Gynecologic Pap Test (Image Guided), Liquid-Based Preparation and Human Papillomavirus (HPV), High-Risk DNA Detection
| Gynecologic Pap Test (Image Guided), Liquid-Based Preparation and Human Papillomavirus (HPV), High-Risk DNA Detection | | | |
| Number | | 199123 |
| CPT | | 87621; 88175 |
| Related Information | | Liquid-Based Gynecologic Pap Test Selection Chart |
Synonyms | | DNAwithPap™ Image Guided |
| Test Includes | | Image-guided liquid-based cytology evaluation and evaluation for the presence of high-risk HPV DNA sequences |
| Special Instructions | | Include date of birth, Social Security number (or other
identification number), previous malignancy, drug therapy,
radiation therapy, LMP, 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:
1) reactive or reparative cellular changes
2) atypical squamous or glandular cells of undetermined
significance
3) 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.) |
| Specimen | | Cervical cells collected by one of the methods described
below. |
| Volume | | ThinPrep® vial or SurePath® vial or ThinPrep®
vial or SurePath® vial with optional additional Digene
DNA collection device (for HPV). |
| Minimum Volume | | 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. |
| Container | | ThinPrep® vial or SurePath® vial or ThinPrep®
vial or SurePath® vial and Digene DNA collection device
(for HPV). |
| Collection | | 1. ThinPrep® vial-broom only
Broom-like collection technique:
- 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.
- 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.
- 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.
- Insert the broom into the cervical os and
rotate 5 times.
- Place the broom head into the CytoRich®
preservative fluid in the SurePath® collection
vial.
- Tightly cap the vial.
Optional dedicated specimen for HPV-Digene hc2 DNA
collection device (supplied by LabCorp):
- First remove excess mucus from the cervical
os and surrounding ectocervix using a cotton or polyester
swab. Discard this swab.
- 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.
- 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 Instructions | | 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 Preparation | | Patient should avoid douches 48-72 hours prior to
examination. Specimen should not be collected during or
shortly after menstrual period. |
| Causes for Rejection | | 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 |
| Use | | Diagnose primary or metastatic neoplasm. The high-risk HPV
test is used for 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. |
| Limitations | | 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 test detects only the
13 most common high-risk HPV types and cannot determine the
specific HPV type present. |
| Methodology | | Image-guided liquid-based Pap test; nucleic acid
amplification (NAA) |
| References | | 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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