The Allplex 2019-nCoV (Seegene) assay: which performances are for SARS-CoV-2 infection diagnosis?

Eur J Clin Microbiol Infect Dis. 2020 Oct;39(10):1997-2000. doi: 10.1007/s10096-020-03930-8. Epub 2020 May 28.

Abstract

Several commercial assays for SARS-CoV-2 RT-PCR are available but few of them were assessed. We evaluate the Allplex 2019-nCoV (Seegene) assay using 41 nasopharyngeal samples. The rates of agreement were 92.7% and 100% with the GeneFinder COVID-19 plus (Elitech) and the diagnosis of the infectious disease specialist respectively. Four samples display a Ct < 22.0 for the E and RdRp genes while the N gene was not detected, suggesting a variability of the viral sequence. There was no cross-reactivity with other respiratory viruses. The Allplex 2019-nCoV appears as a reliable method, but additional evaluations using more samples are needed. RT-PCR assays should probably include at least 2 viral targets.

Keywords: Allplex 2019-nCoV (Seegene); COVID-19; Nasopharyngeal swab; RT-PCR; SARS-CoV-2; Sensitivity.

MeSH terms

  • Betacoronavirus / genetics*
  • COVID-19
  • COVID-19 Testing
  • Clinical Laboratory Techniques / methods
  • Coronavirus Envelope Proteins
  • Coronavirus Infections / diagnosis*
  • Coronavirus Nucleocapsid Proteins
  • Coronavirus RNA-Dependent RNA Polymerase
  • France
  • Humans
  • Nasopharynx / virology
  • Nucleocapsid Proteins / genetics*
  • Pandemics
  • Phosphoproteins
  • Pneumonia, Viral / diagnosis*
  • Prospective Studies
  • RNA-Dependent RNA Polymerase / genetics*
  • Reverse Transcriptase Polymerase Chain Reaction / methods*
  • SARS-CoV-2
  • Viral Envelope Proteins / genetics*
  • Viral Nonstructural Proteins / genetics*

Substances

  • Coronavirus Envelope Proteins
  • Coronavirus Nucleocapsid Proteins
  • Nucleocapsid Proteins
  • Phosphoproteins
  • Viral Envelope Proteins
  • Viral Nonstructural Proteins
  • envelope protein, SARS-CoV-2
  • nucleocapsid phosphoprotein, SARS-CoV-2
  • Coronavirus RNA-Dependent RNA Polymerase
  • NSP12 protein, SARS-CoV-2
  • RNA-Dependent RNA Polymerase