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

CPT: 87491; 87591; 87661; 88175
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Test Details

Use

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

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

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 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, 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 and Aptima® swab transport specimens at room temperature. Pap processing must be done within 21 days of collection. Specimens in ThinPrep® vials must be processed for testing within three months of collection for HPV. SurePath™ vial must be processed for testing within 21 days of collection for HPV. 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.

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 a 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 three months old in ThinPrep® vial. For Chlamydia, Gonococcus, Trichomonas vaginalis: 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 smears 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

American Society for Colposcopy and Cervical Pathology. HPV Genotyping Clinical Update. Hagerstown, Md: ASCCP; 2009:1-3.
Centers for Disease Control and Prevention. Screening test to detect Chlamydia trachomatis and Neisseria gonorrhoeae−2002. MMWR. 2002; 51(RR15). 12418541
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
van Der Schee C, van Belkum A, Zwijgers L, et al. Improved diagnosis of Trichomonas vaginalis infection by PCR using vaginal swabs and urine specimens compared to diagnosis by wet mount microscopy, culture, and fluorescent staining. J Clin Microbiol. 1999; 37(12):4127-4130.4562134
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
196595 Pap IG, Ct-Ng TV rfx HPV all 191121 Test ordered: N/A
196595 Pap IG, Ct-Ng TV rfx HPV all 191158 ****************************** N/A
196595 Pap IG, Ct-Ng TV rfx HPV all 191108 DIAGNOSIS: 22637-3
196595 Pap IG, Ct-Ng TV rfx HPV all 191166 Interpretation N/A
196595 Pap IG, Ct-Ng TV rfx HPV all 191170 Category: N/A
196595 Pap IG, Ct-Ng TV rfx HPV all 191173 Recommendation: N/A
196595 Pap IG, Ct-Ng TV rfx HPV all 191169 Infection: N/A
196595 Pap IG, Ct-Ng TV rfx HPV all 191172 Adequacy: N/A
196595 Pap IG, Ct-Ng TV rfx HPV all 191111 Recommendation: 19773-1
196595 Pap IG, Ct-Ng TV rfx HPV all 191109 Specimen adequacy: 19764-0
196595 Pap IG, Ct-Ng TV rfx HPV all 191159 ****************************** N/A
196595 Pap IG, Ct-Ng TV rfx HPV all 191154 Source: 19763-2
196595 Pap IG, Ct-Ng TV rfx HPV all 191160 Clinician provided ICD9: 52797-8
196595 Pap IG, Ct-Ng TV rfx HPV all 191174 Clinician provided ICD10: 52797-8
196595 Pap IG, Ct-Ng TV rfx HPV all 191107 Clinical history: 22636-5
196595 Pap IG, Ct-Ng TV rfx HPV all 191124 Amended report: N/A
196595 Pap IG, Ct-Ng TV rfx HPV all 191110 Additional comment: 22638-1
196595 Pap IG, Ct-Ng TV rfx HPV all 191125 Addendum: 22639-9
196595 Pap IG, Ct-Ng TV rfx HPV all 191123 Maturation index: N/A
196595 Pap IG, Ct-Ng TV rfx HPV all 191112 Performed by: 19767-3
196595 Pap IG, Ct-Ng TV rfx HPV all 191128 QC reviewed by: N/A
196595 Pap IG, Ct-Ng TV rfx HPV all 191145 Diagnosis provided by: N/A
196595 Pap IG, Ct-Ng TV rfx HPV all 191113 Electronically signed by: 19769-9
196595 Pap IG, Ct-Ng TV rfx HPV all 191139 Special procedure: N/A
196595 Pap IG, Ct-Ng TV rfx HPV all 191129 Cytology history: N/A
196595 Pap IG, Ct-Ng TV rfx HPV all 191179 Previous history: N/A
196595 Pap IG, Ct-Ng TV rfx HPV all 191144 QA comment: N/A
196595 Pap IG, Ct-Ng TV rfx HPV all 019018 . 11546-9
196595 Pap IG, Ct-Ng TV rfx HPV all 191157 Pathologist provided ICD9: 52797-8
196595 Pap IG, Ct-Ng TV rfx HPV all 191175 Pathologist provided ICD10: 52797-8
196595 Pap IG, Ct-Ng TV rfx HPV all 190120 . N/A
196595 Pap IG, Ct-Ng TV rfx HPV all 190109 Note: N/A
196595 Pap IG, Ct-Ng TV rfx HPV all 000000 Test Methodology: 47527-7
196595 Pap IG, Ct-Ng TV rfx HPV all 190119 . N/A
196595 Pap IG, Ct-Ng TV rfx HPV all 186134 Chlamydia, Nuc. Acid Amp 50387-0
196595 Pap IG, Ct-Ng TV rfx HPV all 186135 Gonococcus, Nuc. Acid Amp 50388-8
196595 Pap IG, Ct-Ng TV rfx HPV all 188092 Trich vag by NAA 46154-1
196595 Pap IG, Ct-Ng TV rfx HPV all 191167 Photomicrograph N/A
196595 Pap IG, Ct-Ng TV rfx HPV all 019030 . N/A
196595 Pap IG, Ct-Ng TV rfx HPV all 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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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