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

Gram-Negative

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

 

Targets U.S./FDA-Cleared Outside 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
Automation Sample to Result
Instrumentation VERIGENE Reader and Processor SP
Workflow On-Demand and Scalable
Sample Type Positive Blood Culture Bottle
Pipetting Steps One
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
VERIGENE Gram-Negative Blood Culture Nucleic Acid Test (BC-GN)
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
Luminex Case Study: Med Fusion & VERIGENE
Posters
Clinical Impact After Laboratory Implementation of the Verigene Gram-Negative Bacteria Microarray for Positive Blood Cultures
Use of the VERIGENE Gram Negative Blood Culture (BC-GN) Test for More Rapid Bacterial Identification and Antimicrobial Optimization
Articles and Abstracts
Evaluation of the VERIGENE BC-GN Assay for the Direct Identification of Gram-Negative Bacteria from Blood Culture
Impact of Antimicrobial Stewardship and Rapid Microarray Testing on Patients with Gram-Negative Bacteremia
Identification of Gram-Negative Bacteria and Genetic Resistance Determinants from Positive Blood Culture Broths by Use of the VERIGENE Gram-Negative Blood Culture Multiplex Microarray-Based Molecular Assay
Clinical Impact of Laboratory Implementation of Verigene BC-GN Microarray-Based Assay for Detection of Gram-Negative Bacteria in Positive Blood Cultures

Ordering Information

 

Luminex Online Order Management
Email: [email protected]
Phone: 1-512-336-3550
Toll Free: 1-866-401-5450
Fax: 1-512-219-0544
Fax (Europe, Middle East, India, Asia): +31 (0)73 800 1998
Product Name Kit Size Registration
Status
Part Number
VERIGENE® Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) Kit 20 BC-GN Test Cartridges
20 Extraction Trays
US-IVD
CE Marked
20-005-021
VERIGENE® Gram-Negative Nucleic Acid
(BC-GN) Utility Kit

20 BC-GN Utility Trays US-IVD
CE Marked
20-012-021

 

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 potentially pathogenic gram-negative bacteria which may cause bloodstream infection (BSI). BC-GN is performed directly on blood culture media using BACTEC™ Plus Aerobic/F, BACTEC™ Standard/10 Aerobic/F or BacT/ALERT SA Standard Aerobic blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram-negative bacteria.

BC-GN independently detects and identifies the following Bacterial Genera and Species—Acinetobacter spp., Citrobacter spp., Enterobacter spp., Proteus spp., Escherichia coli1, Klebsiella pneumoniae, Klebsiella oxytoca, Pseudomonas aeruginosa, and Serratia marcescens— and Resistance Markers—CTX-M, KPC, NDM, VIM, IMP, and OXA.

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 to be used to monitor these infections. Sub-culturing of positive blood cultures is necessary to recover organisms for susceptibility testing, identification of organisms not detected by BC-GN, differentiation of mixed growth, 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. including S. dysenteriae, S. flexneri, S. boydii, and S. sonnei.