Multicenter Evaluation of the Cepheid Xpert Xpress SARS-CoV-2/Flu/RSV Test

Mostafa, Heba H.; Carroll, Karen C.; Hicken, Rachel; Berry, Gregory J.; Manji, Ryhana; Smith, Elizabeth; Rakeman, Jennifer L.; Fowler, Randal C.; Leelawong, Mindy; Butler-Wu, Susan M.; Quintero, David; Umali-Wilcox, Minette; Kwiatkowski, Robert; Persing, David H.; Weir, Fred; Loeffelholz, Michael J.

doi:10.1128/jcm.02955-20

Cited by 70 publications

(60 citation statements)

References 43 publications

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“…It should be noted that while Xpert Xpress is often referred to as a point-of-care (POC) test, this testing is not typically performed at the time and place of patient assessment and is more commonly performed in a laboratory setting; therefore, the term RDT would be more appropriate. The most current version of the Xpert SARS-CoV-2 assay is multiplexed with influenza A and B viruses as well as respiratory syncytial virus (RSV), which can present with similar respiratory symptoms ( 315 ). More highly multiplexed assays like BioFire Respiratory Panel 2.1 with SARS-CoV-2 (BioFire Diagnostics, USA) are also available, which allow a syndromic approach with the simultaneous detection of SARS-CoV-2 and several other respiratory viruses ( 316 , 317 ).…”

Section: Laboratory Methods For the Detection Of Sars-cov-2mentioning

confidence: 99%

Tools and Techniques for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)/COVID-19 Detection

et al. 2021

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SUMMARY The coronavirus disease 2019 (COVID-19) pandemic, caused by severe acute respiratory disease coronavirus 2 (SARS-CoV-2), has led to millions of confirmed cases and deaths worldwide. Efficient diagnostic tools are in high demand, as rapid and large-scale testing plays a pivotal role in patient management and decelerating disease spread. This paper reviews current technologies used to detect SARS-CoV-2 in clinical laboratories as well as advances made for molecular, antigen-based, and immunological point-of-care testing, including recent developments in sensor and biosensor devices. The importance of the timing and type of specimen collection is discussed, along with factors such as disease prevalence, setting, and methods. Details of the mechanisms of action of the various methodologies are presented, along with their application span and known performance characteristics. Diagnostic imaging techniques and biomarkers are also covered, with an emphasis on their use for assessing COVID-19 or monitoring disease severity or complications. While the SARS-CoV-2 literature is rapidly evolving, this review highlights topics of interest that have occurred during the pandemic and the lessons learned throughout. Exploring a broad armamentarium of techniques for detecting SARS-CoV-2 will ensure continued diagnostic support for clinicians, public health, and infection prevention and control for this pandemic and provide advice for future pandemic preparedness.

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Section: Laboratory Methods For the Detection Of Sars-cov-2mentioning

confidence: 99%

Tools and Techniques for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)/COVID-19 Detection

et al. 2021

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“…However, practical considerations are still lacking (including the best target populations). Meanwhile, several manufacturers have developed molecular point-of-care tests, most of which additionally target influenza and/or RSV (14,15) while others offer wider respiratory syndromic panel (16).…”

Section: Introductionmentioning

confidence: 99%

SARS-CoV-2 Diagnostic Tests: Algorithm and Field Evaluation From the Near Patient Testing to the Automated Diagnostic Platform

Yin

Debuysschere

Decroly³

et al. 2021

Front. Med.

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Introduction: Since the first wave of COVID-19 in Europe, new diagnostic tools using antigen detection and rapid molecular techniques have been developed. Our objective was to elaborate a diagnostic algorithm combining antigen rapid diagnostic tests, automated antigen dosing and rapid molecular tests and to assess its performance under routine conditions.Methods: An analytical performance evaluation of four antigen rapid tests, one automated antigen dosing and one molecular point-of-care test was performed on samples sent to our laboratory for a SARS-CoV-2 reverse transcription PCR. We then established a diagnostic algorithm by approaching median viral loads in target populations and evaluated the limit of detection of each test using the PCR cycle threshold values. A field performance evaluation including a clinical validation and a user-friendliness assessment was then conducted on the antigen rapid tests in point-of-care settings (general practitioners and emergency rooms) for outpatients who were symptomatic for <7 days. Automated antigen dosing was trialed for the screening of asymptomatic inpatients.Results: Our diagnostic algorithm proposed to test recently symptomatic patients using rapid antigen tests, asymptomatic patients using automated tests, and patients requiring immediate admission using molecular point-of-care tests. Accordingly, the conventional reverse transcription PCR was kept as a second line tool. In this setting, antigen rapid tests yielded an overall sensitivity of 83.3% (not significantly different between the four assays) while the use of automated antigen dosing would have spared 93.5% of asymptomatic inpatient screening PCRs.Conclusion: Using tests not considered the “gold standard” for COVID-19 diagnosis on well-defined target populations allowed for the optimization of their intrinsic performances, widening the scale of our testing arsenal while sparing molecular resources for more seriously ill patients.

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“…The more recently released Cepheid Xpert Xpress SARS-CoV-2/Flu/RSV assay (XpertSFR) also detects SARS-CoV-2 E- and N2-gene targets [ 13 ]. Assuming that the same primer-probe combinations used for the Xpert are also utilised in the XpertSFR, it would be expected that the novel mutations described here would also impact N2-gene detection by the newer XpertSFR assay.…”

Section: Discussionmentioning

confidence: 99%

Lack of N2-gene amplification on the Cepheid Xpert Xpress SARS-CoV-2 assay and potential novel causative mutations: A case series from Auckland, New Zealand

Fox-Lewis

Fox‐Lewis

Harrower

et al. 2021

IDCases

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We describe three cases with viral strains that demonstrate impaired N2-gene detection on the Cepheid Xpert Xpress SARS-CoV-2 assay, with two previously undescribed single nucleotide polymorphisms (SNPs): C29197T and G29227T. We propose that these SNPs are likely responsible since they are in close proximity to the previously described C29200T/C29200A SNPs, already shown to abolish N2-gene detection by the Xpert assay. Whether these SNPs abolish N2-gene detection by the Xpert assay individually or only in combination requires more work to elucidate.

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Multicenter Evaluation of the Cepheid Xpert Xpress SARS-CoV-2/Flu/RSV Test

Cited by 70 publications

References 43 publications

Tools and Techniques for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)/COVID-19 Detection

Tools and Techniques for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)/COVID-19 Detection

SARS-CoV-2 Diagnostic Tests: Algorithm and Field Evaluation From the Near Patient Testing to the Automated Diagnostic Platform

Lack of N2-gene amplification on the Cepheid Xpert Xpress SARS-CoV-2 assay and potential novel causative mutations: A case series from Auckland, New Zealand

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