LIQUID BASED PAP TEST AND HIGH RISK HUMAN PAPILLOMAVIRUS (HPV) DNA TEST

General Information

Alias: ThinPrep, Pap, HPV

Performed: Mon-Fri, 8am-5pm

Turn Around Time: Routine 1-10 business days

CPT Codes: 88175 or 88342. 87621

Performed By: Cytology

Notes:

Hologic evaluated a variety of popular lubricants and found those containing carbomer or carbopol polymers (thickening agents) interfere with the ThinPrep Pap test when found in the sample vial. Hologic recognizes the varying availability of different types of lubricants and recommends that, if used, any lubricant should be applied sparingly. (See Cytology Services Link-Attachment A Hologic Lubricant Guidance Letter) A High risk HPV test may be ordered as a reflex test with a liquid-based Pap Test. Reflex High Risk HPV DNA test applies if the cytologic diagnosis is Atypical Squamous Cells of Undermined Significance (ACS-US) for patients >= 21 years of age or a Low Grade Squamous Intraepithelial lesion (LSIL) for patients >= 50 years of age. Reflex HPV DNA testing will not be performed for any Pap abnormality if there has been a positive HPV DNA test for that patient during the preceding 12 months or for a patient who is <21 years of age. The current test methodology used is the Cobas® HPV Test. It is a clinically validated qualitative in vitro test for the detection of Human Papilloma Virus (HPV) in cervical specimens collected by a clinician using an endocervical brush/spatula and placed in the ThinPrep Pap Test PreservCyt® Solution. The test utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of 14 high-risk (HR) HPV types in a single analysis.

The Cobas® HPV test specifically identifies types HPV16 and HPV18 while concurrently detecting the rest of the high risk types (31,33,35,39,45,51,52,56,58,59,66 and 68).

Clinical Utility: The intended use of this test is as a replacement for the conventional method of Pap smear preparation for use in screening for the presence of atypical cells, cervical cancer, or its precursor lesions (Low-grade Squamous Intraepithelial Lesions, High-grade Squamous Intraepithelial Lesions), as well as all other cytologic categories as defined by The Bethesda System for Reporting Cervical/ Vaginal Cytologic Diagnoses.

Link: Cytology Services Liquid-Based Paps

Unacceptable Conditions:

ThinPrep Preservcyt specimen vial exceeding the expiration date printed on the container. Specimens stored or transported outside of required temperature range 59-86° F (15-30° C).

Unlabeled specimen containers.

A mismatch between the specimen label and the LIS order.

A leaking specimen that is not salvageable.

Incomplete order.

A specimen received > 6 weeks past the date of collection.

HPV testing will not be conducted on a concurrent pap with an unsatisfactory diagnosis.

Components

Specimen Requirements