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Test ID: 83342    
ThinPrep Screen with Human Papillomavirus (HPV) Reflex

Method Description Describes how the test is performed and provides a method-specific reference

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 anti-bodies 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: Digene Hybrid Capture 2 High-Risk HPV DNA Test, Qiagen Inc., Gaithersburg, MD. 2007)

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.

5 days

Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result

8 days

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

Rochester