Gynecologic Pap Test (Image-guided), Liquid-based Preparation and Chlamydia/Gonococcus, NAA With Reflex to High-risk HPV (Cobas®) When ASC-U
Use
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.
Special Instructions
Not provided.
Limitations
Suboptimal evaluation may occur due to inadequate ectocervical, endocervical, or vaginal cell populations. Excessive lubricating jelly can interfere with cytologic examinations, potentially resulting in unsatisfactory Pap results. Using the liquid-based cytology specimen for multiple tests might limit the volume available for Pap processing or HPV testing. HPV detection relies on the presence of viral copies, which can be affected by collection methods and patient factors. Tests for Chlamydia trachomatis and Neisseria gonorrhoeae require special processing procedures and cannot be added afterward. Cross-specimen contamination risk increases if a molecular testing transport device is processed.
Methodology
Other
Biomarkers
LOINC Codes
- 47527-7 - Cytology Cvx/Vag Doc Thin Prep
- 47528-5 - Cytology Cvx/Vag Doc Cyto
- 19764-0 - Stat of Adq Cvx/Vag Cyto-Imp
- 19773-1 - Recom F/U Cvx/Vag Cyto
- 50387-0 - C trach rRNA Cvx Ql NAA+probe
- 50388-8 - N gonorrhoea rRNA Cvx Ql NAA+probe
Result Turnaround Time
2-6 days
Related Documents
For more information, please review the documents below
Specimen
Cervical Swab
Volume
ThinPrep® vial or ThinPrep® vial and Aptima® swab collection kit (for Chlamydia/Gonococcus)
Minimum Volume
Not provided
Container
ThinPrep® vial or ThinPrep® vial and Aptima® swab collection kit (for Chlamydia/Gonococcus)
Collection Instructions
Insert the brush into the endocervical canal until only the bottom fibers are exposed. Rotate it 1/4 to 1/2 turn, transfer cells to the ThinPrep® vial, swirl the brush in the solution, and discard. Ensure an ectocervical sample using a plastic spatula, swirl, and discard. For Chlamydia/Gonococcus, use the Aptima® swab, insert into the cervix, and transfer to the swab specimen transport tube.
Patient Preparation
Avoid douches 48 to 72 hours before examination. Avoid collection during or shortly after the menstrual period.
Storage Instructions
Maintain specimens at room temperature. Pap processing within 21 days of collection; ThinPrep® vials for HPV within six months; Chlamydia/Gonococcus testing within seven days (or 60 days for Aptima® swabs). Do not freeze ThinPrep® specimens.
Causes for Rejection
Improperly collected, labeled, or shipped specimens; paucity of material or discrepancies in sample information; overly aged specimen.