PRODUCTS

PRODUCTS – CLART® EnteroBac

CLART® EnteroBac detects the presence in stool samples of the main types of Bacteria that produce endotoxins and cause diarrhea. Detection technique is based on our CLART® Technology, and includes genetic amplification and visualization in low density microarrays.

Targets detected with the kit:

Advantages of the kit:

CLART® EnteroBac offers the following advantages compared with other classic identification techniques (stool culture):

  • Direct detection of a wide spectrum of bacteria causing diarrhea.
  • Detection of both single and multiple infections in single assay.
  • No need for a stool culture or sample pre-enrichment.
  • Early detection of outbreak causing bacteria such as Salmonella.
  • Total time to get final results: 5 hours.
  • Automatic reading and interpretation of results.
  • Very high sensitivity and specificity values of the analysis due to probe-specific hybridization in the array.
  • User friendly handling of results, with ability to export and keep files of digital data and images.
  • Individualized reports for each patient sample.
  • CLART® EnteroBac system is compatible with automated nucleic acids extractors.

Validated Type of Samples:

CLART® EnteroBac kit has been designed and validated for using stool samples.

Automatic Reading and Interpretation of Results.

Analysis of results is performed in a fully 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).

Reliability of Results:

It is achieved throug incorporation of the following controls:

  • External extraction control to verify that the nucleic acids extraction has been carried out properly.
  • Amplification control to check the amplification efficiency, further allowing distinguish between situations of PCR inhibition and absence of DNA.
  • Biotin markers. They have a dual aim; firstly, they serve as control of the reagents performance.
  • Sensitivity and specificity: The diagnostics sensitivity value depends on the particular bacteria detected, but in no case it is lower than 80%. Specificity value is of 99%. Each target is detected in quadruplicate in order to avoid any possible nonspecific hybridization.
  • The reproducibility and repeatability data are of 91.8% and 97.2% respectively.

Quality Assurance:

CLART® EnteroBac kit fulfills all the requirements of EU guideline 98/79/EC specific for medical devices and in vitro diagnostic products.