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Gynecologic Pap Test (Image-guided), Liquid-based Preparation With Reflex to Human Papillomavirus (HPV) (Aptima®) When ASC-U With Reflex to HPV Genotypes 16 and 18,45

CPT Call client services.

Test Details

Methodology

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

Result Turnaround Time

2 - 4 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

Use

Diagnose primary or metastatic neoplasm. This test aids in the diagnosis of sexually transmitted HPV infection and in the triage of patients with an ASCUS Pap test result. High-risk HPV test is used for types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. If the initial high-risk test is positive, then the residual specimen will be tested for HPV types 16 and 18,45; type 18 cannot be differentiated from type 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 type 18,45 testing is performed.

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.

Storage Instructions

Maintain specimen at room temperature. Specimens must be processed for testing within 21 days of collection for Pap.

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.

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
199340 IGP,rfx Apt HPV ASCU,16/18,45 191121 Test ordered: N/A
199340 IGP,rfx Apt HPV ASCU,16/18,45 191108 DIAGNOSIS: 47528-5
199340 IGP,rfx Apt HPV ASCU,16/18,45 191166 Interpretation 19764-0
199340 IGP,rfx Apt HPV ASCU,16/18,45 191170 Category: N/A
199340 IGP,rfx Apt HPV ASCU,16/18,45 191173 Recommendation: N/A
199340 IGP,rfx Apt HPV ASCU,16/18,45 191169 Infection: N/A
199340 IGP,rfx Apt HPV ASCU,16/18,45 191172 Adequacy: N/A
199340 IGP,rfx Apt HPV ASCU,16/18,45 191111 Recommendation: 19773-1
199340 IGP,rfx Apt HPV ASCU,16/18,45 191109 Specimen adequacy: 19764-0
199340 IGP,rfx Apt HPV ASCU,16/18,45 191154 Source: 19763-2
199340 IGP,rfx Apt HPV ASCU,16/18,45 191160 Clinician provided ICD9: 52797-8
199340 IGP,rfx Apt HPV ASCU,16/18,45 191174 Clinician provided ICD10: 52797-8
199340 IGP,rfx Apt HPV ASCU,16/18,45 191107 Clinical history: 22636-5
199340 IGP,rfx Apt HPV ASCU,16/18,45 191124 Amended report: N/A
199340 IGP,rfx Apt HPV ASCU,16/18,45 191110 Additional comment: 22638-1
199340 IGP,rfx Apt HPV ASCU,16/18,45 191125 Addendum: 22639-9
199340 IGP,rfx Apt HPV ASCU,16/18,45 191123 Maturation index: N/A
199340 IGP,rfx Apt HPV ASCU,16/18,45 191112 Performed by: 19767-3
199340 IGP,rfx Apt HPV ASCU,16/18,45 191128 QC reviewed by: N/A
199340 IGP,rfx Apt HPV ASCU,16/18,45 191145 Diagnosis provided by: N/A
199340 IGP,rfx Apt HPV ASCU,16/18,45 191113 Electronically signed by: 19769-9
199340 IGP,rfx Apt HPV ASCU,16/18,45 191139 Special procedure: N/A
199340 IGP,rfx Apt HPV ASCU,16/18,45 191129 Cytology history: N/A
199340 IGP,rfx Apt HPV ASCU,16/18,45 191179 Previous history: N/A
199340 IGP,rfx Apt HPV ASCU,16/18,45 191144 QA comment: N/A
199340 IGP,rfx Apt HPV ASCU,16/18,45 019018 . 11546-9
199340 IGP,rfx Apt HPV ASCU,16/18,45 191157 Pathologist provided ICD9: 52797-8
199340 IGP,rfx Apt HPV ASCU,16/18,45 191175 Pathologist provided ICD10: 52797-8
199340 IGP,rfx Apt HPV ASCU,16/18,45 190120 . N/A
199340 IGP,rfx Apt HPV ASCU,16/18,45 190109 Note: 8251-1
199340 IGP,rfx Apt HPV ASCU,16/18,45 000000 Test Methodology: 47527-7
199340 IGP,rfx Apt HPV ASCU,16/18,45 190119 . N/A
199340 IGP,rfx Apt HPV ASCU,16/18,45 019054 PDF 11502-2
199340 IGP,rfx Apt HPV ASCU,16/18,45 191167 Photomicrograph N/A
199340 IGP,rfx Apt HPV ASCU,16/18,45 019030 . N/A
199340 IGP,rfx Apt HPV ASCU,16/18,45 019031 Patient Counseling Report N/A
Order Code199340
Order Code NameIGP,rfx Apt HPV ASCU,16/18,45
Order Loinc
Result Code191121
Result Code NameTest ordered:
UofM
Result LOINCN/A
Order Code199340
Order Code NameIGP,rfx Apt HPV ASCU,16/18,45
Order Loinc
Result Code191108
Result Code NameDIAGNOSIS:
UofM
Result LOINC47528-5
Order Code199340
Order Code NameIGP,rfx Apt HPV ASCU,16/18,45
Order Loinc
Result Code191166
Result Code NameInterpretation
UofM
Result LOINC19764-0
Order Code199340
Order Code NameIGP,rfx Apt HPV ASCU,16/18,45
Order Loinc
Result Code191170
Result Code NameCategory:
UofM
Result LOINCN/A
Order Code199340
Order Code NameIGP,rfx Apt HPV ASCU,16/18,45
Order Loinc
Result Code191173
Result Code NameRecommendation:
UofM
Result LOINCN/A
Order Code199340
Order Code NameIGP,rfx Apt HPV ASCU,16/18,45
Order Loinc
Result Code191169
Result Code NameInfection:
UofM
Result LOINCN/A
Order Code199340
Order Code NameIGP,rfx Apt HPV ASCU,16/18,45
Order Loinc
Result Code191172
Result Code NameAdequacy:
UofM
Result LOINCN/A
Order Code199340
Order Code NameIGP,rfx Apt HPV ASCU,16/18,45
Order Loinc
Result Code191111
Result Code NameRecommendation:
UofM
Result LOINC19773-1
Order Code199340
Order Code NameIGP,rfx Apt HPV ASCU,16/18,45
Order Loinc
Result Code191109
Result Code NameSpecimen adequacy:
UofM
Result LOINC19764-0
Order Code199340
Order Code NameIGP,rfx Apt HPV ASCU,16/18,45
Order Loinc
Result Code191154
Result Code NameSource:
UofM
Result LOINC19763-2
Order Code199340
Order Code NameIGP,rfx Apt HPV ASCU,16/18,45
Order Loinc
Result Code191160
Result Code NameClinician provided ICD9:
UofM
Result LOINC52797-8
Order Code199340
Order Code NameIGP,rfx Apt HPV ASCU,16/18,45
Order Loinc
Result Code191174
Result Code NameClinician provided ICD10:
UofM
Result LOINC52797-8
Order Code199340
Order Code NameIGP,rfx Apt HPV ASCU,16/18,45
Order Loinc
Result Code191107
Result Code NameClinical history:
UofM
Result LOINC22636-5
Order Code199340
Order Code NameIGP,rfx Apt HPV ASCU,16/18,45
Order Loinc
Result Code191124
Result Code NameAmended report:
UofM
Result LOINCN/A
Order Code199340
Order Code NameIGP,rfx Apt HPV ASCU,16/18,45
Order Loinc
Result Code191110
Result Code NameAdditional comment:
UofM
Result LOINC22638-1
Order Code199340
Order Code NameIGP,rfx Apt HPV ASCU,16/18,45
Order Loinc
Result Code191125
Result Code NameAddendum:
UofM
Result LOINC22639-9
Order Code199340
Order Code NameIGP,rfx Apt HPV ASCU,16/18,45
Order Loinc
Result Code191123
Result Code NameMaturation index:
UofM
Result LOINCN/A
Order Code199340
Order Code NameIGP,rfx Apt HPV ASCU,16/18,45
Order Loinc
Result Code191112
Result Code NamePerformed by:
UofM
Result LOINC19767-3
Order Code199340
Order Code NameIGP,rfx Apt HPV ASCU,16/18,45
Order Loinc
Result Code191128
Result Code NameQC reviewed by:
UofM
Result LOINCN/A
Order Code199340
Order Code NameIGP,rfx Apt HPV ASCU,16/18,45
Order Loinc
Result Code191145
Result Code NameDiagnosis provided by:
UofM
Result LOINCN/A
Order Code199340
Order Code NameIGP,rfx Apt HPV ASCU,16/18,45
Order Loinc
Result Code191113
Result Code NameElectronically signed by:
UofM
Result LOINC19769-9
Order Code199340
Order Code NameIGP,rfx Apt HPV ASCU,16/18,45
Order Loinc
Result Code191139
Result Code NameSpecial procedure:
UofM
Result LOINCN/A
Order Code199340
Order Code NameIGP,rfx Apt HPV ASCU,16/18,45
Order Loinc
Result Code191129
Result Code NameCytology history:
UofM
Result LOINCN/A
Order Code199340
Order Code NameIGP,rfx Apt HPV ASCU,16/18,45
Order Loinc
Result Code191179
Result Code NamePrevious history:
UofM
Result LOINCN/A
Order Code199340
Order Code NameIGP,rfx Apt HPV ASCU,16/18,45
Order Loinc
Result Code191144
Result Code NameQA comment:
UofM
Result LOINCN/A
Order Code199340
Order Code NameIGP,rfx Apt HPV ASCU,16/18,45
Order Loinc
Result Code019018
Result Code Name.
UofM
Result LOINC11546-9
Order Code199340
Order Code NameIGP,rfx Apt HPV ASCU,16/18,45
Order Loinc
Result Code191157
Result Code NamePathologist provided ICD9:
UofM
Result LOINC52797-8
Order Code199340
Order Code NameIGP,rfx Apt HPV ASCU,16/18,45
Order Loinc
Result Code191175
Result Code NamePathologist provided ICD10:
UofM
Result LOINC52797-8
Order Code199340
Order Code NameIGP,rfx Apt HPV ASCU,16/18,45
Order Loinc
Result Code190120
Result Code Name.
UofM
Result LOINCN/A
Order Code199340
Order Code NameIGP,rfx Apt HPV ASCU,16/18,45
Order Loinc
Result Code190109
Result Code NameNote:
UofM
Result LOINC8251-1
Order Code199340
Order Code NameIGP,rfx Apt HPV ASCU,16/18,45
Order Loinc
Result Code000000
Result Code NameTest Methodology:
UofM
Result LOINC47527-7
Order Code199340
Order Code NameIGP,rfx Apt HPV ASCU,16/18,45
Order Loinc
Result Code190119
Result Code Name.
UofM
Result LOINCN/A
Order Code199340
Order Code NameIGP,rfx Apt HPV ASCU,16/18,45
Order Loinc
Result Code019054
Result Code NamePDF
UofM
Result LOINC11502-2
Order Code199340
Order Code NameIGP,rfx Apt HPV ASCU,16/18,45
Order Loinc
Result Code191167
Result Code NamePhotomicrograph
UofM
Result LOINCN/A
Order Code199340
Order Code NameIGP,rfx Apt HPV ASCU,16/18,45
Order Loinc
Result Code019030
Result Code Name.
UofM
Result LOINCN/A
Order Code199340
Order Code NameIGP,rfx Apt HPV ASCU,16/18,45
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
Reflex Table for .
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 507805 HPV, Aptima High 16/18,45 507801 HPV Aptima 59420-0
Reflex 1
Order Code507805
Order NameHPV, Aptima High 16/18,45
Result Code507801
Result NameHPV Aptima
UofM
Result LOINC59420-0
Reflex Table for .
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 507805 HPV, Aptima High 16/18,45 507801 HPV Aptima 59420-0
Reflex 1
Order Code507805
Order NameHPV, Aptima High 16/18,45
Result Code507801
Result NameHPV Aptima
UofM
Result LOINC59420-0
Reflex Table for .
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 507805 HPV, Aptima High 16/18,45 507801 HPV Aptima 59420-0
Reflex 1
Order Code507805
Order NameHPV, Aptima High 16/18,45
Result Code507801
Result NameHPV Aptima
UofM
Result LOINC59420-0
Reflex Table for .
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 507805 HPV, Aptima High 16/18,45 507801 HPV Aptima 59420-0
Reflex 1
Order Code507805
Order NameHPV, Aptima High 16/18,45
Result Code507801
Result NameHPV Aptima
UofM
Result LOINC59420-0
Reflex Table for .
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 507805 HPV, Aptima High 16/18,45 019054 PDF 11502-2
Reflex 1
Order Code507805
Order NameHPV, Aptima High 16/18,45
Result Code019054
Result NamePDF
UofM
Result LOINC11502-2