Human Papillomavirus (HPV) Genotyping Detection Kit (Real-time PCR)

Cat. No.: UP-HPV24T-24

[INTENDED USE]

Ultrassay HPV genotyping detection kit is intended to qualitatively detect the deoxyribonucleic acid (DNA) of 24 types of human papillomavirus (HPV) in women’s cervical shedding cell samples, and identify the HPVs as Group 1 (6, 11, 42, 43, 44 or 81), Group 2 (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 or 68) or Group 3 (26, 53, 66, 73 or 82).
Human papillomaviruses (HPV) are small, non-enveloped, spherical, diameter of 52-55 nm DNA viruses. The viral particles consist of a single double-stranded circular DNA molecule of about 8000 base-pairs (bp) and with a shape of regular icosahedron and stereo symmetry. Papillomaviruses are highly epitheliotropic, with a highly host-specific affinity and humans are the only host of HPV.
The types of 6, 11, 42, 43, 44 and 81 can cause the skin mucosa wart-like lesions. According to the research results of the WHO International Agency for Research on Cancer (IARC), HPV16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68 genotypes are classified as high-risk types, HPV 26, 53, 66, 73 and 82 genotypes are classified as middle-risk types.
Experimental personnel who perform this test should have received professional training in gene amplification or molecular biology diagnostics and be qualified for relevant experimental operations. There should be having reasonable biosecurity precautions and protective procedures in the laboratories. The test should only be performed in laboratories that follow safety practices according to the applicable Biosafety Regulations in Microbiological and Biomedical Laboratories.
The test results of this kit are for clinical reference only and shall not be used as the sole basis for diagnosis or exclusion.
[TEST PRINCIPLE]
The primers and fluorescent probes of this kit are specifically designed in the L1 loci of HPV genome, and the fluorescent probes are labeled with 6-FAM, HEX/VIC and ROX, respectively. By using Polymerase Chain Reaction (PCR) with TaqMan fluorescent probes, qualitatively detect the types of 6, 11, 16, 18, 26, 31, 33, 35, 39, 42, 43, 44, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73, 81 and 82 HPV DNA from the samples of women’s cervical shedding cells, and identify HPV as Group 1 (6, 11, 42, 43, 44 or 81), Group 2 (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 or 68) or Group 3 (26, 53, 66, 73 or 82). Primers and probe of the internal control (IC) of this kit are designed from human HAPB gene sequence, and the probe is labeled with CY5.

[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 100 copies/reaction.
  • Reliable: Internal reference and blank control, positive control of the whole process quality control.

[ACCEPTABLE SPECIMENS]

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

[APPLICABLE EQUIPMENT]

Applicable to Ultrassay XP96/Mini 16 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.

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