Cervical cancer test kit HPV PLUS ELITe MGB®

HPVHPV 16HPV 18

The HPV PLUS ELITe MGB® Kit is a CE-IVD validated in vitro diagnostic assay designed for the detection and identification of genomic DNA from 14 high-risk HPV types. It is validated according to the new European In Vitro Diagnostic Regulation 746/2017 (IVDR) and operates in association with the fully automated ELITe InGenius® and ELITe BeGenius® systems. The assay specifically enables: - Detection and genotyping of high-risk HPV types 16, 18, 31, and 45. - Detection of the HR1 group: high-risk types 33, 52, and 58. - Detection of the HR2 group: high-risk, non-vaccinal types 35, 39, 51, 56, 59, 66, and 68. This comprehensive diagnostic tool provides a reliable aid in the diagnosis and management of HPV-related diseases through precise molecular detection. Conserved targets: - E6/E7 oncogenes Validation: - IVDR Validated Matrix: - Cervical specimens preserved in cytology fixatives such as ThinPrep® and SurePath® Integrated workflow: - Fully automated process including extraction, amplification and result analysis with ELITe InGenius® & ELITe BeGenius® Genotyping Capacity: - Extended - Vaccine genotypes: 16_31; 18_45; 33/52/58 - Non vaccine genotypes: 35/39/51/56/59/66/68 Technical Specifications / Features: - CE-IVD validated for in vitro diagnostic use - Detects and identifies 14 high-risk HPV types - Validated under European IVDR 746/2017 - Compatible with ELITe InGenius® and ELITe BeGenius® systems - Targets E6/E7 oncogenes - Validated for cervical specimens in ThinPrep® and SurePath® - Fully automated workflow: extraction, amplification, analysis - Extended genotyping: vaccine and non-vaccine HPV types