Multi-center evaluation of cepheid xpert® xpress SARS-CoV-2 point-of-care test during the SARS-CoV-2 pandemic

Wolters, Femke; Bovenkamp, Jeroen van de; Bosch, Bart Van den; Brink, Sharon van den; Broeders, Maaike; Chung, Ngoc Hoa; Favié, Barbara; Goderski, Gabriel; Kuijpers, Judith; Overdevest, Ilse; Rahamat-Langedoen, Janette; Wijsman, Lisa; Melchers, Willem J. G.; Meijer, Adam

doi:10.1016/j.jcv.2020.104426

Cited by 142 publications

(135 citation statements)

References 8 publications

(9 reference statements)

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“…Of these, the fastest two (the Abbott ID NOW and the Mesa Accula) with less than 30 min of delay between sampling and answer accumulated evidence of poorer diagnostic performance with a lack of sensitivity [ 5 , 6 ]. Only the Cepheid Xpert Xpress SARS-CoV-2 assay has shown to be a valuable tool with a run-time of 45−50 min with hands on time limited to 2−3 min [ 7 ]. However, due to the pandemic, we are also facing a global shortage of reagents and kits and uncertainty over the availability of Xpert Xpress cartridges [ 5 ].…”

Section: Introductionmentioning

confidence: 99%

Contribution of VitaPCR SARS-CoV-2 to the emergency diagnosis of COVID-19

Fournier

Zandotti

Ninove

et al. 2020

Journal of Clinical Virology

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Background With the persistent COVID-19 pandemic, there is an urgent need to use rapid and reliable diagnostic tools for highly urgent cases. Antigen tests are disappointing with their lack of sensitivity. Among molecular tools allowing a diagnosis in less than an hour, only one, the Cepheid Xpert Xpress SARS-CoV-2 assay, has exhibited a good sensitivity. However, we are also facing a global shortage of reagents and kits. Thus, it is imperative to evaluate other point-of-care molecular tests. Methods We evaluated the VitaPCR™ RT-PCR assay, whose sample analysis time is of approximately 20 min, in nasopharyngeal secretions from 534 patients presenting to our Institute, for the diagnosis of COVID-19, and compared it to our routine RT-PCR assay. We also compared the two assays with tenfold dilutions of a SARS-CoV-2 strain. Results Compared to our routine RT-PCR and the previous diagnosis of COVID-19, the sensitivity, specificity, positive and negative predictive values of VitaPCR™ can be evaluated to be 99.3 % (155/156), 94.7 % (358/378), 88.6 % (155/175) and 99.7 % (358/359), respectively. Tenfold dilutions of a SARS-CoV-2 strain show that the VitaPCR™ was more sensitive that our routine RT-PCR assay. Conclusion The VitaPCR™ SARS-CoV-2 is an accurate rapid test, suitable for clinical practice that can be performed as part of a point-of-care testing, for the rapid diagnosis of COVID-19.

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Section: Introductionmentioning

confidence: 99%

Contribution of VitaPCR SARS-CoV-2 to the emergency diagnosis of COVID-19

Fournier

Zandotti

Ninove

et al. 2020

Journal of Clinical Virology

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“…Femke et al evaluated Xpert Xpress point-of-care assay (Cepheid GeneXpert systems) for targeting SARS-CoV-2 E-gene and N2-gene in three medical laboratories in the Netherlands. The assay can detect SARS-CoV-2 with a LOD of 8.26 copies/mL in all three laboratories [68]. While Wei et al reported Xpert Xpress test for targeting SARS-CoV-2 E-gene and N2-gene with a LOD of 100 copies/mL [67].…”

Section: Portable Benchtop-sized Analyzersmentioning

confidence: 95%

Laboratory diagnosis of coronavirus disease-2019 (COVID-19)

Zhao

Bao

et al. 2020

Clinica Chimica Acta

134

116

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The outbreak of Coronavirus Disease-2019 (COVID-19) caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) has threatened health worldwide. As of the end of 2020, there were nearly 10 million confirmed cases and nearly 5 million deaths associated with COVID-19. Rapid and early laboratory diagnosis of COVID-19 is the main focus of treatment and control. Molecular tests are the basis for confirmation of COVID-19, but serological tests for SARS-CoV-2 are widely available and play an increasingly important role in understanding the epidemiology of the virus and in identifying populations at higher risk for infection. Pointof-care tests have the advantage of rapid, accurate, portable, low cost and non-specific device requirements, which provide great help for disease diagnosis and detection. This review will discuss the performance of different laboratory diagnostic tests and platforms, as well as suitable clinical samples for testing, and related biosafety protection. This review shall guide for the diagnosis of COVID-19 caused by SARS-CoV-2.

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“…Nucleic acid was extracted and SARS‐CoV‐2 RT‐PCR performed as described above. In addition, samples from inpatients with laboratory‐confirmed COVID‐19 were assessed for SARS‐CoV‐2 by RT‐PCR using the Xpert Xpress SARS‐CoV‐2 assay (Cepheid) according to the manufacturers’ instructions . Semi‐quantitative real time RT‐PCR detection of a human housekeeping gene (RNase P) served as a surrogate marker for the amount of cellular material derived from each swab …”

Section: Methodsmentioning

confidence: 99%

Pandemic printing: a novel 3D‐printed swab for detecting SARS ‐CoV‐2

Williams

Bond

Isles

et al. 2020

Medical Journal of Australia

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Objectives To design and evaluate 3D‐printed nasal swabs for collection of samples for SARS‐CoV‐2 testing. Design An iterative design process was employed. Laboratory evaluation included in vitro assessment of mock nasopharyngeal samples spiked with two different concentrations of gamma‐irradiated SARS‐CoV‐2. A prospective clinical study compared SARS‐CoV‐2 and human cellular material recovery by 3D‐printed swabs and standard nasopharyngeal swabs. Setting, participants Royal Melbourne Hospital, May 2020. Participants in the clinical evaluation were 50 hospital staff members attending a COVID‐19 screening clinic and two inpatients with laboratory‐confirmed COVID‐19. Intervention In the clinical evaluation, a flocked nasopharyngeal swab sample was collected with the Copan ESwab and a mid‐nasal sample from the other nostril was collected with the 3D‐printed swab. Results In the laboratory evaluation, qualitative agreement with regard to SARS‐CoV‐2 detection in mock samples collected with 3D‐printed swabs and two standard swabs was complete. In the clinical evaluation, qualitative agreement with regard to RNase P detection (a surrogate measure of adequate collection of human cellular material) in samples collected from 50 hospital staff members with standard and 3D‐printed swabs was complete. Qualitative agreement with regard to SARS‐CoV‐2 detection in three pairs of 3D‐printed mid‐nasal and standard swab samples from two inpatients with laboratory‐confirmed SARS‐CoV‐2 was also complete. Conclusions Using 3D‐printed swabs to collect nasal samples for SARS‐CoV‐2 testing is feasible, acceptable to patients and health carers, and convenient.

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Multi-center evaluation of cepheid xpert® xpress SARS-CoV-2 point-of-care test during the SARS-CoV-2 pandemic

Cited by 142 publications

References 8 publications

Contribution of VitaPCR SARS-CoV-2 to the emergency diagnosis of COVID-19

Contribution of VitaPCR SARS-CoV-2 to the emergency diagnosis of COVID-19

Laboratory diagnosis of coronavirus disease-2019 (COVID-19)

Pandemic printing: a novel 3D‐printed swab for detecting SARS ‐CoV‐2

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