( specimens that can be tested with the ...)Testing for Human Papillomavirus,Health

specimens that can be tested with the Digene tests include specimens collected with the Digene Cervical Sampler/DNA Collection Device, biopsies collected in Specimen Transport Medium, and specimens collected using a broom type collection device and placed in Cytyc ThinPrep Pap Test PreservCyt Solution. This assay is thought to be best suited for medium-sized to large laboratories with substantial liquid-based Papanicolaou test volume (LBPT). Digene offers The Rapid Capture system for high throughput testing, which handles up to 352 specimens in eight hours.

Until recently, Digenes exclusive rights to many of the high-risk HPV sequences have limited commercialization of diagnostic HPV tests, but the availability of HPV sequences has broadened. Ventana Medical Systems (Tucson) offers Inform HPV, an analyte specific reagent assay that can be performed on both tissue specimens and LBPTs. The assay is an in situ hybridization test performed on histology or LBPT slides that are incubated with fluorescein-tagged DNA probes and counterstained. Microscopic observation of specifically stained target cells indicates HPV is present. Staining is performed on an automated instrument, the Ventana BenchMark. There are separate probe kits for oncogenic and nononcogenic HPV types.

HPV DNA technology with European CE marking includes Amplicor HPV and Linear Array HPV Genotyping Tests (Roche Diagnostics, Basel) and PapilloCheck (Greiner Bio-One GmbH, Frickenhausen). Both the Amplicor and Linear Array tests are PCR-based. Amplicor simultaneously identifies all 13 high-risk HPV genotypes, and the Linear Array test identifies 37 high- and low-risk HPV genotypes. PapilloCheck is a biochip that can differentiate a total of 18 high risk and 6 low risk HPV types. PapilloCheck is a ready-to-use complete test system with all the necessary buffers, solutions, and on chip controls.
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