Gynecologic Pap Test (Image-guided), Liquid-based Preparation and Herpes Simplex Virus (HSV) Types 1 and 2, NAA and Human Papillomavirus (HPV) High-risk DNA Detection With Reflex to HPV Genotypes 16 and 18

CPT: 87529(x2); 87624; 88175
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Test Details

Test Includes

Liquid-based cytology evaluation and evaluation for the presence of high-risk HPV DNA sequences. If the cytology evaluation is within normal limits, and the initial screen is positive for high-risk HPV DNA types in aggregate, then the residual specimen will be tested individually for high-risk HPV genotypes 16 and 18. Testing for HSV type 1 and type 2.

Use

Diagnose primary or metastatic neoplasm. Detect and type active HSV shedding. Diagnosis of sexually-transmitted HPV infection. The initial 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. If the Pap evaluation is within normal limits and the initial HPV test is positive, then the residual specimen will be tested individually for high-risk HPV genotypes 16 and 18. This information, together with the physician's assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. The results of this test are not intended to prevent women from proceeding to colposcopy.

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 is intended for use as an aid in the diagnosis of herpes simplex virus (HSV) infections with active viral shedding; it also differentiates HSV-1 from HSV-2. Negative HSV NAA results indicate lack of viral shedding but do not confirm the absence of previous infection.

Methodology

Image-guided liquid-based Pap test; nucleic acid amplification (NAA)

Specimen Requirements

Specimen

Cervical cells in liquid-based cytology transport

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 performed within 21 days of collection. HPV testing must be performed within three months of collection. SurePath™ vial must be processed for testing within 21 days of collection for HPV. Liquid-based cytology specimens must be tested winthin seven days for HSV.

Causes for Rejection

Improper collection; inadequate specimen; improperly labeled specimen; 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. For HSV: liquid-based cytology specimen more than seven days old.

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. If the additional assay is performed, testing for HPV genotypes 16 and 18 will not be performed due to volume limitations.

HSV NAA is a single test that both detects the presence of HSV DNA and determines which type is present in the positive samples. There is no mechanism, therefore, for testing for HSV-1 without simultaneously testing for HSV-2.

References

American Society for Colposcopy and Cervical Pathology. HPV Genotyping Clinical Update. Hagerstown, Md: ASCCP; 2009:1-3.
Ferris DG, Wright TC Jr, Litaker MS, et al. Triage of women with ASCUS and LSIL on Pap smear reports: Management by repeat Pap smear, HPV DNA testing, or colposcopy? J Fam Pract. 1998 Feb; 46(2):125-134.
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; 281:1605-1610.
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.

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
198325 Pap IG, HSV, HPV, rfx16/18 191121 Test ordered: N/A
198325 Pap IG, HSV, HPV, rfx16/18 191158 ****************************** N/A
198325 Pap IG, HSV, HPV, rfx16/18 191108 DIAGNOSIS: 22637-3
198325 Pap IG, HSV, HPV, rfx16/18 191166 Interpretation N/A
198325 Pap IG, HSV, HPV, rfx16/18 191170 Category: N/A
198325 Pap IG, HSV, HPV, rfx16/18 191173 Recommendation: N/A
198325 Pap IG, HSV, HPV, rfx16/18 191169 Infection: N/A
198325 Pap IG, HSV, HPV, rfx16/18 191172 Adequacy: N/A
198325 Pap IG, HSV, HPV, rfx16/18 191111 Recommendation: 19773-1
198325 Pap IG, HSV, HPV, rfx16/18 191109 Specimen adequacy: 19764-0
198325 Pap IG, HSV, HPV, rfx16/18 191159 ****************************** N/A
198325 Pap IG, HSV, HPV, rfx16/18 191154 Source: 19763-2
198325 Pap IG, HSV, HPV, rfx16/18 191160 Clinician provided ICD9: 52797-8
198325 Pap IG, HSV, HPV, rfx16/18 191174 Clinician provided ICD10: 52797-8
198325 Pap IG, HSV, HPV, rfx16/18 191107 Clinical history: 22636-5
198325 Pap IG, HSV, HPV, rfx16/18 191124 Amended report: N/A
198325 Pap IG, HSV, HPV, rfx16/18 191110 Additional comment: 22638-1
198325 Pap IG, HSV, HPV, rfx16/18 191125 Addendum: 22639-9
198325 Pap IG, HSV, HPV, rfx16/18 191123 Maturation index: N/A
198325 Pap IG, HSV, HPV, rfx16/18 191112 Performed by: 19767-3
198325 Pap IG, HSV, HPV, rfx16/18 191128 QC reviewed by: N/A
198325 Pap IG, HSV, HPV, rfx16/18 191145 Diagnosis provided by: N/A
198325 Pap IG, HSV, HPV, rfx16/18 191113 Electronically signed by: 19769-9
198325 Pap IG, HSV, HPV, rfx16/18 191139 Special procedure: N/A
198325 Pap IG, HSV, HPV, rfx16/18 191129 Cytology history: N/A
198325 Pap IG, HSV, HPV, rfx16/18 191179 Previous history: N/A
198325 Pap IG, HSV, HPV, rfx16/18 191144 QA comment: N/A
198325 Pap IG, HSV, HPV, rfx16/18 019018 . 11546-9
198325 Pap IG, HSV, HPV, rfx16/18 191157 Pathologist provided ICD9: 52797-8
198325 Pap IG, HSV, HPV, rfx16/18 191175 Pathologist provided ICD10: 52797-8
198325 Pap IG, HSV, HPV, rfx16/18 190120 . N/A
198325 Pap IG, HSV, HPV, rfx16/18 190109 Note: N/A
198325 Pap IG, HSV, HPV, rfx16/18 000000 Test Methodology: 47527-7
198325 Pap IG, HSV, HPV, rfx16/18 507303 HPV, high-risk 30167-1
198325 Pap IG, HSV, HPV, rfx16/18 188036 HSV 1 NAA 16130-7
198325 Pap IG, HSV, HPV, rfx16/18 188037 HSV 2 NAA 16131-5
198325 Pap IG, HSV, HPV, rfx16/18 188038 HSV 1 and 2 Tracking N/A
198325 Pap IG, HSV, HPV, rfx16/18 191167 Photomicrograph N/A
198325 Pap IG, HSV, HPV, rfx16/18 019030 . N/A
198325 Pap IG, HSV, HPV, rfx16/18 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 HPV, high-risk
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 507405 HPV, low volume rfx 507405 HPV, low volume rfx 59420-0

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