Evaluation of three molecular carbapenemase tests: Eazyplex SuperBug complete B, Novodiag CarbaR+, and Amplidiag CarbaR+MCR

Holma, Tanja; Antikainen, Jenni; Haiko, Johanna

doi:10.1016/j.mimet.2020.106105

Cited by 3 publications

(5 citation statements)

References 13 publications

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“…Our assays are also comparable to the commercialized CE-IVD LAMP Eazyplex SuperBug kits (complete A, complete B, and CRE; Amplex-Diagnostics GmbH, Germany), designed to detect carbapenemase-producing genes and selected ESBL genes in up to 30 min using the portable Genie II device ( Vergara et al, 2014 ; Findlay et al, 2015 ; Hinic et al, 2015 ; García-Fernández et al, 2016 ; Fiori et al, 2019 ; Moreno-Morales et al, 2020 ; Sekowska et al, 2020 ; Vergara et al, 2020 ; Holma et al, 2021 ). Sensitivity and specificity of the Eazyplex SuperBug kits, assessed on clinical isolates of Enterobacteriaceae ( Vergara et al, 2014 ; Findlay et al, 2015 ), were greater than 95%.…”

Section: Discussionmentioning

confidence: 93%

“…These kits were also tested on bronchoalveolar lavage fluid samples spiked with Enterobacteriaceae and carbapenem-resistant Acinetobacter spp. ( Moreno-Morales et al, 2020 ; Vergara et al, 2020 ), clinical urine samples ( Hinic et al, 2015 ), and rectal swab samples ( Holma et al, 2021 ), with 80%–100% sensitivity, a specificity greater than 95%, and a limit of detection between 10 2 and 10 3 CFUs/ml ( Hinic et al, 2015 ; Moreno-Morales et al, 2020 ; Vergara et al, 2020 ; Holma et al, 2021 ). Other CE-IVD marked portable molecular diagnostics for carbapenemases, which are cartridge-based PCR assays and require minimal sample preparation, such as Xpert Carba-R ( Tenover et al, 2013 ; Anandan et al, 2015 ; Findlay et al, 2015 ; Vergara et al, 2020 ) and Novodiag CarbaR + combining real-time PCR and microarray technologies ( Girlich et al, 2019 ; Holma et al, 2021 ), have been recently commercialized.…”

Section: Discussionmentioning

confidence: 99%

“…( Moreno-Morales et al, 2020 ; Vergara et al, 2020 ), clinical urine samples ( Hinic et al, 2015 ), and rectal swab samples ( Holma et al, 2021 ), with 80%–100% sensitivity, a specificity greater than 95%, and a limit of detection between 10 2 and 10 3 CFUs/ml ( Hinic et al, 2015 ; Moreno-Morales et al, 2020 ; Vergara et al, 2020 ; Holma et al, 2021 ). Other CE-IVD marked portable molecular diagnostics for carbapenemases, which are cartridge-based PCR assays and require minimal sample preparation, such as Xpert Carba-R ( Tenover et al, 2013 ; Anandan et al, 2015 ; Findlay et al, 2015 ; Vergara et al, 2020 ) and Novodiag CarbaR + combining real-time PCR and microarray technologies ( Girlich et al, 2019 ; Holma et al, 2021 ), have been recently commercialized. Both these diagnostic methods detect and differentiate the most prevalent carbapenemases gene families in less than 2 h, from samples to results, and showed high sensitivity and specificity in clinical samples with a limit of detection of 10 2 CFUs/ml ( Tenover et al, 2013 ; Anandan et al, 2015 ; Findlay et al, 2015 ; Girlich et al, 2019 ; Vergara et al, 2020 ; Holma et al, 2021 ).…”

Section: Discussionmentioning

confidence: 99%

“…Other CE-IVD marked portable molecular diagnostics for carbapenemases, which are cartridge-based PCR assays and require minimal sample preparation, such as Xpert Carba-R ( Tenover et al, 2013 ; Anandan et al, 2015 ; Findlay et al, 2015 ; Vergara et al, 2020 ) and Novodiag CarbaR + combining real-time PCR and microarray technologies ( Girlich et al, 2019 ; Holma et al, 2021 ), have been recently commercialized. Both these diagnostic methods detect and differentiate the most prevalent carbapenemases gene families in less than 2 h, from samples to results, and showed high sensitivity and specificity in clinical samples with a limit of detection of 10 2 CFUs/ml ( Tenover et al, 2013 ; Anandan et al, 2015 ; Findlay et al, 2015 ; Girlich et al, 2019 ; Vergara et al, 2020 ; Holma et al, 2021 ). These rapid molecular diagnostics are all highly sensitive and specific but require the use of specialized costly devices and reagents.…”

Section: Discussionmentioning

confidence: 99%

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Development of Loop-Mediated Isothermal Amplification Rapid Diagnostic Assays for the Detection of Klebsiella pneumoniae and Carbapenemase Genes in Clinical Samples

Poirier

Kuang

Siedler

et al. 2022

Front. Mol. Biosci.

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Klebsiella pneumoniae is an important pathogenic bacterium commonly associated with human healthcare and community-acquired infections. In recent years, K. pneumoniae has become a significant threat to global public and veterinary health, because of its high rates of antimicrobial resistance (AMR). Early diagnosis of K. pneumoniae infection and detection of any associated AMR would help to accelerate directed therapy and reduce the risk of the emergence of multidrug-resistant isolates. In this study, we identified three target genes (yhaI, epsL, and xcpW) common to K. pneumoniae isolates from both China and Europe and designed loop-mediated isothermal amplification (LAMP) assays for the detection of K. pneumoniae in clinical samples. We also designed LAMP assays for the detection of five AMR genes commonly associated with K. pneumoniae. The LAMP assays were validated on a total of 319 type reference strains and clinical isolates of diverse genetic backgrounds, in addition to 40 clinical human sputum samples, and were shown to be reliable, highly specific, and sensitive. For the K. pneumoniae–specific LAMP assay, the calculated sensitivity, specificity, and positive and negative predictive values (comparison with culture and matrix-assisted laser desorption/ionization–time of flight mass spectrometry) were all 100% on clinical isolates and, respectively, of 100%, 91%, and 90%, and 100% when tested on clinical sputum samples, while being significantly faster than the reference methods. For the blaKPC and other carbapenemases’ LAMP assays, the concordance between the LAMP results and the references methods (susceptibility tests) was 100%, on both pure cultures (n = 125) and clinical samples (n = 18). In conclusion, we developed highly sensitive and specific LAMP assays for the clinical identification of K. pneumoniae and detection of carbapenem resistance.

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Section: Discussionmentioning

confidence: 93%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Development of Loop-Mediated Isothermal Amplification Rapid Diagnostic Assays for the Detection of Klebsiella pneumoniae and Carbapenemase Genes in Clinical Samples

Poirier

Kuang

Siedler

et al. 2022

Front. Mol. Biosci.

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“…Several experimental studies observed reliable concordance of the eazyplex® SuperBug CRE system when performed on CPO and nEcESBL-PE isolates when compared to cultures or PCR [ 24 – 27 ]. However, when directly performed on rectal swabs, Yamamoto et al observed a PPV of 62% to detect carbapenem-resistant Acinetobacter baumannii , [ 28 ] which is close to our PPV.…”

Section: Discussionmentioning

confidence: 99%

An interventional quasi-experimental study to evaluate the impact of a rapid screening strategy in improving control of nosocomial extended-spectrum beta-lactamase-producing Enterobacterales and carbapenemase-producing organisms in critically ill patients

et al. 2022

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Introduction Rapid molecular tests could accelerate the control of extended-spectrum beta-lactamase-producing Enterobacterales (ESBL-PE) and carbapenemase-producing organisms (CPO) in intensive care units (ICUs). Objective and methods This interventional 12-month cohort study compared a loop-mediated isothermal amplification (LAMP) assay performed directly on rectal swabs with culturing methods (control period, 6 months), during routine ICU screening. Contact precautions (CP) were implemented for CPO or non-E. coli ESBL-producing Enterobacterales (nEcESBL-PE) carriers. Using survival analysis, we compared the time intervals from admission to discontinuation of unnecessary preemptive CP among patients at-risk and the time intervals from screening to implementation of CP among newly identified carriers. We also compared diagnostic performances, and nEcESBL-PE/CPO acquisition rates. This study is registered, ISRCTN 23588440. Results We included 1043 patients. During the intervention and control phases, 92/147 (62.6%) and 47/86 (54.7%) of patients at-risk screened at admission were candidates for early discontinuation of preemptive CP. The LAMP assay had a positive predictive value (PPV) of 44.0% and a negative predictive value (NPV) of 99.9% for CPO, and 55.6% PPV and 98.2% NPV for nEcESBL-PE. Due to result notification and interpretation challenges, the median time from admission to discontinuation of preemptive CP increased during the interventional period from 80.5 (95% CI 71.5–132.1) to 88.3 (95% CI 57.7–103.7) hours (p = 0.47). Due to the poor PPV, we had to stop using the LAMP assay to implement CP. No difference was observed regarding the incidence of nEcESBL-PE and CPO acquisition. Conclusion A rapid screening strategy with LAMP assays performed directly on rectal swabs had no benefit for infection control in a low-endemicity setting.

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Laboratory detection of carbapenemases among Gram-negative organisms

Simner,

Pitout,

Dingle

2024

Clin Microbiol Rev

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SUMMARY The carbapenems remain some of the most effective options available for treating patients with serious infections due to Gram-negative bacteria. Carbapenemases are enzymes that hydrolyze carbapenems and are the primary method driving carbapenem resistance globally. Detection of carbapenemases is required for patient management, the rapid implementation of infection prevention and control (IP&C) protocols, and for epidemiologic purposes. Therefore, clinical and public health microbiology laboratories must be able to detect and report carbapenemases among predominant Gram-negative organisms from both cultured isolates and direct from clinical specimens for treatment and surveillance purposes. There is not a “one size fits all” laboratory approach for the detection of bacteria with carbapenemases, and institutions need to determine what fits best with the goals of their antimicrobial stewardship and IP&C programs. Luckily, there are several options and approaches available for clinical laboratories to choose methods that best suits their individual needs. A laboratory approach to detect carbapenemases among bacterial isolates consists of two steps, namely a screening process ( e.g. , not susceptible to ertapenem, meropenem, and/or imipenem), followed by a confirmation test ( i.e. , phenotypic, genotypic or proteomic methods) for the presence of a carbapenemase. Direct from specimen testing for the most common carbapenemases generally involves detection via rapid, molecular approaches. The aim of this article is to provide brief overviews on Gram-negative bacteria carbapenem-resistant definitions, types of carbapenemases, global epidemiology, and then describe in detail the laboratory methods for the detection of carbapenemases among Gram-negative bacteria. We will specifically focus on the Enterobacterales, Pseudomonas aeruginosa , and Acinetobacter baumannii complex.

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Evaluation of three molecular carbapenemase tests: Eazyplex SuperBug complete B, Novodiag CarbaR+, and Amplidiag CarbaR+MCR

Cited by 3 publications

References 13 publications

Development of Loop-Mediated Isothermal Amplification Rapid Diagnostic Assays for the Detection of Klebsiella pneumoniae and Carbapenemase Genes in Clinical Samples

Development of Loop-Mediated Isothermal Amplification Rapid Diagnostic Assays for the Detection of Klebsiella pneumoniae and Carbapenemase Genes in Clinical Samples

An interventional quasi-experimental study to evaluate the impact of a rapid screening strategy in improving control of nosocomial extended-spectrum beta-lactamase-producing Enterobacterales and carbapenemase-producing organisms in critically ill patients

Laboratory detection of carbapenemases among Gram-negative organisms

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