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DNA ELISA kit HPV SPF10, version 1

Intended use
Sensitive HPV detection in cervical scrapes, biopsies and formalin fixed paraffin embedded samples.

The DNA ELISA kit HPV SPF10, version 1 is an in vitro PCR DNA Elisa (PCR/DEIA) for the qualitative and highly sensitive detection of Human Papillomavirus (HPV) originating from the anogenital tract. Based on the high analytical sensitivity of the assay, this kit is particularly suited for epidemiological and vaccine related studies, using both cervical scrapes and biopsy specimens. This kit detects more than 40 HPV genotypes and is designed to be used in combination with the RHA kit HPV SPF10LiPA25, version 1 for HPV genotyping of PCR/DEIA positive samples. The test should not be used for clinical patient management.

Summary and explanation
Human papillomaviruses are small viruses containing a double-stranded, circular DNA genome of approximately 7,900 base pairs. The viral genome contains early (E), late (L) genes and an untranslated control region. At present, more than 100 different HPV types have been identified based on differences in DNA sequence. HPV types can be subdivided into mucosal types, which can infect anogenital and oraloropharyngeal mucosa, and cutaneous (skin) HPV types. Among the HPV types infecting the anogenital epithelia, a subset of 18 HPV types have been classified as high-risk or probably high-risk for causing alterations of the cervical mucosa and ultimately cervical cancer in women. The DNA ELISA kit HPV SPF10, version 1 allows an easy, reliable and highly sensitive detection of relevant HPV genotypes originating from the anogenital tract.

Principles of the procedure
The DNA ELISA kit HPV SPF10, version 1 is based on an initial PCR followed by a hybridization detection assay (DNA-Elisa or DEIA). During the PCR, the amplified DNA fragments are labeled with biotin. The biotinylated PCR products are captured in a streptavidin-coated microplate well. Next, the non-biotinylated complementary strands are removed by incubation with denaturation solution and washing. After washing, hybridization takes place with a cocktail of labeled HPV-specific probes. The label is detected with a conjugate, which is visualized by a substrate. The presence of HPV DNA in the tested sample is determined by comparing the optical density of the PCR product to that of a cut-off value.

Ordering information
The kit is available for research- and epidemiological studies

REF: K-27 DNA ELISA KIT HPV SPF10, version 1 96 tests
REF: K-27-4 DNA ELISA KIT HPV SPF10, version 1 384 tests

Related products

REF: S-1071 RHA Kit HPV SPF10-LiPA25, version 1 50 tests
REF: S-1026 RHA Kit HPV SPF10-LiPA25, version 1 500 tests

References

1) Kleter et al. (1998), Novel short-fragment PCR assay for highly sensitive broad-spectrum detection of anogenital human papillomaviruses. Am J Pathol 153, 1731-9.

2) Kleter et al. (1999), Development and clinical evaluation of a highly sensitive PCR-reverse hybridization line probe assay for detection and identification of anogenital human papillomavirus. J Clin Microbiol 37, 2508-17.

3) Quint et al. (2001), Comparative analysis of human papillomavirus infections in cervical scrapes and biopsy specimens by general SPF(10) PCR and HPV genotyping. J Pathol 194, 51-8.

4) van Doorn et al. (2002), Genotyping of human papillomavirus in liquid cytology cervical specimens by the PGMY line blot assay and the SPF(10) line probe assay. J Clin Microbiol 40, 979-83.

5) van der Graaf et al. (2002), Human papillomavirus and the long-term risk of cervical neoplasia. Am J Epidemiol 156, 158-64.

6) Shin et al. (2004), Prevalence and determinants of genital infection with papillomavirus, in female and male university students in Busan, South Korea. J Infect Dis 190, 468-76.

7) Harper et al. (2004), Efficacy of a bivalent L1 virus-like particle vaccine in prevention of infection with human papillomavirus types 16 and 18 in young women: a randomised controlled trial. Lancet 364, 1757-65.

8) van Ham et al. (2005), comparison of two commercial assays for detection of human papillomavirus (HPV) in cervical scrape specimens: validation of the Roche AMPLICOR HPV test as a means to screen for HPV genotypes associated with a higher risk of cervical disorders. J Clin Microbiol 43, 2662-7.

9) Harper et al. (2006), Sustained efficacy up to 4-5 years of a bivalent L1 virus-like particle vaccine against human papillomavirus types 16 and 18: follow-up from a randomised control trial. Lancet 367, 1247-55.

10) Safaeian et al.(2007), Comparison of the SPF10-LiPA system to the Hybrid Capture 2 Assay for detection of carcinogenic human papillomavirus genotypes among 5,683 young women in Guanacaste, Costa Rica. J Clin Microbiol 45, 1447-54.

11) de Koning et al. (2008), Prevalence of mucosal and cutaneous human papillomaviruses in different histologic subtypes of vulvar carcinoma. Mod Pathol 21, 334-44.

12) Quint et al. (2009), Comprehensive analysis of Human Papillomavirus and Chlamydia trachomatis in in-situ and invasive cervical adenocarcinoma. Gynecol Oncol 114, 390-4.

13) Lenselink et al. (2009), Detection and genotyping of human papillomavirus in self-obtained cervicovaginal samples by using the FTA cartridge: new possibilities for cervical cancer screening. J Clin Microbiol. 47, 2564-70.

14) Sanjose et al. (2010), Human papillomavirus genotype attribution in invasive cervical cancer: a retrospective cross-sectional worldwide study. Lancet Oncol. 11, 1048-56.

15) Quint et al. (2010), HPV genotyping and HPV16 variant analysis in glandular and squamous neoplastic lesions of the uterine cervix. Gynecol Oncol 117, 297-301.

16) Quint et al. (2012), One virus, one lesion, individual components of CIN lesions contain a specific HPV type. J Pathol 227, 62-71.

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