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Products Line « Molecular Biology « TMA Assays
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APTIMA® HPV Assay
Description

The identification of human papillomavirus (HPV) as the aetiological agent for cervical cancer has had important implications for the future of cervical cancer screening and prevention strategies. Despite the availability of HPV vaccines, regular and adequate screening will remain the mainstay of cervical cancer screening. Molecular tests for high risk HPV subtypes have the potential to improve cancer screening and subsequent diagnosis. Most HPV infections are transient and resolve on their own; however persistent HPV infection by one of the 14 high-risk HPV genotypes can lead to cervical disease which includes cervical cancer.
Commonly used screening methods often provide only limited success:

  •  A single cytology evaluation is only 30% to 50% sensitive for detection of cervical disease, resulting in a high chance of a false negative result. This reduces the opportunity to start a proper course of treatment in a timely manner. (1)
  •  LBC is also more expensive, and is neither more sensitive nor more specific than conventional cytology with respect to detection of histologically confirmed high-grade cervical intraepithelial neoplasia (CIN).
  •  Studies show that HPV DNA assays, while highly sensitive for detecting HPV infection, are less able to distinguish between transient infection and oncogenic transformation. This results in an increased rate of “false positive” results with respect to cervical disease translating into needless patient anxiety as well as unnecessary medical procedures.

Based on published research, the APTIMA HPV E6/E7 mRNA Assay helps physicians differentiate between the presence of transient infection and an HPV infection more likely to transform into cervical disease, which will reduce the number of false positives and help determine the course of treatment. The APTIMA assay detects HPV E6/E7 oncogenes from high-risk genotypes from either a cervical swab or liquid-based cytologic (LBC) media. The assay detects 14 high-risk genotypes (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68) and does not cross-react with 5 low-risk genotypes (6, 11, 42, 43 and 44) or genotype 53.
The assay uses Transcription-Mediated Amplification (TMA) with HPV-specific primers to amplify the HPV mRNA and internal control transcripts. Based on the system that is used a laboratory can test from 100 -1000 samples per day with a single operator. The same system can also perform testing for Chlamydia trachomatis and Neisseria gonorrheae.
Studies support that the APTIMA HPV Assay can:

  1. Provide assurance of high sensitivity for detecting cervical pre-cancers, but with increased specificity for cervical disease
  2. Detect the presence of disease, minimizing the detection of transient HPV infection.
  3. Give confidence to patients with negative results that they are at low risk for disease in the next 12 months.
  4. Reduce reporting of false positives to provide improved patient care, avoid unnecessary medical procedures and reduce costs to the health care professional as well as the patients.

There is enough scientific evidence to shift cervical cancer detection and prevention strategies from the detection of cytological abnormalities using cytology to the detection of HPV infection associated with disease progression.
Detection of high-risk HPV mRNA is considered to be useful in three clinical applications:

  1. As a primary screen
  2. In triage, to select women showing minor cytological lesions (LSIL and ASCUS) needing referral for diagnosis and treatment; and
  3. In follow-up of women treated for high-grade lesions, to predict persistent or recurrent
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