Gynecologic Pap Test (Image-guided), Liquid-based Preparation and Chlamydia/Gonococcus, 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 and Neisseria gonorrhoeae. 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
The accuracy of the test depends on obtaining an adequate ectocervical, endocervical, or vaginal cell population. Excessive use of lubricating jelly can interfere with the cytologic examination leading to unsatisfactory results. The liquid-based cytology specimen may limit the volume available for Pap or HPV testing, and detection of high-risk HPV relies on the presence of a sufficient number of copies. Special specimen processing procedures are required for Chlamydia and Gonococcus testing. Cross-specimen contamination poses a risk particularly when molecular testing transports are processed, although the Aptima® transports mitigate this risk.
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
- 11546-9 - Other Stn Spec
- 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 with optional additional Aptima® swab collection kit (for Chlamydia/Gonococcus)
Minimum Volume
Not provided
Container
ThinPrep® vial or ThinPrep® vial with optional Aptima® swab collection kit (for Chlamydia/Gonococcus)
Collection Instructions
Brush/spatula technique: Insert the brush into the endocervical canal until only the bottommost fibers are exposed. Slowly rotate the brush 1/4 to 1/2 turn in one direction. Do not over-rotate the brush. Then, rotate the brush in the PreservCyt® solution 10 times while pushing against the wall of the ThinPrep® vial. Swirl the brush vigorously to release additional material. Discard the brush. Obtain an adequate sample from the ectocervix using a plastic spatula. Swirl vigorously in the ThinPrep® vial 10 times and discard the spatula. Tighten the cap on the ThinPrep® container so that the torque line on the cap passes the torque line on the vial.
Patient Preparation
Patient should avoid douches 48 to 72 hours prior to examination. Specimen should not be collected during or shortly after menstrual period. Excessive use of lubricating jelly will interfere with cytologic examination.
Storage Instructions
Maintain liquid-based cytology specimens at room temperature. Pap processing must be performed within 21 days of collection. ThinPrep® vial may be stored for six months after the date of collection prior to performing the Cobas® HPV test. Liquid-based cytology specimens must be tested within seven days for Chlamydia/Gonococcus; if the Aptima® swab transport is used, it must be tested within 60 days.
Causes for Rejection
Improper collection; inadequate specimen; improper labeling; frozen specimen; specimen leaked in transit; quantity not sufficient for analysis; name discrepancies; specimen submitted on male patients. For Pap: liquid-based cytology specimen more than 21 days old. For HPV: specimen more than six months old in ThinPrep® vial; excessively bloody specimens. For Chlamydia and Gonococcus: 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 blue-shafted collection swab.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | up to 21 days |
| Frozen | Not advisable |