Comprehensive HPV 28 Genotyping Solution for Advanced Cervical Cancer Screening

Human Papillomavirus (HPV) infection is one of the most common viral infections globally and a leading cause of cervical cancer. While high-risk HPV types are directly associated with cancer development, low-risk types are responsible for benign lesions such as genital warts. Therefore, comprehensive detection and genotyping of HPV are essential for accurate diagnosis, effective screening, and long-term patient management.

Der Cowingene HPV 28 Genotyping Detection Kit (flüssig) is an advanced in vitro diagnostic (IVD) solution designed for the qualitative detection and differentiation of 28 HPV genotypes using real-time PCR technology. By combining high-throughput multiplex detection with precise genotyping capability, this kit provides clinicians with detailed and actionable insights for infection assessment and risk stratification.

Intended Use: Broad-Spectrum HPV Detection for Clinical Risk Stratification

This detection kit is intended for the qualitative detection of HPV DNA in clinical specimens. It enables simultaneous identification of 28 HPV genotypes, including:

High-risk types: 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73, 82

Low-risk types: 6, 11, 40, 42, 43, 44, 54, 61, 81, 83

By covering both high-risk and low-risk HPV types, the kit provides a comprehensive view of infection status, enabling clinicians to distinguish between oncogenic risk and benign conditions. The results serve as important auxiliary evidence for cervical cancer screening, diagnosis, and follow-up monitoring.

Validated Sample Types: Flexible and Patient-Friendly Collection

The kit is validated for use with:

Urine samples

Cervical swabs

This dual-sample compatibility supports both non-invasive screening Und clinical diagnostic sampling, improving patient compliance and enabling wider population coverage. Urine-based testing is especially suitable for large-scale screening programs and self-collection scenarios.

Performance Characteristics: High Sensitivity and Diagnostic Reliability

Ultra-High Analytical Sensitivity

The kit achieves a limit of detection (LoD) of 100 copies/mL across all 28 HPV genotypes. This ensures reliable detection even at low viral loads, supporting early identification of infections.

Excellent Specificity and No Cross-Reactivity

Validation confirms that the kit shows no cross-reactivity with non-target pathogens, including:

Chlamydia trachomatis 

Neisseria gonorrhoeae 

Candida albicans 

Trichomonas vaginalis 

Gardnerella vaginalis 

Ureaplasma species and other HPV types not included in the panel

This guarantees highly accurate results and minimizes false positives.

Strong Anti-Interference Capability

The test performance remains stable in the presence of common interfering substances such as:

Hemoglobin

White blood cells

Cervical mucus

Vaginal care products and lubricants

Antibiotics (e.g., metronidazole)

This ensures consistent results under real clinical conditions.

No Competitive Interference in Multiplex Detection

All HPV genotypes within the assay are independently detected without interference, ensuring accurate multi-target analysis even in co-infection cases.

High Precision and Reproducibility

The kit demonstrates excellent repeatability, with CV ≤ 5% across:

Different days and batches

Different operators and laboratories

Advanced Technical Specifications for High-Throughput Testing

Detection Method: Multiplex real-time PCR (8-analysis system)

Detection Channels: FAM, VIC/HEX, ROX, CY5

Detection Coverage: 28 HPV genotypes

Compatible Instruments: 

ABI 7500

Roche LightCycler 480

Bio-Rad CFX96

Other open real-time PCR platforms

Storage Conditions: ≤ -20°C

Shelf Life: 18 months

Certification: CE-IVD

These specifications ensure seamless integration into existing laboratory workflows and support large-scale screening operations.

Liquid-Based Detection System: Optimized for Accuracy and Efficiency

The liquid-based format offers significant advantages:

Enhanced sample preservation, maintaining nucleic acid integrity

Reduced contamination risk, improving result reliability

Uniform sample processing, ensuring consistent detection

Compatibility with automated workflows, enabling high-throughput testing

This makes the kit highly suitable for hospitals, diagnostic laboratories, and public health screening programs.

Complete Workflow Integration with Supporting Reagents

The kit is compatible with a full range of supporting reagents, including:

DNA/RNA extraction kits

Sample release reagents

Self-collection kits (urine and vaginal)

This enables a standardized, scalable, and efficient diagnostic workflow, from sample collection to final analysis.

Key Advantages for Clinical and Screening Applications

Comprehensive 28-type HPV detection (high-risk + low-risk)

High-resolution genotyping for precise clinical assessment

Ultra-high sensitivity (LoD 100 copies/mL) for early detection

Multiple sample compatibility, including non-invasive urine testing

Strong specificity and anti-interference performance 

No cross-reactivity or competitive interference 

High-throughput capability for large-scale screening

CE-IVD certified, ensuring regulatory compliance

Conclusion: Advancing HPV Screening with Comprehensive Genotyping

The Cowingene HPV 28 Genotyping Detection Kit (Liquid) represents a significant advancement in molecular diagnostics by offering broad-spectrum HPV detection with detailed genotyping capability. Its ability to simultaneously detect both high-risk and low-risk HPV types provides clinicians with a more complete understanding of infection status.

By combining multiplex PCR technology, high analytical sensitivity, and flexible sampling options, this kit enhances early detection, improves clinical decision-making, and supports effective cervical cancer prevention strategies.

As the demand for comprehensive and scalable diagnostic solutions continues to grow, this HPV 28 genotyping kit stands out as a powerful tool for modern laboratories and global screening programs.