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Allplex™ HPV HR Detection
Advanced HPV test solution
for cervical cancer screening
Unique HPV Assay Suitable
for Cervical Cancer Screening & Prevention
0 1
Fully automated workflow
• Enhances efficiency and minimizes human errors through a full automation workflow
0 2
Fast HPV assay
• Suitable for screening programs with short 1.5 hrs PCR time
(50% faster than the previous products)
0 3
Individual 14 high-risk HPV types
• Simultaneously detects and provides of individual 14 types in a single reaction
0 4
Self-collected samples
• Improves patient convenience by expanding applicable sample types including self-collected vaginal specimen
Prospective in HPV Testing for Cervical Cancer Screening
Seegene’s Allplex™
HPV HR Detection
Target
14 High-risk HPVs
Interpretation
Each 14 HPV types
Reaction
One reaction
- HPV16
- HPV51
- HPV18
- HPV52
- HPV31
- HPV56
- HPV33
- HPV58
- HPV35
- HPV59
- HPV39
- HPV66
- HPV45
- HPV68
A Product
Target
14 High-risk HPVs
Interpretation
2 HPV types
Reaction
One reaction
- HPV16
- HPV18
- Other High-risk HPV
B Product
Target
14 High-risk HPVs
Interpretation
6 HPV types
Reaction
Three reaction
- HPV16
- HPV18
- HPV45
- HPV33/58
- HPV31
- HPV56/59/66
- HPV51
- HPV52
- HPV35/39/68
Clinical Performance
Sensitivity 97%, Specificity 95%
Allplex™ HPV HR Detection shows equivalent clinical performance to CE-approved assay.
| CE-Approved Assay | ||||
|---|---|---|---|---|
| Positive | Negative | Total | ||
| Allplex™ HPV HR Detection | Positive | 114 | 38 | 152 |
| Negative | 3 | 705 | 708 | |
| Total | 117 | 743 | 860 | |
| Overall agreement | PPA | NPA |
|---|---|---|
| 95.23% (819/860) | 97.44% (114/117) | 94.89% (705/743) |
Clinical Research Trends
Dynamics of HPV types distribution
For cervical cancer screening, detection of each 14 high-risk HPV types is required.
The prevalence HPV type differs by country or region around the world 1)
The distribution of HPV types varies by country and region.
The HPV vaccination had a substantial impact on HPV types distribution 2)
A number of epidemiological studies have shown that the prevalence of other than HPV16 and 18 is decreased due to vaccination.
1) L Bruni et al., Human Papillomavirus and Related Diseases Report, World.
2) Latsuzbaia A et al., Effectiveness of bivalent and quadrivalent human papillomavirus vaccination in Luxembourg. Cancer Epidemiol. 2019 Dec;63:101593.
An innovative HPV DNA test, Allplex™ HPV HR Detection
Allplex™ HPV HR Detection specifically and simultaneously detects each 14 types, provides Ct values by introducing Seegene’s proprietary ‘3 Ct PCR’ technology.
Seegene’s latest leading-edge technology can detect 15 targets in a single tube.
This proprietary technology is applied to Allplex™ HPV HR Detection assay and provides the broadest information.
The results of these informative tests will help clinicians make evidence-based decisions for patient management.