Customer Center
Login | Register

VERIGENE® GRAM-NEGATIVE BLOOD CULTURE TEST

VERIGENE® Bloodstream Infection Tests | VERIGENE® Gram-Negative Blood Culture Test

 
The VERIGENE® Gram-Negative Blood Culture Test (BC-GN) identifies genus, species, and genetic resistance determinants for a broad panel of gram-negative bacteria directly from positive blood culture bottles

While conventional microbiological methods may require 2-4 days to produce bacterial identification and resistance results, VERIGENE BC-GN provides results within two hours of blood culture positivity.

 

Gram-Negative Blood Culture Test Specifications

 

TargetsU.S./FDA-ClearedOutside U.S.
Species
Escherichia coli*
Klebsiella pneumoniae
Klebsiella oxytoca
Pseudomonas aeruginosa
Serratia marcescens 
Genus
Acinetobacter spp.
Citrobacter spp.
Enterobacter spp.
Proteus spp.
Resistance
CTX-M (ESBL)
IMP (carbapenemase)
KPC (carbapenemase)
NDM (carbapenemase)
OXA (carbapenemase)
VIM (carbapenemase)
* BC-GN will not distinguish Escherichia coli from Shigella spp. (S. dysenteriae, S. flexneri, S. boydii, and S. sonnei).

 

Key Features
AutomationSample to Result
InstrumentationVERIGENE Reader and Processor SP
WorkflowOn-Demand and Scalable
Sample TypePositive Blood Culture Bottle
Pipetting StepsOne
Hands-On Time<5 minutes
Run Time<2 hours
†For use with all continuous monitoring blood culture bottles; see VERIGENE BC-GN package insert for details.
Resources
Videos and Webinars
Each Hour Counts: The Clinical and Economic Case for Rapid Sepsis Diagnostics
Each Hour Counts: Optimizing Therapy for Bloodstream Infections with Rapid Molecular Testing
Each Hour Counts: Improving Management of CRE’s and Other Antibiotic-Resistant BSI’s with Rapid Molecular Diagnostics
Each Hour Counts: Physician and Pharmacist Perspectives on the Value of Rapid Blood Culture Testing
Justification, Validation and Implementation Best Practices for Multiplex Molecular Infectious Disease Tests
In Their Own Words: Dr. Neelam Dhiman at med fusion & Clearpoint Diagnostic Laboratories
Rapid Sepsis Diagnosis at the Detroit Medical Center (Password: SCACM)
Emerging Resistance Among Gram-Negative Bacteria in the Hospital Setting (Password: CVS2014)
Posters
Articles and Abstracts
Decreasing Turnaround Times in Septic Patients Infected with Carbapenemase Producing Gram Negative Organisms, a First Look at an Emerging Technology
Evaluation Of The VERIGENE GN-BC For The Identification Of Gram Negative Bacilli And Detection Of Antibiotic Resistance Mechanisms Directly From Positive Blood Cultures
Evaluation of the VERIGENE BC-GN Assay for the Direct Identification of Gram-Negative Bacteria from Blood Culture
Performance of the VERIGENE BC-GN Assay in an Acute Care Inner-city Hospital
VERIGENE BC-GN Test for Rapid Detection of Gram-Negative Bacteria from Positive Blood Cultures in Pediatric Inpatients: A Multi-Center Evaluation
Accuracy and Potential Clinical Utility of Two Rapid Molecular Panels for Detection of Bloodstream Infection
Multi-Centre Evaluation of VERIGENE BC-GN Test for Rapid Detection of Gram-Negative Bacteria from Positive Blood Cultures from Pediatric Inpatients
Potential Impact of a Microarray-Based Nucleic Acid Assay for the Rapid Detection of Gram-Negative Bacteria and Resistance Markers in Positive Blood Cultures
Rapid Detection of Gram-Negative Bacteria and Resistance Determinants Directly from Positive Blood Cultures Using the Microarray-Based Sample-to-Result VERIGENE BC-GN Assay
Evaluation of the VERIGENE Gram-Negative Blood Culture (BC-GN) Assay and Assessment of Clinical Impact
Use of the VERIGENE Gram-Negative Blood Culture (BC-GN) System for More Rapid Bacterial Identification and Antimicrobial Optimization in Patients with Gram-Negative Rod Bacteremia
Rapid Testing Using VERIGENE® Microarray in Combination with Antimicrobial Stewardship Intervention in Gram-Negative Bacteremia
Impact of a Rapid Molecular Diagnostic Test and Antimicrobial Stewardship on Time to Optimal Therapy in Bacteremic Patients
Outcomes Associated with the Utilization of Rapid Diagnostic Technology and Pharmacist Intervention in the Management of Gram-negative Bacteremia
Antimicrobial Stewardship and the Use of VERIGENE Gram-Positive and Gram-Negative Rapid Identification System
Impact of Rapid Molecular Testing of Gram-Positive Blood Culture Isolates Using VERIGENE Gram-Positive Blood Culture (BC-GP) on Antimicrobial Stewardship and Clinical Outcomes within a Community Health System
Performance and Clinical Uptake of VERIGENE Blood Culture Gram-Negative (BC-GN) Multiplex Molecular Assay
Misidentification of a Bloodstream Klebsiella variicola Infection: An Investigation in Laboratory Diagnosis
Detection of Carbapenem-resistant Enterobacteriaceae (CRE) from Clinical Culture Isolates Using VERIGENE Gram-negative Blood Culture Test (BC-GN) and Biofire FilmArray™ BCID

VERIGENE® BLOODSTREAM INFECTION TESTS

Learn how the VERIGENE® System provides cost-effective bacterial identification and antibiotic resistance determination directly from positive blood culture bottles up to 48 hours faster than conventional methods.
 
Read More

GRAM-POSITIVE BLOOD CULTURE TESTS

Learn how the VERIGENE Gram-Positive Blood Culture Test (BC-GP) can provide results within 2.5 hours of blood culture positivity.
 
 
Read More

For In Vitro Diagnostic Use. Products are region specific and may not be approved in some countries/regions. Please contact Luminex at [email protected] to obtain the appropriate product information for your country of residence.

Intended Use

The VERIGENE® Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) performed using the sample-to-result VERIGENE® System is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative bacteria and resistance markers. BC-GN is performed directly on blood culture media using blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram-negative bacteria as determined by Gram stain.

BC-GN detects and identifies the following Bacterial Genera and Species—Acinetobacter spp., Citrobacter spp., Enterobacter spp., Proteus spp., Escherichia coli1, Klebsiella pneumoniae, Klebsiella oxytoca, and Pseudomonas aeruginosa— and Resistance Markers—CTX-M (blaCTX-M), KPC (blaKPC), NDM (blaNDM), VIM (blaVIM), IMP (blaIMP), and OXA (blaOXA).

BC-GN is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial bloodstream infections; however, is not used to monitor these infections. Sub-culturing of positive blood cultures is necessary to recover organisms for antimicrobial susceptibility testing (AST), for identification of organisms not detected by BC-GN, to detect mixed infections that may not be detected by BC-GN, for association of antimicrobial resistance marker genes to a specific organism, or for epidemiological typing.

  1. BC-GN will not distinguish Escherichia coli from Shigella spp. (S. dysenteriae, S. flexneri, S. boydii, and S. sonnei).