Introduction
Cervical cancer is a life-threating disease in the women’s cervix, which is the fourth killer among cancers for females.
The human papillomavirus (HPV) is a group of DNA virus that only infect with human mucosal cells or epithelial cells and can cause to cancer. There are more than 100 types of HPV. Each type has specific preferred infected area. These HPV can be classified into two groups according to the potential risks to develop cancer, high-risk HPV (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58 and 59, 66 and 68) and low-risk HPV (6, 11, 81).
The infection of high-risk HPV has a strong association with incidence of cervical cancer. High-risk HPV DNA can be found in 99% cervical cases, that 70% of which were caused by high-risk genotype HPV-16 and HPV-18. High-risk HPV DNA screening can more sensitively identify cervical intraepithelial neoplasia (CIN) than other methods. It enables women to access diagnosis at the early stage of HPV infection and to get treatment before development of precancerous lesions and cervical cancer.
Cervical cancer is a preventable cancer. To decrease morbidity and mortality of cervical cancer, encouraging women to take regular HPV screening is important. By the guideline published by WHO in 2021, WHO recommends using HPV DNA detection as the primary screening test for both of” screen-and-treat approach” and “screen, triage and treat approach”.
Bioperfectus Human Papillomavirus Real Time PCR Kit is a qualitative PCR assay intended to detect 18 high-risk genotypes of the human papillomavirus (HPV), including HPV-16, HPV-18 and other 16 common oncogenic types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68, 73, 53, 82 and 26). It has high specificity and sensitivity, can be used for primary cervical cancer screening. Specific genotypes identified can assist doctors to further decide triage and treatment and reduce morbidity and prevalence of cervical cancer.
Features
- 18 high-risk HPV genotypes: Detects HPV 16, HPV 18 and 16 additional oncogenic types.
- Separate HPV 16/18 reporting: Provides type-specific reporting for HPV 16 and HPV 18 to support follow-up decisions.
- Multiple cervical specimen types: Supports HPV DNA detection using cervical exfoliated cells, ThinPrep® and BD SurePath cytology specimens, and cervical swabs.
- Efficient screening workflow: Completes 96 tests in 100 minutes
- Cost-saving: compatible with most mainstream real-time PCR instruments, no specific system required
Parameters
| LOD |
LOD for HPVl6 and HPV18: 500 copies/mL
LOD for the other HPV types (HPV31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68, 73, 53, 82, and 26): 3000 copies/mL
|
| PPA |
95.19% |
| NPA |
96.59% |
| Sample Input Volume |
5 μL |
| Sample Type |
Cervical exfoliated cells
Cytologic samples (ThinPrep®, BD SurePathTM)
Cervical swab
|
| Testing Time |
100 mins |
| Storage Temperature |
-20±5℃ |
| Shelf-life |
12 months |
| Catalog NO. |
Product |
Package |
ThinPrep®, BD SurePathTM sample extraction solution* |
| JC80402-NW-50T |
Human Papillomavirus Real Time PCR Kit |
50 T/Kit |
Compatible with Bioperfectus
DNA extraction kit (SDK80120) and automatic extractors (SSNP series, SMPE-960) |
| JC80402-NWO-50T |
Human Papillomavirus Real Time PCR Kit |
50 T/Kit |
Compatible with other nucleic acid extraction products |
*No specific rules as for non-cytologic samples (cervical swabs).
Applications
- This high-risk HPV DNA test kit is intended for professional cervical screening workflows. Applications include:
- Primary cervical cancer screening: Qualitative detection of 18 high-risk HPV genotypes in eligible cervical specimens.
- HPV 16 and 18 risk stratification support: Separate reporting of HPV 16 and HPV 18 to support follow-up within local screening algorithms.
- Cytology-based laboratory workflows: Testing of cervical exfoliated cells and specimens collected in ThinPrep® or BD SurePath media.
- Cervical swab testing: Professional HPV PCR testing of cervical swabs using the applicable extraction workflow.
Certificates
CE, NMPA
