Pap Test: ThinPrep® with Reflex to Human Papillomavirus (HPV-HR) DNA Probe, High Risk

• 88141
• 88142
• If reflexed to HPV, add 87621, high-risk HPV

Note: A negative result does not rule out the presence of an HPV genotype absent for the test panel, a low-level infection or specimen sampling error.

• Cervical Brushes: Specimens must be collected prior to the application of acetic acid or iodine if a colposcopic examination is being performed. The samples should be collected by using a Digene cervical brush and stored in Digene STM solution.
• Cervical Biopsies: Specimens must be freshly collected, 2 – 5 mm in cross section. The biopsy specimen must be placed immediately into 1 mL of STM and stored frozen.
• Specimens in ThinPrep^® Cytyc PreservCyt™ Solution: There must be at least 4 mL of PreservCyt^™ solution remaining for the HPV DNA test.

Storage/Transport Temperature: Submit specimens according to Biological Substance, Category B, shipping guidelines.

• Unacceptable Conditions:
  • Lack of a properly completed requisition (especially federally required information)
  • Insufficient pertinent clinical history
  • Obscuring inflammation, debris or excessive air-drying
  • Always record if a cytobrush was used to perform the Pap test.
  • Failing to record the use of a cytobrush may result in erroneous atypical results for the patient.
• Stability (collection to initiation of testing):
  • Ambient:
    • ThinPrep^®: 3 weeks at 4° – 37° C

A Pap smear examines the cells of the cervix and detects cell abnormalities. Both, cancerous and precancerous cells can be detected. Pap tests are recommended in women ages 21 – 64, every two years with normal Pap results. Vaginal Pap smears can also be performed but must be noted on the requisition.

The ThinPrep^® Pap test addresses these limitations with liquid-based preparation, improving specimen adequacy and significantly increasing test sensitivity. The ThinPrep^® Pap test is the first test of this kind. Since its
introduction, it has contributed to a further 28% reduction in invasive cervical cancers in the United States.<sup>1

1</sup> _{Surveillance, Epidemiology, and End Results (SEER) Program. SEER Database: Incidence – SEER 9 Regs Public-Use, Nov. 2004 Sub (1973-2002), National Cancer Institute, DCCPS, Surveillance Research Program, Cancer Statistics Branch, released April 2005, based on November 2004 submission.}

Women with atypical squamous cells of undetermined significance should be managed using a program of either repeat cervical cytopathology testing, immediate colposcopy or DNA testing for high-risk types of HPV. Testing for
HPV DNA is the preferred approach when liquid-based cytopathology is used for screening. All women who test positive for high-risk HPV DNA should be referred for colposcopic evaluation. Women with ASC-US who test negative for high-risk HPV DNA can be followed up with repeat cytologic testing at 12 months (2001 ASCCP Guidelines – JAMA 2002; 287:2120-2129).

A positive high-risk HPV test result indicates that the patient may be infected with one or more of the following HPV genotypes: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68, which are associated with cervical cancer and its precursor lesions; however, cross-reactions with other genotypes may occur. Results shouldbe correlated with cytologic/histologic findings.

ThinPrep® 2000 system/routine cytopathologic evaluation/nucleic acid probe

5 – 7 days