Gynecologic Pap Test (IG) + Chlamydia/Gonococcus w/Reflex to High-risk HPV (ASC-U)*

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Category:

Turnaround Time: 2-6 days
CPT Code:

87491; 87591; 88175. 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. The 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 types. This assay aids in the diagnosis of sexually transmitted HPV infection and in the triage of patients with an ASCUS Pap test result.

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 processing or HPV testing. Detection of high-risk HPV is dependent on the number of copies present in the specimen and may be affected by specimen collection methods, patient factors, stage of infection, and the presence of interfering substances.

Testing for Chlamydia trachomatis and Neisseria gonorrhoeae 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. 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.

Ferris DG, Wright TC, Litaker MS, et al. Triage of women with ASCUS and LSIL Pap smear reports: Management by repeat Pap smear, HPV DNA testing, or colposcopy. J Fam Pract. 1998 Feb; 46(2):125-134. PubMed 1877527

Manos MM, Kinney WK, Hurley B, et al. Identifying women with cervical neoplasia: Using human papillomavirus DNA testing for equivocal Papanicolaou results. JAMA. 1999 May 5; 281:1605-1610. PubMed 8116578

Schiffman M, Herrero R, Hildesheim A, et al. HPV DNA testing cervical cancer screening: Results from women in a high-risk province in Costa Rica. JAMA. 2000 Jan 5; 283(1):87-93. PubMed 1954825

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 tests 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.)

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

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.

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 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; if the Aptima® swab transport is used, it must be tested within 60 days.