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

CPT: 87491; 87591; 87661; 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


Related Information


Related Documents

For more information, please view the literature below.

Microbiology Specimen Collection and Transport Guide


    Specimen Requirements


    Specimen

    Cervical cells collected by one of the methods described below.


    Volume

    ThinPrep® vial or ThinPrep® vial with optional additional Aptima® swab collection kit (for Chlamydia/Gonococcus/Trichomonas)


    Minimum Volume

    A minimum volume cannot be determined for the ThinPrep® vial because it varies depending on the cellularity of the specimen. Specimens collected with the Gen-Probe® Aptima® swab collection kit must arrive intact.


    Container

    ThinPrep® vial or ThinPrep® vial with optional Aptima® swab collection kit (for Chlamydia/Gonococcus/Trichomonas)


    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.

    Optional Dedicated Specimen for Chlamydia, Gonococcus, and Trichomonas: Use the Gen-Probe® Aptima® swab collection kit. (Note: Do not use the Gen-Probe® PACE DNA probe 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 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. 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. 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. For Chlamydia, Gonococcus, and Trichomonas: 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 blue-shafted collection swab.


    Test Details


    Use

    Diagnose primary or metastatic neoplasm; detect Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. 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.

    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.

    Any time a transport device used for molecular testing is processed, the chance of cross-specimen contamination increases. Aptima® transports can be placed directly on the analyzer, limiting the possibility of cross-specimen contamination.


    Methodology

    Image-guided liquid-based Pap test; nucleic acid amplification (NAA) for Chlamydia/Gonococcus/Trichomonas and HPV


    LOINC® Map

    Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
    196235 IGP,CtNgTvrfxcobasHPV16/18ASCU 47527-7 191121 Test ordered: N/A
    196235 IGP,CtNgTvrfxcobasHPV16/18ASCU 47527-7 191108 DIAGNOSIS: 47528-5
    196235 IGP,CtNgTvrfxcobasHPV16/18ASCU 47527-7 191166 Interpretation 56850-1
    196235 IGP,CtNgTvrfxcobasHPV16/18ASCU 47527-7 191170 Category: N/A
    196235 IGP,CtNgTvrfxcobasHPV16/18ASCU 47527-7 191173 Recommendation: N/A
    196235 IGP,CtNgTvrfxcobasHPV16/18ASCU 47527-7 191169 Infection: N/A
    196235 IGP,CtNgTvrfxcobasHPV16/18ASCU 47527-7 191172 Adequacy: N/A
    196235 IGP,CtNgTvrfxcobasHPV16/18ASCU 47527-7 191111 Recommendation: 19773-1
    196235 IGP,CtNgTvrfxcobasHPV16/18ASCU 47527-7 191109 Specimen adequacy: 19764-0
    196235 IGP,CtNgTvrfxcobasHPV16/18ASCU 47527-7 191154 Source: 19763-2
    196235 IGP,CtNgTvrfxcobasHPV16/18ASCU 47527-7 191160 Clinician provided ICD9: 52797-8
    196235 IGP,CtNgTvrfxcobasHPV16/18ASCU 47527-7 191174 Clinician provided ICD10: 52797-8
    196235 IGP,CtNgTvrfxcobasHPV16/18ASCU 47527-7 191107 Clinical history: 22636-5
    196235 IGP,CtNgTvrfxcobasHPV16/18ASCU 47527-7 191124 Amended report: N/A
    196235 IGP,CtNgTvrfxcobasHPV16/18ASCU 47527-7 191110 Additional comment: 22638-1
    196235 IGP,CtNgTvrfxcobasHPV16/18ASCU 47527-7 191125 Addendum: 22639-9
    196235 IGP,CtNgTvrfxcobasHPV16/18ASCU 47527-7 191123 Maturation index: N/A
    196235 IGP,CtNgTvrfxcobasHPV16/18ASCU 47527-7 191112 Performed by: 19767-3
    196235 IGP,CtNgTvrfxcobasHPV16/18ASCU 47527-7 191128 QC reviewed by: N/A
    196235 IGP,CtNgTvrfxcobasHPV16/18ASCU 47527-7 191145 Diagnosis provided by: N/A
    196235 IGP,CtNgTvrfxcobasHPV16/18ASCU 47527-7 191113 Electronically signed by: 19769-9
    196235 IGP,CtNgTvrfxcobasHPV16/18ASCU 47527-7 191139 Special procedure: N/A
    196235 IGP,CtNgTvrfxcobasHPV16/18ASCU 47527-7 191129 Cytology history: N/A
    196235 IGP,CtNgTvrfxcobasHPV16/18ASCU 47527-7 191179 Previous history: N/A
    196235 IGP,CtNgTvrfxcobasHPV16/18ASCU 47527-7 191144 QA comment: N/A
    196235 IGP,CtNgTvrfxcobasHPV16/18ASCU 47527-7 019018 . 11546-9
    196235 IGP,CtNgTvrfxcobasHPV16/18ASCU 47527-7 191157 Pathologist provided ICD9: 52797-8
    196235 IGP,CtNgTvrfxcobasHPV16/18ASCU 47527-7 191175 Pathologist provided ICD10: 52797-8
    196235 IGP,CtNgTvrfxcobasHPV16/18ASCU 47527-7 190120 . N/A
    196235 IGP,CtNgTvrfxcobasHPV16/18ASCU 47527-7 190109 Note: N/A
    196235 IGP,CtNgTvrfxcobasHPV16/18ASCU 47527-7 000000 Test Methodology: 47527-7
    196235 IGP,CtNgTvrfxcobasHPV16/18ASCU 47527-7 190119 . N/A
    196235 IGP,CtNgTvrfxcobasHPV16/18ASCU 47527-7 186134 Chlamydia, Nuc. Acid Amp 50387-0
    196235 IGP,CtNgTvrfxcobasHPV16/18ASCU 47527-7 186135 Gonococcus, Nuc. Acid Amp 50388-8
    196235 IGP,CtNgTvrfxcobasHPV16/18ASCU 47527-7 188092 Trich vag by NAA 46154-1
    196235 IGP,CtNgTvrfxcobasHPV16/18ASCU 47527-7 019054 PDF N/A
    196235 IGP,CtNgTvrfxcobasHPV16/18ASCU 47527-7 191167 Photomicrograph N/A
    196235 IGP,CtNgTvrfxcobasHPV16/18ASCU 47527-7 019030 . N/A
    196235 IGP,CtNgTvrfxcobasHPV16/18ASCU 47527-7 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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    The LOINC® codes are copyright © 1994-2021, 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