PRODUCTS

PRODUCTS – CLART® STDs

CLART® STDs is an in vitro diagnostics product used for the detection and typing of bacteria, fungi and parasites causing Sexually Transitted Infections (STIs) of the urogenital tract. Simultaneous detection is performed by multiplex PCR and subsequent visualization in low-density arrays, based on CLART® Technology.

Analysis information

CLART® STDs detects genetic material extracted from urine or swabs samples. 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.

*Microorganism detected with CLART®  STDs

The use of molecular techniques in the detection of sexually transmitted infections reduces the main limitations and disadvantages of conventional detection methods:

  • Sensitivity variations observed with different diagnostic methodologies.
  • Low sensitivity to slow-growing microorganisms.
  • Antibody titer variations due to antiretroviral treatments.

Validated sample types

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

  • Urine.
  • Swabs:  cervical, vaginal, urethral and rectal.

High sensitivity and specificity

The presence of 120 hybridization probes within the array, make it possible to identify, each target at least in triplicate. This ensures specificity and sensitivity of the analysis.

Quality control

CLART® STDs guarantee the quality of the results by including three quality controls in every amplification tube, thus achieving considerable savings in reagents for parallel checks:

  • Amplification control in each amplification tube: prevent false negative results.
  • Endogenous genomic control: certifies the effectiveness of the extraction process.
  • 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 provided for the visualization step.

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 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).

Quality Assurance

CLART® STDs kit for detection of microorganisms that cause infections of the urogenital tract comply with the EU Directive 98/79/EC for IVD products. Only Chlamydia trachomatis diagnosis has been assented by the NB 0318.

Bibliography

1. “Gardnerella, Trichomonas vaginalis, Candida, Chlamydia trachomatis, Mycoplasma hominis and Ureaplasma urealyticum in the genital discharge of symptomatic fertile and asymptomatic infertile women”. New Microbiologica, 33, 69-76, 2010. 2. “Global strategy for the prevention and control of sexually transmitted infections: 2006 -2015 : breaking the chain of transmission”. WHO 3. “Sexually Transmitted Diseases in the United States, 2008 National Surveillance Data for Chlamydia, Gonorrhea, and Syphilis” CDC. 4. “Persistent increase in the incidence of acute male urethritis diagnosed in general practices in France”. British Journal of General Practice 2006; 56: 110–114. 5. “Mycoplasma genitalium presence, resistance and epidemiology in Greenland”. Int J Circumpolar Health 2012, 71:18203