Gynecologic Pap Test-Age-based Guideline for Cervical Cancer (Aptima®) *

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Turnaround Time: 2 - 5 days
Test Type: Cervical cells in ThinPrep® vial


Diagnose primary or metastatic neoplasm. High-risk HPV is used for types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68, without differentiation of the individual type. When the age guideline includes possible genotyping, the residual specimen will be tested individually for high-risk HPV genotypes 16 and 18,45 if the Pap evaluation is within normal limits and the initial HPV test is positive. This information, together with the physician's assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. The results of this test are not intended to prevent women from proceeding to colposcopy.

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 14 most common high-risk HPV types. Reflex testing for genotypes 16 and 18,45 may be indicated based on patient age and other test results.

1. American College of Obstetrics and Gynecologists. Screening for Cervical Cancer. ACOG Practice Bulletin N° 131, November 2012. Obstet Gynecol. 2012 Nov; 120(5):1222-1238.
2. American College of Obstetrics and Gynecologists. Primary and Preventive Care: Periodic Assessments. ACOG Committee Opinion N° 483, April 2011. Obstet Gynecol. 2011 Apr; 117(4):1008-1015.

Collection Details:

Patient Preparation:

Patient should avoid douches 48 to 72 hours prior to examination. Specimen should not be collected during or shortly after menstrual period.

Collection Instructions:

ThinPrep® Vial − Broom or Brush/Spatula:

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 then rotating the brush five 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 release additional 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.

Brush/spatula technique: Insert the brush into the endocervical canal until only the bottommost fibers are exposed. Slowly rotate the brush 1/4 to 1/2 turn in one direction. Do not over-rotate the brush. Then, rotate the brush in the PreservCyt® solution 10 times while pushing against the wall of the ThinPrep® vial. Swirl the brush vigorously to release additional material. Discard the brush. Obtain an adequate sample from the ectocervix using a plastic spatula. Swirl vigorously in the ThinPrep® vial 10 times and discard the spatula. Tighten the cap on the ThinPrep® container so that the torque line on the cap passes the torque line on the vial.

Maintain liquid-based cytology specimen at room temperature. Pap processing must be performed within 21 days of collection. Specimens in ThinPrep® vials must be processed for testing within three months of collection for HPV.