Gynecologic Pap Test (Image-guided), Liquid-based Preparation and Chlamydia/Gonococcus/Trichomonas, NAA With Reflex to Human Papillomavirus (HPV) (Aptima®) When ASC-U 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 ASCUS Pap test result. Detect Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis. 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
Testing requires adequate samples of ectocervical, endocervical, or vaginal cells; suboptimal samples may inhibit evaluation. Lubricating jelly can interfere with cytologic exams, leading to unsatisfactory Pap results. Liquid-based cytology used for multiple tests may limit volume for Pap reprocessing or HPV testing. A negative result does not rule out HPV infection, as low infection levels or sampling errors can produce false negatives. Testing for Chlamydia, Gonococcus, and Trichomonas requires specific specimen processing and cannot be added post-submission.
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
- 19763-2 - Specimen source Cvx/Vag Cyto
- 52797-8 - Dx ICD code
- 22636-5 - Path report.relevant Hx Spec
- 22638-1 - Path report.comments Imp Spec
- 22639-9 - Path report.supplemental reports Spec
- 19767-3 - Cytologist Cvx/Vag Cyto
- 19769-9 - Pathologist Cvx/Vag Cyto
Result Turnaround Time
3-6 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 the Broom-like collection technique, use a broom-like device to collect a sample from the cervix, rinse the device in the PreservCyt® solution, and discard the device after tightening the cap. For the Brush/Spatula technique, use a brush for the endocervical canal and a spatula for the ectocervix with similar procedures for rinsing and disposal. Optional swabs for Chlamydia, Gonococcus, and Trichomonas should be collected with the Gen-Probe® Aptima® swab collection kit.
Patient Preparation
Patients should avoid douches for 48 to 72 hours prior to the exam, and specimens should not be collected during or just post-menstrual period.
Storage Instructions
Maintain specimen at room temperature and process Pap tests within 21 days of collection.
Causes for Rejection
Improper collection, labeling discrepancies, leakage during transit, inappropriate specimen volume, and the use of expired vials are causes for rejection. Pap tests over 21 days old are unacceptable, as are similar delays for HPV testing in ThinPrep® vials and Chlamydia/Gonococcus/Trichomonas more than 7 days old; Aptima® specimens are unacceptable over 60 days old.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 21 days for Pap; 21 days for HPV testing in ThinPrep® vial |