ThinPrep® liquid based Cytology -IVD

TEST:   CPT: 88142 or 88175 (with Imaging), 88141 (requiring a Path review)

Storage Instructions

Limitations

Methodology

Expected Turnaround Time 1-5 days

Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the report is sent to the ordering provider.  Additional time should be allowed for confirmatory, additional tests, or reflex tests. 

Additional Documentation

SPECIMEN COLLECTION GUIDE

SAMPLE REPORT

Specimen Requirements

Specimen

Cervical cells in liquid-based cytology ThinPrep® collection vial with PreserveCyt® solution.

Collection

Click on the ThinPrep® vial image for a color guide

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 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.

Record the patient's name and ID number on the vial, and place it and the test request form in a specimen bag for transport to the laboratory.

Store and transport specimens at room temperature (15 to 30°C). DO NOT freeze.  Specimen must be processed for testing within 21 days of collection.

Patient Preparation

Patient should avoid douches 48 to 72 hours prior to examination.  Specimen should not be collected during or shortly after menstrual period.  Excessive use of lubricating jelly on the vaginal speculum will interfere with cytologic examination.  Only minimal ThinPrep® approved lubricants should be used during collection.

Causes for Rejection

Improperly labeled vial; specimen more than 21 days old (from collection date) in liquid-based preservative; specimen submitted in vial that expired according to manufacturer's label; frozen specimen; improper labeling; specimen leaked in transit; quantity not sufficient for analysis; name discrepancies that are not resolved

Test Details

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.

ThinPrep® Pap test system