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Gynecologic Pap Test (Image-guided), Liquid-based Preparation and Chlamydia/Gonococcus/Trichomonas, NAA and Human Papillomavirus (HPV) (Aptima®) With Reflex to HPV Genotypes 16 and 18,45

Test Number 199315
Test number copied
CPT 87491; 87591; 87624; 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 Documents

For more information, please view the literature below.

Aptima® HPV Assay: Helping you provide better patient care

Microbiology Specimen Collection and Transport Guide

Use

Diagnose primary or metastatic neoplasm; detect Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. 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 type. 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 types 16 and 18,45.

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 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 detects only the 14 most common high-risk HPV types. When reflex conditions are met, HPV type 16 and 18,45 testing is performed.

Testing for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis 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, Neisseria gonorrhoeae, and Trichomonas vaginalis testing.

Specimen Requirements

Specimen

Cervical cells in liquid-based cytology transport

Volume

ThinPrep® 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

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 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 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. 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. Specimens in ThinPrep® vials must be processed for testing within 21 days of collection for HPV. 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; specimen submitted on male patient; specimen submitted in a vial that expired according to the manufacturer's label; frozen specimen; SurePath™ vial. For Pap: liquid-based cytology specimen more than 21 days old. For HPV: specimen more than 21 days old in ThinPrep® vial. 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 collection swab.

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
199315 IGP,CtNgTv,Apt HPV,rfx16/18,45 47527-7 191121 Test ordered: N/A
199315 IGP,CtNgTv,Apt HPV,rfx16/18,45 47527-7 191108 DIAGNOSIS: 47528-5
199315 IGP,CtNgTv,Apt HPV,rfx16/18,45 47527-7 191166 Interpretation 19764-0
199315 IGP,CtNgTv,Apt HPV,rfx16/18,45 47527-7 191170 Category: N/A
199315 IGP,CtNgTv,Apt HPV,rfx16/18,45 47527-7 191173 Recommendation: N/A
199315 IGP,CtNgTv,Apt HPV,rfx16/18,45 47527-7 191169 Infection: N/A
199315 IGP,CtNgTv,Apt HPV,rfx16/18,45 47527-7 191172 Adequacy: N/A
199315 IGP,CtNgTv,Apt HPV,rfx16/18,45 47527-7 191111 Recommendation: 19773-1
199315 IGP,CtNgTv,Apt HPV,rfx16/18,45 47527-7 191109 Specimen adequacy: 19764-0
199315 IGP,CtNgTv,Apt HPV,rfx16/18,45 47527-7 191154 Source: 19763-2
199315 IGP,CtNgTv,Apt HPV,rfx16/18,45 47527-7 191160 Clinician provided ICD9: 52797-8
199315 IGP,CtNgTv,Apt HPV,rfx16/18,45 47527-7 191174 Clinician provided ICD10: 52797-8
199315 IGP,CtNgTv,Apt HPV,rfx16/18,45 47527-7 191107 Clinical history: 22636-5
199315 IGP,CtNgTv,Apt HPV,rfx16/18,45 47527-7 191124 Amended report: N/A
199315 IGP,CtNgTv,Apt HPV,rfx16/18,45 47527-7 191110 Additional comment: 22638-1
199315 IGP,CtNgTv,Apt HPV,rfx16/18,45 47527-7 191125 Addendum: 22639-9
199315 IGP,CtNgTv,Apt HPV,rfx16/18,45 47527-7 191123 Maturation index: N/A
199315 IGP,CtNgTv,Apt HPV,rfx16/18,45 47527-7 191112 Performed by: 19767-3
199315 IGP,CtNgTv,Apt HPV,rfx16/18,45 47527-7 191128 QC reviewed by: N/A
199315 IGP,CtNgTv,Apt HPV,rfx16/18,45 47527-7 191145 Diagnosis provided by: N/A
199315 IGP,CtNgTv,Apt HPV,rfx16/18,45 47527-7 191113 Electronically signed by: 19769-9
199315 IGP,CtNgTv,Apt HPV,rfx16/18,45 47527-7 191139 Special procedure: N/A
199315 IGP,CtNgTv,Apt HPV,rfx16/18,45 47527-7 191129 Cytology history: N/A
199315 IGP,CtNgTv,Apt HPV,rfx16/18,45 47527-7 191179 Previous history: N/A
199315 IGP,CtNgTv,Apt HPV,rfx16/18,45 47527-7 191144 QA comment: N/A
199315 IGP,CtNgTv,Apt HPV,rfx16/18,45 47527-7 019018 . 11546-9
199315 IGP,CtNgTv,Apt HPV,rfx16/18,45 47527-7 191157 Pathologist provided ICD9: 52797-8
199315 IGP,CtNgTv,Apt HPV,rfx16/18,45 47527-7 191175 Pathologist provided ICD10: 52797-8
199315 IGP,CtNgTv,Apt HPV,rfx16/18,45 47527-7 190120 . N/A
199315 IGP,CtNgTv,Apt HPV,rfx16/18,45 47527-7 190109 Note: 8251-1
199315 IGP,CtNgTv,Apt HPV,rfx16/18,45 47527-7 000000 Test Methodology: 47527-7
199315 IGP,CtNgTv,Apt HPV,rfx16/18,45 47527-7 507801 HPV Aptima 59420-0
199315 IGP,CtNgTv,Apt HPV,rfx16/18,45 47527-7 190135 HPV Genotype Reflex N/A
199315 IGP,CtNgTv,Apt HPV,rfx16/18,45 47527-7 186134 Chlamydia, Nuc. Acid Amp 50387-0
199315 IGP,CtNgTv,Apt HPV,rfx16/18,45 47527-7 186135 Gonococcus, Nuc. Acid Amp 50388-8
199315 IGP,CtNgTv,Apt HPV,rfx16/18,45 47527-7 188092 Trich vag by NAA 46154-1
199315 IGP,CtNgTv,Apt HPV,rfx16/18,45 47527-7 019054 PDF 11502-2
199315 IGP,CtNgTv,Apt HPV,rfx16/18,45 47527-7 191167 Photomicrograph N/A
199315 IGP,CtNgTv,Apt HPV,rfx16/18,45 47527-7 019030 . N/A
199315 IGP,CtNgTv,Apt HPV,rfx16/18,45 47527-7 019031 Patient Counseling Report N/A
Order Code199315
Order Code NameIGP,CtNgTv,Apt HPV,rfx16/18,45
Order Loinc47527-7
Result Code191121
Result Code NameTest ordered:
UofM
Result LOINCN/A
Order Code199315
Order Code NameIGP,CtNgTv,Apt HPV,rfx16/18,45
Order Loinc47527-7
Result Code191108
Result Code NameDIAGNOSIS:
UofM
Result LOINC47528-5
Order Code199315
Order Code NameIGP,CtNgTv,Apt HPV,rfx16/18,45
Order Loinc47527-7
Result Code191166
Result Code NameInterpretation
UofM
Result LOINC19764-0
Order Code199315
Order Code NameIGP,CtNgTv,Apt HPV,rfx16/18,45
Order Loinc47527-7
Result Code191170
Result Code NameCategory:
UofM
Result LOINCN/A
Order Code199315
Order Code NameIGP,CtNgTv,Apt HPV,rfx16/18,45
Order Loinc47527-7
Result Code191173
Result Code NameRecommendation:
UofM
Result LOINCN/A
Order Code199315
Order Code NameIGP,CtNgTv,Apt HPV,rfx16/18,45
Order Loinc47527-7
Result Code191169
Result Code NameInfection:
UofM
Result LOINCN/A
Order Code199315
Order Code NameIGP,CtNgTv,Apt HPV,rfx16/18,45
Order Loinc47527-7
Result Code191172
Result Code NameAdequacy:
UofM
Result LOINCN/A
Order Code199315
Order Code NameIGP,CtNgTv,Apt HPV,rfx16/18,45
Order Loinc47527-7
Result Code191111
Result Code NameRecommendation:
UofM
Result LOINC19773-1
Order Code199315
Order Code NameIGP,CtNgTv,Apt HPV,rfx16/18,45
Order Loinc47527-7
Result Code191109
Result Code NameSpecimen adequacy:
UofM
Result LOINC19764-0
Order Code199315
Order Code NameIGP,CtNgTv,Apt HPV,rfx16/18,45
Order Loinc47527-7
Result Code191154
Result Code NameSource:
UofM
Result LOINC19763-2
Order Code199315
Order Code NameIGP,CtNgTv,Apt HPV,rfx16/18,45
Order Loinc47527-7
Result Code191160
Result Code NameClinician provided ICD9:
UofM
Result LOINC52797-8
Order Code199315
Order Code NameIGP,CtNgTv,Apt HPV,rfx16/18,45
Order Loinc47527-7
Result Code191174
Result Code NameClinician provided ICD10:
UofM
Result LOINC52797-8
Order Code199315
Order Code NameIGP,CtNgTv,Apt HPV,rfx16/18,45
Order Loinc47527-7
Result Code191107
Result Code NameClinical history:
UofM
Result LOINC22636-5
Order Code199315
Order Code NameIGP,CtNgTv,Apt HPV,rfx16/18,45
Order Loinc47527-7
Result Code191124
Result Code NameAmended report:
UofM
Result LOINCN/A
Order Code199315
Order Code NameIGP,CtNgTv,Apt HPV,rfx16/18,45
Order Loinc47527-7
Result Code191110
Result Code NameAdditional comment:
UofM
Result LOINC22638-1
Order Code199315
Order Code NameIGP,CtNgTv,Apt HPV,rfx16/18,45
Order Loinc47527-7
Result Code191125
Result Code NameAddendum:
UofM
Result LOINC22639-9
Order Code199315
Order Code NameIGP,CtNgTv,Apt HPV,rfx16/18,45
Order Loinc47527-7
Result Code191123
Result Code NameMaturation index:
UofM
Result LOINCN/A
Order Code199315
Order Code NameIGP,CtNgTv,Apt HPV,rfx16/18,45
Order Loinc47527-7
Result Code191112
Result Code NamePerformed by:
UofM
Result LOINC19767-3
Order Code199315
Order Code NameIGP,CtNgTv,Apt HPV,rfx16/18,45
Order Loinc47527-7
Result Code191128
Result Code NameQC reviewed by:
UofM
Result LOINCN/A
Order Code199315
Order Code NameIGP,CtNgTv,Apt HPV,rfx16/18,45
Order Loinc47527-7
Result Code191145
Result Code NameDiagnosis provided by:
UofM
Result LOINCN/A
Order Code199315
Order Code NameIGP,CtNgTv,Apt HPV,rfx16/18,45
Order Loinc47527-7
Result Code191113
Result Code NameElectronically signed by:
UofM
Result LOINC19769-9
Order Code199315
Order Code NameIGP,CtNgTv,Apt HPV,rfx16/18,45
Order Loinc47527-7
Result Code191139
Result Code NameSpecial procedure:
UofM
Result LOINCN/A
Order Code199315
Order Code NameIGP,CtNgTv,Apt HPV,rfx16/18,45
Order Loinc47527-7
Result Code191129
Result Code NameCytology history:
UofM
Result LOINCN/A
Order Code199315
Order Code NameIGP,CtNgTv,Apt HPV,rfx16/18,45
Order Loinc47527-7
Result Code191179
Result Code NamePrevious history:
UofM
Result LOINCN/A
Order Code199315
Order Code NameIGP,CtNgTv,Apt HPV,rfx16/18,45
Order Loinc47527-7
Result Code191144
Result Code NameQA comment:
UofM
Result LOINCN/A
Order Code199315
Order Code NameIGP,CtNgTv,Apt HPV,rfx16/18,45
Order Loinc47527-7
Result Code019018
Result Code Name.
UofM
Result LOINC11546-9
Order Code199315
Order Code NameIGP,CtNgTv,Apt HPV,rfx16/18,45
Order Loinc47527-7
Result Code191157
Result Code NamePathologist provided ICD9:
UofM
Result LOINC52797-8
Order Code199315
Order Code NameIGP,CtNgTv,Apt HPV,rfx16/18,45
Order Loinc47527-7
Result Code191175
Result Code NamePathologist provided ICD10:
UofM
Result LOINC52797-8
Order Code199315
Order Code NameIGP,CtNgTv,Apt HPV,rfx16/18,45
Order Loinc47527-7
Result Code190120
Result Code Name.
UofM
Result LOINCN/A
Order Code199315
Order Code NameIGP,CtNgTv,Apt HPV,rfx16/18,45
Order Loinc47527-7
Result Code190109
Result Code NameNote:
UofM
Result LOINC8251-1
Order Code199315
Order Code NameIGP,CtNgTv,Apt HPV,rfx16/18,45
Order Loinc47527-7
Result Code000000
Result Code NameTest Methodology:
UofM
Result LOINC47527-7
Order Code199315
Order Code NameIGP,CtNgTv,Apt HPV,rfx16/18,45
Order Loinc47527-7
Result Code507801
Result Code NameHPV Aptima
UofM
Result LOINC59420-0
Order Code199315
Order Code NameIGP,CtNgTv,Apt HPV,rfx16/18,45
Order Loinc47527-7
Result Code190135
Result Code NameHPV Genotype Reflex
UofM
Result LOINCN/A
Order Code199315
Order Code NameIGP,CtNgTv,Apt HPV,rfx16/18,45
Order Loinc47527-7
Result Code186134
Result Code NameChlamydia, Nuc. Acid Amp
UofM
Result LOINC50387-0
Order Code199315
Order Code NameIGP,CtNgTv,Apt HPV,rfx16/18,45
Order Loinc47527-7
Result Code186135
Result Code NameGonococcus, Nuc. Acid Amp
UofM
Result LOINC50388-8
Order Code199315
Order Code NameIGP,CtNgTv,Apt HPV,rfx16/18,45
Order Loinc47527-7
Result Code188092
Result Code NameTrich vag by NAA
UofM
Result LOINC46154-1
Order Code199315
Order Code NameIGP,CtNgTv,Apt HPV,rfx16/18,45
Order Loinc47527-7
Result Code019054
Result Code NamePDF
UofM
Result LOINC11502-2
Order Code199315
Order Code NameIGP,CtNgTv,Apt HPV,rfx16/18,45
Order Loinc47527-7
Result Code191167
Result Code NamePhotomicrograph
UofM
Result LOINCN/A
Order Code199315
Order Code NameIGP,CtNgTv,Apt HPV,rfx16/18,45
Order Loinc47527-7
Result Code019030
Result Code Name.
UofM
Result LOINCN/A
Order Code199315
Order Code NameIGP,CtNgTv,Apt HPV,rfx16/18,45
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 HPV Genotype Reflex
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 507810 HPV Genotypes 16/18,45 507811 HPV Genotype 16 59263-4
Reflex 1
Order Code507810
Order NameHPV Genotypes 16/18,45
Result Code507811
Result NameHPV Genotype 16
UofM
Result LOINC59263-4
Reflex Table for HPV Genotype Reflex
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 507810 HPV Genotypes 16/18,45 507812 HPV Genotype 18,45 75694-0
Reflex 1
Order Code507810
Order NameHPV Genotypes 16/18,45
Result Code507812
Result NameHPV Genotype 18,45
UofM
Result LOINC75694-0
Reflex Table for HPV Genotype Reflex
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 507810 HPV Genotypes 16/18,45 507821 HPV Genotype 16/18,45 Tracking N/A
Reflex 1
Order Code507810
Order NameHPV Genotypes 16/18,45
Result Code507821
Result NameHPV Genotype 16/18,45 Tracking
UofM
Result LOINCN/A
Reflex Table for HPV Genotype Reflex
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 507810 HPV Genotypes 16/18,45 019054 PDF 11502-2
Reflex 1
Order Code507810
Order NameHPV Genotypes 16/18,45
Result Code019054
Result NamePDF
UofM
Result LOINC11502-2