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Gynecologic Pap Test (Image-guided), Liquid-based Preparation With Reflex to Human Papillomavirus (HPV) (Aptima®) When ASC-U, ASC-H, LSIL, HSIL, AGUS With Reflex to HPV Genotypes 16 and 18,45

CPT: To be determined. Updates will be made when available.
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Special Instructions

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.)


Expected Turnaround Time

3 - 6 days


Related Documents


Specimen Requirements


Specimen

Cervical cells in ThinPrep® vial


Volume

ThinPrep® vial


Minimum Volume

A minimum volume cannot be determined for the ThinPrep® vial, because it varies depending on the cellularity of the specimen.


Container

ThinPrep® vial


Collection

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 ¼ to ½ 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.


Storage Instructions

Maintain specimen at room temperature. Specimens must be processed for testing within 21 days of collection for Pap.


Patient Preparation

Patient should avoid douches 48 to 72 hours prior to examination. Specimen should not be collected during or shortly after menstrual period.


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; SurePath™ vial. For Pap: liquid-based cytology specimen more than 21 days old. For HPV: specimen more than three months old in ThinPrep® vial.


Test Details


Use

Diagnose primary or metastatic neoplasm. This test aids in the diagnosis of sexually transmitted HPV infection and in the triage of patients with an abnormal Pap test result. 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. Positive high risk HPV test results reflex the sample for genotyping of types 16 and 18/45.


Limitations

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 and cannot determine the specific HPV type present.


Methodology

Image-guided liquid-based Pap test; nucleic acid amplification (NAA)


LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
199350 IGP,rfxAptima HPV all,16/18,45 191121 Test ordered: N/A
199350 IGP,rfxAptima HPV all,16/18,45 191108 DIAGNOSIS: 47528-5
199350 IGP,rfxAptima HPV all,16/18,45 191166 Interpretation N/A
199350 IGP,rfxAptima HPV all,16/18,45 191170 Category: N/A
199350 IGP,rfxAptima HPV all,16/18,45 191173 Recommendation: N/A
199350 IGP,rfxAptima HPV all,16/18,45 191169 Infection: N/A
199350 IGP,rfxAptima HPV all,16/18,45 191172 Adequacy: N/A
199350 IGP,rfxAptima HPV all,16/18,45 191111 Recommendation: 19773-1
199350 IGP,rfxAptima HPV all,16/18,45 191109 Specimen adequacy: 19764-0
199350 IGP,rfxAptima HPV all,16/18,45 191154 Source: 19763-2
199350 IGP,rfxAptima HPV all,16/18,45 191160 Clinician provided ICD9: 52797-8
199350 IGP,rfxAptima HPV all,16/18,45 191174 Clinician provided ICD10: 52797-8
199350 IGP,rfxAptima HPV all,16/18,45 191107 Clinical history: 22636-5
199350 IGP,rfxAptima HPV all,16/18,45 191124 Amended report: N/A
199350 IGP,rfxAptima HPV all,16/18,45 191110 Additional comment: 22638-1
199350 IGP,rfxAptima HPV all,16/18,45 191125 Addendum: 22639-9
199350 IGP,rfxAptima HPV all,16/18,45 191123 Maturation index: N/A
199350 IGP,rfxAptima HPV all,16/18,45 191112 Performed by: 19767-3
199350 IGP,rfxAptima HPV all,16/18,45 191128 QC reviewed by: N/A
199350 IGP,rfxAptima HPV all,16/18,45 191145 Diagnosis provided by: N/A
199350 IGP,rfxAptima HPV all,16/18,45 191113 Electronically signed by: 19769-9
199350 IGP,rfxAptima HPV all,16/18,45 191139 Special procedure: N/A
199350 IGP,rfxAptima HPV all,16/18,45 191129 Cytology history: N/A
199350 IGP,rfxAptima HPV all,16/18,45 191179 Previous history: N/A
199350 IGP,rfxAptima HPV all,16/18,45 191144 QA comment: N/A
199350 IGP,rfxAptima HPV all,16/18,45 019018 . 11546-9
199350 IGP,rfxAptima HPV all,16/18,45 191157 Pathologist provided ICD9: 52797-8
199350 IGP,rfxAptima HPV all,16/18,45 191175 Pathologist provided ICD10: 52797-8
199350 IGP,rfxAptima HPV all,16/18,45 190120 . N/A
199350 IGP,rfxAptima HPV all,16/18,45 190109 Note: N/A
199350 IGP,rfxAptima HPV all,16/18,45 000000 Test Methodology: 47527-7
199350 IGP,rfxAptima HPV all,16/18,45 190119 . N/A
199350 IGP,rfxAptima HPV all,16/18,45 019054 PDF N/A
199350 IGP,rfxAptima HPV all,16/18,45 191167 Photomicrograph N/A
199350 IGP,rfxAptima HPV all,16/18,45 019030 . N/A
199350 IGP,rfxAptima HPV all,16/18,45 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
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
Reflex 2 507405 HPV, low volume rfx 507405 HPV, low volume rfx 59420-0
Reflex Table for .
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 507805 HPV, Aptima High 16/18,45 507801 HPV Aptima 59420-0
Reflex 2 507825 HPV Genotypes 16/18,45 507811 HPV Genotype 16 59263-4
Reflex Table for .
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 507805 HPV, Aptima High 16/18,45 507801 HPV Aptima 59420-0
Reflex 2 507825 HPV Genotypes 16/18,45 507812 HPV Genotype 18,45 75694-0
Reflex Table for .
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 507805 HPV, Aptima High 16/18,45 507801 HPV Aptima 59420-0
Reflex 2 507825 HPV Genotypes 16/18,45 507813 HPV Genotype 16/18,45 Tracking N/A
Reflex Table for .
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 507805 HPV, Aptima High 16/18,45 507801 HPV Aptima 59420-0
Reflex 2 507825 HPV Genotypes 16/18,45 019054 PDF N/A
Reflex Table for .
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 507805 HPV, Aptima High 16/18,45 019054 PDF N/A

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