Human Papillomavirus (HPV)

Papillomaviruses are a diverse group of viruses that have been found in more than 20 different mammalian species, as well as birds and reptiles. In the 1980s, the newly developed techniques of molecular biology enabled the detection of many human papillomaviruses (HPVs) in benign and malignant lesions. To date, there are more than 200 HPV subtypes. An HPV type is defined as a complete genome whose L1 gene sequence is at least 10% dissimilar to that of any other HPV type.


  • The sample is collected from the endocervix and ectocervix with the which is then placed in the proprietary transport medium.

  • MDL offers the HPV Type-Detect (HPV-TD), with the viral E6/E7 oncogenes as the primer target region.

  • HPV-TD is a nested multiplex PCR which involves multiple rounds of PCR reactions consisting of primary PCR with a large amplicon product and a secondary amplification step to generate a smaller amplicon.

  • The HPV-TD multiplex-nested PCR based assay includes many broad-based HPV genotypes within the first PCR amplification reaction and the second round nested PCR consists of all type specific primers, including the high and low-risk.

  • The HPV-TD was evaluated in 495 cervical scrapes with various histological findings. The HPV prevalence rate was 34.7% in the absence of CIN (CIN 0), 94.2% in the presence of mild to moderate dysplasia (CIN 1/CIN 2), and 97.8% in the presence of CIN 3. In addition, multiple infections were detected in 48% of the patients.
  • Since 40% of HPV infections are mixed infections, HPV-TD can be used to differentiate between newly acquired HPV subtypes and pre-existing infections when applied over time.

  • HPV Type-Detect can detect 19 specific HPV subtypes.

  • Although the genetic variation among HPV types is merely 10%, HPV-TD is highly specific without known cross-reaction to other HPV types.

  • HPV-TD has an analytical sensitivity of 10 HPV genome equivalents per reaction.

  • In HPV-vaccine recipients, HPV-TD can be used to monitor successful immunization and patients stratification as well as to determine if patients have been infected with an HPV genotype other than that protected by the vaccine.
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