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Gynecologic Pap Test (Image-guided), Liquid-based Preparation and Chlamydia/Gonococcus/Trichomonas, NAA

CPT 87491; 87591; 87661; 88175

Test Details

Methodology

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

Result Turnaround Time

3 - 6 days

Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.

Related Information

Related Documents

Use

Diagnose primary or metastatic neoplasm; detect Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis

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.

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, Neisseria gonorrhoeae, and Trichomonas vaginalis requires special procedures to be used in the processing of the cytology specimens; 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.

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

Specimen Requirements

Specimen

Cervical cells collected by one of the methods described below.

Volume

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

Collection Instructions

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 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 ¼ to ½ 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.

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 performed within 21 days of collection. 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.

Patient Preparation

Patient should avoid douches 48 to 72 hours prior to examination. Specimen should not be collected during or shortly after menstrual period.

Causes for Rejection

Improper collection; inadequate specimen; improper labeling; specimen leaked in transit; quantity not sufficient for analysis; name discrepancies; specimens submitted on male patient; specimen submitted in a vial that expired according to manufacturer's label; frozen specimen; SurePath™ vial. For Pap: liquid-based cytology specimen more than 21 days old. For Chlamydia, Gonococcus, and 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.

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
196502 Pap IG, Ct-Ng TV 191121 Test ordered: N/A
196502 Pap IG, Ct-Ng TV 191108 DIAGNOSIS: 47528-5
196502 Pap IG, Ct-Ng TV 191166 Interpretation 19764-0
196502 Pap IG, Ct-Ng TV 191170 Category: N/A
196502 Pap IG, Ct-Ng TV 191173 Recommendation: N/A
196502 Pap IG, Ct-Ng TV 191169 Infection: N/A
196502 Pap IG, Ct-Ng TV 191172 Adequacy: N/A
196502 Pap IG, Ct-Ng TV 191111 Recommendation: 19773-1
196502 Pap IG, Ct-Ng TV 191109 Specimen adequacy: 19764-0
196502 Pap IG, Ct-Ng TV 191154 Source: 19763-2
196502 Pap IG, Ct-Ng TV 191160 Clinician provided ICD9: 52797-8
196502 Pap IG, Ct-Ng TV 191174 Clinician provided ICD10: 52797-8
196502 Pap IG, Ct-Ng TV 191107 Clinical history: 22636-5
196502 Pap IG, Ct-Ng TV 191124 Amended report: N/A
196502 Pap IG, Ct-Ng TV 191110 Additional comment: 22638-1
196502 Pap IG, Ct-Ng TV 191125 Addendum: 22639-9
196502 Pap IG, Ct-Ng TV 191123 Maturation index: N/A
196502 Pap IG, Ct-Ng TV 191112 Performed by: 19767-3
196502 Pap IG, Ct-Ng TV 191128 QC reviewed by: N/A
196502 Pap IG, Ct-Ng TV 191145 Diagnosis provided by: N/A
196502 Pap IG, Ct-Ng TV 191113 Electronically signed by: 19769-9
196502 Pap IG, Ct-Ng TV 191139 Special procedure: N/A
196502 Pap IG, Ct-Ng TV 191129 Cytology history: N/A
196502 Pap IG, Ct-Ng TV 191179 Previous history: N/A
196502 Pap IG, Ct-Ng TV 191144 QA comment: N/A
196502 Pap IG, Ct-Ng TV 019018 . 11546-9
196502 Pap IG, Ct-Ng TV 191157 Pathologist provided ICD9: 52797-8
196502 Pap IG, Ct-Ng TV 191175 Pathologist provided ICD10: 52797-8
196502 Pap IG, Ct-Ng TV 190120 . N/A
196502 Pap IG, Ct-Ng TV 190109 Note: 8251-1
196502 Pap IG, Ct-Ng TV 000000 Test Methodology: 47527-7
196502 Pap IG, Ct-Ng TV 186134 Chlamydia, Nuc. Acid Amp 50387-0
196502 Pap IG, Ct-Ng TV 186135 Gonococcus, Nuc. Acid Amp 50388-8
196502 Pap IG, Ct-Ng TV 188092 Trich vag by NAA 46154-1
196502 Pap IG, Ct-Ng TV 019054 PDF 11502-2
196502 Pap IG, Ct-Ng TV 191167 Photomicrograph N/A
196502 Pap IG, Ct-Ng TV 019030 . N/A
196502 Pap IG, Ct-Ng TV 019031 Patient Counseling Report N/A
Order Code196502
Order Code NamePap IG, Ct-Ng TV
Order Loinc
Result Code191121
Result Code NameTest ordered:
UofM
Result LOINCN/A
Order Code196502
Order Code NamePap IG, Ct-Ng TV
Order Loinc
Result Code191108
Result Code NameDIAGNOSIS:
UofM
Result LOINC47528-5
Order Code196502
Order Code NamePap IG, Ct-Ng TV
Order Loinc
Result Code191166
Result Code NameInterpretation
UofM
Result LOINC19764-0
Order Code196502
Order Code NamePap IG, Ct-Ng TV
Order Loinc
Result Code191170
Result Code NameCategory:
UofM
Result LOINCN/A
Order Code196502
Order Code NamePap IG, Ct-Ng TV
Order Loinc
Result Code191173
Result Code NameRecommendation:
UofM
Result LOINCN/A
Order Code196502
Order Code NamePap IG, Ct-Ng TV
Order Loinc
Result Code191169
Result Code NameInfection:
UofM
Result LOINCN/A
Order Code196502
Order Code NamePap IG, Ct-Ng TV
Order Loinc
Result Code191172
Result Code NameAdequacy:
UofM
Result LOINCN/A
Order Code196502
Order Code NamePap IG, Ct-Ng TV
Order Loinc
Result Code191111
Result Code NameRecommendation:
UofM
Result LOINC19773-1
Order Code196502
Order Code NamePap IG, Ct-Ng TV
Order Loinc
Result Code191109
Result Code NameSpecimen adequacy:
UofM
Result LOINC19764-0
Order Code196502
Order Code NamePap IG, Ct-Ng TV
Order Loinc
Result Code191154
Result Code NameSource:
UofM
Result LOINC19763-2
Order Code196502
Order Code NamePap IG, Ct-Ng TV
Order Loinc
Result Code191160
Result Code NameClinician provided ICD9:
UofM
Result LOINC52797-8
Order Code196502
Order Code NamePap IG, Ct-Ng TV
Order Loinc
Result Code191174
Result Code NameClinician provided ICD10:
UofM
Result LOINC52797-8
Order Code196502
Order Code NamePap IG, Ct-Ng TV
Order Loinc
Result Code191107
Result Code NameClinical history:
UofM
Result LOINC22636-5
Order Code196502
Order Code NamePap IG, Ct-Ng TV
Order Loinc
Result Code191124
Result Code NameAmended report:
UofM
Result LOINCN/A
Order Code196502
Order Code NamePap IG, Ct-Ng TV
Order Loinc
Result Code191110
Result Code NameAdditional comment:
UofM
Result LOINC22638-1
Order Code196502
Order Code NamePap IG, Ct-Ng TV
Order Loinc
Result Code191125
Result Code NameAddendum:
UofM
Result LOINC22639-9
Order Code196502
Order Code NamePap IG, Ct-Ng TV
Order Loinc
Result Code191123
Result Code NameMaturation index:
UofM
Result LOINCN/A
Order Code196502
Order Code NamePap IG, Ct-Ng TV
Order Loinc
Result Code191112
Result Code NamePerformed by:
UofM
Result LOINC19767-3
Order Code196502
Order Code NamePap IG, Ct-Ng TV
Order Loinc
Result Code191128
Result Code NameQC reviewed by:
UofM
Result LOINCN/A
Order Code196502
Order Code NamePap IG, Ct-Ng TV
Order Loinc
Result Code191145
Result Code NameDiagnosis provided by:
UofM
Result LOINCN/A
Order Code196502
Order Code NamePap IG, Ct-Ng TV
Order Loinc
Result Code191113
Result Code NameElectronically signed by:
UofM
Result LOINC19769-9
Order Code196502
Order Code NamePap IG, Ct-Ng TV
Order Loinc
Result Code191139
Result Code NameSpecial procedure:
UofM
Result LOINCN/A
Order Code196502
Order Code NamePap IG, Ct-Ng TV
Order Loinc
Result Code191129
Result Code NameCytology history:
UofM
Result LOINCN/A
Order Code196502
Order Code NamePap IG, Ct-Ng TV
Order Loinc
Result Code191179
Result Code NamePrevious history:
UofM
Result LOINCN/A
Order Code196502
Order Code NamePap IG, Ct-Ng TV
Order Loinc
Result Code191144
Result Code NameQA comment:
UofM
Result LOINCN/A
Order Code196502
Order Code NamePap IG, Ct-Ng TV
Order Loinc
Result Code019018
Result Code Name.
UofM
Result LOINC11546-9
Order Code196502
Order Code NamePap IG, Ct-Ng TV
Order Loinc
Result Code191157
Result Code NamePathologist provided ICD9:
UofM
Result LOINC52797-8
Order Code196502
Order Code NamePap IG, Ct-Ng TV
Order Loinc
Result Code191175
Result Code NamePathologist provided ICD10:
UofM
Result LOINC52797-8
Order Code196502
Order Code NamePap IG, Ct-Ng TV
Order Loinc
Result Code190120
Result Code Name.
UofM
Result LOINCN/A
Order Code196502
Order Code NamePap IG, Ct-Ng TV
Order Loinc
Result Code190109
Result Code NameNote:
UofM
Result LOINC8251-1
Order Code196502
Order Code NamePap IG, Ct-Ng TV
Order Loinc
Result Code000000
Result Code NameTest Methodology:
UofM
Result LOINC47527-7
Order Code196502
Order Code NamePap IG, Ct-Ng TV
Order Loinc
Result Code186134
Result Code NameChlamydia, Nuc. Acid Amp
UofM
Result LOINC50387-0
Order Code196502
Order Code NamePap IG, Ct-Ng TV
Order Loinc
Result Code186135
Result Code NameGonococcus, Nuc. Acid Amp
UofM
Result LOINC50388-8
Order Code196502
Order Code NamePap IG, Ct-Ng TV
Order Loinc
Result Code188092
Result Code NameTrich vag by NAA
UofM
Result LOINC46154-1
Order Code196502
Order Code NamePap IG, Ct-Ng TV
Order Loinc
Result Code019054
Result Code NamePDF
UofM
Result LOINC11502-2
Order Code196502
Order Code NamePap IG, Ct-Ng TV
Order Loinc
Result Code191167
Result Code NamePhotomicrograph
UofM
Result LOINCN/A
Order Code196502
Order Code NamePap IG, Ct-Ng TV
Order Loinc
Result Code019030
Result Code Name.
UofM
Result LOINCN/A
Order Code196502
Order Code NamePap IG, Ct-Ng TV
Order Loinc
Result Code019031
Result Code NamePatient Counseling Report
UofM
Result LOINCN/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 1
Order Code192555
Order NameChange IG Pap to LB Pap
Result Code000000
Result NameLBP CPT Code Automation
UofM
Result LOINC47527-7