Gynecologic Pap Test (Image-guided), Liquid-based Preparation and Chlamydia trachomatis, NAA With Reflex to Human Papillomavirus (HPV) High-risk DNA Detection When ASC-U, ASC-H, LSIL, HSIL, AGUS

CPT: 87491; 88175
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Test Details

Use

Diagnose primary or metastatic neoplasm; detect Chlamydia trachomatis. The high-risk HPV test is used for types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68 without differentiation of the individual types. This assay aids in the diagnosis of sexually-transmitted HPV infection and in the triage of patients with an ASCUS Pap test result.

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 reprocessing or HPV testing. A negative result does not exclude the possibility of an HPV infection since very low levels of infection or sampling error may produce a false-negative result. This test detects only the 13 most common high-risk HPV types and cannot determine the specific HPV type present.

Testing for Chlamydia trachomatis requires special procedures 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 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) (Chlamydia and HPV)

Specimen Requirements

Specimen

Cervical cells collected by one of the methods described below.

Volume

ThinPrep® vial or SurePath™ vial or ThinPrep® vial or SurePath™ vial with optional additional Aptima® swab collection kit (for Chlamydia)

Minimum Volume

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

Container

ThinPrep® vial or SurePath™ vial or ThinPrep® vial or SurePath™ vial and Aptima® swab collection kit (for Chlamydia)

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

ThinPrep® Vial−Broom Only:

Broom-like collection technique: Obtain a sample from the cervix using a broom-like device by inserting the brush portion into the cervical os and then rotate the brush five times. Rinse the collection device in the PreservCyt® solution by pushing the brush into the bottom of the vial 10 times, forcing the bristles to bend apart to release the cervical material. As a final step, twirl the brush between the thumb and forefinger vigorously to release additional cellular material. Discard the collection device. Tighten the cap on the ThinPrep® vial so that the torque line on the cap passes the torque line on the vial.

SurePath™ Vial: When using the SurePath™ vial, the cervical broom must be used for specimen collection. 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.

Optional Dedicated Specimen for Chlamydia: 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 and Aptima® swab transport specimens at room temperature. Pap processing must be done within 21 days of collection. SurePath™ vial must be processed for testing within 21 days of collection for HPV. Specimens in ThinPrep® vials must be processed for testing within three months of collection for HPV. Liquid-based cytology specimens must be tested within seven days for Chlamydia trachomatis; if the Aptima® swab transport is used, it must be tested within 60 days.

Causes for Rejection

Improper collection; inadequate specimen; improper labeling; specimen leaked in transit; quantity not sufficient for analysis; name discrepancies; specimen submitted on male patient; specimen submitted in vial that expired according to manufacturer's label; frozen specimen. For Pap: liquid-based cytology specimen more than 21 days old. For HPV: specimen more than 21 days old in SurePath™ liquid-based preservative; specimen more than three months old in ThinPrep® vial. For Chlamydia trachomatis: 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 (PMP), surgery (including surgical biopsies), exogenous hormones, abnormal vaginal bleeding, abnormal Pap results, IUD, and all other pertinent clinical information on the cytology test request form.

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.)

If ThinPrep® vials are QNS for the hybrid capture assay, then a test requiring a lower input volume will be automatically performed if there is sufficient volume to perform that assay.

References

Ferris DG, Wright TC Jr, Litaker MS, et al. Comparison of two tests for detecting carcinogenic HPV in women with Papanicolaou smear reports of ASCUS and LSIL. J Fam Pract. 1998 Feb; 46(2):136-141. 9487319
Hutchinson ML, Cassin CM, Ball HG 3rd. The efficacy of an automated preparation device for cervical cytology. Am J Clin Pathol. 1991 Sep; 96(3):300-305. 1877527
Hutchinson ML, Isenstein LM, Goodman A, et al, Homogeneous sampling accounts for the increased diagnostic accuracy using the ThinPrep® Processor. Am J Clin Pathol. 1994 Feb; 101(2):215-219. 8116578
Joseph MG, Cragg F, Wright VC, Kontozoglou TE, Downing P, Marks FR. Cyto-histological correlates in a colposcopic clinic: A 1-year prospective study. Diagn Cytopathol. 1991; 7(5):477-481. 1954825
Wilbur DC, Cibas ES, Merritt S, James LP, Berger BM, Bonfiglio TA. ThinPrep® Processor. Clinical trials demonstrate an increased detection rate of abnormal cervical cytologic specimens. Am J Clin Pathol. 1994 Feb; 101(2):209-214.8116577

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
198888 Pap IG, Ct, rfx HPV all pth 191121 Test ordered: N/A
198888 Pap IG, Ct, rfx HPV all pth 191158 ****************************** N/A
198888 Pap IG, Ct, rfx HPV all pth 191108 DIAGNOSIS: 22637-3
198888 Pap IG, Ct, rfx HPV all pth 191166 Interpretation N/A
198888 Pap IG, Ct, rfx HPV all pth 191170 Category: N/A
198888 Pap IG, Ct, rfx HPV all pth 191173 Recommendation: N/A
198888 Pap IG, Ct, rfx HPV all pth 191169 Infection: N/A
198888 Pap IG, Ct, rfx HPV all pth 191172 Adequacy: N/A
198888 Pap IG, Ct, rfx HPV all pth 191111 Recommendation: 19773-1
198888 Pap IG, Ct, rfx HPV all pth 191109 Specimen adequacy: 19764-0
198888 Pap IG, Ct, rfx HPV all pth 191159 ****************************** N/A
198888 Pap IG, Ct, rfx HPV all pth 191154 Source: 19763-2
198888 Pap IG, Ct, rfx HPV all pth 191160 Clinician provided ICD9: 52797-8
198888 Pap IG, Ct, rfx HPV all pth 191174 Clinician provided ICD10: 52797-8
198888 Pap IG, Ct, rfx HPV all pth 191107 Clinical history: 22636-5
198888 Pap IG, Ct, rfx HPV all pth 191124 Amended report: N/A
198888 Pap IG, Ct, rfx HPV all pth 191110 Additional comment: 22638-1
198888 Pap IG, Ct, rfx HPV all pth 191125 Addendum: 22639-9
198888 Pap IG, Ct, rfx HPV all pth 191123 Maturation index: N/A
198888 Pap IG, Ct, rfx HPV all pth 191112 Performed by: 19767-3
198888 Pap IG, Ct, rfx HPV all pth 191128 QC reviewed by: N/A
198888 Pap IG, Ct, rfx HPV all pth 191145 Diagnosis provided by: N/A
198888 Pap IG, Ct, rfx HPV all pth 191113 Electronically signed by: 19769-9
198888 Pap IG, Ct, rfx HPV all pth 191139 Special procedure: N/A
198888 Pap IG, Ct, rfx HPV all pth 191129 Cytology history: N/A
198888 Pap IG, Ct, rfx HPV all pth 191179 Previous history: N/A
198888 Pap IG, Ct, rfx HPV all pth 191144 QA comment: N/A
198888 Pap IG, Ct, rfx HPV all pth 019018 . 11546-9
198888 Pap IG, Ct, rfx HPV all pth 191157 Pathologist provided ICD9: 52797-8
198888 Pap IG, Ct, rfx HPV all pth 191175 Pathologist provided ICD10: 52797-8
198888 Pap IG, Ct, rfx HPV all pth 190120 . N/A
198888 Pap IG, Ct, rfx HPV all pth 190109 Note: N/A
198888 Pap IG, Ct, rfx HPV all pth 000000 Test Methodology: 47527-7
198888 Pap IG, Ct, rfx HPV all pth 190119 . N/A
198888 Pap IG, Ct, rfx HPV all pth 186114 Chlamydia, Nuc. Acid Amp 50387-0
198888 Pap IG, Ct, rfx HPV all pth 191167 Photomicrograph N/A
198888 Pap IG, Ct, rfx HPV all pth 019030 . N/A
198888 Pap IG, Ct, rfx HPV all pth 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

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CPT Statement/Profile Statement

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