Gynecologic Pap Test (Image-guided), Liquid-based Preparation and Chlamydia/Gonococcus/Trichomonas, NAA With Reflex to Cobas® High-risk HPV With HPV Genotypes 16 and 18 When ASC-U, ASC-H, LSIL, HSIL, AGUS
Use
The Gynecologic Pap test is used to diagnose primary or metastatic neoplasm, as well as detect infections such as those caused by Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. Additionally, it includes an HPV test that specifically identifies high-risk HPV types HPV16 and HPV18, while also detecting other high-risk types including 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68, but without further differentiation. This test aids in the screening of premalignant and malignant cervical conditions.
Special Instructions
Not provided.
Limitations
Failure to collect an adequate ectocervical, endocervical, or vaginal cell population can lead to suboptimal evaluation. Excessive use of lubricating jelly can interfere with cytologic examination. The liquid-based cytology specimen must be adequately sampled for processing tests for Chlamydia, Gonococcus, and Trichomonas, as these cannot be added after submission. Cross-contamination risk exists when a molecular testing device is used, though the Aptima® transports aim to mitigate this risk.
Methodology
Other
Biomarkers
LOINC Codes
- 47528-5 - Cytology Cvx/Vag Doc Cyto
- 19764-0 - Stat of Adq Cvx/Vag Cyto-Imp
- 19763-2 - Specimen source Cvx/Vag Cyto
- 52797-8 - Dx ICD code
- 19767-3 - Cytologist Cvx/Vag Cyto
- 19769-9 - Pathologist Cvx/Vag Cyto
- 47527-7 - Cytology Cvx/Vag Doc Thin Prep
- 50387-0 - C trach rRNA Cvx Ql NAA+probe
- 50388-8 - N gonorrhoea rRNA Cvx Ql NAA+probe
- 46154-1 - T vaginalis rRNA Spec Ql NAA+probe
Result Turnaround Time
3-6 days
Related Documents
For more information, please review the documents below
Specimen
Other
Volume
ThinPrep® vial or ThinPrep® vial with optional Aptima® swab collection kit
Minimum Volume
Not provided
Container
ThinPrep® vial
Collection Instructions
Use the brush/spatula technique to collect cells. Rotate the brush in the endocervical canal and in PreservCyt® solution as instructed before discarding. Obtain ectocervical sample using a plastic spatula in the ThinPrep® vial and discard. For Chlamydia, Gonococcus, Trichomonas testing, use the Gen-Probe® Aptima® swab collection kit as instructed.
Patient Preparation
Avoid douches 48-72 hours before examination. Do not collect the specimen during or shortly after menstruation. Avoid excess use of lubricating jelly.
Storage Instructions
Store at room temperature. Pap processing must occur within 21 days of collection. ThinPrep® vial can be kept for six months before conducting Cobas® HPV test. HPV testing requires the liquid-based specimen to be used within seven days for Chlamydia, Gonococcus, Trichomonas testing or 60 days if Aptima® swab transport is used.
Causes for Rejection
Specimen collection errors, improper labeling, insufficient quantity, or submissions on male patients are potential causes for rejection. For Pap: liquid-based cytology specimens over 21 days; for HPV: specimen more than six months in ThinPrep® vial or excessively bloody specimens; for Chlamydia, Gonococcus, and Trichomonas: specimen over seven days or Aptima® specimen over 60 days.