Human Papillomavirus High Risk TypeIndications:
Many women with high-risk types of HPV infection never progress to more severe cervical cell changes or cancer. However, high-risk HPV types have been found in most women who are diagnosed with cervical cancer. HPV testing for high-risk types may help determine treatment for a woman with minor cervical cell changes. ThinPrep Liquid Based pap test. One specimen will be used to provide samples for both the Pap test and/or the High Risk (HR) HPV test.
Sampling of the superficial cells of the cervix, endocervix and/or vagina to detect premalignant and malignant lesions of the uterine cervix and other abnormalities of the reproductive tract. The Thin Prep® Pap Test™ ™ is intended as a replacement for the conventional method of Pap smear preparation. Studies have shown that this procedure decreases fixation artifacts, provides a more uniform specimen for microscopic evaluation and increases the yield of abnormal cells.
1. Vaginal speculum
2. Thin Prep® Collection Kit (which includes plastic spatula and brush or broom device
and PreservCyt® Solution vial
3. CPA gynecologic cytology requisition form
4. biohazard bag for specimen transport
Please note the following Thin Prep® Pap Test™ important information:
• Wooden spatulas cannot be used for the Thin Prep® Pap Test™. The wood is porous
and cellular material will stick to the collection device and not be transferred to the collection
vial. The Thin Prep® Pap Test™ is only FDA approved for use with the plastic spatula
device, brush or broom device.
• Caution: PreservCyt® solution contains methanol, which is poisonous and may be fatal or
cause blindness if swallowed. Vapor is harmful if inhaled. This solution causes eye and skin
irritation. PreservCyt® is flammable: keep away from fire, heat, sparks and flame. Other
solutions must not be substituted for PreservCyt® solution. PreservCyt® should be stored
and disposed of in accordance with local, state and federal regulations. Check the expiration
date on the vial prior to use. The laboratory cannot accept samples in expired
In premenopausal patients, obtain specimen during second half of menstrual cycle (if possible) to avoid obscuring blood. Instruct the patient not to douche or engage in sexual intercource within 24 hours of the procedure
1. Print the patient's name (last, first) on the PreservCyt® solution vial. The laboratory
CANNOT accept unlabeled specimens. Check the expiration date to be sure the solution
has not expired. The laboratory CANNOT accept specimens in expired solution vials.
2. Place the patient in the lithotomy position. Using a speculum lubricated with warm water,
expose the cervix as fully as possible. DO NOT use lubricant as this will interfere with the
3. If excess mucus, exudates or blood is present at the cervical os, remove with a folded
gauze pad or large cotton-tipped swab.
4. SPATULA/BRUSH TECHNIQUE: Obtain an adequate sample from the ectocervix
(and transition zone if visible) by rotating the plastic spatula device five times around the
circumference of the cervix. Rinse the spatula in the PreservCyt® solution vial by swirling
the spatula vigorously 10 times in the vial. Discard the spatula. Obtain an adequate sample
from the endocervix by inserting the brush device into the cervix until only the bottom most
fibers are exposed. Slowly rotate ¼ to ½ turn in one direction. DO NOT OVER ROTATE.
Rinse the brush in the PreservCyt® solution by rotating the device in the solution while
pushing against the wall of the vial. Rotate 10 times. As a final step, swirl the brush
vigorously to further release material. Discard the brush. BROOM TECHNIQUE: Obtain
an adequate sample from both the ectocervix and endocervix simultaneously by inserting
the center of the device into the cervical os until gentle resistance is felt and the outer-most
tips of the broom are flat on the ectocervix. Push gently and rotate the broom five times,
in a clockwise direction, 360 degrees around the os. Rinse the broom in the PreservCyt®
solution vial by rotating the device in the solution 10 times, pushing the bristles of the
broom against the bottom and edges of the vial (like rinsing a paint brush) to dislodge the
material. Discard the broom. DO NOT cut off the end of the collection device and leave
in the vial. The cellular material will harden onto the device and not effectively transfer to
5. Tighten the cap on the PreservCyt® solution vial so the torque line on the cap passes the
torque line on the vial.
6. Use the specimen collection biohazard bags provided by CPA. Place the completed
requisition in the outside pocket and the properly labeled PreservCyt® solution vial in
the zip lock portion of the bag. Send to CPA for processing. The laboratory CANNOT
accept unlabeled vials or specimens without a properly filled out requisition form.
If additional educational materials are desired on the proper collection technique used for the Thin Prep® Pap Test™, please contact CPA.
Submit all patient information following the procedure for "Completing a Gynecologic Cytology Requisition".
Complete test requisition including last and first name of patient, patient's date of birth and social security number, body site and source of specimen collected. Label specimen container (using the labels provided on the requisition) with patient's first name and last name, and body site/source. The container must have at least two (2) unique identifiers. Examples of unique identifiers: patient name, DOB, unique bar code, etc. Include pertinent clinical information, i.e., previous malignancy, radiation therapy, drugs, etc. Place container in a specimen bag with a biohazard label. Place the requisition in the side pocket of the specimen bag.
924 Montclair Road, Suite 200, Birmingham, Alabama 35213 P: 888.553.8584 F: 205.591.5051