PRODUCTS

CLART® HPV LINE

Is an in vitro diagnostics product line for the detection and genotyping of different types of human Papillomavirus (HPV) by means of multiplex PCR followed by visualization in low-density arrays, based on CLART® Technology.

CLART® HPV Line includes the following products:

CLART® HPV4
  • Detection of High Risk genotypes (16 18 31 33 35 39 45 51 52 56 58 59 66 68A-68B) plus Low Risk (6 11)
  • No extraction of DNA is required (pre-treatment might be needed depending on the type of sample)
  • Validated for the following types of sample:
    • Liquid cytology.
    • Swabs
    • STM.
  • Compatible with any GENOMICA’s automation system
CLART® HPV3
  • Detection 49 genotypes including High Risk (16 18 31 33 35 39 45 51 52 56 58 59 66 68) Low Risk (6 11 40 42 43 44 54 61 62 70 71 72 81 83 84 85 89) and genotypes of undetermined risk (for research only): 34, 64, 67, 69 74, 86, 87, 97, 101, 102, 103, 106, 150, 151.
  • Suitable for multiple extraction systems.
  • Validated for the following types of sample:
    • Liquid cytology
    • Swabs
    • FFPE tissues
Línea CLART® HPVs
  • Detección de los Genotipos de Alto Riesgo (16 18 31 33 35 39 45 51 52 56 58 59 66 68A-68B) más los dos de Bajo Riesgo más comunes (6 11).
  • No requiere extracción de ADN (Dependiendo del tipo de muestra podría ser necesario un pretratamiento).
  • Validado para los siguientes tipos de muestras:
    • Torunda seca.
    • Citología liquida.
    • STM
  • Compatible con cualquier sistema de automatización de GENOMICA
CLART® HPV2
  • Detection of 35 genotypes: High risk (16 18 31 33 35 39 45 51 52 56 58 59 66 68B) Prob. High Risk (26 53 73 82) and Low Risk (6 11 40 42 43 44 54 61 62 70 71 72 81 83 84 85 89).
  • Suitable for multiple extraction systems.
  • Validated for the following types of sample:
    • Liquid cytology
    • Swabs
    • FFPE tissues
  • Compatible with any GENOMICA’s automation system

Analysis information

CLART® HPV Line allows to detect HPV genotypes of both, High and Low Risk, in a single trial. Classification of HPV types into high or Low Risk is determined by the innate ability of viruses considered high risk to cause cervical cancer and their involvement in other cancer types (pharyngeal, anal …).

CLART® HPV Line also enables to detect co-infections in a sample, thereby facilitating follow up of patients with a long-term infection.

Genotyping of HPV infection provides a tool both to monitor infection in a single patient, and also to carry out epidemiological studies in those populations where vaccination has already been implemented in girls.

High sensitivity and specificity

Very high sensitivity and specificity values are achieved with any CLART® HPV Line kit, due to type-specific probe hybridization and presence of probes in triplicate for each genotype within the array.

Quality control

CLART® HPV Line ensures the quality of the results by including several controls in each test:

  • Amplification control in each amplification tube: avoids false negative results.
  • Endogenous genomic control: certifies the effectiveness of the extraction process and the presence of sample in the test.
  • Biotin markers: they have a dual aim; firstly, they act as reference system for the automatic alignment of the array grid and, secondly, they serve as a control of the reagents performance.

Automatic interpretation of the results

Analysis of results is performed in a fully automatic wasy 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).

CLART® HPV Line kits fulfills all the requirements of EU guideline 98/79/EC specific for medical devices and in vitro diagnostic products and has the Declaration of Conformity according to Annex III of the mentioned guideline.

NEDxA

NEDxA is the new GENOMICA’s instrument for HPV genotyping. This revolutionary device is capable of detecting 14 high risk types in less than 75 minutes and with a minimum manual work.

Bibliography

1. “Prevalence of HPV Infection among females in the United States”. JAMA. 2007; 297(8):812-81.

2. “High frequency of multiple HPV types in cervical specimens from Danish women”. APMIS 2009, 117: 108-114.

3. “External quality assessment for molecular detection of human papillomaviruses”. Journal of Clinical Virology 48 (2010) 251-254.

4. “Human Papillomavirus 2 Assay Compared With the Hybrid Capture 2 Test”. Journal of Medical Virology 2011 83:272-276 (2011).

5. “Identification of Multiple HPV Types on Spermatozoa from Human Sperm Donors”. PLOS ONE. March 2011, Volume 6, Issue 3, e18095.