REALQUALITY RQ-HPV Screen
Description
REALQUALITY RQ-HPV Screen is a CE-IVD diagnostic device for Real time PCR identification of 14 HPV genotypes with high oncogenic risk: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68 and genotyping of HPV 16 and HPV 18.
Peculiarity
REALQUALITY RQ-HPV Screen can be used:
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as a primary screening test to identify patients with an increased risk of developing cervical cancer or the presence of high-grade lesions, on DNA extracted from liquid-based cytology samples.
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as an auxiliary test for the diagnosis and monitoring of HPV infections, on DNA extracted from human clinical samples.
The device has been validated, as a primary screening test, on DNA extracted from liquid-based cytology samples (PreservCyt Solution - Hologic; Iacobellis et al., 2018). As an auxiliary test for the diagnosis and monitoring of HPV infections, the kit was validated on DNA extracted from cervical, vaginal, urethral, buccal, and anal swabs, from urethral, vaginal and foreskin biopsy tissue, and Formalin-Fixed Paraffin-Embedded (FFPE) histology samples.
Iacobellis M, Violante C, Notarachille G, Simone A, Scarfì R, Giuffrè G. Virology Journal, 15(1):48, 2018.
Kit content
The kit includes:
- ready-to-use reagents for Real-Time PCR
- amplification control (amplification of the beta-globin-BG gene)
- positive control (DNA containing fragments of HPV 16, HPV 18, HPV 33 genomes and the BG gene)
- dUTP/UNG system for preventing carry-over contamination
The HPV Screen kit has been validated for screening according to Meijer's guidelines (Meijer et al., 2009).
The device is validated for application on DNA extracted by the most commonly used manual and automatic extraction methods including: GENEQUALITY X120 - GENEQUALITY X120 Pathogen Kit (AB ANALITICA).
Meijer CJ, Berkhof J, Castle PE, Hesselink AT, Franco EL, Ronco G, Arbyn M, Bosch FX, Cuzick J, Dillner J, Heideman DA, Snijders PJ. Int J of Cancer, 24(3), 516-20, 2009.
