Gynecologic Pap Test (Image-guided), Liquid-based Preparation and Chlamydia/Gonococcus, NAA With Reflex to High-risk HPV (Cobas®) When ASC-U using SurePath™ specimen
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 type. 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
Ensure to include the patient's date of birth, Social Security number (or other ID), past malignancy history, drug and radiation therapy records, and last menstrual period details. The test requires a dedicated specimen for Chlamydia and Gonococcus detection. It's important to note that in accordance with CLIA criteria, samples may be referred for pathologist review under specific conditions which will incur additional charges.
Limitations
The test's accuracy can be compromised if adequate ectocervical, endocervical, or vaginal cell populations are not obtained. The presence of excessive lubricating jelly on the vaginal speculum could interfere with cytologic examination, resulting in unsatisfactory Pap outcomes. HPV detection relies on the number of viral copies present and may be influenced by collection methods, patient conditions, infection stage, and interfering substances.
Methodology
Immunoassay (Other)
Biomarkers
LOINC Codes
- 47528-5
- 19764-0
- 19773-1
- 19763-2
- 52797-8
- 22636-5
- 22638-1
- 22639-9
- 19767-3
- 19769-9
- 50387-0
- 50388-8
- 8251-1
- 47527-7
- 59420-0
Result Turnaround Time
3-7 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
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.
Patient Preparation
Patient should avoid douches 48 to 72 hours prior to examination. Specimen should not be collected during or shortly after 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.