ePlex® BCID Panels

Bringing the power of GenMark ePlex® syndromic panels together with Roche

GenMark ePlex BCID panels

Infectious diseases, such as blood stream infections that can lead to sepsis, respiratory infections and diarrhea are among the top causes of death worldwide.1,2

These and other infectious diseases can be considered syndromes (a group of symptoms that may not point to a specific causative agent) and may be difficult to diagnose using conventional diagnostic testing methods that look for a single or small number of disease-causing pathogens.

Blood Culture Identification (BCID) Panels

The more you detect, the better you protect


The ePlex® Blood Culture Identification (BCID) Panels provide broad coverage of organisms that can lead to sepsis along with their resistance genes. This broad coverage means that about 95% of currently identified bloodstream infections can be detected early with the ePlex® BCID Panels, compared to other panels that detect significantly fewer sepsis-causing bacteria and fungi.

ePlex BCID panels

Explore the BCID Panel details

COVID-19 grew to pandemic proportions in 2020, with global case numbers approaching 100M by the end of the year. Although most cases are mild, some patients are at higher risk, with an overall mortality rate of >2%.3

The mortality rate of sepsis can be as high as 75% depending on the agent causing infection.4

Because the clinical presentation of COVID-19 and sepsis can be similar, antimicrobial use has increased during the pandemic3 further driving antimicrobial resistance. Rapid detection or rule-out of bacterial or fungal co-infections and secondary infections can help you reduce unnecessary or inadequate antimicrobial therapy.

Covid 19

It is estimated that 20-30% of patients receive ineffective initial antibiotic therapy and the mortality rate for these patients increases up to 7.6% for every hour effective antibiotics are delayed.5,6

The ePlex® BCID Panels aid you in the identification of bacterial and fungal organisms as well as antibiotic resistance genes within approximately 1.5 hours of blood culture bottle positivity, allowing treatment decisions to occur days earlier than with conventional methods. Unique ePlex solutions, like the ePlex® Templated Comments Module, can help to improve antimicrobial stewardship and optimize patient care.

The ePlex® BCID Panels offer the broadest coverage of organisms and resistance markers that cause bloodstream infections (BSI) and can lead to sepsis, including anaerobes and multi-drug resistant organisms (MDRO), as well as common and emerging fungal pathogens (Table 1). The ePlex® BCID Fungal Pathogen (FP) Panel was the first FDA-cleared multiplex molecular panel to include Candida auris, a multi-drug resistant fungal organism that is increasing in prevalence around the world.7

ePlex® BCID Panels detect more of the organisms that cause bloodstream infections than other multiplex panels

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ePlex® BCID Panels detect more of the organisms that cause bloodstream infections than other multiplex panels

% ORGANISM INCLUSIVITY

  5 US HOSPITALS GENMARK CLINICAL STUDY POTULA* WEIGHTED AVERAGE
Number of samples (n) 15793 1979 2746 20518
ePlex BCiD Panel 94.3% 93.6% 97.8% ^94.6%
Competitor 1 BCID 84.3% 86.6% 89.6% 85.3%
Competitor 1 BCID v2 86.8% 89.1% 90.4% 86.4%
Competitor 2 BC 83.1% 83.0% 85.5% 83.5%
Competitor 3 BC ID 78.1% 82.1% 85.9% 73.3%
Competitor 3 BC AST 68.5% 74.4% 80.9% 64.5%
Blood culture panel target inclusivity based on prevalence of organisms that cause bloodstream infections in the United States – 3 clinical sample sets: a) Combined 5 US geographically diverse hospitals (n=15,793), b) GenMark’s prospective clinical trial database (n=1976 from 10 US clinical study sites), c) Potula et. al. (2015) MLO ; https://www.mlo-online.com/automated-blood-culture-testing.php (n = 2,569)4

The ePlex® BCID Panels include 4 gram-positive and 6 gram-negative resistance genes that can be detected days earlier than conventional antimicrobial susceptibility tests (AST), enabling earlier escalation of therapy for resistant organisms or de-escalation of empirical antimicrobials in the case of common contaminants or when a narrower antibiotic is more appropriate. Rapid detection of antibiotic resistance genes when applied with local epidemiology of resistance, has been shown to have a high percent agreement with subsequent phenotypic susceptibility testing, allowing for recommendation of a targeted therapy earlier.7

As much as 15 to 30% of positive blood cultures may be due to contaminants which can result in continuation of unnecessary antibiotics.ePlex® BCID Panels are designed to allow you to more rapidly differentiate a contaminant from a true infection, enabling rapid de-escalation and discharge of patients with a bloodstream infection 2-3 days earlier than conventional methods. Common contaminants included on the ePlex® BCID-GP panel but not on most competitor’s panels include:

  • Bacillus subtilis
  • Corynebacterium
  • Cutibacterium acnes
  • Micrococcus
  • Lactobacillus
BCID Gram Positive

ePlex® BCID-GP Panel


Gram-Positive Organisms
Bacillus cereus group
Bacillus subtilis group
Corynebacterium
Cutibacterium acnes (Propionibacterium acnes)
Enterococcus
Enterococcus faecalis
Enterococcus faecium
Lactobacillus
Listeria
Listeria monocytogenes
Micrococcus
Staphylococcus
Staphylococcus aureus
Staphylococcus epidermidis
Staphylococcus lugdunensis
Streptococcus
Streptococcus agalactiae (GBS)
Streptococcus anginosus group
Streptococcus pneumoniae
Streptococcus pyogenes (GAS)

Resistance Genes
mecA
mecC
vanA
vanB

Pan Targets
Pan Gram-Negative
Pan Candida

BCID Gram Negative

ePlex® BCID-GN Panel


Gram-Negative Organisms
Acinetobacter baumannii
Bacteroides fragilis
Citrobacter
Cronobacter sakazakii
Enterobacter (non-cloacae complex)
Enterobacter cloacae complex
Escherichia coli
Fusobacterium nucleatum
Fusobacterium necrophorum
Haemophilus influenzae
Klebsiella oxytoca
Klebsiella pneumoniae group
Morganella morganii
Neisseria meningitidis
Proteus
Proteus mirabilis
Pseudomonas aeruginosa
Salmonella
Serratia
Serratia marcescens
Stenotrophomonas maltophilia

Resistance Genes
CTX-M
IMP
KPC
NDM
OXA (OXA-23 and OXA-48)
VIM

Pan Targets
Pan Gram-Positive
Pan Candida

BCID Fungal Organisms

ePlex® BCID-FP Panel

Fungal Organisms
Candida albicans
Candida auris
Candida dubliniensis
Candida famata
Candida glabrata
Candida guilliermondii
Candida kefyr
Candida krusei
Candida lusitaniae
Candida parapsilosis
Candida tropicalis
Cryptococcus gattii
Cryptococcus neoformans
Fusarium
Rhodotorula

Registration status

CE-IVD, US-IVD 

 

Package inserts

GenMark IFUs can be accessed through the customer resource center.

 

Intended use

BCID-GP

BCID-GP

The GenMark ePlex® Blood Culture Identification Gram-Positive (ePlex BCID-GP) Panel is a qualitative nucleic acid multiplex in vitro diagnostic test intended for use on GenMark’s ePlex Instrument for simultaneous qualitative detection and identification of multiple potentially pathogenic gram-positive bacterial organisms and select determinants associated with antimicrobial resistance in positive blood culture. In addition, the ePlex BCID-GP Panel is capable of detecting a wide variety of gram-negative bacteria (Pan Gram-Negative assay) and several Candida species (Pan Candida assay). The ePlex BCID-GP Panel is performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system and which contain gram-positive organism.

The following bacterial organisms and genes associated with antibiotic resistance are identified using the ePlex BCID-GP Panel: Bacillus cereus group, Bacillus subtilis group, Corynebacterium, Cutibacterium acnes (Propionibacterium acnes), Enterococcus, Enterococcus faecalis, Enterococcus faecium, Lactobacillus, Listeria, Listeria monocytogenes, Micrococcus, Staphylococcus, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus, Streptococcus agalactiae (GBS), Streptococcus anginosus group, Streptococcus pneumoniae, Streptococcus pyogenes (GAS), mecA, mecC, vanA and vanB.

The ePlex BCID-GP Panel contains assays for the detection of genetic determinants associated with resistance to methicillin (mecA and mecC) and vancomycin (vanA and vanB) to aid in the identification of potentially antimicrobial resistant organisms in positive blood culture samples. The antimicrobial resistance gene detected may or may not be associated with the agent responsible for disease.

The ePlex BCID-GP Panel also contains targets designed to detect a broad range of organisms with a potentially misleading Gram stain result or organisms that may be missed by Gram staining altogether, for example in the case of co-infections. These include a broad Pan Gram-Negative assay as well as a Pan Candida assay, which is designed to detect four of the most prevalent Candida species: Candida albicans, Candida glabrata, Candida krusei and Candida parapsilosis.

The detection and identification of specific bacterial and fungal nucleic acids from individuals exhibiting signs and/or symptoms of bloodstream infection aids in the diagnosis of bloodstream infection when used in conjunction with other clinical information. The results from the ePlex BCID-GP Panel are intended to be interpreted in conjunction with Gram stain results and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.

Negative results in the setting of a suspected bloodstream infection may be due to infection with pathogens that are not detected by this test. Positive results do not rule out co-infection with other organisms; the organism(s) detected by the ePlex BCID-GP Panel may not be the definite cause of disease. Additional laboratory testing (e.g. sub-culturing of positive blood cultures for identification of organisms not detected by ePlex BCID-GP Panel and for susceptibility testing, differentiation of mixed growth and association of antimicrobial resistance marker genes to a specific organism) and clinical presentation must be taken into consideration in the final diagnosis of blood stream infection.

BCID-GN

BCID-GN

The GenMark ePlex® Blood Culture Identification Gram-Negative (ePlex BCID-GN) Panel is a qualitative nucleic acid multiplex in vitro diagnostic test intended for use on GenMark’s ePlex Instrument for simultaneous qualitative detection and identification of multiple potentially pathogenic gram-negative bacterial organisms and select determinants associated with antimicrobial resistance in positive blood culture. In addition, the ePlex BCID-GN Panel is capable of detecting several gram-positive bacteria (Pan Gram-Positive assay) and several Candida species (Pan Candida assay). The ePlex BCID-GN Panel is performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system and which contain gram-negative organism.

The following bacterial organisms and genes associated with antibiotic resistance are identified using the ePlex BCID-GN Panel: Acinetobacter baumannii, Bacteroides fragilis, Citrobacter, Cronobacter sakazakii, Enterobacter cloacae complex, Enterobacter (non-cloacae complex), Escherichia coli, Fusobacterium necrophorum, Fusobacterium nucleatum, Haemophilus influenzae, Klebsiella oxytoca, Klebsiella pneumoniae group, Morganella morganii, Neisseria meningitidis, Proteus, Proteus mirabilis, Pseudomonas aeruginosa, Salmonella, Serratia, Serratia marcescens, Stenotrophomonas maltophilia, CTX-M (blaCTX-M), IMP (blaIMP) , KPC (blaKPC) , NDM (blaNDM), OXA (blaOXA) (OXA-23 and OXA-48 groups only), and VIM (blaVIM).

The ePlex BCID-GN Panel contains assays for the detection of genetic determinants associated with resistance to antimicrobial agents including CTX-M(blaCTX-M), which is associated with resistance to extended spectrum beta-lactamase (ESBL)-mediated resistance to penicillins, cephalosporins, and monobactams, as well as OXA (blaOXA) (OXA-23 and OXA-48 groups only), KPC (blaKPC), and metallo-beta-lactamases IMP (blaIMP), VIM (blaVIM), and NDM (blaNDM), which is associated with carbapenemase-mediated resistance. The antimicrobial resistance gene detected may or may not be associated with the agent responsible for disease. Negative results for these select antimicrobial resistance assays do not indicate susceptibility, as there are multiple mechanisms of resistance in gram-negative bacteria.

The ePlex BCID-GN Panel also contains targets designed to detect a broad range of organisms with a potentially misleading Gram stain result or organisms that may be missed by Gram staining altogether, for example in the case of co-infections. These include a broad Pan Gram-Positive assay (which is designed to detect Bacillus cereus group, Bacillus subtilis group, Enterococcus, Staphylococcus, and Streptococcus), as well as a Pan Candida assay, which is designed to detect four Candida species: Candida albicans, Candida glabrata, Candida krusei, and Candida parapsilosis.

The detection and identification of specific bacterial and fungal nucleic acids from individuals exhibiting signs and/or symptoms of bloodstream infection aids in the diagnosis of bloodstream infection when used in conjunction with other clinical information. The results from the ePlex BCID-GN Panel are intended to be interpreted in conjunction with Gram stain results and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.

Negative results in the setting of a suspected bloodstream infection may be due to infection with pathogens that are not detected by this test. Positive results do not rule out co-infection with other organisms; the organism(s) detected by the ePlex BCID-GN Panel may not be the definite cause of disease. Additional laboratory testing (e.g. sub-culturing of positive blood cultures for identification of organisms not detected by ePlex BCID-GN Panel and for susceptibility testing, differentiation of mixed growth, and association of antimicrobial resistance marker genes to a specific organism) and clinical presentation must be taken into consideration in the final diagnosis of bloodstream infection.

BCID-FP

BCID-FP

The GenMark ePlex® Blood Culture Identification Fungal Pathogen (ePlex BCID-FP) Panel is a qualitative nucleic acid multiplex in vitro diagnostic test intended for use on GenMark’s ePlex Instrument for simultaneous detection and identification of multiple potentially pathogenic fungal organisms in positive blood culture. The ePlex BCID-FP Panel is performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system and which contain fungal organism.

The following fungal organisms are identified using the ePlex BCID-FP Panel: Candida albicans, Candida auris, Candida dubliniensis, Candida famata, Candida glabrata, Candida guilliermondii, Candida kefyr, Candida krusei, Candida lusitaniae, Candida parapsilosis, Candida tropicalis, Cryptococcus gattii, Cryptococcus neoformans, Fusarium and Rhodotorula.

The detection and identification of specific fungal nucleic acids from individuals exhibiting signs and/or symptoms of bloodstream infection aids in the diagnosis of bloodstream infection when used in conjunction with other clinical information. The results from the ePlex BCID-FP Panel are intended to be interpreted in conjunction with Gram stain results and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.

Negative results in the setting of a suspected bloodstream infection may be due to infection with pathogens that are not detected by this test. Positive results do not rule out co-infection with other organisms; the organism(s) detected by the ePlex BCID-FP Panel may not be the definite cause of disease. Additional laboratory testing (e.g. sub-culturing of positive blood cultures for identification of organisms not detected by ePlex BCID-FP Panel, susceptibility testing and differentiation of mixed growth) and clinical presentation must be taken into consideration in the final diagnosis of bloodstream infection.

References

  1. Lozano R, et al., The Lancet 2012; 380: 2095–2128.
  2. Fact Sheet Sepsis. V2_Sepsis Fact Sheet. World Sepsis Day. Global Sepsis Alliance. Center for Sepsis Control & Care.
  3. IDSA: Better Tests Better Care, The Promise of Next Generation Diagnostics.
  4. Kumar, et al. (2006) Crit Care Med. 34 (6):1589-1596
  5. Singh, N. (2001) Clin Infect Dis, 33(10):1692-1696
  6. Detection rate based on panel inclusivity only, not a sensitivity/performance claim
  7. Pogue, JM, et al. (2018) Antimicrob Agents Chemother: 62(5):e02538-17
  8. Murray, P. et. al. (2012), Crit Care Med,Current Approaches to the Diagnosis of Bacterial and Fungal Bloodstream Infections for the ICU.

ePlex® Panels, System and Software are developed and manufactured by GenMark  GenMark Diagnostics, Inc. and distributed by Roche.