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.

 

 

Ordering Information

 

Luminex Online Order Management
Email: [email protected]
Phone: +31 (0)73 800 1900
Fax: +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

 


 

 

View More Assays Available on Our VERIGENE® Menu:

 

VERIGENE® Gram-Positive Blood Culture AssayVERIGENE® C. diff AssayVERIGENE® Enteric Pathogens TestVERIGENE® Respiratory Pathogens Flex Test

 

 


 

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.