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

CPT: 87491; 87591; 88175
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Test Details

Use

Diagnose primary or metastatic neoplasm; detect Chlamydia trachomatis and Neisseria gonorrhoeae. 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 and Neisseria gonorrhoeae 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 and Neisseria gonorrhoeae 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 and HPV

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)

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)

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.

Optional Dedicated Specimen for Chlamydia and Gonococcus: 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; if the Aptima® swab transport is used, it must be tested within 60 days. 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. For Chlamydia and Gonococcus: 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.

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
196230 IGP,CtNg,rfxcobasHPV16/18ASCU 191121 Test ordered: N/A
196230 IGP,CtNg,rfxcobasHPV16/18ASCU 191158 ****************************** N/A
196230 IGP,CtNg,rfxcobasHPV16/18ASCU 191108 DIAGNOSIS: 22637-3
196230 IGP,CtNg,rfxcobasHPV16/18ASCU 191166 Interpretation N/A
196230 IGP,CtNg,rfxcobasHPV16/18ASCU 191170 Category: N/A
196230 IGP,CtNg,rfxcobasHPV16/18ASCU 191173 Recommendation: N/A
196230 IGP,CtNg,rfxcobasHPV16/18ASCU 191169 Infection: N/A
196230 IGP,CtNg,rfxcobasHPV16/18ASCU 191172 Adequacy: N/A
196230 IGP,CtNg,rfxcobasHPV16/18ASCU 191111 Recommendation: 19773-1
196230 IGP,CtNg,rfxcobasHPV16/18ASCU 191109 Specimen adequacy: 19764-0
196230 IGP,CtNg,rfxcobasHPV16/18ASCU 191159 ****************************** N/A
196230 IGP,CtNg,rfxcobasHPV16/18ASCU 191154 Source: 19763-2
196230 IGP,CtNg,rfxcobasHPV16/18ASCU 191160 Clinician provided ICD9: 52797-8
196230 IGP,CtNg,rfxcobasHPV16/18ASCU 191174 Clinician provided ICD10: 52797-8
196230 IGP,CtNg,rfxcobasHPV16/18ASCU 191107 Clinical history: 22636-5
196230 IGP,CtNg,rfxcobasHPV16/18ASCU 191124 Amended report: N/A
196230 IGP,CtNg,rfxcobasHPV16/18ASCU 191110 Additional comment: 22638-1
196230 IGP,CtNg,rfxcobasHPV16/18ASCU 191125 Addendum: 22639-9
196230 IGP,CtNg,rfxcobasHPV16/18ASCU 191123 Maturation index: N/A
196230 IGP,CtNg,rfxcobasHPV16/18ASCU 191112 Performed by: 19767-3
196230 IGP,CtNg,rfxcobasHPV16/18ASCU 191128 QC reviewed by: N/A
196230 IGP,CtNg,rfxcobasHPV16/18ASCU 191145 Diagnosis provided by: N/A
196230 IGP,CtNg,rfxcobasHPV16/18ASCU 191113 Electronically signed by: 19769-9
196230 IGP,CtNg,rfxcobasHPV16/18ASCU 191139 Special procedure: N/A
196230 IGP,CtNg,rfxcobasHPV16/18ASCU 191129 Cytology history: N/A
196230 IGP,CtNg,rfxcobasHPV16/18ASCU 191179 Previous history: N/A
196230 IGP,CtNg,rfxcobasHPV16/18ASCU 191144 QA comment: N/A
196230 IGP,CtNg,rfxcobasHPV16/18ASCU 019018 . 11546-9
196230 IGP,CtNg,rfxcobasHPV16/18ASCU 191157 Pathologist provided ICD9: 52797-8
196230 IGP,CtNg,rfxcobasHPV16/18ASCU 191175 Pathologist provided ICD10: 52797-8
196230 IGP,CtNg,rfxcobasHPV16/18ASCU 190120 . N/A
196230 IGP,CtNg,rfxcobasHPV16/18ASCU 190109 Note: N/A
196230 IGP,CtNg,rfxcobasHPV16/18ASCU 000000 Test Methodology: 47527-7
196230 IGP,CtNg,rfxcobasHPV16/18ASCU 190119 . N/A
196230 IGP,CtNg,rfxcobasHPV16/18ASCU 186114 Chlamydia, Nuc. Acid Amp 50387-0
196230 IGP,CtNg,rfxcobasHPV16/18ASCU 186122 Gonococcus, Nuc. Acid Amp 50388-8
196230 IGP,CtNg,rfxcobasHPV16/18ASCU 191167 Photomicrograph N/A
196230 IGP,CtNg,rfxcobasHPV16/18ASCU 019030 . N/A
196230 IGP,CtNg,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 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 507301 HPV, high-risk 507303 HPV, high-risk 30167-1
Reflex 2 000000 507405 000000 59420-0
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 61372-9
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 61373-7

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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