Gynecologic Pap Test (Image-guided), Liquid-based Preparation and Human Papillomavirus (HPV) (Aptima®) Detection With Reflex to HPV Genotypes 16 and 18,45 on High-risk Positive Specimens

TEST: 199344
Test number copied
CPT: 88175; 87624
Print Share

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

2 - 6 days

Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.

Related Documents

Specimen Requirements

Specimen

Cervical cells in liquid-based cytology transport

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 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 21 days of collection for HPV.

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 21 days old in ThinPrep® vial.

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. If the initial high-risk HPV test is positive, then the residual specimen will be tested for HPV types 16 and 18,45; type 18 cannot be differentiated from type 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. When reflex conditions are met, HPV type 16 and 18,45 testing is performed.

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
199344 IGP, Apt HPV,rfx 16/18,45 33717-0 191121 Test ordered: N/A
199344 IGP, Apt HPV,rfx 16/18,45 33717-0 191108 DIAGNOSIS: 47528-5
199344 IGP, Apt HPV,rfx 16/18,45 33717-0 191166 Interpretation 56850-1
199344 IGP, Apt HPV,rfx 16/18,45 33717-0 191170 Category: N/A
199344 IGP, Apt HPV,rfx 16/18,45 33717-0 191173 Recommendation: N/A
199344 IGP, Apt HPV,rfx 16/18,45 33717-0 191169 Infection: N/A
199344 IGP, Apt HPV,rfx 16/18,45 33717-0 191172 Adequacy: N/A
199344 IGP, Apt HPV,rfx 16/18,45 33717-0 191111 Recommendation: 19773-1
199344 IGP, Apt HPV,rfx 16/18,45 33717-0 191109 Specimen adequacy: 19764-0
199344 IGP, Apt HPV,rfx 16/18,45 33717-0 191154 Source: 19763-2
199344 IGP, Apt HPV,rfx 16/18,45 33717-0 191160 Clinician provided ICD9: 52797-8
199344 IGP, Apt HPV,rfx 16/18,45 33717-0 191174 Clinician provided ICD10: 52797-8
199344 IGP, Apt HPV,rfx 16/18,45 33717-0 191107 Clinical history: 22636-5
199344 IGP, Apt HPV,rfx 16/18,45 33717-0 191124 Amended report: N/A
199344 IGP, Apt HPV,rfx 16/18,45 33717-0 191110 Additional comment: 22638-1
199344 IGP, Apt HPV,rfx 16/18,45 33717-0 191125 Addendum: 22639-9
199344 IGP, Apt HPV,rfx 16/18,45 33717-0 191123 Maturation index: N/A
199344 IGP, Apt HPV,rfx 16/18,45 33717-0 191112 Performed by: 19767-3
199344 IGP, Apt HPV,rfx 16/18,45 33717-0 191128 QC reviewed by: N/A
199344 IGP, Apt HPV,rfx 16/18,45 33717-0 191145 Diagnosis provided by: N/A
199344 IGP, Apt HPV,rfx 16/18,45 33717-0 191113 Electronically signed by: 19769-9
199344 IGP, Apt HPV,rfx 16/18,45 33717-0 191139 Special procedure: N/A
199344 IGP, Apt HPV,rfx 16/18,45 33717-0 191129 Cytology history: N/A
199344 IGP, Apt HPV,rfx 16/18,45 33717-0 191179 Previous history: N/A
199344 IGP, Apt HPV,rfx 16/18,45 33717-0 191144 QA comment: N/A
199344 IGP, Apt HPV,rfx 16/18,45 33717-0 019018 . 11546-9
199344 IGP, Apt HPV,rfx 16/18,45 33717-0 191157 Pathologist provided ICD9: 52797-8
199344 IGP, Apt HPV,rfx 16/18,45 33717-0 191175 Pathologist provided ICD10: 52797-8
199344 IGP, Apt HPV,rfx 16/18,45 33717-0 190120 . N/A
199344 IGP, Apt HPV,rfx 16/18,45 33717-0 190109 Note: N/A
199344 IGP, Apt HPV,rfx 16/18,45 33717-0 000000 Test Methodology: 47527-7
199344 IGP, Apt HPV,rfx 16/18,45 33717-0 507801 HPV Aptima 59420-0
199344 IGP, Apt HPV,rfx 16/18,45 33717-0 019054 PDF N/A
199344 IGP, Apt HPV,rfx 16/18,45 33717-0 191167 Photomicrograph N/A
199344 IGP, Apt HPV,rfx 16/18,45 33717-0 019030 . N/A
199344 IGP, Apt HPV,rfx 16/18,45 33717-0 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 HPV Aptima
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 507810 HPV Genotypes 16/18,45 507811 HPV Genotype 16 59263-4
Reflex Table for HPV Aptima
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 507810 HPV Genotypes 16/18,45 507812 HPV Genotype 18,45 75694-0
Reflex Table for HPV Aptima
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 507810 HPV Genotypes 16/18,45 507821 HPV Genotype 16/18,45 Tracking N/A
Reflex Table for HPV Aptima
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 507810 HPV Genotypes 16/18,45 019054 PDF N/A

For Providers

Please login to order a test

Order a Test

© 2021 Laboratory Corporation of America® Holdings and Lexi-Comp Inc. All Rights Reserved.

CPT Statement/Profile Statement

The LOINC® codes are copyright © 1994-2021, 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