Gynecologic Pap Test (Image-guided), Liquid-based Preparation and High-risk HPV (Cobas®) With HPV Genotypes 16 and 18 using SurePath™ specimen

CPT: 87624; 88175
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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

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.)


Expected Turnaround Time

3 - 7 days


Specimen Requirements


Specimen

Cervical cells in SurePath™ vial


Volume

Entire SurePath™ vial


Minimum Volume

Entire SurePath™ vial


Container

SurePath™ vial


Collection

SurePath™ vial - Using a cervical broom: 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.


Storage Instructions

Room temperature


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 patients. For Pap: liquid-based cytology specimen more than 21 days old. For HPV: specimen more than four weeks old in SurePath™ vial; excessively bloody specimens.


Test Details


Use

Diagnose primary or metastatic neoplasm. The HPV test specifically identifies types HPV16 and HPV18 while concurrently detecting the rest of the high-risk types 31,33,35,39,45,51,52,56,58,59,66, and 68, without further specific differentiation.


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.

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.


Methodology

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


LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
196190 IGP, cobasHPV16/18 191121 Test ordered: N/A
196190 IGP, cobasHPV16/18 191108 DIAGNOSIS: 47528-5
196190 IGP, cobasHPV16/18 191166 Interpretation 56850-1
196190 IGP, cobasHPV16/18 191170 Category: N/A
196190 IGP, cobasHPV16/18 191173 Recommendation: N/A
196190 IGP, cobasHPV16/18 191169 Infection: N/A
196190 IGP, cobasHPV16/18 191172 Adequacy: N/A
196190 IGP, cobasHPV16/18 191111 Recommendation: 19773-1
196190 IGP, cobasHPV16/18 191109 Specimen adequacy: 19764-0
196190 IGP, cobasHPV16/18 191154 Source: 19763-2
196190 IGP, cobasHPV16/18 191160 Clinician provided ICD9: 52797-8
196190 IGP, cobasHPV16/18 191174 Clinician provided ICD10: 52797-8
196190 IGP, cobasHPV16/18 191107 Clinical history: 22636-5
196190 IGP, cobasHPV16/18 191124 Amended report: N/A
196190 IGP, cobasHPV16/18 191110 Additional comment: 22638-1
196190 IGP, cobasHPV16/18 191125 Addendum: 22639-9
196190 IGP, cobasHPV16/18 191123 Maturation index: N/A
196190 IGP, cobasHPV16/18 191112 Performed by: 19767-3
196190 IGP, cobasHPV16/18 191128 QC reviewed by: N/A
196190 IGP, cobasHPV16/18 191145 Diagnosis provided by: N/A
196190 IGP, cobasHPV16/18 191113 Electronically signed by: 19769-9
196190 IGP, cobasHPV16/18 191139 Special procedure: N/A
196190 IGP, cobasHPV16/18 191129 Cytology history: N/A
196190 IGP, cobasHPV16/18 191179 Previous history: N/A
196190 IGP, cobasHPV16/18 191144 QA comment: N/A
196190 IGP, cobasHPV16/18 019018 . 11546-9
196190 IGP, cobasHPV16/18 191157 Pathologist provided ICD9: 52797-8
196190 IGP, cobasHPV16/18 191175 Pathologist provided ICD10: 52797-8
196190 IGP, cobasHPV16/18 190120 . N/A
196190 IGP, cobasHPV16/18 190109 Note: N/A
196190 IGP, cobasHPV16/18 000000 Test Methodology: 47527-7
196190 IGP, cobasHPV16/18 507386 HPV other hr types 71431-1
196190 IGP, cobasHPV16/18 507387 HPV 16 77399-4
196190 IGP, cobasHPV16/18 507388 HPV 18 77400-0
196190 IGP, cobasHPV16/18 191167 Photomicrograph N/A
196190 IGP, cobasHPV16/18 019030 . N/A
196190 IGP, cobasHPV16/18 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

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