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Gynecologic Pap Test (Image-guided), Liquid-based Preparation and Human Papillomavirus (HPV) (Aptima®)
Diagnose primary or metastatic neoplasm. 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.
Failure to obtain adequate ectocervical, endocervical, or vaginal cell population is suboptimal for evaluation. Excessive use of lubricating jelly on the vaginal speculum will interfere with cytologic examination and may lead to unsatisfactory Pap results.
The use of the liquid-based cytology specimen for multiple tests may limit the volume available for Pap reprocessing or HPV testing. A negative result does not exclude the possibility of an HPV infection since very low levels of infection or sampling error may produce a false-negative result. This test detects only the 14 most common high-risk HPV types.
Image-guided liquid-based Pap test; nucleic acid amplification (NAA)
Cervical cells in liquid-based cytology transport
ThinPrep® vial or SurePath™ vial
A minimum volume cannot be determined for the ThinPrep® vial because it varies depending on the cellularity of the specimen. The entire SurePath™ specimen should arrive intact.
ThinPrep® vial or SurePath™ vial
Patient should avoid douches 48 to 72 hours prior to examination. Specimen should not be collected during or shortly after menstrual period.
ThinPrep® Vial − Broom or Brush/Spatula:
Broom-like collection technique: Obtain a sample from the cervix using a broom-like device by inserting the brush portion into the cervical os and then rotate the brush five times. Rinse the collection device in the PreservCyt® solution by pushing the brush into the bottom of the vial 10 times, forcing the bristles to bend apart to release the cervical material. As a final step, twirl the brush between the thumb and forefinger vigorously to release additional cellular material. Discard the collection device. Tighten the cap on the ThinPrep® vial so that the torque line on the cap passes the torque line on the vial.
Brush/spatula technique: Insert the brush into the endocervical canal until only the bottommost fibers are exposed. Slowly rotate the brush 1/4 to 1/2 turn in one direction. Do not over-rotate the brush. Then, rotate the brush in the PreservCyt® solution 10 times while pushing against the wall of the ThinPrep® vial. Swirl the brush vigorously to release additional material. Discard the brush. Obtain an adequate sample from the ectocervix using a plastic spatula. Swirl vigorously in the ThinPrep® vial 10 times and discard the spatula. Tighten the cap on the ThinPrep® container so that the torque line on the cap passes the torque line on the vial.
SurePath™ Vial: When using the SurePath™ vial, the cervical broom must be used for specimen collection. 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.
Maintain liquid-based cytology specimen at room temperature. Pap processing must be performed within 21 days of collection. Specimens in ThinPrep® vials must be processed for testing within three months of collection for HPV. SurePath™ vial must be processed for testing within 21 days of collection for HPV.
Causes for Rejection
Improper collection; inadequate specimen; improper labeling; specimen leaked in transit; quantity not sufficient for analysis; name discrepancies; specimen submitted on male patient; specimen submitted in vial that expired according to manufacturer's label; frozen specimen. For Pap: liquid-based cytology specimen more than 21 days old. For HPV: specimen more than three months old in ThinPrep® vial; specimen more than 21 days old in SurePath™ vial.
Include date of birth, Social Security number (or other identification number), previous malignancy, drug therapy, radiation therapy, last menstrual period (LMP), postmenopausal patient (PMP), surgery (including surgical biopsies), exogenous hormones, abnormal vaginal bleeding, abnormal Pap results, IUD, and all other pertinent clinical information on the cytology test request form.
Note: In accordance with criteria established by CLIA, Pap tests will be referred for pathologist review if laboratory personnel suspect:
• Reactive or reparative cellular changes
• Atypical squamous or glandular cells of undetermined significance
• Cells in the premalignant or malignant category
In these cases, LabCorp will charge for the associated service. (Slides that are routinely reviewed by a pathologist for quality control purposes are not included.)
|Order Code||Order Code Name||Order Loinc||Result Code||Result Code Name||UofM||Result LOINC|
|199330||IGP, Aptima HPV||191121||Test ordered:||N/A|
|199330||IGP, Aptima HPV||191108||DIAGNOSIS:||22637-3|
|199330||IGP, Aptima HPV||191166||Interpretation||N/A|
|199330||IGP, Aptima HPV||191170||Category:||N/A|
|199330||IGP, Aptima HPV||191173||Recommendation:||N/A|
|199330||IGP, Aptima HPV||191169||Infection:||N/A|
|199330||IGP, Aptima HPV||191172||Adequacy:||N/A|
|199330||IGP, Aptima HPV||191111||Recommendation:||19773-1|
|199330||IGP, Aptima HPV||191109||Specimen adequacy:||19764-0|
|199330||IGP, Aptima HPV||191154||Source:||19763-2|
|199330||IGP, Aptima HPV||191160||Clinician provided ICD9:||52797-8|
|199330||IGP, Aptima HPV||191174||Clinician provided ICD10:||52797-8|
|199330||IGP, Aptima HPV||191107||Clinical history:||22636-5|
|199330||IGP, Aptima HPV||191124||Amended report:||N/A|
|199330||IGP, Aptima HPV||191110||Additional comment:||22638-1|
|199330||IGP, Aptima HPV||191125||Addendum:||22639-9|
|199330||IGP, Aptima HPV||191123||Maturation index:||N/A|
|199330||IGP, Aptima HPV||191112||Performed by:||19767-3|
|199330||IGP, Aptima HPV||191128||QC reviewed by:||N/A|
|199330||IGP, Aptima HPV||191145||Diagnosis provided by:||N/A|
|199330||IGP, Aptima HPV||191113||Electronically signed by:||19769-9|
|199330||IGP, Aptima HPV||191139||Special procedure:||N/A|
|199330||IGP, Aptima HPV||191129||Cytology history:||N/A|
|199330||IGP, Aptima HPV||191179||Previous history:||N/A|
|199330||IGP, Aptima HPV||191144||QA comment:||N/A|
|199330||IGP, Aptima HPV||019018||.||11546-9|
|199330||IGP, Aptima HPV||191157||Pathologist provided ICD9:||52797-8|
|199330||IGP, Aptima HPV||191175||Pathologist provided ICD10:||52797-8|
|199330||IGP, Aptima HPV||190120||.||N/A|
|199330||IGP, Aptima HPV||190109||Note:||N/A|
|199330||IGP, Aptima HPV||000000||Test Methodology:||47527-7|
|199330||IGP, Aptima HPV||507801||HPV Aptima||59420-0|
|199330||IGP, Aptima HPV||191167||Photomicrograph||N/A|
|199330||IGP, Aptima HPV||019030||.||N/A|
|199330||IGP, Aptima HPV||019031||Patient Counseling Report||N/A|
|Reflex Table for Test Methodology:|
|Order Code||Order Name||Result Code||Result Name||UofM||Result LOINC|
|Reflex 1||192555||Change IG Pap to LB Pap||000000||LBP CPT Code Automation||47527-7|