Test ID: 83343    
ThinPrep Diagnostic with Human Papillomavirus (HPV) Reflex

A ThinPrep Pap specimen is collected, processed on a T2000 or T3000 processor and stained with a Pap stain. Cases are examined microscopically and those with cytologic diagnoses of atypical squamous cells of undetermined significance (ASCUS) are referred to the Virology Laboratory for human papillomavirus (HPV) testing if the patient is 21 or older.(Operator’s Manual: ThinPrep 2000 System, Cytyc, Marlboro, MA; Operator’s Manual: ThinPrep 3000 Processor, Cytyc, Marlboro, MA)

The Digene hc2 High-Risk HPV DNA Test using Hybrid Capture 2 (hc2) technology (Qiagen Inc.) is an In Vitro nucleic acid hybridization assay with signal amplification using microplate chemiluminescence for the qualitative detection of thirteen high-risk types of human papillomavirus (HPV) DNA in cervical specimens. The HPV types detected by the assay are the high-risk HPV types 16/18/31/33/35/39/45/51/52/56/58/59/68. The hc2 High-Risk HPV DNA Test cannot determine the specific HPV type present. Specimens containing the target DNA hybridize with a specific HPV RNA probe cocktail. The resultant RNA:DNA hybrid is captured onto the surface of a microplate well coated with antibodies specific for RNA:DNA hybrids. Immobilized hybrids are then reacted with alkaline phosphatase conjugated antibodies specific for the RNA:DNA hybrids, and detected with a chemiluminescent substrate. Several alkaline phosphatase molecules are conjugated to each antibody. Multiple conjugated antibodies bind to each captured hybrid resulting in substantial signal amplification. As the substrate is cleaved by the bound alkaline phosphatase, light is emitted that is measured as relative light units (RLUs) on a luminometer. The intensity of the light emitted denotes the presence or absence of target DNA in the specimen.(Package insert: Digene Hybrid Capture 2 High-Risk HPV DNA Test, Qiagen Inc., Gaithersburg, MD. 2007) 

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