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Gynecologic Pap Test−Age-based Guideline for Cervical Cancer Screening (Cobas® method) Plus Chlamydia/Gonococcus/Trichomonas

CPT: Call client services.

Special Instructions

Include date of birth, Social Security number (or other identification number), previous malignancy, drug therapy, radiation therapy, last menstrual period (LMP), postmenopausal patient (PMP), surgery (including surgical biopsies), exogenous hormones, abnormal vaginal bleeding, abnormal Pap results, IUD, and all other pertinent clinical information on the cytology test request form.

Note: In accordance with criteria established by CLIA, Pap smears will be referred for pathologist review if laboratory personnel suspect:

• Reactive or reparative cellular changes

• Atypical squamous or glandular cells of undetermined significance

• 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.)


Related Information


Specimen Requirements


Specimen

Cervical cells in ThinPrep® vial


Volume

ThinPrep® vial


Minimum Volume

A minimum volume cannot be determined for the ThinPrep® vial because it varies depending on the cellularity of the specimen.


Container

ThinPrep® vial


Collection

Brush/spatula technique: Insert the brush into the endocervical canal until only the bottom-most 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. Tighten the cap on the ThinPrep® container so that the torque line on the cap passes the torque line on the vial.


Storage Instructions

Maintain liquid-based cytology specimens at room temperature. Pap processing must be performed within 21 days of collection. ThinPrep® vial may be stored for six months after the date of collection prior to performing the Cobas® HPV test. ThinPrep® specimens should not be frozen. Liquid-based cytology specimens must be tested within seven days for Chlamydia/Gonococcus/Trichomonas.


Patient Preparation

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


Causes for Rejection

Improper collection; inadequate specimen; improper labeling; frozen specimen; specimen leaked in transit; quantity not sufficient for analysis; name discrepancies; specimen submitted on male patients; For Pap: liquid-based cytology specimen more than 21 days old. For HPV: specimen more than six months old in ThinPrep® vial; excessively bloody specimens. For Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis: liquid-based cytology specimen more than seven days old.


Test Details


Use

Diagnose primary or metastatic neoplasm. Detect Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. High-risk HPV is used for types 16 and 18 and a combined result for types 31,33,35,39,45,51,52,56,58,59,66, and 68, without differentiation of the individual type. 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.


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 14 most common high-risk HPV types.

Testing for Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis requires special procedures be used in the processing of the cytology specimen; therefore, testing for these organisms cannot be added on after the specimen has been submitted.


Methodology

Image-guided liquid-based Pap test; nucleic acid amplification (NAA). LabCorp protocol is based on ACOG guidelines.


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