Gynecologic Pap Test−Age-based Guideline for Cervical Cancer (Aptima®) and STDs

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. When the age guideline includes possible genotyping, the residual specimen will be tested individually for high-risk HPV genotypes 16 and 18,45 if the Pap evaluation is within normal limits and the initial HPV test is positive. 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.

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.)

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. Reflex testing for genotypes 16 and 18,45 may be indicated based on patient age and other test results. Testing for Chlamydia trachomatis and Neisseria gonorrhoeaerequires that 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.

Image-guided liquid-based Pap test; nucleic acid amplification (NAA). LabCorp protocol is based on the ACOG guidelines.^1,2 Aptima® is a registered trademark of Gen-Probe Inc.