Gynecologic Pap Test−Age-based Guideline for Cervical Cancer (Aptima®)
Also known as: Age-based Guideline for Cervical Cancer, Cervical Cancer Screening
Use
Diagnose primary or metastatic neoplasm. High-risk HPV 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.
Special Instructions
The test instructions specify the need to include date of birth, Social Security number, previous malignancy, drug therapy, radiation therapy, last menstrual period, postmenopausal patient status, surgeries, exogenous hormones, abnormal vaginal bleeding, abnormal Pap results, IUD usage, and other pertinent clinical information on the cytology test request form.
Limitations
There may be limitations due to failure to obtain adequate ectocervical, endocervical, or vaginal cell population, which is suboptimal for evaluation. Excessive use of lubricating jelly on the vaginal speculum interferes with cytologic examination and may lead to unsatisfactory Pap results. Furthermore, using the liquid-based cytology specimen for multiple tests might limit the volume available for Pap reprocessing or HPV testing. A negative result does not exclude the possibility of HPV infection, as 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.
Methodology
Other
Biomarkers
LOINC Codes
- 47798-3
Result Turnaround Time
2-5 days
Related Documents
For more information, please review the documents below
Specimen
Other
Volume
ThinPrep® vial
Minimum Volume
Not provided
Container
ThinPrep® vial
Collection Instructions
For Broom-like collection technique: insert the brush into the cervical os, rotate five times, rinse in PreservCyt® solution. For Brush/spatula technique: insert the brush in the endocervical canal, rotate, rinse in PreservCyt® solution. Adequately collect from the ectocervix using a spatula, swirl in ThinPrep® vial.
Patient Preparation
Avoid douches 48 to 72 hours prior to examination. Do not collect specimen during or shortly after menstrual period.
Storage Instructions
Maintain at room temperature. Pap processing within 21 days; HPV testing within 3 months.
Causes for Rejection
Improper collection, inadequate specimen, improper labeling, specimen leaked, insufficient quantity, name discrepancies, specimen on male patient, expired vial, frozen specimen, submission in SurePath™ vial.