Gynecologic Pap Test (Image-guided), Liquid-based Preparation and High-risk HPV (Cobas®) With Reflex to HPV Genotypes 16 and 18

CPT: 87624; 88175. If reflex testing is performed, concomitant CPT codes/charges will apply.
Print Share

Test Details

Use

Diagnose primary or metastatic neoplasm. Diagnosis of sexually-transmitted HPV infection. The initial high-risk HPV test is used for types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. If the Pap evaluation is within normal limits and the initial HPV test is positive, the specimen will be tested for high-risk HPV types 16 and 18. This information, together with the physician's assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. The results of this test are not intended to prevent women from proceeding to colposcopy.

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 processing or HPV testing. Detection of high-risk HPV is dependent on the number of copies present in the specimen and may be affected by specimen collection methods, patient factors, stage of infection, and the presence of interfering substances.

Methodology

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

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

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

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.

Storage Instructions

Maintain liquid-based cytology specimens at room temperature. Pap processing must be performed within 21 days of collection. ThinPrep® vial may be stored for six months after the date of collection prior to performing the Cobas® HPV test. ThinPrep® specimens should not be frozen.

Causes for Rejection

Improper collection; inadequate specimen; improper labeling; frozen specimen; specimen leaked in transit; quantity not sufficient for analysis; name discrepancies; specimen submitted on male patients. For Pap: liquid-based cytology specimen more than 21 days old. For HPV: specimen more than six months old in ThinPrep® vial; excessively bloody specimens.

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.)

References

American Society for Colposcopy and Cervical Pathology. HPV Genotyping Clinical Update. Hagerstown, Md: ASCCP; 2009:1-3.
Ferris DG, Wright TC, Litaker MS, et al. Triage of women with ASCUS and LSIL Pap smear reports: Management by repeat Pap smear, HPV DNA testing, or colposcopy. J Fam Pract. 1998 Feb; 46(2):125-134.1877527
Manos MM, Kinney WK, Hurley B, et al. Identifying women with cervical neoplasia: Using human papillomavirus DNA testing for equivocal Papanicolaou results. JAMA. 1999 May 5; 281:1605-1610.8116578
Schiffman M, Herrero R, Hildesheim A, et al. HPV DNA testing cervical cancer screening: Results from women in a high-risk province in Costa Rica. JAMA. 2000 Jan 5; 283(1):87-93.1954825

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
196305 IGP, cobasHPV, rfx16/18 191121 Test ordered: N/A
196305 IGP, cobasHPV, rfx16/18 191158 ****************************** N/A
196305 IGP, cobasHPV, rfx16/18 191108 DIAGNOSIS: 22637-3
196305 IGP, cobasHPV, rfx16/18 191166 Interpretation N/A
196305 IGP, cobasHPV, rfx16/18 191170 Category: N/A
196305 IGP, cobasHPV, rfx16/18 191173 Recommendation: N/A
196305 IGP, cobasHPV, rfx16/18 191169 Infection: N/A
196305 IGP, cobasHPV, rfx16/18 191172 Adequacy: N/A
196305 IGP, cobasHPV, rfx16/18 191111 Recommendation: 19773-1
196305 IGP, cobasHPV, rfx16/18 191109 Specimen adequacy: 19764-0
196305 IGP, cobasHPV, rfx16/18 191159 ****************************** N/A
196305 IGP, cobasHPV, rfx16/18 191154 Source: 19763-2
196305 IGP, cobasHPV, rfx16/18 191160 Clinician provided ICD9: 52797-8
196305 IGP, cobasHPV, rfx16/18 191174 Clinician provided ICD10: 52797-8
196305 IGP, cobasHPV, rfx16/18 191107 Clinical history: 22636-5
196305 IGP, cobasHPV, rfx16/18 191124 Amended report: N/A
196305 IGP, cobasHPV, rfx16/18 191110 Additional comment: 22638-1
196305 IGP, cobasHPV, rfx16/18 191125 Addendum: 22639-9
196305 IGP, cobasHPV, rfx16/18 191123 Maturation index: N/A
196305 IGP, cobasHPV, rfx16/18 191112 Performed by: 19767-3
196305 IGP, cobasHPV, rfx16/18 191128 QC reviewed by: N/A
196305 IGP, cobasHPV, rfx16/18 191145 Diagnosis provided by: N/A
196305 IGP, cobasHPV, rfx16/18 191113 Electronically signed by: 19769-9
196305 IGP, cobasHPV, rfx16/18 191139 Special procedure: N/A
196305 IGP, cobasHPV, rfx16/18 191129 Cytology history: N/A
196305 IGP, cobasHPV, rfx16/18 191179 Previous history: N/A
196305 IGP, cobasHPV, rfx16/18 191144 QA comment: N/A
196305 IGP, cobasHPV, rfx16/18 019018 . 11546-9
196305 IGP, cobasHPV, rfx16/18 191157 Pathologist provided ICD9: 52797-8
196305 IGP, cobasHPV, rfx16/18 191175 Pathologist provided ICD10: 52797-8
196305 IGP, cobasHPV, rfx16/18 190120 . N/A
196305 IGP, cobasHPV, rfx16/18 190109 Note: N/A
196305 IGP, cobasHPV, rfx16/18 000000 Test Methodology: 47527-7
196305 IGP, cobasHPV, rfx16/18 507390 HPV, cobas high-risk 59420-0
196305 IGP, cobasHPV, rfx16/18 191167 Photomicrograph N/A
196305 IGP, cobasHPV, rfx16/18 019030 . N/A
196305 IGP, cobasHPV, rfx16/18 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

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