross-reactivity with other respiratory viruses was observed.
Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
SARS-CoV-2
/
COVID-19
Type of study:
Diagnostic study
/
Experimental Studies
/
Prognostic study
/
Randomized controlled trials
Limits:
Humans
Language:
English
Journal:
Diagn Microbiol Infect Dis
Year:
2022
Document Type:
Article
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