Gynecologic Pap Test (Image-guided), Liquid-based Preparation and Chlamydia/Gonococcus, NAA with Reflex to Human Papillomavirus (HPV) (Aptima®) When ASC-U, ASC-H, LSIL, HSIL, AGUS With Reflex to HPV Genotypes 16 and 18,45
Use
Diagnose primary or metastatic neoplasm. This test aids in the diagnosis of sexually transmitted HPV infection and in the triage of patients with an abnormal Pap test result. 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. Positive high risk HPV test results reflex the sample for genotyping of types 16 and 18/45.
Special Instructions
Not provided.
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.
Methodology
Image-guided liquid-based Pap test; nucleic acid amplification (NAA)
Biomarkers
LOINC Codes
- 47527-7
- 47528-5
- 56850-1
- 19773-1
- 19764-0
- 19763-2
- 52797-8
- 22636-5
- 22638-1
- 22639-9
- 19767-3
- 19769-9
- 11546-9
- 47527-7
- 50387-0
- 50388-8
Result Turnaround Time
3-6 days
Related Documents
For more information, please review the documents below
Specimen
Unknown
Volume
Not provided
Minimum Volume
Not provided
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; specimen leaked in transit; quantity not sufficient for analysis; name discrepancies; specimen submitted on male patient; specimen submitted in vial that expired according to manufacturer's label; frozen specimen; SurePath™ vial. For Pap: liquid-based cytology specimen more than 21 days old. For HPV: specimen more than 21 days old in ThinPrep® vial. For Chlamydia trachomatis and Neisseria gonorrhoeae: liquid-based cytology specimen more than seven days old; Aptima® specimen more than 60 days old; Gen-Probe® Aptima® collection tube with multiple swabs, white-shafted cleaning swab, or any swab other than the collection swab.