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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. | 
