High-risk Human Papillomavirus (HPV) Detection Kit (Real-time PCR)

[REF] UBP-C00948G

[Specification] 48 tests/kit (Lyophilized)

[Intended Use]

This kit is intended for the in-vitro qualitative detection of nucleic acids of 18 high-risk HPV types (16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73, 82) in cervical exfoliated cells, and genotyping for 16 and 18 HPV types. An additional primer pair and probe target the human β-globin gene to provide a process control.

[Summary]

Human Papilloma virus (HPV), belonging to the Papillomaviridae family, is a small, circular, non-enveloped, double-stranded DNA virus, with a genome length of about 8,000 base pairs (bp). HPV infection is very common in women. About 80% of women have been infected with HPV in their lifetime, and 90% of them can be naturally cleared within one to two years. Based on their oncogenic potential, HPVs are classified as low-risk, associated with benign warts or epithelial lesions, or high-risk, that can cause oropharyngeal and anogenital malignancies, including cancers of the cervix, vulva, vagina, penis, and anus.

High-risk HPV (hrHPV) types are responsible for ~5% of all human cancers and are detected in 99.7% of cervical cancer cases, the fourth most common cancer in women, accounting for 7.5% of all cancer-associated deaths in women worldwide per year.

[Test Principles]

It was used for qualitative detection of 18 high-risk human papillomavirus nucleic acid DNA (HPV16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73, 82) in vitro in cervical exhumation cells, and typing of HPV16 and 18 types.

The PCR amplification reaction system of this kit also contains the Uracil-N-Glycosylase and can selectively break the uracil glycosiside bond in the PCR fragment containing dUTP, effectively reducing false positives due to contamination of the PCR product.

[Advantage]

  • Professional: Nucleic Acid Test is the “gold standard” for Virus Detection
  • Specificity: No cross-reaction with other fusion genes.
  • Sensitivity: Limit of detection to 50 copies/reaction.
  • Reliable: Internal reference and blank control, positive control of the whole process quality control.
  • Lyophilized kit which can be stored at room temperature.

[Acceptable Specimens]

The samples for testing are women’s cervical shedding cells, collected by using cervical shedding cell collectors.

[Applicable Equipment]

Applicable to Ultrassay eQ9600 Real time qPCR system, ABI 7500 Real-Time PCR thermocycles, Bio-Rad CFX 96 and other PCR thermocycles which can detect FAM, VIC/HEX, ROX and CY5 fluorescence.

[Instruction for use]