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Gynecologic Pap Test (Image-guided), Liquid-based Preparation and Chlamydia/Gonococcus, NAA With Reflex to High-risk HPV (Cobas®) When ASC-U

Test Number 196315
Test number copied
CPT 87491; 87591; 88175. If reflex testing is performed, concomitant CPT codes/charges will apply.

Test Details

Result Turnaround Time

2 - 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

For more information, please view the literature below.

Microbiology Specimen Collection and Transport Guide

Use

Diagnose primary or metastatic neoplasm; detect Chlamydia trachomatis and Neisseria gonorrhoeae. The high-risk HPV test is used for types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68 without differentiation of the individual types. This assay aids in the diagnosis of sexually transmitted HPV infection and in the triage of patients with an ASCUS Pap test result.

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.)

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 processing or HPV testing. Detection of high-risk HPV is dependent on the number of copies present in the specimen and may be affected by specimen collection methods, patient factors, stage of infection, and the presence of interfering substances.

Testing for Chlamydia trachomatis and Neisseria gonorrhoeae requires special procedures 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 and Neisseria gonorrhoeae 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

Ferris DG, Wright TC, Litaker MS, et al. Triage of women with ASCUS and LSIL Pap smear reports: Management by repeat Pap smear, HPV DNA testing, or colposcopy. J Fam Pract. 1998 Feb; 46(2):125-134.1877527
Manos MM, Kinney WK, Hurley B, et al. Identifying women with cervical neoplasia: Using human papillomavirus DNA testing for equivocal Papanicolaou results. JAMA. 1999 May 5; 281:1605-1610.8116578
Schiffman M, Herrero R, Hildesheim A, et al. HPV DNA testing cervical cancer screening: Results from women in a high-risk province in Costa Rica. JAMA. 2000 Jan 5; 283(1):87-93.1954825

Specimen Requirements

Specimen

Cervical cells collected by one of the methods described below.

Volume

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

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)

Collection Instructions

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.

Optional Dedicated Specimen for Chlamydia and Gonococcus: 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. ThinPrep® vial may be stored for six months after the date of collection prior to performing the cobas® HPV test. ThinPrep® specimens should not be frozen. Liquid-based cytology specimens must be tested within seven days for Chlamydia/Gonococcus; 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; frozen specimen; specimen leaked in transit; quantity not sufficient for analysis; name discrepancies; specimen submitted on male patient. For Pap: liquid-based cytology specimen more than 21 days old. For HPV: specimen more than six months old in ThinPrep® vial; excessively bloody specimens. For Chlamydia trachomatis and Neisseria gonorrhoeae: 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
196315 IGP,CtNg,rfxcobasHPV ASCU 47527-7 191121 Test ordered: N/A
196315 IGP,CtNg,rfxcobasHPV ASCU 47527-7 191108 DIAGNOSIS: 47528-5
196315 IGP,CtNg,rfxcobasHPV ASCU 47527-7 191166 Interpretation 19764-0
196315 IGP,CtNg,rfxcobasHPV ASCU 47527-7 191170 Category: N/A
196315 IGP,CtNg,rfxcobasHPV ASCU 47527-7 191173 Recommendation: N/A
196315 IGP,CtNg,rfxcobasHPV ASCU 47527-7 191169 Infection: N/A
196315 IGP,CtNg,rfxcobasHPV ASCU 47527-7 191172 Adequacy: N/A
196315 IGP,CtNg,rfxcobasHPV ASCU 47527-7 191111 Recommendation: 19773-1
196315 IGP,CtNg,rfxcobasHPV ASCU 47527-7 191109 Specimen adequacy: 19764-0
196315 IGP,CtNg,rfxcobasHPV ASCU 47527-7 191154 Source: 19763-2
196315 IGP,CtNg,rfxcobasHPV ASCU 47527-7 191160 Clinician provided ICD9: 52797-8
196315 IGP,CtNg,rfxcobasHPV ASCU 47527-7 191174 Clinician provided ICD10: 52797-8
196315 IGP,CtNg,rfxcobasHPV ASCU 47527-7 191107 Clinical history: 22636-5
196315 IGP,CtNg,rfxcobasHPV ASCU 47527-7 191124 Amended report: N/A
196315 IGP,CtNg,rfxcobasHPV ASCU 47527-7 191110 Additional comment: 22638-1
196315 IGP,CtNg,rfxcobasHPV ASCU 47527-7 191125 Addendum: 22639-9
196315 IGP,CtNg,rfxcobasHPV ASCU 47527-7 191123 Maturation index: N/A
196315 IGP,CtNg,rfxcobasHPV ASCU 47527-7 191112 Performed by: 19767-3
196315 IGP,CtNg,rfxcobasHPV ASCU 47527-7 191128 QC reviewed by: N/A
196315 IGP,CtNg,rfxcobasHPV ASCU 47527-7 191145 Diagnosis provided by: N/A
196315 IGP,CtNg,rfxcobasHPV ASCU 47527-7 191113 Electronically signed by: 19769-9
196315 IGP,CtNg,rfxcobasHPV ASCU 47527-7 191139 Special procedure: N/A
196315 IGP,CtNg,rfxcobasHPV ASCU 47527-7 191129 Cytology history: N/A
196315 IGP,CtNg,rfxcobasHPV ASCU 47527-7 191179 Previous history: N/A
196315 IGP,CtNg,rfxcobasHPV ASCU 47527-7 191144 QA comment: N/A
196315 IGP,CtNg,rfxcobasHPV ASCU 47527-7 019018 . 11546-9
196315 IGP,CtNg,rfxcobasHPV ASCU 47527-7 191157 Pathologist provided ICD9: 52797-8
196315 IGP,CtNg,rfxcobasHPV ASCU 47527-7 191175 Pathologist provided ICD10: 52797-8
196315 IGP,CtNg,rfxcobasHPV ASCU 47527-7 190120 . N/A
196315 IGP,CtNg,rfxcobasHPV ASCU 47527-7 190109 Note: 8251-1
196315 IGP,CtNg,rfxcobasHPV ASCU 47527-7 000000 Test Methodology: 47527-7
196315 IGP,CtNg,rfxcobasHPV ASCU 47527-7 190119 . N/A
196315 IGP,CtNg,rfxcobasHPV ASCU 47527-7 186114 Chlamydia, Nuc. Acid Amp 50387-0
196315 IGP,CtNg,rfxcobasHPV ASCU 47527-7 186122 Gonococcus, Nuc. Acid Amp 50388-8
196315 IGP,CtNg,rfxcobasHPV ASCU 47527-7 019054 PDF 11502-2
196315 IGP,CtNg,rfxcobasHPV ASCU 47527-7 191167 Photomicrograph N/A
196315 IGP,CtNg,rfxcobasHPV ASCU 47527-7 019030 . N/A
196315 IGP,CtNg,rfxcobasHPV ASCU 47527-7 019031 Patient Counseling Report N/A
Order Code196315
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc47527-7
Result Code191121
Result Code NameTest ordered:
UofM
Result LOINCN/A
Order Code196315
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc47527-7
Result Code191108
Result Code NameDIAGNOSIS:
UofM
Result LOINC47528-5
Order Code196315
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc47527-7
Result Code191166
Result Code NameInterpretation
UofM
Result LOINC19764-0
Order Code196315
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc47527-7
Result Code191170
Result Code NameCategory:
UofM
Result LOINCN/A
Order Code196315
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc47527-7
Result Code191173
Result Code NameRecommendation:
UofM
Result LOINCN/A
Order Code196315
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc47527-7
Result Code191169
Result Code NameInfection:
UofM
Result LOINCN/A
Order Code196315
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc47527-7
Result Code191172
Result Code NameAdequacy:
UofM
Result LOINCN/A
Order Code196315
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc47527-7
Result Code191111
Result Code NameRecommendation:
UofM
Result LOINC19773-1
Order Code196315
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc47527-7
Result Code191109
Result Code NameSpecimen adequacy:
UofM
Result LOINC19764-0
Order Code196315
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc47527-7
Result Code191154
Result Code NameSource:
UofM
Result LOINC19763-2
Order Code196315
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc47527-7
Result Code191160
Result Code NameClinician provided ICD9:
UofM
Result LOINC52797-8
Order Code196315
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc47527-7
Result Code191174
Result Code NameClinician provided ICD10:
UofM
Result LOINC52797-8
Order Code196315
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc47527-7
Result Code191107
Result Code NameClinical history:
UofM
Result LOINC22636-5
Order Code196315
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc47527-7
Result Code191124
Result Code NameAmended report:
UofM
Result LOINCN/A
Order Code196315
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc47527-7
Result Code191110
Result Code NameAdditional comment:
UofM
Result LOINC22638-1
Order Code196315
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc47527-7
Result Code191125
Result Code NameAddendum:
UofM
Result LOINC22639-9
Order Code196315
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc47527-7
Result Code191123
Result Code NameMaturation index:
UofM
Result LOINCN/A
Order Code196315
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc47527-7
Result Code191112
Result Code NamePerformed by:
UofM
Result LOINC19767-3
Order Code196315
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc47527-7
Result Code191128
Result Code NameQC reviewed by:
UofM
Result LOINCN/A
Order Code196315
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc47527-7
Result Code191145
Result Code NameDiagnosis provided by:
UofM
Result LOINCN/A
Order Code196315
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc47527-7
Result Code191113
Result Code NameElectronically signed by:
UofM
Result LOINC19769-9
Order Code196315
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc47527-7
Result Code191139
Result Code NameSpecial procedure:
UofM
Result LOINCN/A
Order Code196315
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc47527-7
Result Code191129
Result Code NameCytology history:
UofM
Result LOINCN/A
Order Code196315
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc47527-7
Result Code191179
Result Code NamePrevious history:
UofM
Result LOINCN/A
Order Code196315
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc47527-7
Result Code191144
Result Code NameQA comment:
UofM
Result LOINCN/A
Order Code196315
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc47527-7
Result Code019018
Result Code Name.
UofM
Result LOINC11546-9
Order Code196315
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc47527-7
Result Code191157
Result Code NamePathologist provided ICD9:
UofM
Result LOINC52797-8
Order Code196315
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc47527-7
Result Code191175
Result Code NamePathologist provided ICD10:
UofM
Result LOINC52797-8
Order Code196315
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc47527-7
Result Code190120
Result Code Name.
UofM
Result LOINCN/A
Order Code196315
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc47527-7
Result Code190109
Result Code NameNote:
UofM
Result LOINC8251-1
Order Code196315
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc47527-7
Result Code000000
Result Code NameTest Methodology:
UofM
Result LOINC47527-7
Order Code196315
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc47527-7
Result Code190119
Result Code Name.
UofM
Result LOINCN/A
Order Code196315
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc47527-7
Result Code186114
Result Code NameChlamydia, Nuc. Acid Amp
UofM
Result LOINC50387-0
Order Code196315
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc47527-7
Result Code186122
Result Code NameGonococcus, Nuc. Acid Amp
UofM
Result LOINC50388-8
Order Code196315
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc47527-7
Result Code019054
Result Code NamePDF
UofM
Result LOINC11502-2
Order Code196315
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc47527-7
Result Code191167
Result Code NamePhotomicrograph
UofM
Result LOINCN/A
Order Code196315
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc47527-7
Result Code019030
Result Code Name.
UofM
Result LOINCN/A
Order Code196315
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc47527-7
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
Reflex Table for .
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 507390 HPV, cobas high-risk 507390 HPV, cobas high-risk 59420-0
Reflex 1
Order Code507390
Order NameHPV, cobas high-risk
Result Code507390
Result NameHPV, cobas high-risk
UofM
Result LOINC59420-0