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Clinical evaluation of the GSD NovaPrime® SARS-CoV-2 RTq-PCR assay.
Tré-Hardy, Marie; Piteüs, Sébastien; Beukinga, Ingrid; Blairon, Laurent.
  • Tré-Hardy M; Department of Laboratory Medicine, Iris Hospitals South, Brussels, Belgium; Faculty of Medicine, Université Libre de Bruxelles, Brussels, Belgium; Department of Pharmacy, Namur Research Institute for Life Sciences, University of Namur, Belgium. Electronic address: mtrehardy@his-izz.be.
  • Piteüs S; Department of Laboratory Medicine, Iris Hospitals South, Brussels, Belgium.
  • Beukinga I; Department of Laboratory Medicine, Iris Hospitals South, Brussels, Belgium.
  • Blairon L; Department of Laboratory Medicine, Iris Hospitals South, Brussels, Belgium.
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.
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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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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