Gynecologic Pap Test (Image Guided), Liquid-Based Preparation and Human Papillomavirus (HPV), High- and Low-Risk DNA Detection
Gynecologic Pap Test (Image Guided), Liquid-Based Preparation and Human Papillomavirus (HPV), High- and Low-Risk DNA Detection
    
Number
198190
CPT
87621 (x2); 88175
Related Information
  • Liquid-Based Gynecologic Pap Test Selection Chart
    • Synonyms
    HPV Hybrid Capture II® Assay, High/Low Risk ; Image-Guided Liquid-Based Pap ; Liquid-Based Pap, Image Guided ; Out-of-the-Vial Testing
    Test Includes
    Image-guided liquid-based cytology evaluation and evaluation for the presence of high- and low-risk HPV DNA sequences
    Special Instructions
    Include patient's name, date of birth, Social Security number, previous malignancy, drug therapy, radiation therapy, last menstrual period (LMP), postmenopausal patient (PMP), surgery (including surgical biopsies), exogenous hormones, abnormal vaginal bleeding, abnormal Pap results, IUD, and all other pertinent clinical information on the cytology request form.

    Note: In accordance with criteria established by CLIA, Pap smears will be referred for pathologist review if laboratory personnel suspect:

    • reactive or reparative cellular changes
    • atypical squamous or glandular cells of undetermined significance
    • cells in the premalignant or malignant category

    In these cases, LabCorp will charge for the associated service. (Slides that are routinely reviewed by a pathologist for quality control purposes are not included.)

    SpecimenSpecimen - Updated August 6 2007
    Cervical cells collected by one of the methods described below.
    VolumeVolume - Updated August 6 2007
    ThinPrep® vial or SurePath® vial or ThinPrep® vial or SurePath® vial with optional additional Digene DNA collection device (for HPV).
    Minimum VolumeMinimum Volume - Updated August 6 2007
    A minimum volume cannot be determined for the ThinPrep® vial because it varies depending on the cellularity of the specimen. The entire SurePath® specimen should arrive intact. Specimens collected with the Digene DNA collection device must arrive intact.
    ContainerContainer - Updated August 6 2007
    ThinPrep® vial or SurePath® vial or ThinPrep® vial or SurePath® vial and Digene DNA collection device (for HPV).
    CollectionCollection - Updated August 6 2007
    1. ThinPrep® vial-broom only
    Broom-Like Collection Technique:
    1. Obtain a sample from the cervix using a broom-like device by inserting the brush portion into the cervical os and rotate the brush 5 times.
    2. Rinse the collection device in the PreservCyt® solution by pushing the brush into the bottom of the vial 10 times, forcing the bristles to bend apart to release the cervical material. As a final step, twirl the brush between the thumb and forefinger vigorously to further release cellular material. Discard the collection device.
    3. Tighten the cap on the ThinPrep® vial so that the torque line on the cap passes the torque line on the vial.
    2. SurePath® vial
    When using the SurePath® vial, the cervical broom must be used for specimen collection.
    1. Insert the broom into the cervical os and rotate 5 times.
    2. Place the broom head into the CytoRich® preservative fluid in the SurePath® collection vial.
    3. Tightly cap the vial.

    Optional dedicated specimen for HPV-Digene hc2 DNA collection device (supplied by LabCorp):

    1. First remove excess mucus from the cervical os and surrounding ectocervix using a cotton or polyester swab. Discard this swab.
    2. To obtain specimen, insert the Digene Cervical Sampling Brush 1.0-1.5 centimeters into the cervical os until the largest bristles touch the ectocervix. Do not insert brush completely into the cervical canal. Rotate brush 3 full turns in a counterclockwise direction, remove from the canal.
    3. Insert brush into the transport tube. Snap off shaft at scored line, leaving brush end inside tube, and recap securely by snapping in place.
    Storage InstructionsStorage Instructions - Updated August 6 2007
    Maintain liquid-based cytology specimens at room temperature. Maintain Digene DNA collection kit at room temperature for up to 2 weeks, and refrigerated for up to 3 weeks. Pap processing must be done within 21 days of collection. Cervical specimens collected using the Digene DNA collection device or SurePath® vial must be processed for testing within 21 days of collection for HPV. Specimens in ThinPrep® vials must be processed for testing within 3 months of collection for HPV.
    Patient PreparationPatient Preparation - Updated August 6 2007
    Patient should avoid douches 48-72 hours prior to examination. Specimen should not be collected during or shortly after menstrual period.
    Causes for RejectionCauses for Rejection - Updated July 10 2008
    Improper collection or inadequate specimen; improperly labeled specimen; specimen leaked in transit; quantity not sufficient for analysis; name discrepancies; specimens submitted on male patients; For Pap: liquid-based cytology specimen more than 21 days old; For HPV: specimen more than 21 days old in Digene DNA collection kit or SurePath® liquid-based preservative, specimen more than 3 months old in ThinPrep® vial; specimen was submitted in a vial that expired according to the manufacturer's label
    UseUse - Updated August 6 2007
    Diagnose primary or metastatic neoplasm.
    The HPV test provides a qualitative molecular detection of 18 different human papillomavirus types in cervical specimens. The HPV test distinguishes between two HPV DNA groups: low-risk HPV types (6,11,42,43,44) and high-risk types (16,18,31,33,35,39,45,51,52,56,58,59,68), without differentiation of the individual type. This assay aids in the diagnosis of sexually-transmitted HPV infection and for the triage of patients with an ASCUS Pap smear result.
    LimitationsLimitations - Updated August 6 2007
    Failure to obtain adequate ectocervical, endocervical, or vaginal cell population is suboptimal for evaluation. Excessive use of lubricating jelly on the vaginal speculum will interfere with cytologic examination and may lead to unsatisfactory Pap results. The use of the liquid-based cytology specimen for multiple tests may limit the volume available for Pap reprocessing or HPV testing.

    A negative result does not exclude the possibility of an HPV infection since very low levels of infection or sampling error may produce a false-negative result. This HPV test distinguishes between two groups of HPV types: low-risk HPV (6,11,42,43,44) and high-risk HPV (16,18,31,33,35,39,45,51, 52,56,58,59,68) and cannot determine the specific HPV type present.

    MethodologyMethodology - Updated August 6 2007
    Image-guided liquid-based Pap test; nucleic acid amplification (NAA)
    ReferencesReferences - Updated August 6 2007

    Ferris DG, Wright TC Jr, Litaker MS, et al, “Comparison of Two Tests for Detecting Carcinogenic HPV in Women With Papanicolaou Smear Reports of ASC-US and LSIL,” J Fam Pract, 1998, 46(2):136-141.

    Manos MM, Kinney WK, Hurley LB, et al, “Identifying Women With Cervical Neoplasia: Using Human Papillomavirus DNA Testing for Equivocal Papanicolaou Results,” JAMA, 1999, 281 (17):1605-1610.

    Schiffman M, Herrero R, Hildesheim A, et al, “HPV DNA Testing in Cervical Cancer Screening: Results From Women in a High-Risk Province of Costa Rica,” JAMA, 2000, 283(1):87-93.


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