Cervical cancer is the world’s fourth most common cancer in women, with an estimated incidence of 604,000 new cases and 342,000 deaths in 2020, according to the WHO.
The primary cause of pre-cancerous and cancerous cervical lesions is infection with high-risk or oncogenic human papillomavirus (HPV) types: 16 and 18. Therefore, early diagnosis and personalised follow-ups for each patient are essential in order to minimise the risk of developing cancer of the cervix after an HPV infection and, for this reason, an increasing number of countries are implementing population screening algorithms for women over the age of 30 through PCR molecular tests.
The HPV Screening Real Time PCR kit and HPV Direct Flow CHIP kit are designed to detect 14 HPV genotypes with a high oncogenic risk (HR) or complete full genotyping of 35 HPV types.
Genotyping of 35 HR and LR HPV genotypes
IVDR test designed for the simultaneous detection and genotyping of 35 HPV types (high-risk: HPV 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73 and 82, and low-risk: HPV 6, 11, 40, 42, 43, 44, 54, 55, 61, 62, 67, 69, 70, 71, 72, 81 and 84) using multiplex PCR – reverse dot blot hybridisation.
The HPV Direct Flow CHIP methodology consists of performing PCR amplification of a fragment of the L1 viral region, followed by hybridisation on a membrane CHIP containing HPV genotype-specific probes using DNA Flow technology. The whole process is automated within the HybriSpot platform.
Kit details:
IVDR test to detect 14 high-risk genotypes using multiplex real-time PCR.
The test can simultaneously and specifically identify HPV genotypes 16 and 18 and detect 12 HR genotypes (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68), using purified DNA from cervico-vaginal samples. Amplified HPV target region: L1
The Vitro HPV Screening kit is approved for use in most extractors available on the market, including Vitro’s proprietary extractors: MAIS and Victoria V96.
El kit Vitro HPV Screening está validado para usar en la mayoría de los extractores del mercado, incluyendo los extractores propios de Vitro: MAIS y Victoria V96.
Kit details:
IVDR test to detect 15 high-risk genotypes using multiplex real-time PCR.
The test can simultaneously and specifically identify HPV genotypes 6 and 11 and detect 13 LR genotypes (40, 42, 43, 44, 55, 61, 62, 67, 69, 70, 71, 72 and 81), using purified DNA from cervico-vaginal samples. Amplified HPV target region: L1.
The Vitro HPV Screening and HPV Direct Flow Chip kits both play a crucial role by establishing a risk threshold, enabling the early detection of potential cases of human papillomavirus infection. They also help to improve the diagnostic algorithm by identifying specific HPV genotypes, including those covered by the available vaccines, which not only facilitates the assessment of vaccine efficacy, but also provides valuable information for informed clinical decision-making and the implementation of more effective preventive strategies.
Our kits have been endorsed by several scientific publications and meet the standards of various quality programmes.
Vitro has joined the strategy to eliminate cervical cancer promoted by the WHO, by developing comprehensive solutions unlike any other on the market, for HPV screening and genotyping, thereby helping to improve diagnosis.
Countries around the world are working to accelerate the elimination of cervical cancer over the coming decades, having agreed on three targets that must be met by 2030:
Meeting these three targets will help to bring about an immediate and rapid reduction in mortality rates due to invasive cervical cancer.
Over 30 years of experience in developing and manufacturing reagents for immunohistochemistry, molecular diagnostic products, instruments and software.
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