ThinPrep Diagnostic 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 appropriate cytologic diagnoses 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 cobas human papillomavirus (HPV) test targets and detects nucleic acid from the L1 region of the HPV genome using real-time polymerase chain reaction (PCR) technology. The cobas HPV test is used for the in vitro qualitative detection of 14 high-risk HPV types commonly associated with cervical cancer. The assay is able to specifically assess for the presence or absence of HPV genotypes 16 and 18 while concurrently detecting the remaining 12 high risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68). The cobas HPV test is used in conjunction with the cobas 4800 System. The cobas 4800 System comprises the cobas x 480 instrument and cobas z 480 analyzer that fully automates the cobas HPV from sample extraction through amplification, detection, and data reduction.(Procedure manual and package insert: cobas HPV test. Roche Diagnostics. Indianapolis, IN, version 05641268001-01EN)
Supplemental Report Indicates whether the report includes an additional document with charts, images or other enriched information
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 if HPV testing has not been performed. 1 week if HPV testing has been performed.
Performing Laboratory Location The location of the laboratory that performs the test