Gynecologic Pap Test−Age-based Guideline for Cervical Cancer (Aptima®) Plus Chlamydia/Gonococcus
Also known as: Age-based Guideline for Cervical Cancer Plus Chlamyda/Gonococcus, Cervical Cancer Screening Plus Chlamydia/Gonococcus
Use
Diagnose primary or metastatic neoplasm; detect Chlamydia trachomatis and Neisseria gonorrhoeae. 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. When the age guideline includes possible genotyping, the residual specimen will be tested individually for high-risk HPV genotypes 16 and 18,45 if the Pap evaluation is within normal limits and the initial HPV test is positive. This information, together with the physician's assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. The results of this test are not intended to prevent women from proceeding to colposcopy.
Special Instructions
Not provided.
Limitations
Pap tests that do not have adequate ectocervical, endocervical, or vaginal cell populations may be inadequate for evaluation. The excessive use of lubricating jelly can interfere with the results. The liquid-based specimen must not be overused for multiple tests, limiting the volume available for Pap reprocessing or HPV testing. A negative result does not exclude the possibility of HPV infection due to potential low infection levels or sampling errors. This test detects only the 14 most common high-risk HPV types. Reflex genotype testing may be indicated depending on age and test results, and special procedures are necessary for Chlamydia and Gonococcus testing, which cannot be added post-submission.
Methodology
Immunoassay (IHC)
Biomarkers
LOINC Codes
- 47527-7 - Cytology Cvx/Vag Doc Thin Prep
- 50387-0 - C trach rRNA Cvx Ql NAA+probe
- 50388-8 - N gonorrhoea rRNA Cvx Ql NAA+probe
- 59420-0 - HPV I/H Risk 4 DNA Cvx Ql Probe+sig amp
- 8251-1 - Service Cmnt-Imp
- 11502-2 - Laboratory report
- 47399-4
- 47400-0
Result Turnaround Time
3-7 days
Related Documents
For more information, please review the documents below
Specimen
Other
Volume
ThinPrep® vial
Minimum Volume
Not provided
Container
ThinPrep® vial
Collection Instructions
Use a broom-like device to collect a sample from the cervix by inserting the brush into the cervical os and rotating it five times. Rinse the brush in the PreservCyt® solution within the ThinPrep® vial. Alternatively, use a brush/spatula technique, collecting an endocervical sample with a brush and ectocervical sample with a spatula, swirling both in the vial.
Patient Preparation
The patient should avoid douches 48 to 72 hours before examination and not collect during or shortly after the menstrual period.
Storage Instructions
Maintain at room temperature; Pap processing within 21 days, HPV testing within three months, and Chlamydia/Gonococcus testing within seven days of collection.
Causes for Rejection
Reasons for rejection include improper collection, inadequate specimen, improper labeling, specimen leakage, insufficient quantity, incorrect patient identification, expired vial use, frozen specimen, and vials older than specified limits for Pap, HPV, and Chlamydia/Gonococcus tests.