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

[REF] UBP-C00432H

[Specification] 32 tests/kit

[Intended Use]

This kit is used for qualitative detection of nucleic acid of 28 types of human papillomavirus (HPV6, 11, 16, 18, 26, 31, 33, 35, 39, 40, 42, 43, 44, 45, 51, 52, 53, 54, 56, 58, 59, 61, 66, 68, 73, 81, 82, 83) in female cervical exfoliated cells, but is not used for completely genotyping. It provides auxiliary means for the diagnosis and treatment of HPV infection.

Cervical cancer is one of the most common malignant tumors of female reproductive tract. Previous studies have shown that persistent infection and multiple infection of human papillomavirus is one of the important causes of cervical cancer. At present, there is still a lack of recognized effective treatment means for HPV, so early detection and early prevention of cervical HPV are the keys to block cancer. To establish a simple, specific and rapid etiological diagnosis method is of great significance in the clinical diagnosis of cervical cancer.

This test cannot be used independently or prior to cervical cytology. It is not recommended to use this test alone for cervical cancer screening in people of any age. This method is not a substitute for cervical cytology and should not be used alone as a basis for patient management. It should not be used for clinical purposes related to cervical cancer screening because no corresponding clinical trials have been conducted.

[Test Principles]

The kit uses multiple real time PCR to detect the genotyping of 28 types HPV through 7 PCR reaction solution. Highly specific primers and probes are designed based on the L1 gene target sequence of HPV. The specific probe is labeled with FAM fluorophore (HPV6, 16, 26, 40, 53, 58, 73), VIC fluorophore (HPV11, 18, 33, 43, 51, 59, 81), CY5 fluorophore (HPV35, 44, 45, 54, 56, 68, 82) or ROX fluorophore (HPV31, 39, 42, 52, 61, 66, 83) at 5′, and the 3′ quencher group is BHQ1 or BHQ2. During the PCR amplification, specific primers and probes bind to their respective target sequences. When Taq enzyme encounters the probes bound to the target sequence, it exerts the function of 5′ end exonuclease to separate the reporter fluorophore from the quencher fluorophore, so that the fluorescence monitoring system can receive the fluorescent signal, that is, every time a DNA strand is amplified, a fluorescent molecule is formed, which realizes the complete synchronization of the accumulation of fluorescent signals and the formation of PCR products, so as to achieve genotyping detection of 28 types of human papillomavirus (HPV 6, 11, 16, 18, 26, 31, 33, 35, 39, 40, 42, 43, 44, 45, 51, 52, 53, 54, 56, 58, 59, 61, 66, 68, 73, 81, 82, 83) in cervical exfoliated cell samples, providing auxiliary means for the diagnosis and treatment of patients with HPV infection.


  • 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.


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


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.