Hc2 High-Risk HPV DNA Test 

An in vitro nucleic Acid Hybridization Microplate Assay with Amplification using Microplate chemiluminescene for the Qualitative Detection of 13 High-Risk types of human papillomavirus(HPV) DNA in cervical Specimen’s. 

  SUMMARY AND EXPLANATION

The presence of certain HPV types in the female genital tract is associated whit a number of diseases including condyloma, bowenoid papulosis, cervical, vaginal, and vulvar intraepithelial neoplasia and carcinoma. It is generally accepted that these viruses are predominantly sexually transmitted and that high-risk HPV types are the major recognized risk factor for development of cervical cancer.
Human papillomaviruses are composed of an icosahadral viral particle (virion) containing an 8000 base pair double-stranded circular DNA molecule surrounded by a protein capsid. Following infection of epithelial cell, the viral DNA becomes established throughout the entire thickness of the epithelium. Thus, viral DNA can be found either in virions or as episomal or integrated HPV sequences, depending upon the type and grade of lesion.
To date HPV cannot be cultured in vitro, and immunological tests are inadequate to determine the presence of HPV cervical infection. Indirect evidence of anogenital HPV infection can be obtained through physical examination by the presence of specimens. Alternately, biopsies can be analyzed by nucleic acid hybridization to directly detect the presence of HPV DNA.

Historically, HPV 18 has been regarded at high risk cancer associated HPV Types 31 33 and 35 have been demonstrated to have an intermediate association with cancer. This intermediate association is due to the fact that these type of more frequently detected high grade squamous intraepithelial lesions rather than the cancers. Therefore induction of cancer due to the presence of these types is less likely then when high risk HPV DNA types of presence. These HPV types can also be categorized into intermediate and high risk groupers based on their re3l;atiove distribution in variou8s hitopathological diagnosis categories.

  PRINCIPLE OF THE PROCEDURE 

THE HC2 High-Risk HPV DNA Test using capture 2 technology is a nucleic acid hybridization assay with signal amplification that utilizes microplate chemiluminescent detection. Specimens containing the target DNA hybridize with a specific HPV RNA probe. The resultant RNA:DNA hybrids are captured onto the surface of a microplate well coated with antibodies specific for RNA:DNA hybrids.several alkaline phosphatase molecules are conjugated to each anti body. As the substrate is cleaved by the bound alkaline phosphatase, light is emitted which is measured as relative light units on a luminometer.

An RLU measurement equal to or greater than the cutoff value indicates the presence of high-risk HPV DNA sequences in the specimen. High volume sample-throughput testing with the hc2 High-risk HPV DNA Test can be performed utilizing the rapid capture system (RCS). To enable high volume sample-throughput testing, all the procedural steps of the assay are performed by the RCS, with the exception of specimen denaturation, chemiluminescent signal detection, and result reporting.