Gynecologic Pap Test (Image-guided), Liquid-based Preparation and Chlamydia/Gonococcus/Trichomonas, NAA With Reflex to High-risk HPV (Cobas®) With HPV Genotypes 16 and 18 When ASC-U
Use
Diagnose primary or metastatic neoplasm; detect Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. The HPV test specifically identifies types HPV16 and HPV18 while concurrently detecting the rest of the high-risk types: 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68 without further specific differentiation.
Special Instructions
Not provided.
Limitations
Inadequate collection of ectocervical, endocervical, or vaginal cells can impair evaluation accuracy. Overuse of lubricating jelly on the speculum can interfere with cytological examination, potentially leading to unsatisfactory results. If a liquid-based cytology specimen is used for multiple tests, it may reduce the volume for Pap or HPV testing. Detection of high-risk HPV depends on the number of viral copies in the specimen and can be affected by collection methods, patient factors, infection stage, and interfering substances. Testing for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis must be done using specific procedures and cannot be added after submission of the specimen. There is an increased risk of cross-contamination when using molecular testing transport devices.
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
- 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
- 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
2-6 days
Related Documents
For more information, please review the documents below
Specimen
Cervical Swab
Volume
ThinPrep® vial or ThinPrep® vial with optional additional Aptima® swab collection kit (for Chlamydia/Gonococcus/Trichomonas)
Minimum Volume
Not provided
Container
ThinPrep® vial
Collection Instructions
For Pap collection: Use the brush/spatula technique. Insert the brush into the endocervical canal, rotate 1/4 to 1/2 turn in one direction, then in PreservCyt® solution, rotate 10 times, swirl the brush vigorously, and discard it. Use a spatula to obtain an ectocervical sample, swirl in a ThinPrep® vial, then discard. For Chlamydia/Gonococcus/Trichomonas: Use the Gen-Probe® Aptima® swab collection kit. Clean the cervix, insert the swab into the cervix, rotate for 10 to 30 seconds, and place it in the transport tube.
Patient Preparation
Avoid douches 48 to 72 hours prior. Do not collect during or after menstrual period. Excessive lubricant will interfere with examination.
Storage Instructions
Keep at room temperature. Pap processing must occur within 21 days of collection. For HPV, ThinPrep® vial is valid for 6 months. For Chlamydia/Gonococcus/Trichomonas, test within 7 days; Aptima® transport is valid for 60 days.
Causes for Rejection
Improper collection, inadequate specimen, improper labeling, leaked specimen, insufficient quantity, patient name discrepancies, submission on male patients. Pap: Over 21 days old; HPV: Over 6 months in ThinPrep® vial; Chlamydia/Gonococcus/Trichomonas: Over 7 days old in ThinPrep® vial, over 60 days in Aptima® collection.