What is in the HPV Detection Kit?

The TRUPCR® HPV High Risk Genotyping Kit is an in vitro real-time PCR assay developed for the qualitative detection and genotyping of high-risk HPV DNA. It targets the E6 and E7 oncogenes, key indicators of oncogenic activity and disease progression.

The assay detects 14 high-risk HPV types:
HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68
These genotypes are well-established as causative agents in cervical cancer and other HPV-associated malignancies.

Kit configuration:

• Dual-tube format separating genotype detection

• TaqMan-based hydrolysis probes

• Internal control targeting human DNA (for extraction and amplification validation)

• Master mix and reaction buffers optimized for real-time PCR

The test is validated for cervical swab and other clinical sample types, with proven accuracy across a wide range of viral loads.

Role of HPV Genotypes in Disease

HPV (Human Papillomavirus) is one of the most prevalent sexually transmitted infections worldwide. While many HPV-positive cases resolve spontaneously, persistent infection with high-risk types is strongly associated with cervical cancer, as well as cancers of the anus, vulva, vagina, penis, and oropharynx.

E6 and E7 oncogenes, expressed in high-risk HPV types, are responsible for disrupting cell cycle regulation by degrading tumor suppressor proteins like p53 and Rb. This leads to uncontrolled cell proliferation and, over time, malignant transformation.

Among all HPV-related cancers, cervical cancer remains the most studied and best understood. Approximately 99.7% of cervical cancer cases are associated with high-risk HPV genotypes—particularly HPV16 and HPV18. Molecular detection of these genotypes significantly enhances the sensitivity and predictive value of cervical screening programs, especially when compared to traditional cytology (Pap smears).

About the TRUPCR® HPV High Risk Genotyping Kit

This genotyping assay is designed for laboratories requiring precise, reliable detection of high-risk HPV infections. Its focus on the E6/E7 region offers two major benefits:

1. Specificity to oncogenic activity (differentiates transient vs. progressive infections)

2. Sensitivity even with low viral copy numbers, due to E6/E7 persistence after viral integration

Core product attributes:

• Real-time amplification of the E6/E7 region

• No cross-reactivity with low-risk HPV genotypes or other pathogens

• CE-IVD compliant for clinical diagnostic use

• Validated against gold-standard molecular assays

• Easy to interpret with software-compatible output from most PCR systems

This makes it ideal for use in primary screening, follow-up testing, and vaccine efficacy studies.

Principle and Workflow

The TRUPCR® HPV High Risk Genotyping Kit operates on the principle of TaqMan hydrolysis probe-based real-time PCR. Here’s a simplified breakdown:

1. Sample Collection & Extraction: DNA is isolated from cervical or genital swabs.

2. PCR Setup: Reaction mix includes target primers/probes for E6/E7 and internal control.

3. Real-time Amplification:

   • FAM/HEX channels indicate HPV-positive genotypes

   • TEXAS RED or ROX validates sample via internal control

4. Analysis: Ct values and fluorescence curves confirm presence/absence of HPV DNA

The dual-tube approach supports high-throughput workflows and simplifies genotyping interpretation. The entire process—from extraction to result—can be completed in approximately 2 hours.

Clinical Application

The TRUPCR® HPV kit supports a wide range of applications in clinical and research settings:

• Cervical cancer screening for early detection of high-risk HPV

• Triage of cytology-equivocal cases (e.g., ASC-US, LSIL)

• Post-treatment follow-up to monitor HPV clearance

• Vaccine impact monitoring in immunization programs

• Research studies on HPV genotype distribution and persistence

With a growing emphasis on HPV-targeted prevention and personalized gynecologic care, this assay is an indispensable tool for both public health and individual patient management.