* HPV DNA 15/31 Type
This product is used to Predict Human Papilloma Virus Infections Evolving into Cervical Cancer.
International Patent Technology
Easy to operate (Nucleic acid extraction, PCR amplification, Interpretation of results < 3 hours)
One 96-throughput thermal cycler can detect 94 samples in a single batch, more efficient
Fully automatic data analysis software, result interpretation is smarter and faster
High sensitivity, strong specificity
DESCRIPTION
Successfully obtained in the EU CE access certification
Passed ISO13485 certification
Cervical cancer is the fourth most frequently occurring cancer in women around the world, also affecting young women during their reproductive years, and estimated to kill 250,000 women annually. Since the development of the Papanicolaou (Pap) test, screening has been essential in identifying cervical cancer at a treatable stage. With the identification of the human papillomavirus (HPV) as the causative agent of essentially all cervical cancer cases, HPV molecular screening tests and HPV vaccines for primary prevention against the virus have been developed. HPV is however the most commonly acquired sexually transmitted virus, with around four out of five people (80%) contracting this infection at some point during their lifetime.
Currently available HPV tests are unable to discriminate HPV infections regressing spontaneously from those turning into cancer. Screening refusal is also an important problem in several European countries, mainly as a result of social, economic and/or racial/ethnic barriers, hindering cervical cancer prevention in these women. This, together with current failure to implement gender-neutral HPV vaccination with high coverage in the great majority of countries, have resulted in IARC’s projections showing that, unless innovative preventive measures are implemented promptly, the burden of cervical cancer is expected to increase to almost 460.000 deaths per year by 2040, an increase of nearly 50% over the estimated number of deaths in 2018.
Recommendation
WHO guideline for screening and treatment of cervical pre-cancer lesions for cervical cancer prevention, 2021.
HPV DNA testing as preferred method for cervical cancer screening
Clinical significance:
• Expanded testing for HPV types that cause cervical cancer
In addition to the 14 high-risk HPV types announced by WHO, the detection of intermediate-risk HPV types that may cause cancerous cells is added.
•Aids in the diagnosis of skin warts and genital related disorders
Includes testing for types 6 and 11 for HPV vaccine prophylaxis and testing for many other low-risk HPV types that cause skin warts.
•Prognosis of oropharyngeal carcinoma and establishment of individualized treatment plan
Patients with HPV-positive oropharyngeal cancer have better treatment effect and prognosis than HPV-negative
patients, and de-escalation of treatment is an option.
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