Gynecologic Pap Test (Image-guided), Liquid-based Preparation and Chlamydia/Gonococcus/Trichomonas, NAA With Reflex to Human Papillomavirus (HPV) (Aptima®) When ASC-U, ASC-H, LSIL, HSIL, AGUS

CPT: 87491; 87591; 87798; 88175
Print Share

Test Details

Use

Diagnose primary or metastatic neoplasm; detect Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis. This test aids in the diagnosis of sexually transmitted HPV infection. 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 and cannot determine the specific HPV type present.

Testing for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis requires special procedures to be used in the processing of the cytology specimen; therefore, testing for these organisms cannot be added on after the specimen has been submitted. The liquid-based cytology specimen must be processed for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis testing.

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.

Optional Dedicated Specimen for Chlamydia, Gonococcus, and Trichomonas: Use the Gen-Probe® Aptima® swab collection kit. Clean the cervix using the larger, white-shafted swab supplied in the Gen-Probe® Aptima® swab collection kit and discard. Insert the smaller, blue-shafted swab into the cervix and rotate for 10 to 30 seconds to ensure good sampling. Carefully withdraw the blue-shafted swab, avoiding contact with the vaginal mucosa. Remove the cap from the swab specimen transport tube and immediately place the specimen collection swab into the transport tube. Break the swab shaft at the scoreline, using care to avoid splashing contents. Recap the swab specimen transport tube tightly.

Storage Instructions

Maintain liquid-based cytology and Aptima® swab transport 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 for HPV. Liquid-based cytology specimens must be tested within seven days for Chlamydia/Gonococcus/Trichomonas; if the Aptima® swab transport is used, it must be tested within 60 days.

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 a vial that expired according to the 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. For Chlamydia, Gonococcus, and Trichomonas vaginalis: liquid-based cytology specimen more than seven days old, Aptima® specimen more than 60 days old; Gen-Probe® Aptima® collection tube with multiple swabs; white-shafted cleaning swab, or any swab other than the collection swab.

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
199360 IGP,CtNgTv,rfx Apt HPV all 191121 Test ordered: N/A
199360 IGP,CtNgTv,rfx Apt HPV all 191158 ****************************** N/A
199360 IGP,CtNgTv,rfx Apt HPV all 191108 DIAGNOSIS: 22637-3
199360 IGP,CtNgTv,rfx Apt HPV all 191166 Interpretation N/A
199360 IGP,CtNgTv,rfx Apt HPV all 191170 Category: N/A
199360 IGP,CtNgTv,rfx Apt HPV all 191173 Recommendation: N/A
199360 IGP,CtNgTv,rfx Apt HPV all 191169 Infection: N/A
199360 IGP,CtNgTv,rfx Apt HPV all 191172 Adequacy: N/A
199360 IGP,CtNgTv,rfx Apt HPV all 191111 Recommendation: 19773-1
199360 IGP,CtNgTv,rfx Apt HPV all 191109 Specimen adequacy: 19764-0
199360 IGP,CtNgTv,rfx Apt HPV all 191159 ****************************** N/A
199360 IGP,CtNgTv,rfx Apt HPV all 191154 Source: 19763-2
199360 IGP,CtNgTv,rfx Apt HPV all 191160 Clinician provided ICD9: 52797-8
199360 IGP,CtNgTv,rfx Apt HPV all 191174 Clinician provided ICD10: 52797-8
199360 IGP,CtNgTv,rfx Apt HPV all 191107 Clinical history: 22636-5
199360 IGP,CtNgTv,rfx Apt HPV all 191124 Amended report: N/A
199360 IGP,CtNgTv,rfx Apt HPV all 191110 Additional comment: 22638-1
199360 IGP,CtNgTv,rfx Apt HPV all 191125 Addendum: 22639-9
199360 IGP,CtNgTv,rfx Apt HPV all 191123 Maturation index: N/A
199360 IGP,CtNgTv,rfx Apt HPV all 191112 Performed by: 19767-3
199360 IGP,CtNgTv,rfx Apt HPV all 191128 QC reviewed by: N/A
199360 IGP,CtNgTv,rfx Apt HPV all 191145 Diagnosis provided by: N/A
199360 IGP,CtNgTv,rfx Apt HPV all 191113 Electronically signed by: 19769-9
199360 IGP,CtNgTv,rfx Apt HPV all 191139 Special procedure: N/A
199360 IGP,CtNgTv,rfx Apt HPV all 191129 Cytology history: N/A
199360 IGP,CtNgTv,rfx Apt HPV all 191179 Previous history: N/A
199360 IGP,CtNgTv,rfx Apt HPV all 191144 QA comment: N/A
199360 IGP,CtNgTv,rfx Apt HPV all 019018 . 11546-9
199360 IGP,CtNgTv,rfx Apt HPV all 191157 Pathologist provided ICD9: 52797-8
199360 IGP,CtNgTv,rfx Apt HPV all 191175 Pathologist provided ICD10: 52797-8
199360 IGP,CtNgTv,rfx Apt HPV all 190120 . N/A
199360 IGP,CtNgTv,rfx Apt HPV all 190109 Note: N/A
199360 IGP,CtNgTv,rfx Apt HPV all 000000 Test Methodology: 47527-7
199360 IGP,CtNgTv,rfx Apt HPV all 190119 . N/A
199360 IGP,CtNgTv,rfx Apt HPV all 186134 Chlamydia, Nuc. Acid Amp 50387-0
199360 IGP,CtNgTv,rfx Apt HPV all 186135 Gonococcus, Nuc. Acid Amp 50388-8
199360 IGP,CtNgTv,rfx Apt HPV all 188092 Trich vag by NAA 46154-1
199360 IGP,CtNgTv,rfx Apt HPV all 191167 Photomicrograph N/A
199360 IGP,CtNgTv,rfx Apt HPV all 019030 . N/A
199360 IGP,CtNgTv,rfx Apt HPV all 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
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 000000 507405 000000 59420-0
Reflex Table for .
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 507800 HPV Aptima 507801 HPV Aptima 59420-0

For Providers

Please login to order a test.

 

© 2017  Laboratory Corporation of America® Holdings and Lexi-Comp Inc. All Rights Reserved.

CPT Statement/Profile Statement

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