Gynecologic Pap Test (Image-guided), Liquid-based Preparation and Chlamydia/Gonococcus/Trichomonas, NAA and High-risk HPV (Cobas®) With HPV Genotypes 16 and 18 using SurePath™ specimen
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
The test's accuracy can be compromised if an adequate ectocervical, endocervical, or vaginal cell population is not collected, or if excessive lubricating jelly is used on the vaginal speculum, which can interfere with cytologic examination. For HPV detection, factors such as specimen collection methods, patient conditions, stage of infection, and the presence of interfering substances can influence results. Specimen integrity can also be compromised if stability conditions (e.g., age of the specimen) are not met, particularly for Pap (21 days), HPV (4 weeks), and Aptima® specimens (60 days).
Methodology
Other
Biomarkers
LOINC Codes
- 47527-7 - Cytology Cvx/Vag Doc Thin Prep
- 52797-8 - Dx ICD code
- 8251-1 - Service Cmnt-Imp
- 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
- 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
4-7 days
Related Documents
For more information, please review the documents below
Specimen
Other
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 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/Gonococcus/Trichomonas: use an Aptima® vaginal swab or unisex swab collection kit following specified procedures for each type.
Patient Preparation
Patient should avoid douches 48 to 72 hours prior to examination. 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. Specific rejection criteria for Pap, HPV, and Chlamydia/Gonococcus/Trichomonas apply based on specimen age and condition.