Analytical performance and potential clinical utility of the GenMark Dx ePlex® blood culture identification gram-positive panel

McCarty, Todd P; White, Cameron; Meeder, Jeremy; Moates, Derek; Pierce, Hannah; Edwards, William S; Hutchinson, Jamie; Lee, R A; Leal, Sixto M.

doi:10.1016/j.diagmicrobio.2022.115762

Cited by 6 publications

(3 citation statements)

References 42 publications

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“…Overall, the ePlex® BCID mPCR was able to identify all bacteria present in 88% of the BC samples, comparable to previous studies, including 69% of the polymicrobial samples for which MALDI-TOF-based rapid techniques are not reliable [15,[26][27][28][29][30][31]. In comparison, respectively 78% and 77% were identi ed in RCTs testing FilmArray ® BCID or Accelerate PhenoTest ® BC kit, and 89% in a prospective controlled clinical trial using rapid MALDI-TOF identi cation on bacterial pellets [8, 9,21].…”

Section: Discussionsupporting

confidence: 77%

Clinical impact and cost-consequence analysis of ePlex® Blood Culture Identification Panels for the rapid diagnosis of bloodstream infections: a single-center randomized controlled trial

Caspar,

Deves,

Richarme

et al. 2024

Preprint

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Purpose. To assess clinical impact and perform cost-consequence analysis of the broadest multiplex PCR panels available for the rapid diagnosis of bloodstream infections (BSI). Methods. Single-center, randomized controlled trial conducted from June 2019 to February 2021 at a French University hospital with an institutional antimicrobial stewardship program. Primary endpoint was the percentage of patients with optimized antimicrobial treatment 12h after transmission of positivity and Gram stain results from the first positive BC. Results. This percentage was significantly higher in the multiplex PCR (mPCR) group (90/105 = 85.7% %, IC95% [77.5 ; 91.8] vs. 68/107 = 63.6%, IC95% [53.7 ; 72.6]; p<10-3) at interim analysis, resulting in the early termination of the study after the inclusion of 309 patients. For patients not optimized at baseline, the median time to obtain an optimized therapy was much shorter in the mPCR group than in the control group (6.9h, IQR [2.9; 17.8] vs 26.4h, IQR [3.4; 47.5]; p=0.001). Early optimization of antibiotic therapy resulted in a non-statistically significant decrease in mortality from 12.4% to 8.8% (p=0.306), with a tendency for a lower median length of stay (18 vs. 20 days; p=0.064) and a non-significant reduction in the average cost per patient of €3,065 (p=0.15). mPCR identified all the bacteria present in 88% of the samples. Conclusion. Despite its higher laboratory cost, the use of multiplex PCR for BSI diagnosis leads to early-optimised therapy, seems cost-effective and could reduce mortality and length of stay. Their impact could probably be improved if implemented 24/7.

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Section: Discussionsupporting

confidence: 77%

Clinical impact and cost-consequence analysis of ePlex® Blood Culture Identification Panels for the rapid diagnosis of bloodstream infections: a single-center randomized controlled trial

Caspar,

Deves,

Richarme

et al. 2024

Preprint

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“…Meanwhile, DNA microarrays perform hybridization-based genotyping on a chip immobilized with various types of single-stranded DNA (ssDNA) sequences and is a comparatively high-throughput genotyping technology [ 9 ]. Thus, DNA microarray products like Verigene [ 10 , 11 , 12 ] and ePlex [ 13 , 14 , 15 ] are practically applied for pathogenic genotyping in respiratory tract infection and sepsis.…”

Section: Introductionmentioning

confidence: 99%

“…Despite the capability of DNA microarrays to simultaneously identify up to 300,000 target sequences [ 16 ], the process takes from 1.5 to 3 h to identify the target gene [ 10 , 11 , 12 , 13 , 14 , 15 ], owing to several operation steps, including gene amplification, target ssDNA synthesis from double-stranded DNA (dsDNA) amplicons, labeling, and washing [ 9 , 17 ]. Overall, conventional genotyping technologies face limitations concerning the coexistence of short detection times and the range of detectable target types.…”

Section: Introductionmentioning

confidence: 99%

Miniaturization of CRISPR/Cas12-Based DNA Sensor Array by Non-Contact Printing

Shigemori,

Fujita,

Tamiya

et al. 2024

Micromachines

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DNA microarrays have been applied for comprehensive genotyping, but remain a drawback in complicated operations. As a solution, we previously reported the solid-phase collateral cleavage (SPCC) system based on the clustered regularly interspaced short palindromic repeat/CRISPR-associated protein 12 (CRISPR/Cas12). Surface-immobilized Cas12-CRISPR RNA (crRNA) can directly hybridize target double-stranded DNA (dsDNA) and subsequently produce a signal via the cleavage of single-stranded DNA (ssDNA) reporter immobilized on the same spot. Therefore, SPCC-based multiplex dsDNA detection can be performed easily. This study reports the miniaturization of SPCC-based spots patterned by a non-contact printer and its performance in comprehensive genotyping on a massively accumulated array. Initially, printing, immobilization, and washing processes of Cas12–crRNA were established to fabricate the non-contact-patterned SPCC-based sensor array. A target dsDNA concentration response was obtained based on the developed sensor array, even with a spot diameter of 0.64 ± 0.05 mm. Also, the limit of detection was 572 pM, 531 pM, and 3.04 nM with 40, 20, and 10 nL-printing of Cas12–crRNA, respectively. Furthermore, the sensor array specifically detected three dsDNA sequences in one-pot multiplexing; therefore, the feasibility of comprehensive genotyping was confirmed. These results demonstrate that our technology can be miniaturized as a CRISPR/Cas12-based microarray by using non-contact printing. In the future, the non-contact-patterned SPCC-based sensor array can be applied as an alternative tool to DNA microarrays.

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Clinical impact and cost-consequence analysis of ePlex® blood culture identification panels for the rapid diagnosis of bloodstream infections: a single-center randomized controlled trial

Caspar,

Deves,

Richarme

et al. 2024

Eur J Clin Microbiol Infect Dis

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To assess clinical impact and perform cost-consequence analysis of the broadest multiplex PCR panels available for the rapid diagnosis of bloodstream infections (BSI). Single-center, randomized controlled trial conducted from June 2019 to February 2021 at a French University hospital with an institutional antimicrobial stewardship program. Primary endpoint was the percentage of patients with optimized antimicrobial treatment 12 h after transmission of positivity and Gram stain results from the first positive BC. This percentage was significantly higher in the multiplex PCR (mPCR) group (90/105 = 85.7% %, CI95% [77.5 ; 91.8] vs. 68/107 = 63.6%, CI95% [53.7 ; 72.6]; p < 10− 3) at interim analysis, resulting in the early termination of the study after the inclusion of 309 patients. For patients not optimized at baseline, the median time to obtain an optimized therapy was much shorter in the mPCR group than in the control group (6.9 h, IQR [2.9; 17.8] vs. 26.4 h, IQR [3.4; 47.5]; p = 0.001). Early optimization of antibiotic therapy resulted in a non-statistically significant decrease in mortality from 12.4 to 8.8% (p = 0.306), with a trend towards a shorter median length of stay (18 vs. 20 days; p = 0.064) and a non-significant reduction in the average cost per patient of €3,065 (p = 0.15). mPCR identified all the bacteria present in 88% of the samples. Despite its higher laboratory cost, the use of multiplex PCR for BSI diagnosis leads to early-optimised therapy, seems cost-effective and could reduce mortality and length of stay. Their impact could probably be improved if implemented 24/7.

show abstract

Analytical performance and potential clinical utility of the GenMark Dx ePlex® blood culture identification gram-positive panel

Cited by 6 publications

References 42 publications

Clinical impact and cost-consequence analysis of ePlex® Blood Culture Identification Panels for the rapid diagnosis of bloodstream infections: a single-center randomized controlled trial

Clinical impact and cost-consequence analysis of ePlex® Blood Culture Identification Panels for the rapid diagnosis of bloodstream infections: a single-center randomized controlled trial

Miniaturization of CRISPR/Cas12-Based DNA Sensor Array by Non-Contact Printing

Clinical impact and cost-consequence analysis of ePlex® blood culture identification panels for the rapid diagnosis of bloodstream infections: a single-center randomized controlled trial

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