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Multicenter Study
. 2020 Jul:128:104426.
doi: 10.1016/j.jcv.2020.104426. Epub 2020 May 11.

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

Femke Wolters  1 , Jeroen van de Bovenkamp  2 , Bart van den Bosch  3 , Sharon van den Brink  4 , Maaike Broeders  2 , Ngoc Hoa Chung  4 , Barbara Favié  4 , Gabriel Goderski  4 , Judith Kuijpers  3 , Ilse Overdevest  2 , Janette Rahamat-Langedoen  3 , Lisa Wijsman  4 , Willem Jg Melchers  3 , Adam Meijer  4
Affiliations
Multicenter Study

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

Femke Wolters et al. J Clin Virol. 2020 Jul.

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.

Keywords: COVID-19; GeneXpert; Molecular point of care test; Pandemic; SARS-CoV-2.

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Conflict of interest statement

Declaration of Competing Interest None.

Figures

Fig. 1
Fig. 1
Results of SARS-CoV-2 containing specimens of the specificity panel. Labs indicated with 1, 2 and 3; In-house = In house RT-PCR with target gene indicated; GeneX = Xpert Xpress SARS-CoV-2; negative results indicated with Ct value 45.
Fig. 2
Fig. 2
Results of the sensitivity panel for in-house E-gene (in-house E) and Xpert Xpress SARS-CoV-2 (GeneX E and N2). Individual labs are indicated with 1, 2 and 3; negative results indicated at a Ct value 45.
Fig. 3
Fig. 3
Results of clinical samples with high SARS-CoV-2 viral load. Panel consists of samples tested in in-house RT-PCR positive for E-gene and RdRp-gene. In-house E-gene (in-house E) and Xpert Xpress SARS-CoV-2 (GeneX E and N2). Individual labs are indicated with 1, 2 and 3; negative results indicated at a Ct value 45.
Fig. 4
Fig. 4
Results of clinical samples with lower SARS-CoV-2 viral loads, for in-house E-gene (in-house E) and Xpert Xpress SARS-CoV-2 (GeneX E and N2). Individual labs are indicated with 1, 2 and 3; negative results indicated at a Ct value 45. Xpert E-only and N2-only results were for 2 different specimens.
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