Gynecologic Pap Test (Image-guided), Liquid-based Preparation and Chlamydia/Gonococcus, NAA and High-risk HPV (Cobas®) With HPV Genotypes 16 and 18 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
Inadequate ectocervical, endocervical, or vaginal cell population may hinder evaluation. Excessive use of lubricating jelly can interfere with cytologic examination. Detection of high-risk HPV relies on the specimen's copy numbers and can be influenced by collection methods, patient factors, infection stage, and interfering substances.
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
- 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
Result Turnaround Time
4-7 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 into the cervical os and rotate five times. Place the broom head into the CytoRich™ preservative fluid in the SurePath™ vial and cap tightly. Use Aptima® vaginal or unisex swab kit to collect for Chlamydia and Gonococcus.
Patient Preparation
Avoid douches 48 to 72 hours prior. Do not collect during or shortly after menstrual period.
Storage Instructions
Room temperature
Causes for Rejection
Improper collection, inadequate specimen, improper labeling, frozen specimen, leakage, insufficient quantity, name discrepancies. For Pap: cytology specimen > 21 days old; HPV: specimen > 4 weeks old in SurePath™; excessively bloody specimens; Chlamydia/Gonococcus: Aptima® specimen > 60 days, tube with multiple swabs or wrong swab.