Gynecologic Pap Test (Image-guided), Liquid-based Preparation and Chlamydia/Gonococcus, NAA and Human Papillomavirus (HPV) (Aptima®) With Reflex to HPV Genotypes 16 and 18,45
Use
Diagnose primary or metastatic neoplasm; detect Chlamydia trachomatis and Neisseria gonorrhoeae. High-risk HPV test 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. If the Pap evaluation is within normal limits and the initial HPV test is positive, then the residual specimen will be tested individually for high-risk HPV types 16 and 18,45.
Special Instructions
Not provided.
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 as 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.
Methodology
Immunoassay (Multiplex Protein Panel)
Biomarkers
Result Turnaround Time
3-6 days
Related Documents
For more information, please review the documents below
Specimen
Cervical Swab
Volume
ThinPrep® vial
Minimum Volume
Not provided
Container
ThinPrep® vial
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 rotate 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 ¼ to ½ 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.
Patient Preparation
Patient should avoid douches 48 to 72 hours prior to examination. Specimen should not be collected during or shortly after the menstrual period.
Storage Instructions
Maintain liquid-based cytology and Aptima® swab transport specimens at room temperature. Pap processing must be done within 21 days of collection. Specimens in ThinPrep® vials must be processed for testing within 21 days of collection for HPV. Liquid-based cytology specimens must be tested within seven days for Chlamydia/Gonococcus; if the Aptima® swab transport is used, it must be tested within 60 days.
Causes for Rejection
Improper collection; inadequate specimen; improper labeling; specimen leaked in transit; quantity not sufficient for analysis; name discrepancies; specimen submitted on male patient; specimen submitted in a vial that expired according to manufacturer's label; frozen specimen; SurePath™ vial. For Pap: liquid-based cytology specimen more than 21 days old. For HPV: specimen more than 21 days old in ThinPrep® vial. For Chlamydia trachomatis and Neisseria gonorrhoeae: liquid-based cytology specimen more than seven days old; Aptima® specimen more than 60 days old; Gen-Probe® Aptima® collection tube with multiple swabs, white-shafted cleaning swab, or any swab other than the collection swab.