AmpFire HPV High Risk Genotyping

The AmpFire HPV High Risk Genotyping is an isothermal nucleic acid amplification assay for the qualitative genotyping of high risk types of human papillomavirus (HPV). High risk HPV specific primers and fluorescent probes are used to amplify regions of viral genomic DNA including E6/E7 regions under isothermal conditions.

The assay genotypes HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, and 68. Cervical specimens that may be tested with the Atila AmpFire HPV High Risk Genotyping assay include dry cervical swab, PreservCyt Solution (using an aliquot that is removed prior to or after processing for the PreservCyt Pap test), BD SurePath Preservative Fluid (using an aliquot that is removed prior to or after processing for the BD SurePath Pap test and formalin-fixed paraffin-embedded (FFPE) tissue specimens.

Human papillomavirus (HPV) is the most common sexually transmitted virus in the world. In most cases, HPV infections are transient, and the body will clear the virus on its own. In some instances, however, the virus is persistent and will cause normal cells to become abnormal, leading to cancer.

These oncogenic types of HPV are classified as high risk and include HPV 16 and 18. Other types are considered low risk, as they do not appear to cause cancer. According to the World Health Organization (WHO), HPV is the second biggest cause of female cancer mortality worldwide, claiming about 250000 lives annually.

In Europe alone, the disease claims about 15000 lives each year. It is estimated that nearly 70% of cervical cancers are caused by HPV types 16 and 18.