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Gynecologic Pap Test, Liquid-based Preparation With Reflex to Human Papillomavirus (HPV) High-risk DNA Detection When ASC-U
Liquid-based cytology; HPV high-risk probe cocktail typing if indicated. If reflex testing is performed, additional charges/CPT code(s) may apply.
Diagnose primary or metastatic neoplasm. The high-risk HPV test is used for types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 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 smear result.
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 13 most common high-risk HPV types and cannot determine the specific HPV type present.
Liquid-based Pap test; nucleic acid amplification (NAA)
Cervical cells collected by one of the methods described below.
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−Broom Only:
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.
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 specimens at room temperature. Pap processing must be done within 21 days of collection. SurePath™ vial must be processed for testing within 21 days of collection for HPV. Specimens in ThinPrep® vials must be processed for testing within three months of collection of 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 21 days old in SurePath™ liquid-based preservative; specimen more than three months old in ThinPrep® 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.)
If ThinPrep® vials are QNS for the hybrid capture assay, then a test requiring a lower input volume will be automatically performed if there is sufficient volume to perform that assay.
|Order Code||Order Code Name||Order Loinc||Result Code||Result Code Name||UofM||Result LOINC|
|192047||Pap Lb, rfx HPV ASCU||019018||.||11546-9|
|192047||Pap Lb, rfx HPV ASCU||019030||.||N/A|
|192047||Pap Lb, rfx HPV ASCU||019031||Patient Counseling Report||N/A|
|192047||Pap Lb, rfx HPV ASCU||190109||Note:||N/A|
|192047||Pap Lb, rfx HPV ASCU||190119||.||N/A|
|192047||Pap Lb, rfx HPV ASCU||191107||Clinical history:||22636-5|
|192047||Pap Lb, rfx HPV ASCU||191108||DIAGNOSIS:||22637-3|
|192047||Pap Lb, rfx HPV ASCU||191109||Specimen adequacy:||19764-0|
|192047||Pap Lb, rfx HPV ASCU||191110||Additional comment:||22638-1|
|192047||Pap Lb, rfx HPV ASCU||191111||Recommendation:||19773-1|
|192047||Pap Lb, rfx HPV ASCU||191112||Performed by:||19767-3|
|192047||Pap Lb, rfx HPV ASCU||191113||Electronically signed by:||19769-9|
|192047||Pap Lb, rfx HPV ASCU||191121||Test ordered:||N/A|
|192047||Pap Lb, rfx HPV ASCU||191123||Maturation index:||N/A|
|192047||Pap Lb, rfx HPV ASCU||191124||Amended report:||N/A|
|192047||Pap Lb, rfx HPV ASCU||191125||Addendum:||22639-9|
|192047||Pap Lb, rfx HPV ASCU||191128||QC reviewed by:||N/A|
|192047||Pap Lb, rfx HPV ASCU||191129||Cytology history:||N/A|
|192047||Pap Lb, rfx HPV ASCU||191139||Special procedure:||N/A|
|192047||Pap Lb, rfx HPV ASCU||191144||QA comment:||N/A|
|192047||Pap Lb, rfx HPV ASCU||191145||Diagnosis provided by:||N/A|
|192047||Pap Lb, rfx HPV ASCU||191154||Source:||19763-2|
|192047||Pap Lb, rfx HPV ASCU||191157||Pathologist provided ICD9:||52797-8|
|192047||Pap Lb, rfx HPV ASCU||191160||Clinician provided ICD9:||52797-8|
|192047||Pap Lb, rfx HPV ASCU||191166||Interpretation||N/A|
|192047||Pap Lb, rfx HPV ASCU||191167||Photomicrograph||N/A|
|192047||Pap Lb, rfx HPV ASCU||191169||Infection:||N/A|
|192047||Pap Lb, rfx HPV ASCU||191170||Category:||N/A|
|192047||Pap Lb, rfx HPV ASCU||191172||Adequacy:||N/A|
|192047||Pap Lb, rfx HPV ASCU||191173||Recommendation:||N/A|
|192047||Pap Lb, rfx HPV ASCU||191174||Clinician provided ICD10:||52797-8|
|192047||Pap Lb, rfx HPV ASCU||191175||Pathologist provided ICD10:||52797-8|
|192047||Pap Lb, rfx HPV ASCU||191179||Previous history:||N/A|
|192047||Pap Lb, rfx HPV ASCU||000000||LBP CPT Code Automation||47527-7|
|Reflex Table for .|
|Order Code||Order Name||Result Code||Result Name||UofM||Result LOINC|
|Reflex 1||507301||HPV, high-risk||507303||HPV, high-risk||30167-1|