Gynecologic Pap Test (Image-guided), Liquid-based Preparation and Human Papillomavirus (HPV) (Aptima®)

CPT: 87624; 88175
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Test Details

Use

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.

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.

Methodology

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

Specimen Requirements

Specimen

Cervical cells in liquid-based cytology transport

Volume

ThinPrep® vial or SurePath™ vial

Minimum Volume

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.

Container

ThinPrep® vial or SurePath™ vial

Patient Preparation

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

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 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.

Storage Instructions

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.

Clinical Information

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.)

LOINC® Map

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 191158 ****************************** 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 191159 ****************************** N/A
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
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

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The LOINC® codes are copyright © 1994-2017, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee. Permission is granted in perpetuity, without payment of license fees or royalties, to use, copy, or distribute the LOINC® codes for any commercial or non-commercial purpose, subject to the terms under the license agreement found at https://loinc.org/license/. Additional information regarding LOINC® codes can be found at LOINC.org, including the LOINC Manual, which can be downloaded at LOINC.org/downloads/files/LOINCManual.pdf