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Multi-center evaluation of cepheid xpert® xpress SARS-CoV-2 point-of-care test during the SARS-CoV-2 pandemic.
J Clin Virol. 2020 07; 128:104426.JC

Abstract

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.

Authors+Show Affiliations

Department of Medical Microbiology, Radboud university medical center, Nijmegen, The Netherlands. Electronic address: femke.wolters@radboudumc.nl.Laboratory for Medical Microbiology, PAMM Laboratories, Veldhoven, The Netherlands.Department of Medical Microbiology, Radboud university medical center, Nijmegen, The Netherlands.National Institute for Public Health and the Environment (RIVM), Centre for Infectious Disease Control (CIb), Centre for Infectious Diseases Research, Diagnostics and Laboratory Surveillance, Bilthoven, The Netherlands.Laboratory for Medical Microbiology, PAMM Laboratories, Veldhoven, The Netherlands.National Institute for Public Health and the Environment (RIVM), Centre for Infectious Disease Control (CIb), Centre for Infectious Diseases Research, Diagnostics and Laboratory Surveillance, Bilthoven, The Netherlands.National Institute for Public Health and the Environment (RIVM), Centre for Infectious Disease Control (CIb), Centre for Infectious Diseases Research, Diagnostics and Laboratory Surveillance, Bilthoven, The Netherlands.National Institute for Public Health and the Environment (RIVM), Centre for Infectious Disease Control (CIb), Centre for Infectious Diseases Research, Diagnostics and Laboratory Surveillance, Bilthoven, The Netherlands.Department of Medical Microbiology, Radboud university medical center, Nijmegen, The Netherlands.Laboratory for Medical Microbiology, PAMM Laboratories, Veldhoven, The Netherlands.Department of Medical Microbiology, Radboud university medical center, Nijmegen, The Netherlands.National Institute for Public Health and the Environment (RIVM), Centre for Infectious Disease Control (CIb), Centre for Infectious Diseases Research, Diagnostics and Laboratory Surveillance, Bilthoven, The Netherlands.Department of Medical Microbiology, Radboud university medical center, Nijmegen, The Netherlands.National Institute for Public Health and the Environment (RIVM), Centre for Infectious Disease Control (CIb), Centre for Infectious Diseases Research, Diagnostics and Laboratory Surveillance, Bilthoven, The Netherlands.

Pub Type(s)

Evaluation Study
Journal Article
Multicenter Study

Language

eng

PubMed ID

32417674

Citation

Wolters, Femke, et al. "Multi-center Evaluation of Cepheid Xpert® Xpress SARS-CoV-2 Point-of-care Test During the SARS-CoV-2 Pandemic." Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology, vol. 128, 2020, p. 104426.
Wolters F, van de Bovenkamp J, van den Bosch B, et al. Multi-center evaluation of cepheid xpert® xpress SARS-CoV-2 point-of-care test during the SARS-CoV-2 pandemic. J Clin Virol. 2020;128:104426.
Wolters, F., van de Bovenkamp, J., van den Bosch, B., van den Brink, S., Broeders, M., Chung, N. H., Favié, B., Goderski, G., Kuijpers, J., Overdevest, I., Rahamat-Langedoen, J., Wijsman, L., Melchers, W. J., & Meijer, A. (2020). Multi-center evaluation of cepheid xpert® xpress SARS-CoV-2 point-of-care test during the SARS-CoV-2 pandemic. Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology, 128, 104426. https://doi.org/10.1016/j.jcv.2020.104426
Wolters F, et al. Multi-center Evaluation of Cepheid Xpert® Xpress SARS-CoV-2 Point-of-care Test During the SARS-CoV-2 Pandemic. J Clin Virol. 2020;128:104426. PubMed PMID: 32417674.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Multi-center evaluation of cepheid xpert® xpress SARS-CoV-2 point-of-care test during the SARS-CoV-2 pandemic. AU - Wolters,Femke, AU - van de Bovenkamp,Jeroen, AU - van den Bosch,Bart, AU - van den Brink,Sharon, AU - Broeders,Maaike, AU - Chung,Ngoc Hoa, AU - Favié,Barbara, AU - Goderski,Gabriel, AU - Kuijpers,Judith, AU - Overdevest,Ilse, AU - Rahamat-Langedoen,Janette, AU - Wijsman,Lisa, AU - Melchers,Willem Jg, AU - Meijer,Adam, Y1 - 2020/05/11/ PY - 2020/05/02/received PY - 2020/05/05/accepted PY - 2020/5/18/pubmed PY - 2020/7/7/medline PY - 2020/5/18/entrez KW - COVID-19 KW - GeneXpert KW - Molecular point of care test KW - Pandemic KW - SARS-CoV-2 SP - 104426 EP - 104426 JF - Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology JO - J Clin Virol VL - 128 N2 - 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. SN - 1873-5967 UR - https://www.unboundmedicine.com/medline/citation/32417674/Multi_center_evaluation_of_cepheid_xpert®_xpress_SARS_CoV_2_point_of_care_test_during_the_SARS_CoV_2_pandemic_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1386-6532(20)30168-2 DB - PRIME DP - Unbound Medicine ER -