INNO-LiPA HPV Genotyping Extra
INNO-LiPA HPV Genotyping Extra is a line probe assay, based on the reverse hybridization principle, designed for the identification of 28 different genotypes of the human papillomavirus (HPV) by detection of specific sequences in the L1 region of the HPV genome.
The assay uses the proven SPF10* primer set for the highly sensitive amplification of most clinically relevant HPV genotypes. In addition, a set of primers for the amplification of the human HLA-DPB1 gene has been added to monitor sample quality and extraction, as well as the addition of UNG to the amplification mixture as a contamination prevention measure.
The assay covers all currently known high-risk HPV genotypes and probable high-risk HPV genotypes (16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73, 82) as well as a number of low-risk HPV genotypes (6, 11, 40, 43, 44, 54, 70) and some additional types (69, 71, 74).
Fully automated processing of the strips is possible using Auto-LiPA 48 or Autoblot (MedTec Inc.). Automated and objective interpretation of the strips is provided with LiRAS® for LiPA HPV (article number: 81085, CE).
NOTE: This product is sold under licensing arrangements between Innogenetics N.V. and Invitrogen IP Holdings, Inc. The purchase price of this product includes limited, nontransferable rights under European Patent Numbers 0401037; 0522884; and 0415755 and corresponding foreign patents, other than United States patents, owned by Invitrogen Corporation to use only this amount of the product to practice the claims in said patents solely for activities of the purchaser in detection of human papillomavirus (HPV) within the field of human diagnostics. No other rights are conveyed. Further information on purchasing licenses under the above patents may be obtained by contacting the Licensing Department, Invitrogen Corporation, 1600 Faraday Avenue, Carlsbad, CA 92008. Email: outlicensing@invitrogen.com.
*Patent protected: EP patent 1012348B; US patent 6,482,588B.
Article number: 81063
One strip – one test for the identification of the most relevant HPV genotypes.
Features & Benefits
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Genotypes
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28 HPV genotypes including all 18 high-risk genotypes
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Controls
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Confidence with unique HPV control line to confirm the presence of a broad range of mucosal HPV genotypes, plus additional controls to optimize sample processing
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| Streamlining |
Easy and ready-to-use master mix, with Taq provided for minimum manipulation steps and hands on time
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Applications
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- Proven quality performance on cervical scrapes
- Potential use for biopsies and paraffin-embedded material (Pirog EC, et al. Am J Pathol. 2000;157:1055-62.)
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Automation available
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- up to 20 or up to 48 tests per run from hybridization to color development
- Results within 3 hours
- Minimum hands-on time, accurate results |
| Software |
Objective interpretation with LiRAS® for LiPA HPV
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Strip desing
HPV types identified by INNO-LiPA HPV Genotyping Extra:
- High risk: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68, 73, 82
- Probable high risk: 26, 53, 66
- Low risk: 6, 11, 40, 43, 44, 54, 70
- Additional types: 69, 71, 74
The INNO-LiPA HPV Genotyping tests have proven to be a reliable method for the sensitive identification of HPV genotypes and multiple HPV infections.
Fontaine V et al. J Clin Microbiol. 2007;45:928-34.
Safaeian M et al. J Clin Microbiol. 2007;45:1447-54.
Publications
Background
Cervical cancer is the second most common cancer among women worldwide. Virtually 99% of such cancers are caused by persistent infection with the human papillomavirus (HPV). This virus occurs in a variety of related genotypes, with high-risk HPV genotypes 16 and 18 accounting for about 70% of cervical neoplasia. These and a handful of other high-risk genotypes are the principal causes of cervical cancer. Unfortunately, some 10% of women are unable to clear the virus, thereby increasing the risk for progression to cervical precancer [cervical intraepithelial neoplasia grades 2 and 3 (CIN-2/-3)].
Cervical cancer is a preventable and curable disease. Classical Pap smear testing alone is an insufficient diagnostic tool since sensitivity is, at best, between 50% and 75% (≤85% with liquid-based cytology). The concomitant use of modern HPV DNA testing can increase sensitivity to 95%. HPV testing of high-risk genotypes is now commercially available as CE-marked IVD products. Importantly, information about the type and persistence of an individual’s HPV infection are key factors to help guide patient management.
6 key facts about HPV
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Cervical cancer is caused by persistent HPV infection.
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The risk for cervical cancer is related to HPV genotype and its persistence.
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HPV genotypes 16 and 18 are particularly associated with cancer risk.
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Almost 30% of cervical cancers are associated with non-16/18 genotypes.
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The geographic distribution of HPV genotypes is not uniform.
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Current HPV vaccines can only protect against types 16 and 18.
The diagnostic test developed by Innogenetics not only includes the important HPV high-risk genotypes 16 and 18 that are present in the recently approved prophylactic vaccines, but also includes other key high-risk genotypes not covered by the vaccines. The INNO-LiPA HPV Genotyping Extra test will provide important information to complement Pap testing and current DNA-based HPV screening tests. Furthermore, the test could prove useful in the selection of individuals eligible for preventive HPV vaccination, efficacy follow-up, detection of subsequent HPV infections (including mixed infections), epidemiological surveys, clinical trial stratification, and determination of viral persistence.
Customer support
For all inquiries regarding Innogenetics products and instrumentation, we offer the services of our customer support team. This team of technical experts is committed to dealing with
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General inquiries
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Technical assistance
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Complaint resolution
The customer support team is designed to be your principle point of contact. They will ensure that the appropriate person handles all product-related inquiries. For this service please contact us via e-mail, call us (+32-9 329 16 11), or fax (+32-9 329 17 75).