Single-Point Mutations in the N Gene of SARS-CoV-2 Adversely Impact Detection by a Commercial Dual Target Diagnostic Assay
Sharon Miller, Terence Lee, Adam Merritt, Todd Pryce, Avram Levy, David Speers
Abstract
This paper reports the identification of single-point mutations in the N gene of SARS-CoV-2 associated with a gene target failure by the Cepheid Xpert commercial system. In order to determine the mutation(s) responsible for the N gene detection failures, the genomic products from the Cepheid Xpert system were sequenced and compared to whole genomes of SARS-CoV-2 from clinical cases. This report is the first to our knowledge which characterizes the amplified PCR products of the Xpert system, confirming the mutations associated with the gene target failure. The mutations identified have previously been reported.
Topics & Concepts
GeneMutationGeneticsBiologyGenomeGold standard (test)Polymerase chain reactionDiagnostic testGene mutationDNA sequencingComputational biologyPoint mutationGenetic testingGenetic diagnosisWhole genome sequencingVirologyNucleic acidNucleic Acid Amplification TestsGeneXpert MTB/RIFSARS-CoV-2 and COVID-19 ResearchCOVID-19 Clinical Research Studiesvaccines and immunoinformatics approaches