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VA-Wide, Multicenter Verification Study of the Cepheid Xpert SARS-CoV-2 Assay.

ABSTRACT: Early in the Severe Acute Respiratory Syndrome Coronavirus 2 pandemic, there was a progressive increase in diagnostic demands that developed within a relatively short period of time. On February 4, 2020, the Secretary of Health and Human Services issued the Emergency Use Authorization for in vitro diagnostics assays for the Severe Acute Respiratory Syndrome Coronavirus 2 virus. Subsequently, multiple assays were approved under the Emergency Use Authorization, including the Cepheid Xpert SARS-CoV-2 assay. Presented here is a description of the nationally coordinated verification study of the Cepheid assay that was performed within the Veteran's Affairs Health System. This coordinated study helped to expedite the verification process for a majority of the Veteran's Affairs system labs, preserved precious system resources, and highlighted the power of a national medical system in response to an emergency.

SUBMITTER: Obeidat M

PROVIDER: S-EPMC8107920 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Recommendations for sample pooling on the Cepheid GeneXpert® system using the Cepheid Xpert® Xpress SARS-CoV-2 assay.

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| S-EPMC7592518 | biostudies-literature

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| S-EPMC7217789 | biostudies-literature

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| S-EPMC7435359 | biostudies-literature

Validation and verification of the Abbott RealTime SARS-CoV-2 assay analytical and clinical performance.

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| S-EPMC7395853 | biostudies-literature

Misidentification of meticillin-resistant <i>Staphylococcus aureus</i> by the Cepheid Xpert MRSA NxG assay, the Netherlands, February to March 2021.

Project description:We describe two false-negative results in the detection of meticillin-resistant Staphylococcus aureus (MRSA) of sequence type 398 and spa type t011 using the Cepheid Xpert MRSA NxG assay. The isolates were recovered in late February and early March 2021 from two patients in different hospitals in the northern Netherlands. Variations between the two isolate genomes indicate that this MRSA strain might have been spreading for some time and could have disseminated to other regions of the Netherlands and other European countries.

| S-EPMC8447827 | biostudies-literature

Meta-analysis of the Cepheid Xpert® CT/NG assay for extragenital detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections.

Project description:Background Most studies evaluating extragenital testing performance for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) detection by the Xpert® CT/NG show high per cent agreement with comparison assays; however, the precision around positive per cent agreement is low and thus the values that have been reported are not highly informative. Therefore, a systematic review was conducted and data from five studies were combined to better assess positive per cent agreement. METHODS:The literature indexed on PubMed.gov was searched. Included studies were those that were an evaluation of the Xpert CT/NG assay with rectal and/or pharyngeal specimen types compared with another nucleic acid amplification test (NAAT), the Aptima transcription mediated amplification assay. A full Bayesian method was used for bivariate fixed-effect meta-analysis of positive and negative per cent agreement and pooled estimates (and 95% confidence intervals (CI)) were presented for each. RESULTS:The pooled positive and negative per cent agreement for detection of CT in rectal specimens was 89.72% (95% CI: 84.97%, 93.64%) and 99.23% (95% CI: 98.74%, 99.60%), and in pharyngeal specimens, they were 89.96% (95% CI: 66.38%, 99.72%) and 99.62% (95% CI: 98.95%, 99.95%) respectively. For NG detection in rectal specimens, the pooled positive and negative per cent agreement was 92.75% (95% CI: 87.91%, 96.46%) and 99.75% (95% CI: 99.46%, 99.93%), and in pharyngeal specimens, they were 92.51% (95% CI: 85.84%, 97.18%) and 98.56% (95% CI: 97.69%, 99.23%) respectively. CONCLUSIONS:It was found that the Xpert CT/NG assay performed similarly to the Aptima transcription mediated amplification assay for the detection of CT and NG in extragenital specimens. The Xpert assay has the benefit of providing faster results at the point-of-care, thus reducing the turnaround time for results, potentially enabling same-day treatment.

| S-EPMC6954977 | biostudies-literature

Prevalence of a Single-Nucleotide Variant of SARS-CoV-2 in Korea and Its Impact on the Diagnostic Sensitivity of the Xpert Xpress SARS-CoV-2 Assay.

Project description:The sensitivity of molecular diagnostics could be affected by nucleotide variants in pathogen genes, and the sites affected by such variants should be monitored. We report a single-nucleotide variant (SNV) in the nucleocapsid (N) gene of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), i.e., G29179T, which impairs the diagnostic sensitivity of the Xpert Xpress SARS-CoV-2 assay (Cepheid, Sunnyvale, CA, USA). We observed significant differences between the threshold cycle (Ct) values for envelope (E) and N genes and confirmed the SNV as the cause of the differences using Sanger sequencing. This SNV, G29179T, is the most prevalent in Korea and is associated with the B.1.497 virus lineage, which is dominant in Korea. Clinical laboratories should be aware of the various SNVs in the SARS-CoV-2 genome and consider their potential effects on the diagnosis of coronavirus disease 2019.

| S-EPMC8368233 | biostudies-literature

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