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)
14 days after report issued if HPV testing has not been performed. 1 week if HPV testing has been performed.