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

[REF] UBP-C00650H

[Specification] 50 tests/kit

[Intended Use]

The kit is used for qualitative fluorescence-based PCR detection of nucleic acid fragments specific to 14 human papillomavirus (HPV) types (HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68) in cervical exfoliated cells in women, as well as for HPV 16/18 typing to help diagnose and treat HPV infection.

Cervical cancer is one of the most common malignant tumors in the female reproductive tract. It has been shown that persistent HPV infection and multiple infections are one of major causes of cervical cancer. Currently there is still a lack of generally accepted effective treatments for cervical cancer caused by HPV. Therefore, early detection and prevention of cervical infection caused by HPV are the keys to prevention of cervical cancerization. Establishment of simple, specific and rapid diagnostic tests for pathogens is of great significance for clinical diagnosis of cervical cancer.

The test using the kit cannot be used alone or prior to the application of cervical cytology, i.e., it is not recommended to use the test alone for cervical cancer screening in people of any age. The test cannot replace cervical cytology and cannot be used alone as a basis for patient management. Since no corresponding clinical trials of the kit have been conducted, it shall not be used for clinical purposes related to cervical cancer screening.

[Test Principles]

The kit uses multiplex fluorescence-based qPCR. It contains highly specific primers and probes designed according to target sequences in the HPV L1 gene. The specific probes are labeled with four distinct fluorophores, FAM (HPV 18), VIC (16), ROX (HPV31,33,35,39,45,51,52,56,58,59,66 and 68) and CY5 (internal reference) at the 5′-end, and a quencher (BHQ1 or BHQ2) at the 3’-end. During PCR amplification, the specific primers and probes separately bind to their own target sequences. When the Taq DNA polymerase encounters the  probes binding to their target sequences, it exhibits the exonuclease activity at the 5′-end to isolate the fluorophores (reporter dyes) from the quencher, thereby allowing the fluorescence- monitoring system to receive fluorescence signals, i.e., when  a DNA strand is amplified, a fluorescent molecule will be formed to achieve complete synchronization of PCR product formation and fluorescence signal accumulation, thereby qualitatively detecting nucleic acid fragments specific to 14 HPV types (HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 ,68) in cervical exfoliated cells to help diagnose and treat 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.

[Acceptable Specimens]

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

[Applicable Equipment]

Applicable to Ultrassay Archimed X4/X6/, eQ9600, eQ164CP, eQmini 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]