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

CPT: 87624; 88175
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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.

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.

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; for HPV)

Specimen Requirements

Specimen

Cervical cells in SurePath™ vial

Volume

Entire SurePath™ vial

Minimum Volume

Entire SurePath™ vial

Container

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

SurePath™ vial - Using a cervical broom: 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

Room temperature

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 four weeks old in SurePath™ 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

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
196120 IGP, cobasHPV, rfx16/18 191121 Test ordered: N/A
196120 IGP, cobasHPV, rfx16/18 191158 ****************************** N/A
196120 IGP, cobasHPV, rfx16/18 191108 DIAGNOSIS: 22637-3
196120 IGP, cobasHPV, rfx16/18 191166 Interpretation N/A
196120 IGP, cobasHPV, rfx16/18 191170 Category: N/A
196120 IGP, cobasHPV, rfx16/18 191173 Recommendation: N/A
196120 IGP, cobasHPV, rfx16/18 191169 Infection: N/A
196120 IGP, cobasHPV, rfx16/18 191172 Adequacy: N/A
196120 IGP, cobasHPV, rfx16/18 191111 Recommendation: 19773-1
196120 IGP, cobasHPV, rfx16/18 191109 Specimen adequacy: 19764-0
196120 IGP, cobasHPV, rfx16/18 191159 ****************************** N/A
196120 IGP, cobasHPV, rfx16/18 191154 Source: 19763-2
196120 IGP, cobasHPV, rfx16/18 191160 Clinician provided ICD9: 52797-8
196120 IGP, cobasHPV, rfx16/18 191174 Clinician provided ICD10: 52797-8
196120 IGP, cobasHPV, rfx16/18 191107 Clinical history: 22636-5
196120 IGP, cobasHPV, rfx16/18 191124 Amended report: N/A
196120 IGP, cobasHPV, rfx16/18 191110 Additional comment: 22638-1
196120 IGP, cobasHPV, rfx16/18 191125 Addendum: 22639-9
196120 IGP, cobasHPV, rfx16/18 191123 Maturation index: N/A
196120 IGP, cobasHPV, rfx16/18 191112 Performed by: 19767-3
196120 IGP, cobasHPV, rfx16/18 191128 QC reviewed by: N/A
196120 IGP, cobasHPV, rfx16/18 191145 Diagnosis provided by: N/A
196120 IGP, cobasHPV, rfx16/18 191113 Electronically signed by: 19769-9
196120 IGP, cobasHPV, rfx16/18 191139 Special procedure: N/A
196120 IGP, cobasHPV, rfx16/18 191129 Cytology history: N/A
196120 IGP, cobasHPV, rfx16/18 191179 Previous history: N/A
196120 IGP, cobasHPV, rfx16/18 191144 QA comment: N/A
196120 IGP, cobasHPV, rfx16/18 019018 . 11546-9
196120 IGP, cobasHPV, rfx16/18 191157 Pathologist provided ICD9: 52797-8
196120 IGP, cobasHPV, rfx16/18 191175 Pathologist provided ICD10: 52797-8
196120 IGP, cobasHPV, rfx16/18 190120 . N/A
196120 IGP, cobasHPV, rfx16/18 190109 Note: N/A
196120 IGP, cobasHPV, rfx16/18 000000 Test Methodology: 47527-7
196120 IGP, cobasHPV, rfx16/18 507390 HPV, cobas high-risk 59420-0
196120 IGP, cobasHPV, rfx16/18 191167 Photomicrograph N/A
196120 IGP, cobasHPV, rfx16/18 019030 . N/A
196120 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

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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