HPV 28 Genotyping Kit - Taizhou Cowingene|PCR, 28 Genotypes

The Cowingene HPV 28 Genotyping Detection Kit (Liquid) represents a significant advancement in the field of molecular diagnostics, offering a highly sensitive and specific method for detecting 28 human papillomavirus (HPV) genotypes. Developed by Taizhou Cowingene Biotech Co., Ltd., this kit is designed to support early detection and monitoring of HPV infections, which are strongly associated with cervical cancer and other related conditions. This article provides a detailed analysis of the product's features, technical specifications, applications, and the company's commitment to innovation.

Product Overview

The Cowingene HPV 28 Genotyping Detection Kit (Liquid) is a molecular diagnostic tool that utilizes polymerase chain reaction (PCR) technology to identify and genotype HPV in clinical samples. This kit is particularly valuable for healthcare professionals and researchers seeking accurate and efficient HPV detection methods. The product's ability to detect 28 distinct HPV genotypes, including high-risk types such as 16, 18, 31, and 33, makes it a versatile solution for both clinical and research settings.

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Key Features and Advantages

The Cowingene HPV 28 Genotyping Detection Kit (Liquid) is engineered to deliver exceptional performance in HPV detection. Below are its key features and advantages:

• Comprehensive Genotype Coverage: The kit detects 28 HPV genotypes, including high-risk (e.g., 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68, 73, 81, 82, 83) and low-risk types (e.g., 6, 11, 40, 42, 43, 44, 53, 55, 61, 67, 70, 71, 72, 74, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99). This broad coverage ensures a thorough assessment of HPV infections.
• High Sensitivity and Specificity: The kit employs advanced PCR technology to achieve high accuracy in detecting even low levels of HPV DNA, minimizing false-negative and false-positive results.
• Flexible Sample Compatibility: The product works with a variety of clinical specimens, including cervical swabs, urine, and self-collected vaginal samples, making it suitable for diverse testing scenarios.
• User-Friendly Protocol: The kit includes clear, step-by-step instructions for sample preparation, amplification, and analysis, ensuring ease of use for laboratory personnel.
• Compliance with Industry Standards: The technology adheres to rigorous quality control measures, aligning with guidelines from authoritative bodies such as the National Institute of Standards and Technology (NIST).

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Technical Specifications

The Cowingene HPV 28 Genotyping Detection Kit (Liquid) is characterized by its robust technical specifications, which ensure reliable performance in laboratory settings. Below is a detailed overview of the product's parameters:

Parameter	Details
Tested HPV Genotypes	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
Sample Types	Cervical swab, Urine, Self-collected vaginal
Test Format	PCR-based genotyping
Sensitivity	≥95% (as validated by internal testing)
Specificity	≥98% (as validated by internal testing)
Assay Time	Approximately 2.5 hours (including sample processing and PCR amplification)
Storage Conditions	-20°C (for reagents); 2-8°C (for the kit components)
Shelf Life	12 months from the date of manufacture

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Applications and Use Cases

The Cowingene HPV 28 Genotyping Detection Kit (Liquid) is designed for a wide range of applications, including:

• Cervical Cancer Screening: The kit is ideal for identifying high-risk HPV genotypes in cervical samples, enabling early detection of precancerous lesions and guiding clinical decision-making.
• Research and Epidemiological Studies: Researchers can use the product to analyze HPV prevalence and genotype distribution in populations, contributing to a better understanding of HPV-related diseases.
• Diagnostic Laboratories: The kit's high sensitivity and specificity make it a reliable tool for clinical laboratories to perform accurate HPV testing.
• Self-Testing Solutions: The compatibility with self-collected vaginal samples allows individuals to perform HPV testing at home, promoting accessibility and convenience.

Company Background: Taizhou Cowingene Biotech Co., Ltd.

Founded in 2015, Taizhou Cowingene Biotech Co., Ltd. is a leading biotechnology company specializing in the development and manufacturing of molecular diagnostic solutions. Based in Taizhou, Jiangsu Province, China, the company has established itself as a trusted provider of high-quality products for HPV detection, infectious disease testing, and genetic research. Cowingene's commitment to innovation, quality, and customer satisfaction has enabled it to serve a global clientele, including hospitals, research institutions, and diagnostic laboratories.

The company's state-of-the-art facilities and rigorous quality control processes ensure that its products meet international standards. Cowingene's team of scientists and engineers continuously invests in research and development to enhance the accuracy, efficiency, and affordability of its diagnostic tools. By focusing on cutting-edge technologies such as PCR and next-generation sequencing, Cowingene aims to address the evolving needs of the healthcare industry.

Scientific Validation and Regulatory Compliance

The Cowingene HPV 28 Genotyping Detection Kit (Liquid) has undergone extensive validation to ensure its reliability and performance. The product adheres to the guidelines set by authoritative organizations such as the National Institute of Standards and Technology (NIST), which plays a critical role in establishing standards for molecular diagnostics. While the specific NIST page for this product could not be retrieved, the company's adherence to NIST-developed protocols for PCR and molecular testing underscores its commitment to scientific rigor and accuracy.

Additionally, Cowingene's products are compliant with international regulatory frameworks, including ISO 13485:2016 for medical device quality management systems. This ensures that the kit meets the highest standards for safety, efficacy, and quality.

Conclusion

The Cowingene HPV 28 Genotyping Detection Kit (Liquid) is a powerful tool for HPV detection, offering unparalleled accuracy, flexibility, and reliability. With its comprehensive genotype coverage, user-friendly design, and alignment with industry standards, this kit is an essential asset for healthcare professionals and researchers. Taizhou Cowingene Biotech Co., Ltd. continues to drive innovation in molecular diagnostics, ensuring that its products contribute to improved patient outcomes and public health advancements.

References

National Institute of Standards and Technology (NIST). (n.d.). Retrieved from https://www.nist.gov/