GenómicaPRODUCTS - CLART® SeptiBac

CLART® SeptiBac is an in vitro diagnostics product used for the detection and typing of Gram positive and Gram negative bacteria and fungi causing septicemia. Simultaneous detection is performed by multiplex PCR and subsequent visualization in low-density arrays, based on CLART® Technology.


Analysis Information

CLART® SeptiBac detects, in positive blood cultures, Gram positive and Gram negative bacteria and fungi that cause septicemia. A global time reduction of the diagnosis is achieved, of more than 24 hours in many cases, thus allowing the physician to make adjustments in medication and / or therapies administered to each patient.

 

Moreover, CLART® SeptiBac enables to detect Methicillin resistance marker "mecA" in bacteria of the Staphylococcus genus.


SeptiBac


The use of molecular techniques in the detection of Sepsis reduces main limitations and disadvantages of conventional blood cultures:


  • Sensitivity variations associated to sample volume.
  • Total time to get the results.
  • Low sensitivity to slow-growing microorganisms.

Validated sample types

CLART® SeptiBac kit has been developed and validated for the detection of different causative agents of septicemia in the following samples:

 

  • Positive Blood Culture.

 

High sensitivity and specificity

Very high sensitivity and specificity values are achieved with CLART® SeptiBac, due to probe-specific hybridization and presence of each probe in triplicate within the array.

 

Quality control

CLART® SeptiBac guarantees the quality of the results by including several controls in each test:

 

  • Amplification control in each amplification tube: avoids false negative results.
  • Endogenous genomic control: certifies the effectiveness of the extraction process and the presence of sample in the test.
  • Biotin markers: they have a dual aim; firstly, they act as reference system for the automatic alignment of the array grid and, secondly, they serve as control of the reagents performance.

 

Automatic reading and interpretation of results

Analysis of results is performed in afully automatic way by SAICLART®, the GENOMICA image processing software for microarrays. This software can automatically detect and interpret all the targets present in the image, thus avoiding any subjectivity that might be introduced  by the user. The user thus obtains the results in a fast, simple and reproducible way, presented in clear and concise reports that can be printed or exported to the laboratory information management system (LIMS).

CLART® SeptiBac Kit, for the detection of Gram positive and Gram negative bacteria and fungi causing septicemia complies with EU directive 98/79/EC for IVD.

 

Bibliography

1. “Hemocultivos”. 2nd Ed. (3a). Eds. Cercenado E. and R. Canton. Procedimientos en Microbiología Clínica. Sociedad Española de Microbiología Clínica, SEIMC (2003).

2. “Diseño y optimización de un sistema de detección molecular por microarrays para la rápida identificación de bacterias gram positivas y hongos en hemocultivos positivos”. Enfermedades Infecciosas y Microbiología Clínica. Vol 29, 33-34 (2011). 15th Congreso de la Sociedad. Española de Microbiología Clínica (SEIMC). Junio