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

CPT: 87624; 88175
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Test Details

Use

Diagnose primary or metastatic neoplasm. The HPV test specifically identifies types HPV16 and HPV18 while concurrently detecting the rest of the high-risk types: 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68 without further specific differentiation.

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. Excessive use of lubricating jelly will interfere with cytologic examination.

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

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
196210 IGP, cobasHPV16/18 191121 Test ordered: N/A
196210 IGP, cobasHPV16/18 191158 ****************************** N/A
196210 IGP, cobasHPV16/18 191108 DIAGNOSIS: 22637-3
196210 IGP, cobasHPV16/18 191166 Interpretation N/A
196210 IGP, cobasHPV16/18 191170 Category: N/A
196210 IGP, cobasHPV16/18 191173 Recommendation: N/A
196210 IGP, cobasHPV16/18 191169 Infection: N/A
196210 IGP, cobasHPV16/18 191172 Adequacy: N/A
196210 IGP, cobasHPV16/18 191111 Recommendation: 19773-1
196210 IGP, cobasHPV16/18 191109 Specimen adequacy: 19764-0
196210 IGP, cobasHPV16/18 191159 ****************************** N/A
196210 IGP, cobasHPV16/18 191154 Source: 19763-2
196210 IGP, cobasHPV16/18 191160 Clinician provided ICD9: 52797-8
196210 IGP, cobasHPV16/18 191174 Clinician provided ICD10: 52797-8
196210 IGP, cobasHPV16/18 191107 Clinical history: 22636-5
196210 IGP, cobasHPV16/18 191124 Amended report: N/A
196210 IGP, cobasHPV16/18 191110 Additional comment: 22638-1
196210 IGP, cobasHPV16/18 191125 Addendum: 22639-9
196210 IGP, cobasHPV16/18 191123 Maturation index: N/A
196210 IGP, cobasHPV16/18 191112 Performed by: 19767-3
196210 IGP, cobasHPV16/18 191128 QC reviewed by: N/A
196210 IGP, cobasHPV16/18 191145 Diagnosis provided by: N/A
196210 IGP, cobasHPV16/18 191113 Electronically signed by: 19769-9
196210 IGP, cobasHPV16/18 191139 Special procedure: N/A
196210 IGP, cobasHPV16/18 191129 Cytology history: N/A
196210 IGP, cobasHPV16/18 191179 Previous history: N/A
196210 IGP, cobasHPV16/18 191144 QA comment: N/A
196210 IGP, cobasHPV16/18 019018 . 11546-9
196210 IGP, cobasHPV16/18 191157 Pathologist provided ICD9: 52797-8
196210 IGP, cobasHPV16/18 191175 Pathologist provided ICD10: 52797-8
196210 IGP, cobasHPV16/18 190120 . N/A
196210 IGP, cobasHPV16/18 190109 Note: N/A
196210 IGP, cobasHPV16/18 000000 Test Methodology: 47527-7
196210 IGP, cobasHPV16/18 507386 HPV other hr types 71431-1
196210 IGP, cobasHPV16/18 507387 HPV 16 61372-9
196210 IGP, cobasHPV16/18 507388 HPV 18 61373-7
196210 IGP, cobasHPV16/18 191167 Photomicrograph N/A
196210 IGP, cobasHPV16/18 019030 . N/A
196210 IGP, cobasHPV16/18 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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