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 using SurePath™ specimen
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 effectiveness of the test can be significantly compromised by the failure to obtain adequate ectocervical, endocervical, or vaginal cell populations. The overuse of lubricating jelly on the vaginal speculum can lead to unsatisfactory Pap results due to interference with cytologic examination. The detection of high-risk HPV depends on the specimen's copy number and can be influenced by collection methods, patient factors, stage of infection, and interfering substances.
Methodology
Other
Biomarkers
Chlamydia trachomatis
MicroorganismHPV
MicroorganismNeisseria gonorrhoeae
Microorganism
LOINC Codes
- 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
- 11546-9 - Other Stn Spec
- 8251-1 - Service Cmnt-Imp
- 47527-7 - Cytology Cvx/Vag Doc Thin Prep
- 71431-1 - HPV HR 12 DNA Cvx Ql NAA+probe
- 77399-4 - HPV16 DNA Cvx Ql NAA+probe
- 77400-0 - HPV18 DNA Cvx Ql NAA+probe
Result Turnaround Time
2-5 days
Related Documents
For more information, please review the documents below
Specimen
Cervical Swab
Volume
Entire SurePath™ vial and Aptima® device
Minimum Volume
Entire SurePath™ vial and Aptima® device
Container
SurePath™ vial and Aptima® device
Collection Instructions
SurePath™ vial - Using a cervical broom: Insert the broom into the cervical os and rotate five times. Place the broom head into the CytoRich™ preservative fluid in the SurePath™ collection vial. Tightly cap the vial. For Chlamydia and Gonococcus: Aptima® vaginal swab or unisex swab collection kit. Vaginal Swab Kit: Collect vaginal fluid sample using the Gen-Probe® Aptima® swab by contacting the swab to the lower third of the vaginal wall and rotating the swab for 10 to 30 seconds to absorb fluid. Immediately place the swab into the transport tube and carefully break the swab shaft against the side of the tube. Tightly screw on the cap. Unisex Swab Kit: Clean the cervix using the larger, white-shafted swab supplied in the Gen-Probe® Aptima® swab collection kit and discard. Insert the smaller, blue-shafted swab into the cervix and rotate for 10 to 30 seconds to ensure good sampling. Carefully withdraw the blue-shafted swab, avoiding contact with the vaginal mucosa. Remove the cap from the swab specimen transport tube and immediately place the specimen collection swab into the transport tube. Break the swab shaft at the scoreline, using care to avoid splashing contents. Recap the swab specimen transport tube tightly.
Patient Preparation
Patients should avoid douches 48 to 72 hours prior to examination. The specimen should not be collected during or shortly after the menstrual period.
Storage Instructions
Room temperature
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 four weeks old in SurePath™ vial; excessively bloody specimens. For Chlamydia and Gonococcus: Aptima® specimen more than 60 days old; Gen-Probe® Aptima® collection tube with multiple swabs or white-shafted cleaning swab.