HPV introduction
Human Papilloma Virus (HPV). Although the majority of HPV infections do not cause symptoms and are self-limiting, persistent infections can lead to disease. In women, persistent infections with specific types of HPV (most commonly type 16 and type 18) can result in pre-cancerous lesions, which, if left untreated, may progress to cervical cancer. HPV infection is also associated with cancers of the oropharynx and anal canal, as well as other conditions in both men and women.
While the majority of HPV infections remain asymptomatic and self-resolve, persistent infections can lead to disease. In females, persistent infections with specific HPV types, most notably types 16 and 18, may result in precancerous lesions, which, if left untreated, can progress to cervical cancer. HPV infection is also associated with oropharyngeal cancer and anogenital cancers in both males and females, as well as various other pathological conditions.
There are more than 100 types of HPV, each identified by a numerical designation. Some types can cause genital or anal warts but do not lead to cancer. However, almost all cases of cervical cancer (99%) are linked to HPV infection in the genital region. There are 14 high-risk types of HPV that can cause cancer, including types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. Among them, types 16 and 18 together account for approximately 70% of all cervical cancer cases worldwide.
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.
ADVANTAGES
- 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 variants were detected.
TopSENSI® HPV 6, 11, 16, 18 & High Risk qPCR Kit
SPECIFICATIONS
| Target | 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; Texas-Red: 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 |
| Components of | HR qPCR mix, 4TYPE qPCR mix, HR positive control, 4TYPE positive control, negative control, PCR tube |
Recommended extraction kit
| Silica column extraction | HI-162
HI-712 HI-112 |
TopPURE® HPV DNA Extraction Kit |
| Automatic extraction | HI-612 | TopPURE® Maga Genomic DNA/RNA Extraction Kit |
