HPV sign Genotyping Test Kits

For complete genotyping of human papillomavirus

Products

The HPV sign Genotyping Test Kits is intended for in vitro diagnostic use in Europe.

Features

  • Genotyping of more than 100 HPV types
  • Sensitivity and specificity
  • Mutation tolerance; identification of sequence variants
  • Specimen flexibility, including swabs and FFPE samples
  • Updated HPV sequence library with IdentiFire software

Product Details

The HPV sign Q96 complete and HPV sign Q24 complete kits provide complete genotyping of HPV with the capability to identify up to 100 HPV types. The kits provide follow-up testing to positive results with the digene HC2 High-Risk HPV DNA Test. Both kits offer Pyrosequencing using the Rotor-Gene Q with PyroMark Q24 or the PyroMark Q96.

Principle

The novel technology of the HPV sign Q96 and Q24 complete kits allow sequencing of a 30 base pair, hypervariable, genomic region of human papillomavirus (HPV). Both kits (Q96 and Q24) can be used in combination with the appropriate Pyrosequencing platform to detect and analyze HPV genotypes. Starting from a single amplification product, direct sequencing provides reliable identification of HPV genotypes.
The HPV sign kits include an HPV Library, which permits detection of low- and high-risk HPV types. Sample sequences are aligned against genotype-specific sequences in the HPV Library using IdentiFire software. This enables accurate detection of more than 100 HPV types, including all anogenital high- and low-risk types, with results expressed by a score number based on the homology to the reference sequences included in the HPV sign Library.

Procedure

Starting from a single amplification product, direct sequencing provides reliable identification of HPV genotypes. PCR amplification is performed using provided primers and reagents on the Rotor-Gene Q instrument. Next, sequencing of up to 22 samples in 2 hours is done using the chosen Pyrosequencing instrument. Sample sequences are aligned against genotype-specific sequences in the HPV Library using the IdentiFire software. This enables accurate detection and identification of up to 100 HPV types, with results expressed by a score number based on the homology to the reference sequences included in the HPV sign Library.

Applications

The HPV sign Q24 complete and HPV sign Q96 complete kits provide full genotype coverage for adaptation to all countries. The tests may be used for follow-up of a positive digene HC2 High-Risk HPV DNA Test. The HPV sign Q24 complete and HPV sign Q96 complete kits may be used in diagnosing HPV infection and as a follow-up to a positive HPV DNA Test in a screening setting.

Handbooks for both HPV sign complete kits are available with purchase. QIAGEN acts as exclusive co-distributor of the HPV sign Q24 complete and HPV sign Q96 complete kits.

Supporting data and figures

Resources

Safety Data Sheets (1)
Certificates of Analysis (1)