Gynecologic Pap Test (Image-guided), Liquid-based Preparation and Herpes Simplex Virus (HSV) Types 1 and 2, NAA

CPT: 87529(x2); 88175
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Test Details

Use

Diagnose primary or metastatic neoplasm; detect and type active HSV shedding

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. 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 absence of previous infection.

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.

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. Excessive use of lubricating jelly will interfere with cytologic examination.

Collection

ThinPrep® Vial − Broom or Brush/Spatula:

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.

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.

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 specimen at room temperature. Specimens must be processed for Pap testing within 21 days of collection. Specimens must be processed for HSV testing within seven days 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 a vial that expired according to manufacturer's label; frozen specimen. For Pap: liquid-based cytology specimen more than 21 days old. 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 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.)

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.

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
198300 Pap IG, HSV 1/2 NAA 191121 Test ordered: N/A
198300 Pap IG, HSV 1/2 NAA 191158 ****************************** N/A
198300 Pap IG, HSV 1/2 NAA 191108 DIAGNOSIS: 22637-3
198300 Pap IG, HSV 1/2 NAA 191166 Interpretation N/A
198300 Pap IG, HSV 1/2 NAA 191170 Category: N/A
198300 Pap IG, HSV 1/2 NAA 191173 Recommendation: N/A
198300 Pap IG, HSV 1/2 NAA 191169 Infection: N/A
198300 Pap IG, HSV 1/2 NAA 191172 Adequacy: N/A
198300 Pap IG, HSV 1/2 NAA 191111 Recommendation: 19773-1
198300 Pap IG, HSV 1/2 NAA 191109 Specimen adequacy: 19764-0
198300 Pap IG, HSV 1/2 NAA 191159 ****************************** N/A
198300 Pap IG, HSV 1/2 NAA 191154 Source: 19763-2
198300 Pap IG, HSV 1/2 NAA 191160 Clinician provided ICD9: 52797-8
198300 Pap IG, HSV 1/2 NAA 191174 Clinician provided ICD10: 52797-8
198300 Pap IG, HSV 1/2 NAA 191107 Clinical history: 22636-5
198300 Pap IG, HSV 1/2 NAA 191124 Amended report: N/A
198300 Pap IG, HSV 1/2 NAA 191110 Additional comment: 22638-1
198300 Pap IG, HSV 1/2 NAA 191125 Addendum: 22639-9
198300 Pap IG, HSV 1/2 NAA 191123 Maturation index: N/A
198300 Pap IG, HSV 1/2 NAA 191112 Performed by: 19767-3
198300 Pap IG, HSV 1/2 NAA 191128 QC reviewed by: N/A
198300 Pap IG, HSV 1/2 NAA 191145 Diagnosis provided by: N/A
198300 Pap IG, HSV 1/2 NAA 191113 Electronically signed by: 19769-9
198300 Pap IG, HSV 1/2 NAA 191139 Special procedure: N/A
198300 Pap IG, HSV 1/2 NAA 191129 Cytology history: N/A
198300 Pap IG, HSV 1/2 NAA 191179 Previous history: N/A
198300 Pap IG, HSV 1/2 NAA 191144 QA comment: N/A
198300 Pap IG, HSV 1/2 NAA 019018 . 11546-9
198300 Pap IG, HSV 1/2 NAA 191157 Pathologist provided ICD9: 52797-8
198300 Pap IG, HSV 1/2 NAA 191175 Pathologist provided ICD10: 52797-8
198300 Pap IG, HSV 1/2 NAA 190120 . N/A
198300 Pap IG, HSV 1/2 NAA 190109 Note: N/A
198300 Pap IG, HSV 1/2 NAA 000000 Test Methodology: 47527-7
198300 Pap IG, HSV 1/2 NAA 188036 HSV 1 NAA 16130-7
198300 Pap IG, HSV 1/2 NAA 188037 HSV 2 NAA 16131-5
198300 Pap IG, HSV 1/2 NAA 188038 HSV 1 and 2 Tracking N/A
198300 Pap IG, HSV 1/2 NAA 191167 Photomicrograph N/A
198300 Pap IG, HSV 1/2 NAA 019030 . N/A
198300 Pap IG, HSV 1/2 NAA 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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