A multiplex real-time PCR-based in vitro diagnostic assay for the simultaneous qualitative detection and differentiation of Human Papillomavirus (HPV) genotypes 16 and 18 from cervical and vaginal specimens. Utilizes highly specific E6/E7 gene-targeted primers and probes with an endogenous internal control (HEX channel) to ensure reliable, clinically actionable results.
Human Papillomavirus (HPV) is the most common sexually transmitted infection worldwide. While most HPV infections resolve spontaneously, persistent infection with high-risk genotypes — particularly HPV 16 and HPV 18 — is a leading cause of cervical cancer, accounting for approximately 70% of all cervical cancer cases globally.
Accurate identification of HPV 16 and HPV 18 is essential for cervical cancer screening, risk stratification, and guiding clinical management decisions. The Genplex™ HPV 16 & 18 RT-PCR Kit detects HPV DNA using highly specific E6/E7 gene-targeted primers and fluorescent probes — targeting the oncogenic regions most critical for carcinogenesis.
Three fluorescence channels are used: FAM channel detects HPV 16, Cy5 channel detects HPV 18, and the HEX channel monitors an endogenous internal control for validation of DNA extraction quality and assay inhibition.
Advanced molecular diagnostic capabilities engineered for clinical excellence and research-grade precision.
Sensitivity ≥99% with highly specific E6/E7 gene-targeted primers — reliable screening of HPV 16 & 18 even at low copy numbers.
HEX-labeled endogenous IC validates DNA extraction quality and monitors each reaction for inhibition, preventing false negatives.
Detects and differentiates HPV 16 and HPV 18 simultaneously in a single multiplex reaction.
Optimized cycling parameters deliver rapid, reproducible results with minimal hands-on time.
Validated on Bio-Rad CFX96, Qiagen Rotor-Gene Q, and equivalent FAM/HEX/Cy5 detection channel platforms.
Primers and probes specifically target the E6 and E7 oncogenic regions — the most clinically significant HPV genomic regions.
Designed for diverse diagnostic and research use cases across the clinical spectrum.
Qualitative detection of high-risk HPV 16 & 18 in cervical specimens for primary cervical cancer screening programs.
Triage women with abnormal cervical cytology to guide colposcopy referral decisions.
Monitor for HPV persistence following cervical lesion treatment to assess recurrence risk.
Population-level surveillance of HPV genotype prevalence and distribution.
| Parameter | Value / Description |
|---|---|
| Target Pathogens | HPV Genotype 16 & HPV Genotype 18 |
| Assay Type | Qualitative Multiplex RT-PCR |
| Gene Targets | E6/E7 oncogenic regions |
| Detection Channels | FAM (HPV 16), Cy5 (HPV 18), HEX (Internal Control) |
| Sample Type | Cervical swab, vaginal swab |
| Sensitivity | ≥ 99% |
| Internal Control | Endogenous HEX internal control |
| Compatible Instruments | Bio-Rad CFX96, Qiagen Rotor-Gene Q, and equivalent FAM/HEX/Cy5 platforms |
| Intended Use | In Vitro Diagnostic (IVD) |
| Storage | -20°C |
For in vitro diagnostic use. Contact your regional distributor or ProbGen representative to place an order.
| Product Name | Cat. No. | Pack Size |
|---|---|---|
| GENPLEX™ Human Papilloma Virus Detection 16 & 18 RT-PCR KIT (Multiplex) | GP1033-48 | 48 tests |
| GENPLEX™ Human Papilloma Virus Detection 16 & 18 RT-PCR KIT (Multiplex) | GP1031-96 | 96 tests |
| GENPLEX™ Human Papilloma Virus (HPV) Detection 16 & 18 KIT (Singleplex) | GP1033-48 | 48 tests |
| GENPLEX™ Human Papilloma Virus (HPV) Detection 16 & 18 KIT (Singleplex) | GP1031-96 | 96 tests |
Contact our scientific team for technical specifications, bulk pricing, or to request a demonstration of our diagnostics solutions.
Contact Us All Products