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

TEST: 196225
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CPT: 88175
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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.)

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 Information

Related Documents

For more information, please view the literature below.

Microbiology Specimen Collection and Transport Guide

    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

    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.

    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.

    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.

    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)

    LOINC® Map

    Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
    196225 IGP, rfxcobasHPV16/18ASCU 191121 Test ordered: N/A
    196225 IGP, rfxcobasHPV16/18ASCU 191108 DIAGNOSIS: 47528-5
    196225 IGP, rfxcobasHPV16/18ASCU 191166 Interpretation 19764-0
    196225 IGP, rfxcobasHPV16/18ASCU 191170 Category: N/A
    196225 IGP, rfxcobasHPV16/18ASCU 191173 Recommendation: N/A
    196225 IGP, rfxcobasHPV16/18ASCU 191169 Infection: N/A
    196225 IGP, rfxcobasHPV16/18ASCU 191172 Adequacy: N/A
    196225 IGP, rfxcobasHPV16/18ASCU 191111 Recommendation: 19773-1
    196225 IGP, rfxcobasHPV16/18ASCU 191109 Specimen adequacy: 19764-0
    196225 IGP, rfxcobasHPV16/18ASCU 191154 Source: 19763-2
    196225 IGP, rfxcobasHPV16/18ASCU 191160 Clinician provided ICD9: 52797-8
    196225 IGP, rfxcobasHPV16/18ASCU 191174 Clinician provided ICD10: 52797-8
    196225 IGP, rfxcobasHPV16/18ASCU 191107 Clinical history: 22636-5
    196225 IGP, rfxcobasHPV16/18ASCU 191124 Amended report: N/A
    196225 IGP, rfxcobasHPV16/18ASCU 191110 Additional comment: 22638-1
    196225 IGP, rfxcobasHPV16/18ASCU 191125 Addendum: 22639-9
    196225 IGP, rfxcobasHPV16/18ASCU 191123 Maturation index: N/A
    196225 IGP, rfxcobasHPV16/18ASCU 191112 Performed by: 19767-3
    196225 IGP, rfxcobasHPV16/18ASCU 191128 QC reviewed by: N/A
    196225 IGP, rfxcobasHPV16/18ASCU 191145 Diagnosis provided by: N/A
    196225 IGP, rfxcobasHPV16/18ASCU 191113 Electronically signed by: 19769-9
    196225 IGP, rfxcobasHPV16/18ASCU 191139 Special procedure: N/A
    196225 IGP, rfxcobasHPV16/18ASCU 191129 Cytology history: N/A
    196225 IGP, rfxcobasHPV16/18ASCU 191179 Previous history: N/A
    196225 IGP, rfxcobasHPV16/18ASCU 191144 QA comment: N/A
    196225 IGP, rfxcobasHPV16/18ASCU 019018 . 11546-9
    196225 IGP, rfxcobasHPV16/18ASCU 191157 Pathologist provided ICD9: 52797-8
    196225 IGP, rfxcobasHPV16/18ASCU 191175 Pathologist provided ICD10: 52797-8
    196225 IGP, rfxcobasHPV16/18ASCU 190120 . N/A
    196225 IGP, rfxcobasHPV16/18ASCU 190109 Note: N/A
    196225 IGP, rfxcobasHPV16/18ASCU 000000 Test Methodology: 47527-7
    196225 IGP, rfxcobasHPV16/18ASCU 190119 . N/A
    196225 IGP, rfxcobasHPV16/18ASCU 019054 PDF N/A
    196225 IGP, rfxcobasHPV16/18ASCU 191167 Photomicrograph N/A
    196225 IGP, rfxcobasHPV16/18ASCU 019030 . N/A
    196225 IGP, rfxcobasHPV16/18ASCU 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 .
    Order Code Order Name Result Code Result Name UofM Result LOINC
    Reflex 1 507385 HPV, cobas high-risk/16/18 507386 HPV other hr types 71431-1
    Reflex Table for .
    Order Code Order Name Result Code Result Name UofM Result LOINC
    Reflex 1 507385 HPV, cobas high-risk/16/18 507387 HPV 16 77399-4
    Reflex Table for .
    Order Code Order Name Result Code Result Name UofM Result LOINC
    Reflex 1 507385 HPV, cobas high-risk/16/18 507388 HPV 18 77400-0
    Reflex Table for .
    Order Code Order Name Result Code Result Name UofM Result LOINC
    Reflex 1 507385 HPV, cobas high-risk/16/18 019054 PDF N/A

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