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

Autor: Willem J. G. Melchers, Judith Kuijpers, Sharon van den Brink, Janette Rahamat-Langedoen, Maaike Broeders, Bart van den Bosch, I. T. M. A. Overdevest, Jeroen H.B. van de Bovenkamp, Lisa Wijsman, Adam Meijer, Barbara Favié, Gabriel Goderski, Femke Wolters, Ngoc Hoa Chung
Rok vydání: 2020
Předmět:
0301 basic medicine
2019-20 coronavirus outbreak
medicine.medical_specialty
Molecular point of care test
COVID-19 Vaccines
Time Factors
Coronavirus disease 2019 (COVID-19)
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Point-of-care testing
viruses
030106 microbiology
Pneumonia
Viral
GeneXpert
Sensitivity and Specificity
Article
03 medical and health sciences
Betacoronavirus
0302 clinical medicine
COVID-19 Testing
Virology
Nasopharynx
Pandemic
medicine
Humans
030212 general & internal medicine
skin and connective tissue diseases
Pandemics
Netherlands
GeneXpert MTB/RIF
Women's cancers Radboud Institute for Molecular Life Sciences [Radboudumc 17]
business.industry
SARS-CoV-2
Clinical Laboratory Techniques
Reverse Transcriptase Polymerase Chain Reaction
fungi
COVID-19
Reproducibility of Results
virus diseases
Viral Load
body regions
Infectious Diseases
lnfectious Diseases and Global Health Radboud Institute for Health Sciences [Radboudumc 4]
Point-of-Care Testing
Emergency medicine
business
Coronavirus Infections
Zdroj: Journal of Clinical Virology
Journal of Clinical Virology, 128
ISSN: 1386-6532
Popis: Contains fulltext : 220114.pdf (Publisher’s version ) (Closed access) BACKGROUND: With the outbreak of SARS-CoV-2, rapid diagnostics are paramount to contain the current pandemic. The routinely used realtime RT-PCR is sensitive, specific and able to process large batches of samples. However, turnaround time is long and in cases where fast obtained results are critical, molecular point of care tests (POCT) can be an alternative. Here we report on a multicenter evaluation of the Cepheid Xpert Xpress SARS-CoV-2 point-of-care test. STUDY DESIGN: The Xpert Xpress SARS-CoV-2 assay was evaluated against the routine in-house real-time RT-PCR assays in three medical microbiology laboratories in The Netherlands. A sensitivity and specificity panel was tested consisting of a dilution series of SARS-CoV-2 and ten samples containing SARS-CoV-2 and a range of other seasonal respiratory viruses. Additionally, 58 samples of patients positive for SARS-CoV-2 with different viral loads and 30 tested negative samples in all three Dutch laboratories using an in-house RT-PCR, were evaluated using Cepheids Xpert Xpress SARS-CoV-2 cartridges. RESULTS: Xpert Xpress SARS-CoV-2 point of care test showed equal performance compared to routine in-house testing with a limit of detection (LOD) of 8.26 copies/mL. Other seasonal respiratory viruses were not detected. In clinical samples Xpert Xpress SARS-CoV-2 reaches an agreement of 100 % compared to all in-house RT-PCRs CONCLUSION: Cepheids GeneXpert Xpert Xpress SARS-CoV-2 is a valuable addition for laboratories in situations where rapid and accurate diagnostics are of the essence.
Databáze: OpenAIRE
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