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Analytical Performance of Sensitivity and Specificity for Rapid Multiplex High Risk Human Papillomavirus Detection Kit: HPV ViroCheck

Human papillomaviruses (HPVs) are major causes of cervical cancer. Sixteen high risk HPVs, HPV 16, HPV 18, HPV31, HPV 33, HPV 35, HPV 39, HPV 45, HPV 51, HPV 52, HPV 53, HPV 56, HPV 58, HPV 59, HPV 66, HPV 68, and HPV 69 are found in cervical cancer. HPVs 16 and 18 are mainly presented in 70% of cervical cancer. Therefore, identifying the presence of these high-risk HPVs is crucial. The objective of this study is to establish the HPV ViroCheck for detecting 16 HR-HPVs and genotypes of HPVs 16 and 18, as well as to analyze the analytical performance of HPV ViroCheck. We performed the analytical sensitivity of HPV E6 / E7 genes of 16 high risk HPVs to confirm the limit of detection. Then, a cross reactivity of HPV ViroCheck with microorganisms and viruses related to the cervix were analyzed for analytical specificity. Analytical sensitivity of high risk HPV genotypes ranged from 1 to 100 copies when using cloned DNAs. The limit of detection was 10 cells for both SiHa and HeLa cells. Cervical-related microorganisms and viruses did not show cross-reactivity to HPV DNA. Moreover, the intra- and inter-assay coefficient variations (CVs) were below 5%. In conclusion, HPV Virocheck will be useful for the detection of 16 HR HPVs, as well as HPV 16 and HPV 18 genotypes rapidly.

HPV DNA tests, as developed for early cancer screening using molecular biology techniques, were recommended by the clinical guidelines implemented from American society for colposcopy and cervical pathology. The combination of an HPV DNA test and a Pap test in cervical cancer screening have been focused since 2009 [4,5]. Now, HPV and Pap co-testing were required for routine screening in initial assessment and the management guidelines for over 20s years old women [6].
In the Korean Society of Gynecologic Oncology, importance of HPV tests was stand out. It was recommended that specific HPV types in HR HPV-positive/cytology-negative women, and a positive test for HPV 16 or 18 should lead to colposcopy [7]. Especially, women for HPV 16 and/or 18 with ASC-US or LSIL cytology can be diagnosed directly to colposcopy and shown positive results [7,8].
As HPV infection on diagnosis of cervical cancer is increasingly important, the oncogenic process in cervical cancer is studied and the upregulation of HPV E6/E7 oncoproteins is a marker for an increased risk of cervical cancer [9.10]. HPV E6 oncoproteins promote degradation of p53 and disrupts the function of the apoptosis [11,12].
HPV E7 oncoproteins inactivates pRb and dysregulates cell cycle [13,14]. Therefore, detection of E6/E7 oncogene expression could be more specific and a better predictor of cervical cancer risk than the detection of HPV DNA.
In our previous study, HPV E6/E7 oncogenic detection showed better specificity than HPV commercialized DNA kit [15] for each well.
The multiplex RT-qPCR assay detected HPV E6/E7 genes, simultaneously in three tubes by incorporating alpha 9, alpha 7, and alpha 5,6-specific TaqMan probes      1). Therefore, the analytical detection limit of the assay was determined to provide enough fluorescence intensity to serve as the minimum detection sensitivity. Moreover, the analytical specificity was tested also using HPV negative cervical cancer cell line C33A along with 46 other types of microbial DNA including viruses and bacteria mixed with. There was no cross-reaction, demonstrating that the presence of other cervical related microbial DNA mixed with HPV DNA did not affect the performance of the assay (Table 3).
Currently, there are several commercially available HPV tests. Hybrid Capture2, which is approved by the FDA, is protein [25]. The other HPV vaccine was VGX-3100.
VGX-3100 is a combination of two plasmids encoding optimized HPV16 and 18 E6 and E7 antigens [26]. VGX-3100 was administered through intramuscular injection followed by electroporation to 18 female patients who had been previously treated for CIN2/3 lesions [27]. Each patient received three rounds of vaccination, which was well tolerated with no observed dose-limiting toxicities. As therapeutic vaccines using HPV E6/E7 were developed, the complementary diagnosis for follow-up of vaccine efficacy will be needed.