human papilloma virus hpv pcr - Taizhou Cowingene Biotech|HPV Detection, Genotyping, PCR Technology

Introduction

The Cowingene HPV 28 Genotyping Detection Kit (Liquid) represents a significant advancement in molecular diagnostics for Human Papillomavirus (HPV) detection. Developed by Taizhou Cowingene Biotech Co., Ltd., this kit combines cutting-edge PCR technology with a comprehensive genotyping approach to identify 28 high-risk HPV subtypes. As a critical tool in cervical cancer screening, the kit provides clinicians with a reliable solution for early detection and risk stratification.

Product Overview

Manufactured by Taizhou Cowingene Biotech Co., Ltd., the Cowingene HPV 28 Genotyping Detection Kit is designed for use in clinical laboratories and research facilities. This liquid-based detection system offers a streamlined workflow, reducing processing time while maintaining high analytical sensitivity and specificity.

Key Features and Advantages

• Comprehensive Genotyping: Detects 28 high-risk HPV subtypes including 6, 11, 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, and 83.
• Robust Sample Compatibility: Validated for use with cervical swabs, urine, and self-collected vaginal specimens.
• High Sensitivity and Specificity: Utilizes optimized PCR protocols to ensure accurate detection even at low viral loads.
• Automated Workflow: Streamlines the testing process with minimal manual intervention.
• Compliance with Industry Standards: Meets regulatory requirements for molecular diagnostic testing.

Technical Specifications

Parameter	Details
Test Type	28-Genotype HPV Detection
Sample Types	Cervical swab, Urine, Self-collected vaginal
Target Subtypes	6, 11, 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
PCR Technology	Real-time PCR with fluorescence detection
Sample Volume	1 mL (for urine and self-collected vaginal samples)
Test Time	Approximately 2.5 hours (excluding sample preparation)
Storage Conditions	2-8°C for reagents; -20°C for long-term storage

Applications in Clinical Practice

The Cowingene HPV 28 Genotyping Detection Kit is widely used in various clinical settings:

• Cervical Cancer Screening: Identifies high-risk HPV infections that may lead to cervical cancer, enabling early intervention.
• Follow-up Monitoring: Tracks HPV clearance after treatment, providing valuable insights into patient outcomes.
• Research Studies: Supports epidemiological research on HPV prevalence and genotyping patterns.
• Sexually Transmitted Infection (STI) Management: Detects HPV in non-cervical samples, expanding diagnostic capabilities.

Company Background: Taizhou Cowingene Biotech Co., Ltd.

Founded in 2015, Taizhou Cowingene Biotech Co., Ltd. is a leading biotechnology company specializing in molecular diagnostics. With a focus on innovation and quality, the company has developed a range of diagnostic solutions for infectious diseases, cancer biomarkers, and genetic disorders. Their commitment to scientific excellence is reflected in the rigorous validation processes applied to all products, including the HPV 28 Genotyping Detection Kit.

Scientific Validation and Regulatory Compliance

The Cowingene HPV 28 Genotyping Detection Kit has undergone extensive validation to ensure clinical reliability. According to NIST (National Institute of Standards and Technology) guidelines for molecular diagnostic testing, the kit meets critical performance parameters such as:

• Limit of Detection (LOD): 100 copies/mL for most HPV subtypes
• Specificity: 99.8% as demonstrated in clinical trials
• Reproducibility: Coefficient of variation (CV)

These standards align with the NIST framework for ensuring accuracy in molecular assays, reinforcing the kit's credibility in clinical settings.

Conclusion

The Cowingene HPV 28 Genotyping Detection Kit (Liquid) stands out as a reliable and efficient solution for HPV detection. With its comprehensive genotyping capabilities, user-friendly workflow, and adherence to international standards, this kit is an essential tool for modern diagnostic laboratories. As research continues to evolve, Taizhou Cowingene Biotech Co., Ltd. remains committed to advancing diagnostic technologies that improve patient care and public health outcomes.

References

National Institute of Standards and Technology (NIST) - Guidelines for Molecular Diagnostic Testing

Taizhou Cowingene Biotech Co., Ltd. - Product Specifications and Validation Data