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

Test Number 196335

CPT 88175

Test Details

Methodology

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

Result Turnaround Time

2 - 5 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.

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.

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.)

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.

Specimen Requirements

Specimen

Cervical cells in SurePath™ vial

Volume

Entire SurePath™ vial

Minimum Volume

Entire SurePath™ vial

Container

SurePath™ vial

Collection Instructions

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.

LOINC® Map

Order Code	Order Code Name	Result Code	Result Code Name	Result LOINC
196335	IGP, rfxcobasHPV16/18ASCU	191121	Test ordered:	N/A
196335	IGP, rfxcobasHPV16/18ASCU	191108	DIAGNOSIS:	47528-5
196335	IGP, rfxcobasHPV16/18ASCU	191166	Interpretation	19764-0
196335	IGP, rfxcobasHPV16/18ASCU	191170	Category:	N/A
196335	IGP, rfxcobasHPV16/18ASCU	191173	Recommendation:	N/A
196335	IGP, rfxcobasHPV16/18ASCU	191169	Infection:	N/A
196335	IGP, rfxcobasHPV16/18ASCU	191172	Adequacy:	N/A
196335	IGP, rfxcobasHPV16/18ASCU	191111	Recommendation:	19773-1
196335	IGP, rfxcobasHPV16/18ASCU	191109	Specimen adequacy:	19764-0
196335	IGP, rfxcobasHPV16/18ASCU	191154	Source:	19763-2
196335	IGP, rfxcobasHPV16/18ASCU	191160	Clinician provided ICD9:	52797-8
196335	IGP, rfxcobasHPV16/18ASCU	191174	Clinician provided ICD10:	52797-8
196335	IGP, rfxcobasHPV16/18ASCU	191107	Clinical history:	22636-5
196335	IGP, rfxcobasHPV16/18ASCU	191124	Amended report:	N/A
196335	IGP, rfxcobasHPV16/18ASCU	191110	Additional comment:	22638-1
196335	IGP, rfxcobasHPV16/18ASCU	191125	Addendum:	22639-9
196335	IGP, rfxcobasHPV16/18ASCU	191123	Maturation index:	N/A
196335	IGP, rfxcobasHPV16/18ASCU	191112	Performed by:	19767-3
196335	IGP, rfxcobasHPV16/18ASCU	191128	QC reviewed by:	N/A
196335	IGP, rfxcobasHPV16/18ASCU	191145	Diagnosis provided by:	N/A
196335	IGP, rfxcobasHPV16/18ASCU	191113	Electronically signed by:	19769-9
196335	IGP, rfxcobasHPV16/18ASCU	191139	Special procedure:	N/A
196335	IGP, rfxcobasHPV16/18ASCU	191129	Cytology history:	N/A
196335	IGP, rfxcobasHPV16/18ASCU	191179	Previous history:	N/A
196335	IGP, rfxcobasHPV16/18ASCU	191144	QA comment:	N/A
196335	IGP, rfxcobasHPV16/18ASCU	019018	.	11546-9
196335	IGP, rfxcobasHPV16/18ASCU	191157	Pathologist provided ICD9:	52797-8
196335	IGP, rfxcobasHPV16/18ASCU	191175	Pathologist provided ICD10:	52797-8
196335	IGP, rfxcobasHPV16/18ASCU	190120	.	N/A
196335	IGP, rfxcobasHPV16/18ASCU	190109	Note:	8251-1
196335	IGP, rfxcobasHPV16/18ASCU	000000	Test Methodology:	47527-7
196335	IGP, rfxcobasHPV16/18ASCU	190119	.	N/A
196335	IGP, rfxcobasHPV16/18ASCU	191167	Photomicrograph	N/A
196335	IGP, rfxcobasHPV16/18ASCU	019030	.	N/A
196335	IGP, rfxcobasHPV16/18ASCU	019031	Patient Counseling Report	N/A
Order Code	196335
Order Code Name	IGP, rfxcobasHPV16/18ASCU
Order Loinc
Result Code	191121
Result Code Name	Test ordered:
UofM
Result LOINC	N/A
Order Code	196335
Order Code Name	IGP, rfxcobasHPV16/18ASCU
Order Loinc
Result Code	191108
Result Code Name	DIAGNOSIS:
UofM
Result LOINC	47528-5
Order Code	196335
Order Code Name	IGP, rfxcobasHPV16/18ASCU
Order Loinc
Result Code	191166
Result Code Name	Interpretation
UofM
Result LOINC	19764-0
Order Code	196335
Order Code Name	IGP, rfxcobasHPV16/18ASCU
Order Loinc
Result Code	191170
Result Code Name	Category:
UofM
Result LOINC	N/A
Order Code	196335
Order Code Name	IGP, rfxcobasHPV16/18ASCU
Order Loinc
Result Code	191173
Result Code Name	Recommendation:
UofM
Result LOINC	N/A
Order Code	196335
Order Code Name	IGP, rfxcobasHPV16/18ASCU
Order Loinc
Result Code	191169
Result Code Name	Infection:
UofM
Result LOINC	N/A
Order Code	196335
Order Code Name	IGP, rfxcobasHPV16/18ASCU
Order Loinc
Result Code	191172
Result Code Name	Adequacy:
UofM
Result LOINC	N/A
Order Code	196335
Order Code Name	IGP, rfxcobasHPV16/18ASCU
Order Loinc
Result Code	191111
Result Code Name	Recommendation:
UofM
Result LOINC	19773-1
Order Code	196335
Order Code Name	IGP, rfxcobasHPV16/18ASCU
Order Loinc
Result Code	191109
Result Code Name	Specimen adequacy:
UofM
Result LOINC	19764-0
Order Code	196335
Order Code Name	IGP, rfxcobasHPV16/18ASCU
Order Loinc
Result Code	191154
Result Code Name	Source:
UofM
Result LOINC	19763-2
Order Code	196335
Order Code Name	IGP, rfxcobasHPV16/18ASCU
Order Loinc
Result Code	191160
Result Code Name	Clinician provided ICD9:
UofM
Result LOINC	52797-8
Order Code	196335
Order Code Name	IGP, rfxcobasHPV16/18ASCU
Order Loinc
Result Code	191174
Result Code Name	Clinician provided ICD10:
UofM
Result LOINC	52797-8
Order Code	196335
Order Code Name	IGP, rfxcobasHPV16/18ASCU
Order Loinc
Result Code	191107
Result Code Name	Clinical history:
UofM
Result LOINC	22636-5
Order Code	196335
Order Code Name	IGP, rfxcobasHPV16/18ASCU
Order Loinc
Result Code	191124
Result Code Name	Amended report:
UofM
Result LOINC	N/A
Order Code	196335
Order Code Name	IGP, rfxcobasHPV16/18ASCU
Order Loinc
Result Code	191110
Result Code Name	Additional comment:
UofM
Result LOINC	22638-1
Order Code	196335
Order Code Name	IGP, rfxcobasHPV16/18ASCU
Order Loinc
Result Code	191125
Result Code Name	Addendum:
UofM
Result LOINC	22639-9
Order Code	196335
Order Code Name	IGP, rfxcobasHPV16/18ASCU
Order Loinc
Result Code	191123
Result Code Name	Maturation index:
UofM
Result LOINC	N/A
Order Code	196335
Order Code Name	IGP, rfxcobasHPV16/18ASCU
Order Loinc
Result Code	191112
Result Code Name	Performed by:
UofM
Result LOINC	19767-3
Order Code	196335
Order Code Name	IGP, rfxcobasHPV16/18ASCU
Order Loinc
Result Code	191128
Result Code Name	QC reviewed by:
UofM
Result LOINC	N/A
Order Code	196335
Order Code Name	IGP, rfxcobasHPV16/18ASCU
Order Loinc
Result Code	191145
Result Code Name	Diagnosis provided by:
UofM
Result LOINC	N/A
Order Code	196335
Order Code Name	IGP, rfxcobasHPV16/18ASCU
Order Loinc
Result Code	191113
Result Code Name	Electronically signed by:
UofM
Result LOINC	19769-9
Order Code	196335
Order Code Name	IGP, rfxcobasHPV16/18ASCU
Order Loinc
Result Code	191139
Result Code Name	Special procedure:
UofM
Result LOINC	N/A
Order Code	196335
Order Code Name	IGP, rfxcobasHPV16/18ASCU
Order Loinc
Result Code	191129
Result Code Name	Cytology history:
UofM
Result LOINC	N/A
Order Code	196335
Order Code Name	IGP, rfxcobasHPV16/18ASCU
Order Loinc
Result Code	191179
Result Code Name	Previous history:
UofM
Result LOINC	N/A
Order Code	196335
Order Code Name	IGP, rfxcobasHPV16/18ASCU
Order Loinc
Result Code	191144
Result Code Name	QA comment:
UofM
Result LOINC	N/A
Order Code	196335
Order Code Name	IGP, rfxcobasHPV16/18ASCU
Order Loinc
Result Code	019018
Result Code Name	.
UofM
Result LOINC	11546-9
Order Code	196335
Order Code Name	IGP, rfxcobasHPV16/18ASCU
Order Loinc
Result Code	191157
Result Code Name	Pathologist provided ICD9:
UofM
Result LOINC	52797-8
Order Code	196335
Order Code Name	IGP, rfxcobasHPV16/18ASCU
Order Loinc
Result Code	191175
Result Code Name	Pathologist provided ICD10:
UofM
Result LOINC	52797-8
Order Code	196335
Order Code Name	IGP, rfxcobasHPV16/18ASCU
Order Loinc
Result Code	190120
Result Code Name	.
UofM
Result LOINC	N/A
Order Code	196335
Order Code Name	IGP, rfxcobasHPV16/18ASCU
Order Loinc
Result Code	190109
Result Code Name	Note:
UofM
Result LOINC	8251-1
Order Code	196335
Order Code Name	IGP, rfxcobasHPV16/18ASCU
Order Loinc
Result Code	000000
Result Code Name	Test Methodology:
UofM
Result LOINC	47527-7
Order Code	196335
Order Code Name	IGP, rfxcobasHPV16/18ASCU
Order Loinc
Result Code	190119
Result Code Name	.
UofM
Result LOINC	N/A
Order Code	196335
Order Code Name	IGP, rfxcobasHPV16/18ASCU
Order Loinc
Result Code	191167
Result Code Name	Photomicrograph
UofM
Result LOINC	N/A
Order Code	196335
Order Code Name	IGP, rfxcobasHPV16/18ASCU
Order Loinc
Result Code	019030
Result Code Name	.
UofM
Result LOINC	N/A
Order Code	196335
Order Code Name	IGP, rfxcobasHPV16/18ASCU
Order Loinc
Result Code	019031
Result Code Name	Patient Counseling Report
UofM
Result LOINC	N/A

Reflex Table for Test Methodology:
	Order Code	Order Name	Result Code	Result Name	Result LOINC
Reflex 1	192555	Change IG Pap to LB Pap	000000	LBP CPT Code Automation	47527-7
Reflex 1
Order Code	192555
Order Name	Change IG Pap to LB Pap
Result Code	000000
Result Name	LBP CPT Code Automation
UofM
Result LOINC	47527-7

Reflex Table for .
	Order Code	Order Name	Result Code	Result Name	Result LOINC
Reflex 1	507385	HPV, cobas high-risk/16/18	507386	HPV other hr types	71431-1
Reflex 1
Order Code	507385
Order Name	HPV, cobas high-risk/16/18
Result Code	507386
Result Name	HPV other hr types
UofM
Result LOINC	71431-1

Reflex Table for .
	Order Code	Order Name	Result Code	Result Name	Result LOINC
Reflex 1	507385	HPV, cobas high-risk/16/18	507387	HPV 16	77399-4
Reflex 1
Order Code	507385
Order Name	HPV, cobas high-risk/16/18
Result Code	507387
Result Name	HPV 16
UofM
Result LOINC	77399-4

Reflex Table for .
	Order Code	Order Name	Result Code	Result Name	Result LOINC
Reflex 1	507385	HPV, cobas high-risk/16/18	507388	HPV 18	77400-0
Reflex 1
Order Code	507385
Order Name	HPV, cobas high-risk/16/18
Result Code	507388
Result Name	HPV 18
UofM
Result LOINC	77400-0

Reflex Table for .
	Order Code	Order Name	Result Code	Result Name	Result LOINC
Reflex 1	507385	HPV, cobas high-risk/16/18	019054	PDF	11502-2
Reflex 1
Order Code	507385
Order Name	HPV, cobas high-risk/16/18
Result Code	019054
Result Name	PDF
UofM
Result LOINC	11502-2

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