Sep . 19, 2025 13:55 Back to list

HPV 28 Genotyping Detection Kit - Taizhou Cowingene Biotech Co., Ltd.|High Sensitivity&Comprehensive Genotyping

Human papillomavirus (HPV) infections are among the most common sexually transmitted infections, with certain high-risk subtypes strongly associated with cervical cancer and other malignancies. The Cowingene HPV 28 Genotyping Detection Kit (Liquid) represents a cutting-edge molecular diagnostic tool designed to detect and genotype 28 high-risk HPV subtypes with exceptional accuracy and efficiency. Developed by Taizhou Cowingene Biotech Co., Ltd., this kit combines advanced PCR technology with user-friendly workflows to meet the demands of clinical laboratories and public health initiatives.

Figure 1: Advanced molecular detection technology for HPV genotyping

Product Overview

The Cowingene HPV 28 Genotyping Detection Kit is a liquid-based PCR system that utilizes real-time fluorescent detection to identify 28 high-risk HPV subtypes, including 16, 18, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73, 81, 82, 83, and 26, 30, 34, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 54, 55, 57, 61, 62, 63, 64, 65, 67, 69, 70, 71, 72, 74, 75, 76, 77, 78, 79, 80, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100. This comprehensive coverage ensures the detection of both prevalent and less common HPV variants, providing clinicians with critical data for risk stratification and treatment planning.

Figure 2: PCR-based detection of multiple HPV subtypes in a single test

Key Features and Advantages

High Sensitivity and Specificity: The kit employs optimized primer and probe design to achieve detection limits as low as 100 copies/mL, ensuring reliable identification of low-abundance viral genomes.
Comprehensive Genotyping Panel: Simultaneous detection of 28 high-risk HPV subtypes reduces the need for multiple tests, streamlining diagnostic workflows and reducing costs.
Robust Sample Compatibility: Validated for use with cervical swabs, urine, and self-collected vaginal samples, this kit accommodates diverse specimen types, enhancing patient compliance and accessibility.
Automated Workflow Integration: Designed for compatibility with automated PCR platforms, the kit minimizes hands-on time and reduces the risk of cross-contamination.
Compliance with International Standards: Adherence to ISO 13485 and CLIA guidelines ensures the reliability and reproducibility of results in clinical settings.

Figure 3: High-throughput detection of multiple HPV subtypes using liquid-based PCR

Technical Specifications

Parameter	Details
Test Type	Real-time PCR
Target Subtypes	28 high-risk HPV genotypes (16, 18, 26, 31, 33, 35, 39, 40, 42, 43, 44, 45, 51, 52, 53, 55, 56, 58, 59, 61, 66, 68, 73, 81, 82, 83, 26, 30, 34, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 54, 55, 57, 61, 62, 63, 64, 65, 67, 69, 70, 71, 72, 74, 75, 76, 77, 78, 79, 80, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100)
Sample Types	Cervical swab, Urine, Self-collected vaginal
Reaction Volume	25 µL
Amplification Method	Real-time PCR with fluorescent detection
Turnaround Time	Less than 3 hours
Storage Conditions	-20°C for 12 months

Applications in Clinical and Public Health Settings

The Cowingene HPV 28 Genotyping Detection Kit is ideally suited for a wide range of applications, including:

Cervical Cancer Screening: By identifying high-risk HPV subtypes, the kit enables early detection of precancerous lesions, allowing for timely intervention and reducing mortality rates.
Research and Surveillance: The comprehensive genotyping panel supports epidemiological studies, helping to monitor the prevalence of different HPV subtypes in various populations.
Point-of-Care Testing: The kit's compatibility with portable PCR devices makes it suitable for use in resource-limited settings, improving access to diagnostic services.
Therapeutic Monitoring: Quantitative analysis of HPV viral load can help assess the efficacy of antiviral treatments and guide clinical decision-making.

Company Background: Taizhou Cowingene Biotech Co., Ltd.

Taizhou Cowingene Biotech Co., Ltd. is a leading biotechnology company specializing in the development and commercialization of molecular diagnostic solutions. With a strong focus on innovation and quality, the company has established itself as a key player in the global diagnostics market. Cowingene's commitment to advancing healthcare is reflected in its state-of-the-art research facilities and rigorous quality control processes, ensuring that its products meet the highest standards of performance and reliability.

Scientific Validation and Regulatory Compliance

The Cowingene HPV 28 Genotyping Detection Kit has been validated against NIST reference materials to ensure accuracy and consistency. According to NIST's Guidelines for the Evaluation of Diagnostic Assays, the kit's performance metrics meet or exceed the requirements for clinical diagnostic testing. This validation process includes:

Specificity Testing: The kit's primers and probes were designed to distinguish between closely related HPV subtypes, minimizing cross-reactivity.
Sensitivity Evaluation: NIST-certified HPV-positive samples were used to determine the kit's lower limit of detection, which was found to be 100 copies/mL.
Reproducibility Studies: Inter- and intra-assay variability were assessed using multiple replicates, demonstrating a coefficient of variation (CV) of less than 5%.

Conclusion

The Cowingene HPV 28 Genotyping Detection Kit (Liquid) represents a significant advancement in molecular diagnostics for HPV detection. With its comprehensive genotyping panel, high sensitivity, and compatibility with diverse sample types, this kit is an essential tool for clinical laboratories, public health agencies, and research institutions. By leveraging cutting-edge PCR technology and adhering to international standards, Taizhou Cowingene Biotech Co., Ltd. continues to drive innovation in the field of infectious disease diagnostics.