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CLART® STIs A&B

CLART® STIs A&B

CLART® STIs A&B are products for in Vitro diagnostics used for the detection and typing of those bacteria, fungi and parasites causing urogenital tract infections. Detection is performed simultaneously by performing multiplex PCR and its subsequent visualization with CLART ® Technology, based on low-density microarrays.

 

Analysis information

CLART® STIs 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 by CLART® STIs A. Remaining microorganisms are detected by CLART® STIs B.

 

Using molecular techniques in the detection of STIs reduces the main limitations and disadvantages of conventional detection:

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

 

Validated sample types

Both kits CLART® STIs A and CLART® STIs B have been developed and validated for the detection of different causative agents of STIs in the following samples:

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

 

High sensitivity and specificity

The 120 array hybridization probes, make it capable for identifying ,at least triplicate, each target. This will ensure the specificity and sensitivity of analysis.

 

Quality control

CLART ® STIs A&B guarantee the quality of the results with the inclusion of three quality controls in every amplification tube, thus achieving considerable savings in reagents for parallel checks:

1.

Amplification control in each amplification tube: prevent false negative results.

2.
Endogenous genomic control: certifies the effectiveness of the extraction process.
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 provided for the visualization step.

 

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 array, 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).

 

Quality Assurance

CLART® STIs A&B for detection of microorganisms that cause infections of the urogenital tract fulfills the European Directive 98/79/EC for IVD products. Only Chlamydia trachomatis diagnosis has been assented by the NB 0318.

Category
Department
Medical specialty
Required sample
Urine
Swab
Turn around time
3 days
Technology
CLART