ThinPrep Diagnostic with Human Papillomavirus (HPV) for Women 30 Years and Older
Method Description Describes how the test is performed and provides a method-specific reference
The ThinPrep pap specimen is processed on a T2000 or T3000 processor, producing a slide that is stained with a Papanicolaou stain. The stained slides are examined microscopically.(Operatorâ€™s Manual: ThinPrep 2000 System, Cytyc, Marlboro, MA; Operatorâ€™s Manual: ThinPrep 3000 Processor, Cytyc, Marlboro, MA)
High-risk HPV testing is performed on the original ThinPrep pap specimen. The hc2 DNA (Digene) assay is a qualitative HPV test that identifies the presence of most high-risk types of the virus (16/18/31/33/35/39/45/51/52/56/58/59/68). hc2 is a sandwich capture, molecular hybridization assay with signal amplification that utilizes chemiluminescent detection and is performed in microplate wells. 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 antihybrid antibodies conjugated to alkaline phosphatase and detected with a chemiluminescent substrate. As the substrate is cleaved by the bound alkaline phosphatase, light is emitted, which is measured as relative light units (RLUs) on a luminometer. The intensity of the light is proportional to the amount of target DNA in the specimen.(Package insert: hc2 DNA Test, Digene Corp., Beltsville, MD. 2002)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Friday; Varies
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
14 days after report issued
Performing Laboratory Location The location of the laboratory that performs the test