HPV introduction
Human Papillomavirus (HPV) is a common sexually transmitted DNA virus. It is recognized as the etiological agent of a spectrum of diseases in both males and females, including precancerous lesions that may progress to malignancy and the formation of genital warts.
Although the majority of HPV infections are asymptomatic and resolve spontaneously, persistent infection can lead to pathology. In women, chronic infection with specific high-risk genotypes—most notably types 16 and 18—can induce precancerous cervical lesions that, if untreated, may advance to invasive cervical carcinoma. HPV is also implicated in oropharyngeal and anogenital cancers as well as other disease entities in both sexes.
More than 100 HPV genotypes have been identified, each designated by a numerical identifier. Certain low-risk genotypes cause anogenital warts but lack oncogenic potential. However, nearly all cases of cervical cancer (approximately 99 percent) are attributable to genital HPV infection. Fourteen high-risk genotypes are classified as carcinogenic—types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68—with types 16 and 18 together accounting for roughly 70 percent of global cervical cancer cases.
TopSENSI ® HPV 6, 11, 16, 18 & High Risk qPCR Kit is employed for the qualitative detection of HPV-DNA encompassing 12 high-risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68) and the identification of HPV types 6, 11, 16, and 18 within specimens extracted from cervical smears/ cervical biopsies utilizing Real-time PCR technology.
The kit offers several advantages: high specificity, high sensitivity, and an internal control system that helps monitor sample collection, extraction, and amplification. The test results from this kit are intended for clinical reference only and should not be used as the sole basis for diagnosis or exclusion.
HIGHLIGHTS
- Simple process easy manipulation
- The time to perform PCR is fast, only about 1 hour and 30 minutes
- High specificity and sensitivity
- Taqman probe technology
- Many HPV genotypes were detected.
The TopSENSI® HPV 6, 11, 16, 18 & High Risk qPCR Kit
SPECIFICATIONS
| Targets | Detection of high-risk (HR) HPV types and differentiation of four specific HPV types: HPV 6, HPV 11, HPV 16, and HPV 18 |
| Input sample | Cervical smear or biopsy |
| Extraction sample volume | 200 µL |
| PCR sample volume | 10 µL |
| Fluorescent channels | For HR qPCR Mix: FAM: HR, HEX: internal control For 4TYPE qPCR Mix: FAM: HPV 18; HEX: HPV 11, TexasRed: HPV 16, Cy5: HPV 6 |
| Technology | TaqMan probe |
| Analytical sensitivity | + High-risk HPV (HR): 24 copies/reaction + HPV 6: 9 copies/reaction + HPV 11: 10 copies/reaction + HPV 16: 19 copies/reaction + HPV 18: 8 copies/reaction |
| PCR time | 1 hour 20 minutes |
| Analytical Specificity | Kit only detects HPV-DNA |
| Storage | 12 months at -20oC |
| Kit components | HR qPCR mix, 4TYPE qPCR mix, HR positive control, 4TYPE positive control, negative control, PCR tube |
Recommended extraction kit
| Silica column extraction | TopPURE® HPV DNA Extraction Kit |
| TopPURE® Fluid Viral Extraction Kit | |
| TopPURE® Genomic DNA Extraction Kit | |
| Automatic magbead extraction | TopPURE® Maga Genomic DNA/RNA Extraction Kit |
Read more: Instructional Video for Qualitative Real-time PCR Kit
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