CLART® SeptiBac is a product for in Vitro diagnostics used for the detection and typing of Gram positive, Gram negative bacteria and fungi causing septicemia. Detection is performed simultaneously by multiplex PCR and its subsequent visualization with CLART ® Technology, based on low-density arrays.
CLART® SeptiBac detects, from positive blood cultures, Gram positive, Gram negative and fungi that cause septicemia. This will get a reduction in overall time of diagnosis, more than 24 hours in many cases, allowing the physician to make adjustments in medication and / or therapies administered to each patient.
Moreover, CLART® SeptiBac is able to detect Methicillin resistance marker "mecA" in bacteria of the Staphylococcus genus.
The use of molecular techniques in the detection of Sepsis reduces the principal 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.
High sensitivity and specificity
The hybridization is performed specifically for each probe on the array and in triplicates for each genotype, therefore the sensitivity and specificity of the assay are very high.
CLART ® SeptiBac guarantees the quality of the results with the inclusion of quality controls in the amplification tubes, thus achieving considerable savings in reagents for parallel checks:
|1. Amplification control in each amplification tube: avoid false negative results.|
|2. Endogenous genomic control: certifies the effectiveness of the extraction process and the presence of sample in the test.|
|3. Biotin markers: they have a dual aim; firstly, act as reference system for the automatic alignment of the array grid and, secondly, serve as control of the reagents performance.|
Automatic reading and interpretation of results
The analysis is performed in a fully automatic way by the SAICLART®, the GENOMICA image processing software for microarrays. This software can detect and interpret automatically all the targets present in the image, thus avoiding any subjectivity that could introduce the user intervention. That way, user 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, Gram negative and fungi causing septicemia complies with EU directive 98/79/EC for IVD.