ProDx High-Risk HPV (14 Types) DNA qPCR Detection Kit
Manufactured by Shanghai Promega Biological Products, Ltd.

The ProDx High-Risk HPV (14 types) DNA qPCR Detection Kit is a two-dye multiplex fluorescent probe based on the TaqMan® real-time PCR assay system. The assay can specifically detect 14 high-risk types of HPV (Human papillomavirus) viral DNA and an endogenous internal control (IC) that is a highly conserved region in the human β-globin gene (HBB) in one reaction. The internal control is designed to control the effectiveness of sample collection, DNA extraction and PCR amplification process. The system also includes dUTP and Uracil N-Glycosylase (UNG) to minimize PCR carryover contamination. The amplified HPV and IC DNA fragments are detected in FAM and ROX channels, respectively, with the Applied Biosystems® 7500 Real-Time PCR System.

Performance Specifications
Sample Types: Urethral and cervical swabs.
Analytical Sensitivity: Detects >50 copies/µl of reference DNA.
Analytical Specificity: Negative against CT, NG, UU, HSV, HCMV and 12 other  microorganisms commonly found in the urethral and cervical area.
Precision: The intra- and inter-batch assay variation coefficients <5%.

• Efficient Design: Single-tube reaction detecting 14 high-risk types of HPV and one internal control (IC).
• High Level of DNA Recovery: One-step DNA extraction method with Chelex®-100 removes inhibitors and maintains DNA.
• Sensitive Detection: Use the robust Promega GoTaq® Hot Start DNA Polymerase for room temperature setup.
• Simple Operation: One-tube PCR master mix design greatly reduces setup time.
• Reliable Results: Designed with human β-globin gene (HBB) endogenous internal control (IC) to control the effectiveness in sample collection, DNA extraction and PCR amplification process. The system also includes dUTP and Uracil N-Glycosylase (UNG) to minimize PCR product contamination.

For in vitro diagnostic use. This product is only available in China.

This product is intended for professional use only. Diagnostic results obtained using the product must be interpreted in conjunction with other clinical or laboratory data. Other specimen types have not been validated and may result in false positive or false negative results.

References

1. Cuschieri, K.S. et al. (2005) Persistent high risk HPV infection associated with development of cervical neoplasia in a prospective population study. J. Clin Pathol. 58, 946–50.
2. Walboomers, J.M. et al. (1999) Human papillomavius is a necessary cause of invasive cervical cancer worldwide. J. Pathol. 189, 12–9.
3. Lindh, M. et al. (2007) Real-time TaqMan PCR targeting 14 human papilloma virus types. J. Clinical Virology 40, 321–4.
4. Rodrigues, M. et al. (2009) GP5+/6+ SYBR Green methodology for simultaneous screening and quantification of human papillomavirus. J. Clinical Virology 45, 90–5.
5. Munoz, N. et al. (2003) Epidemiologic classification of human papillomavirus types associated with cervical cancer. New England Journal of Medicine 348, 518–27.