.:: GENOMICA S.A.U. ::.

CLART® HPV 2

CE Mark

CLART^® HPV2 is the State-Of-The-Art system for genetic identification of HPV.

Based on our low density microarray for in vitro diagnostic, this system allows the user to detect infections and coinfections of up to 35 of the most relevant HPV genotypes.

CLART^®HPV 2 presents the following technical characteristics:

ANALYSIS INFORMATION

The technique allows you to detect infections and coinfections of up to 35 HPV genotypes. This genotypes have been classified as “High Risk”: 16, 18, 26, 31, 33, 35, 39, 43, 45, 51, 52, 53, 56, 58, 59, 66, 68, 70, 73, 85 and 89; and “Low Risk”:6, 11, 40, 42, 44, 54, 61, 62, 71, 72, 81, 83 and 84, of cervical cancer (see table 1).

Table 1: JAMA, Dunne et al 2007

HIGH SENSITIVITY AND SPECIFICITY

Due to the specific hybridisation with each specific probe on the array.

QUALITY RESULTS

CLART^® HPV 2 kits warranties the quality of their results by including several internal controls:

Genomic DNA control: Assures presence of DNA in the sample.
Internal amplification control: Verifies the correct amplification reaction in each sample.
Triplicates for each probe in each CLART-Strip: Each HPV genotype probe and control is present in triplicates in order to aboid transient alterations of the spots that could affect the final results.

VALIDATED SAMPLE TYPES

Liquid Cytology
Swabs
Paraffin/Formol included tissues

AUTOMATIC INTERPRETATION OF THE RESULTS

Results will be processed by our specifically designed software. This software will automatically detect and interpret your results, thus avoiding subjective interpretation of your results. Moreover, this exclusive software will generate a report for each of your samples.

CLART^® HPV 2 kit, accomplish with all the normatives described in EU 98/79/EC for IVD.

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