ViroKey® MP HPV 16, 18 PCR Test
Real-Time PCR Detection of High-Risk HPV Types 16 and 18
The ViroKey MP HPV 16, 18 PCR Test is a real-time polymerase chain reaction (PCR)-based in vitro diagnostic test to be used for qualitative detection of 18 genotypes of human papillomavirus (HPV) DNA, including the differentiation of high-risk HPV genotypes 16 and 18 from types 26, 31, 33, 35, 39, 45, 51 52, 53, 56, 58, 59, 66 , 68, 73 and 82 in cervical shedding cell samples, aiding in the diagnosis of HPV infection.
Comprehensive and Reliable Detection:
- Detect a total of 18 genotypes while differentiating HPV 16 and 18, all in one run
- Identify as many as 16 other high-/medium-risk genotypes
- High concordance with leading PCR kits in the market
Optimising Laboratory Efficiency
- Manual workflow allows for low throughput testing; no batching required
- Quick and easy protocol
Compatible with Various RT-PCR Instruments
- Applied Biosystems 7500 Real-Time PCR System
- Bio-Rad CFX96 Real-Time PCR Detection System
Maximizing Cost Effectiveness
- Detecting multiple types of HPV in one run allows for saving of consumable and reagent costs
| Regulatory Status | CE-IVD | ||||||||||
| Workflow | Manual | ||||||||||
| Detection & Differentiation of HPV Genotypes | Total GTs Detected | 18 Genotypes | |||||||||
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High-Risk GTs Detected |
16 and 18 |
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| Other GTs Detected (Pooled) |
26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73 and 82 |
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| Sample Types |
Cervical swabs |
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| Sensitivity | HPV 16: 100% (95%CI: 94.87, 100), HPV 18: 100% (95%CI: 93.12, 100) | ||||||||||
| Specificity | HPV 16: 99.28% (95%CI: 98.16, 99.72), HPV 18: 99.65% (95%CI: 98.74, 99.9) | ||||||||||
| Limit of Detection |
500 copies/mL (HPV16, 18) |
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| Turnaround Time | 1-3 hours depending on sample throughput and proficiency | ||||||||||
| Hands-on Time | 0.5 hours depending on sample throughput and proficiency | ||||||||||
| Validated Instruments | Applied Biosystems 7500 Real-Time PCR System Bio-Rad CFX96 Real-Time PCR Detection System |
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| Fluorescence Detectors (Dyes) | FAM/Green | HPV-16 | |||||||||
| HEX/VIC/Yellow | HPV-18 | ||||||||||
| ROX | Other GTs | ||||||||||
| Cy5/Red | Internal Control | ||||||||||
| ViroKey MP HPV 16, 18 PCR Test Flyer | RUO | EN |
| Product | Pack Size | Item Number |
|---|---|---|
| ViroKey MP HPV 16, 18 PCR Test (24) | 24 tests | 301119 |
| ViroKey MP HPV 16, 18 PCR Test (2x24) | 2x24 tests | 301147 |
| ViroKey MP HPV 16, 18 PCR Test (4x24) | 4x24 tests | 301148 |
For availability in your country, please contact your Vela Diagnostics sales representative. Availability is subject to country's regulatory approval.
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