Gynecologic Pap Test + C/G w/Reflex to HPV High-risk (ASC-U, ASC-H, LSIL, HSIL, AGUS)w/Reflex to 16 and 18*

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Category:

Turnaround Time: 3-7 days
CPT Code:

 87491; 87591; 88142. If reflex testing is performed, concomitant CPT codes/charges will apply.

Reference Range:

Negative for intraepithelial lesion or malignancy.

Overview:

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, and 68, without differentiation of the individual types. This assay aids in the diagnosis of sexually-transmitted HPV infection and in the triage of patients with an ASCUS Pap test result. When the high-risk HPV result is positive, the specimen is tested specifically for types 16 and 18.

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.

Testing for Chlamydia trachomatis and Neisseria gonorrhoeae requires special procedures to be used in the processing of the cytology specimen; therefore testing for these organisms cannot be added on after the specimen has been submitted. The liquid-based cytology specimen must be processed for Chlamydia trachomatis and Neisseria gonorrhoeae testing.

Any time a transport device used for molecular testing is processed, the chance of cross-specimen contamination increases. Aptima® transports can be placed directly on the analyzer limiting the possibility of cross-specimen contamination.

American Society for Colposcopy and Cervical Pathology. HPV Genotyping Clinical Update. Hagerstown, Md: ASCCP; 2009:1-3.

Centers for Disease Control and Prevention. Screening Tests to Detect Chlamydia trachomatis and Neisseria gonorrhoeae Infections -- 2002. MMWR Recomm Rep. 2002; 51(RR-15), 1-38. PubMed 12418541

Hutchinson ML, Cassin CM, Ball HG 3rd. The efficacy of an automated preparation device for cervical cytology. Am J Clin Pathol. 1991; 96(3):300-305. PubMed 1877527

Hutchinson ML, Isenstein LM, Goodman A, et al. Homogeneous sampling accounts for the increased diagnostic accuracy using the ThinPrep® Processor. Am J Clin Pathol. 1994; 101(2):215-219. PubMed 8116578

Joseph MG, Cragg F, Wright VC, et al. Cytohistological correlates in a colposcopic clinic: A 1-year prospective study. Diagn Cytopathol. 1991; 7(5):477-481. PubMed 1954825

Wilbur DC, Cibas ES, Merritt S, et al. ThinPrep® Processor: Clinical trials demonstrate an increased detection rate of abnormal cervical cytologic specimens. Am J Clin Pathol. 1994; 101(2):209-214. PubMed 8116577

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:

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.)

If ThinPrep® vials are QNS for the hybrid capture assay, then a test requiring a lower input volume will be automatically performed if there is sufficient volume to perform that assay. If the additional assay is performed, testing for HPV genotypes 16 and 18 will not be performed due to volume limitations.

ThinPrep® vial or SurePath™ vial or ThinPrep® vial or SurePath™ vial and Aptima® swab collection kit (for Chlamydia/Gonococcus).

ThinPrep® Vial−Broom Only:

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 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.

SurePath™ Vial: When using the SurePath™ vial, the cervical broom must be used for specimen collection. Insert the broom into the cervical os and rotate five times. Place the broom head into the CytoRich™ preservative fluid in the SurePath™ collection vial. Tightly cap the vial.

Optional Dedicated Specimen for Chlamydia and Gonococcus: Use the Gen-Probe® Aptima® swab collection kit. (Note: Do not use the Gen-Probe® PACE DNA probe collection kit.) Clean the cervix using the larger, white-shafted swab supplied in the Gen-Probe® Aptima® swab collection kit and discard. Insert the smaller, blue-shafted swab into the cervix and rotate for 10 to 30 seconds to ensure good sampling. Carefully withdraw the blue-shafted swab, avoiding contact with the vaginal mucosa. Remove the cap from the swab specimen transport tube and immediately place the specimen collection swab into the transport tube. Break the swab shaft at the scoreline, using care to avoid splashing contents. Recap the swab specimen transport tube tightly.

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 three months of collection for HPV. SurePath™ vial 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.