Gynecologic Pap Test (Image-guided), Liquid-based Preparation and Human Papillomavirus (HPV) High- and Low-risk DNA Detection

CPT: 87624; 88175
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Test Details

Test Includes

Image-guided liquid-based cytology evaluation and evaluation for the presence of high- and low-risk HPV DNA sequences

Use

Diagnose primary or metastatic neoplasm. The HPV test provides a qualitative molecular detection of 18 different human papillomavirus types in cervical specimens. The HPV test distinguishes between two HPV DNA groups: low-risk HPV types: 6, 11, 42, 43, 44 and high-risk types: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 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 HPV test distinguishes between two groups of HPV types: low-risk HPV (6, 11, 42, 43, 44) and high-risk HPV (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 89, 68) and cannot determine the specific HPV type present.

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.

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.

Container

ThinPrep® vial or SurePath™ vial.

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.

Storage Instructions

Maintain liquid-based cytology 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.

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 three months old in ThinPrep® vial; specimen more than 21 days old in SurePath™ vial.

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 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.)

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
Manos MM, Kinney WK, Hurley LB, et al. Identifying women with cervical neoplasia: Using human papillomavirus DNA testing for equivocal Papanicolaou results. JAMA. 1999 May 5; 281(17):1605-1610. 10235153
Schiffman M, Herrero R, Hildesheim A, et al. HPV DNA testing in cervical cancer screening: results from women in a high-risk province of Costa Rica. JAMA. 2000 Jan 5; 283(1):87-93. 10632285

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
198190 Pap IG, HPV-h+lr 191121 Test ordered: N/A
198190 Pap IG, HPV-h+lr 191158 ****************************** N/A
198190 Pap IG, HPV-h+lr 191108 DIAGNOSIS: 22637-3
198190 Pap IG, HPV-h+lr 191166 Interpretation N/A
198190 Pap IG, HPV-h+lr 191170 Category: N/A
198190 Pap IG, HPV-h+lr 191173 Recommendation: N/A
198190 Pap IG, HPV-h+lr 191169 Infection: N/A
198190 Pap IG, HPV-h+lr 191172 Adequacy: N/A
198190 Pap IG, HPV-h+lr 191111 Recommendation: 19773-1
198190 Pap IG, HPV-h+lr 191109 Specimen adequacy: 19764-0
198190 Pap IG, HPV-h+lr 191159 ****************************** N/A
198190 Pap IG, HPV-h+lr 191154 Source: 19763-2
198190 Pap IG, HPV-h+lr 191160 Clinician provided ICD9: 52797-8
198190 Pap IG, HPV-h+lr 191174 Clinician provided ICD10: 52797-8
198190 Pap IG, HPV-h+lr 191107 Clinical history: 22636-5
198190 Pap IG, HPV-h+lr 191124 Amended report: N/A
198190 Pap IG, HPV-h+lr 191110 Additional comment: 22638-1
198190 Pap IG, HPV-h+lr 191125 Addendum: 22639-9
198190 Pap IG, HPV-h+lr 191123 Maturation index: N/A
198190 Pap IG, HPV-h+lr 191112 Performed by: 19767-3
198190 Pap IG, HPV-h+lr 191128 QC reviewed by: N/A
198190 Pap IG, HPV-h+lr 191145 Diagnosis provided by: N/A
198190 Pap IG, HPV-h+lr 191113 Electronically signed by: 19769-9
198190 Pap IG, HPV-h+lr 191139 Special procedure: N/A
198190 Pap IG, HPV-h+lr 191129 Cytology history: N/A
198190 Pap IG, HPV-h+lr 191179 Previous history: N/A
198190 Pap IG, HPV-h+lr 191144 QA comment: N/A
198190 Pap IG, HPV-h+lr 019018 . 11546-9
198190 Pap IG, HPV-h+lr 191157 Pathologist provided ICD9: 52797-8
198190 Pap IG, HPV-h+lr 191175 Pathologist provided ICD10: 52797-8
198190 Pap IG, HPV-h+lr 190120 . N/A
198190 Pap IG, HPV-h+lr 190109 Note: N/A
198190 Pap IG, HPV-h+lr 000000 Test Methodology: 47527-7
198190 Pap IG, HPV-h+lr 500469 HPV, high-risk 30167-1
198190 Pap IG, HPV-h+lr 500459 HPV, low-risk 42481-2
198190 Pap IG, HPV-h+lr 191167 Photomicrograph N/A
198190 Pap IG, HPV-h+lr 019030 . N/A
198190 Pap IG, HPV-h+lr 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

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