Gynecologic Pap Test (Image-guided), Liquid-based Preparation and Chlamydia trachomatis, NAA

CPT: 87491; 88175
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Test Details

Use

Diagnose primary or metastatic neoplasm; detect Chlamydia trachomatis

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.

Testing for Chlamydia trachomatis 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 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)

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 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.

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. 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 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 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

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, et al. Cytohistological correlates in a colposcopic clinic: A 1-year prospective study. Diagn Cytopathol. 1991; 7(5):477-481.1954825
Wilbur DC, Cibas ES, Merritt S, et al. 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
197676 Pap IG, Ct 191121 Test ordered: N/A
197676 Pap IG, Ct 191158 ****************************** N/A
197676 Pap IG, Ct 191108 DIAGNOSIS: 22637-3
197676 Pap IG, Ct 191166 Interpretation N/A
197676 Pap IG, Ct 191170 Category: N/A
197676 Pap IG, Ct 191173 Recommendation: N/A
197676 Pap IG, Ct 191169 Infection: N/A
197676 Pap IG, Ct 191172 Adequacy: N/A
197676 Pap IG, Ct 191111 Recommendation: 19773-1
197676 Pap IG, Ct 191109 Specimen adequacy: 19764-0
197676 Pap IG, Ct 191159 ****************************** N/A
197676 Pap IG, Ct 191154 Source: 19763-2
197676 Pap IG, Ct 191160 Clinician provided ICD9: 52797-8
197676 Pap IG, Ct 191174 Clinician provided ICD10: 52797-8
197676 Pap IG, Ct 191107 Clinical history: 22636-5
197676 Pap IG, Ct 191124 Amended report: N/A
197676 Pap IG, Ct 191110 Additional comment: 22638-1
197676 Pap IG, Ct 191125 Addendum: 22639-9
197676 Pap IG, Ct 191123 Maturation index: N/A
197676 Pap IG, Ct 191112 Performed by: 19767-3
197676 Pap IG, Ct 191128 QC reviewed by: N/A
197676 Pap IG, Ct 191145 Diagnosis provided by: N/A
197676 Pap IG, Ct 191113 Electronically signed by: 19769-9
197676 Pap IG, Ct 191139 Special procedure: N/A
197676 Pap IG, Ct 191129 Cytology history: N/A
197676 Pap IG, Ct 191179 Previous history: N/A
197676 Pap IG, Ct 191144 QA comment: N/A
197676 Pap IG, Ct 019018 . 11546-9
197676 Pap IG, Ct 191157 Pathologist provided ICD9: 52797-8
197676 Pap IG, Ct 191175 Pathologist provided ICD10: 52797-8
197676 Pap IG, Ct 190120 . N/A
197676 Pap IG, Ct 190109 Note: N/A
197676 Pap IG, Ct 000000 Test Methodology: 47527-7
197676 Pap IG, Ct 186114 Chlamydia, Nuc. Acid Amp 50387-0
197676 Pap IG, Ct 191167 Photomicrograph N/A
197676 Pap IG, Ct 019030 . N/A
197676 Pap IG, Ct 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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