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HPV Detection & Genotyping

Human Papillomavirus (HPV) testing

It is well known that the presence of HPV shows strong correlation with the incidence of cervical cancer and its pre-cancerous states. HPV can be detected in almost 100% of cervical carcinoma patients. HPV genotypes are classified as low-risk or high-risk in regard to their ability to cause cervical carcinoma.
The cumulative lifetime incidence of HPV infection is 70-80 percent in many countries. A certain ratio of women who become infected with HPV develop a persistent infection that can lead to precancerous changes in the cervix.

The traditional screening method (PAP smear) has a shortcoming in that women with negative PAP smear test results can continue to develop cervical carcinoma.
The interest is growing worldwide in the use of HPV DNA test to supplement cervical cancer prevention PAP smear programs. Combining these two methods can help eradicate cervical cancer.
Furthermore, HPV DNA testing is the optimal way to determine the treatment after borderline PAP smear test results such as ASCUS (atypical PAP or atypical squamous cells of undetermined significance).
Several large population-based trials have demonstrated that tests detecting human papillomavirus (HPV) DNA of oncogenic types (hrHPV) are more effective in reducing cervical cancer than the cytology.  [1, 2]. The latest cervical cancer screening guidelines recommend hrHPV DNA testing as a primary screening test [3, 4].

The meta-analysis by Arbyn et al. demonstrated that validated PCR-based tests detecting hrHPV DNA are as accurate on self-samples as on clinician-collected samples [5]. According to the latest cervical cancer screening guideline offering self-sampling kits for HPV testing is an opportunity to reach women who do not attend the regular screening program, thereby increasing the effectiveness of the overall program [3] [6].

References
1. Ronco, G., et al., Efficacy of HPV-based screening for prevention of invasive cervical cancer: follow-up of four European randomised controlled trials. Lancet, 2014. 383(9916): p. 524-32.
2. Dillner, J., et al., Long term predictive values of cytology and human papillomavirus testing in cervical cancer screening: joint European cohort study. BMJ, 2008. 337: p. a1754.
3. Karsa, L., M. Arbyn, and H. Vuyst, European guidelines for quality assurance in cervical cancer screening. Summary of the supplements on HPV screening and vaccination. Papillomavirus research, 2015. 1: p. 22-31.
4. Huh, W.K., et al., Use of primary high-risk human papillomavirus testing for cervical cancer screening: interim clinical guidance. Gynecol Oncol, 2015. 136(2): p. 178-82.
5. Arbyn, M., et al., Accuracy of human papillomavirus testing on self-collected versus clinician-collected samples: a meta-analysis. Lancet Oncol, 2014. 15(2): p. 172-83.
6. Arbyn, M. and P.E. Castle, Offering Self-Sampling Kits for HPV Testing to Reach Women Who Do Not Attend in the Regular Cervical Cancer Screening Program. Cancer Epidemiol Biomarkers Prev, 2015. 24(5): p. 769-72.


Benefit of PCR in Human Papillomavirus detection with GenoID PCR technology

Overall, there are approximately 100 genotypes of HPV. 50 out of these can cause infection in the genital region and 14 are known to be in the high-risk group. For high-quality patient management, it is required to detect all anogenital HPV and especially the high-risk genotypes.
A technology that meets these requirements has to be both highly sensitive and specific allowing precise discrimination of HPV types. Only one technology provides this outstanding set of features: PCR, which stands for polymerase chain reaction. DNA based PCR methods are used widely to detect HPV infections. Besides being the most sensitive diagnostic methods, these supply important typing information for counseling, selection of therapy, follow-up and vaccine monitoring.
On the basis of this technology GenoID manufactures the Full Spectrum HPV detection kit. The kit is the result of years of research and development and is based on the assay used in GenoID’s clinical laboratory where tens of thousands of HPV tests have been performed. Precise discrimination of the genotypes relies on a unique HPV DNA signature discovered by GenoID’s researchers.
Researchers at GenoID have developed a system that features a balanced sensitivity of amplification and an automated, high throughput typing method (hybridization) using the virus L1 gene sequence that is suitable for consensus amplification of HPV types and it is also possible to design both separate general and type-specific probes to the same amplicon. The system allows simultaneous detection and typing of 48 HPV types.

The Full Spectrum HPV test service is designed to detect the genital HPV genotypes in the following constitution:

PCR based Human papillomavirus (HPV) group detection & genotyping:

Genotyping of all HR-HPV types: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68
Genotyping of LR-HPV types: 6, 11
Group detection of LR-HPV types: 42, 43, 44
Group detection of non-classified (NA)-HPV types: 2, 3, 7, 10, 13, 26, 27, 28, 29, 30, 34, 40, 53, 54, 57, 61, 67, 70, 72, 73, 74, 81, 82, 83, 84, 85, 89, 90, 91


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