PCG® HPV Genotyping Kit
Principle: Multiplex Real-time PCR using TaqMan Probes
Intended Use:Detect and genotype 16 types of Human Papillomavirus (HPV), including 2 low-risk types (6, 11) and 14 high-risk types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68)
Overview
Enables detecting various types: Detect and genotype 16 HPV types, including 2 low-risk types and 14 high-risk types
Compatible with a wide range of Real-time PCR devices
Simple workflow: The activated PCR Master Mix mixture can be used for up to 2 months
PCG® HPV Genotyping Kit enables detect and genotype 16 types of Human Papillomavirus (HPV), including 2 low-risk types (6, 11) and 14 high-risk types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68). The kit is recommended
to be used for the following cases:
- Women aged 30-65, should do HPV test every 5 years
- Abnormal PAP test results
- PAP test shows abnormal cells or PAP test results are unclear
- Women with a history of uterine diseases
Specification
| Regulatory Status | RUO |
| Intended User | For professional use in laboratories with trained |
| Technology | Multiplex real-time PCR using TaqMan Probe |
| Type of Analysis | Qualitative and Genotype |
| Target | The L1, E6 và E7 gene of HPV 16 types |
| Sensitivity (LoD with 95% probability) |
Based on WHO International Standards:
HPV16 (NIBSC code: 06/ 202): 39.85 copies/ rxn
HPV18 (NIBSC code: 06/ 206): 37.57 copies/ rxn
|
| Clinical sensitivity |
97.1%
|
| Clinical specificity | 96.9% |
| Repeatability | CV ≤ 5% (Within-run precision) |
| Reproducibility |
CV ≤ 5% (Between-run precision)
|
| Extraction/ Inhibition Control |
Proper sampling, DNA extraction efficiency and PCR inhibition control by Internal Control (beta-Actin gen)
|
| Validated Specimen | Cervial smear and urethral smear samples |
| Instruments |
QuantStudio™ 3 Real-time PCR System
QuantStudio™ 5 Real-time PCR System
QuantStudio™ 7 Real-time PCR System
CFX96™/ Dx Real-time PCR Detection System
|
| Required Detection Channels |
FAM, VIC/ HEX, ROX, CY5: Detect HPV types
ROX (PCG® HPV Mix 1): Detect IC (Internal Control)
|
| Storage | -20ºC (±5ºC), 12 months |
Workflow
Order information
| Product name | Package | REF |
|
PCG® HPV Genotyping Kit
|
50 tests/ kit | PR2000050 |
| 100 tests/ kit | PR2000100 |
