HPV PLUS ELITe MGB®

Human Papilloma Virus (HPV) infection is the most common sexually transmitted infection worldwide, with most sexually active individuals acquiring HPV at some point during their lifetime. Most HPV infections are transient and cleared spontaneously by the immune system without causing disease. However, persistent infection with specific high-risk HPV (hrHPV) genotypes can lead to integration of the viral genome into cervical epithelial cells and sustained expression of the oncogenic proteins E6 and E7, promoting cellular transformation and progression to cervical precancer and cancer. Persistent hrHPV infection is the primary cause of cervical cancer, which is among the most common cancer in women worldwide. High-risk genotypes include HPV 16, 18, 31,45, 33, 35, 39, 51, 52, 56, 58, 59, 66, and 68 that are responsible for the majority of cervical cancer cases. HPV 16 and HPV 18 account for approximately 70% of cervical cancers, while several other high-risk genotypes also contribute to disease burden.

Molecular detection of high-risk HPV DNA plays a key role across multiple applications in cervical cancer prevention, including primary screening for early identification of women at increased risk of developing clinically significant cervical lesions, triage, complementary testing alongside cytology, and follow-up testing of women with abnormal or high-risk findings. HPV PLUS ELITe MGB® Kit is a qualitative multiplex Real-Time PCR assay for the detection and identification of the genomic DNA of Human Papilloma Virus 14 high-risk types extracted from clinical specimens. The assay specifically enables:

• Detection and genotypingof 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.

The assay enables differentiation of HPV genotypes covered by current vaccines from genotypes not covered by the vaccines, with vaccine-associated genotypes detected in separate channels.

HPV PLUS ELITe MGB® Kit is validated on ELITe InGenius® and ELITe BeGenius® instruments for cervical specimens preserved in liquid-based cytology fixatives.