Abstract
The Cepheid Xpert® Xpress SARS-CoV-2 assay is 1 of the several real-time reverse transcription polymerase chain reaction (RT-PCR) assays that received Emergency Use Authorization from the United States Food and Drug Administration (FDA) for detection of SARS-CoV-2. Here we report 4 SARS-CoV-2 samples that were reported as presumptive positives on the Cepheid platform while reported as positives on alternative RT-PCR platforms. Whole genome sequencing indicated that the samples were Delta variants and had point mutations in the N gene which potentially interfered with SARS-CoV-2 detection. Two types of point mutations were found in these samples in the US CDC 2019-nCoV Real time PCR N2 Probe region: C29203T and C29200T. C29203T is a novel point mutation, and C29200T has not been previously reported in the Delta variants. This underlines the fact that mutations in the real-time RT-PCR assay target region could hinder accurate detection of SARS-CoV-2.
Keywords: C29200T; C29203T; Cepheid Xpert® Xpress SARS-CoV-2 assay; false negative; presumptive positive.
【저자키워드】 False negative, C29200T, C29203T, Cepheid Xpert® Xpress SARS-CoV-2 assay, presumptive positive., 【초록키워드】 SARS-CoV-2, Mutation, 2019-nCoV, Delta, drug, delta variant, RT-PCR, FDA, Emergency use authorization, variants, polymerase chain reaction, SARS-CoV-2 detection, Whole genome sequencing, point mutations, reverse transcription, United States, Cepheid, N gene, real-time RT-PCR, real time PCR, RT-PCR assay, platform, Delta variants, False negative, food, Point mutation, Emergency, Chain Reaction, PCR assay, false, authorization, positive, US CDC, United States Food and Drug Administration, polymerase chain, reported, indicated, the United State, 【제목키워드】 SARS-CoV-2, delta variant, positive, N mutation,