Gynecologic Pap Test (Image-guided), Liquid-based Preparation and High-risk HPV (Cobas®) With Reflex to HPV Genotypes 16 and 18

Test Number 196305

CPT 87624; 88175. If reflex testing is performed, concomitant CPT codes/charges will apply.

Test Details

Methodology

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

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

Cervical / Vaginal Specimens

Use

Diagnose primary or metastatic neoplasm. Diagnosis of sexually-transmitted HPV infection. The initial 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 Pap evaluation is within normal limits and the initial HPV test is positive, the specimen will be tested for high-risk HPV types 16 and 18. This information, together with the physician's assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. The results of this test are not intended to prevent women from proceeding to colposcopy.

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.

Specimen Requirements

Specimen

Cervical cells in ThinPrep® vial

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

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.

Storage Instructions

Maintain liquid-based cytology 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.

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 six months old in ThinPrep® vial; excessively bloody specimens.

References

American Society for Colposcopy and Cervical Pathology. HPV Genotyping Clinical Update. Hagerstown, Md: ASCCP; 2009:1-3.

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

LOINC® Map

Order Code	Order Code Name	Result Code	Result Code Name	Result LOINC
196305	IGP, cobasHPV, rfx16/18	191121	Test ordered:	N/A
196305	IGP, cobasHPV, rfx16/18	191108	DIAGNOSIS:	47528-5
196305	IGP, cobasHPV, rfx16/18	191166	Interpretation	19764-0
196305	IGP, cobasHPV, rfx16/18	191170	Category:	N/A
196305	IGP, cobasHPV, rfx16/18	191173	Recommendation:	N/A
196305	IGP, cobasHPV, rfx16/18	191169	Infection:	N/A
196305	IGP, cobasHPV, rfx16/18	191172	Adequacy:	N/A
196305	IGP, cobasHPV, rfx16/18	191111	Recommendation:	19773-1
196305	IGP, cobasHPV, rfx16/18	191109	Specimen adequacy:	19764-0
196305	IGP, cobasHPV, rfx16/18	191154	Source:	19763-2
196305	IGP, cobasHPV, rfx16/18	191160	Clinician provided ICD9:	52797-8
196305	IGP, cobasHPV, rfx16/18	191174	Clinician provided ICD10:	52797-8
196305	IGP, cobasHPV, rfx16/18	191107	Clinical history:	22636-5
196305	IGP, cobasHPV, rfx16/18	191124	Amended report:	N/A
196305	IGP, cobasHPV, rfx16/18	191110	Additional comment:	22638-1
196305	IGP, cobasHPV, rfx16/18	191125	Addendum:	22639-9
196305	IGP, cobasHPV, rfx16/18	191123	Maturation index:	N/A
196305	IGP, cobasHPV, rfx16/18	191112	Performed by:	19767-3
196305	IGP, cobasHPV, rfx16/18	191128	QC reviewed by:	N/A
196305	IGP, cobasHPV, rfx16/18	191145	Diagnosis provided by:	N/A
196305	IGP, cobasHPV, rfx16/18	191113	Electronically signed by:	19769-9
196305	IGP, cobasHPV, rfx16/18	191139	Special procedure:	N/A
196305	IGP, cobasHPV, rfx16/18	191129	Cytology history:	N/A
196305	IGP, cobasHPV, rfx16/18	191179	Previous history:	N/A
196305	IGP, cobasHPV, rfx16/18	191144	QA comment:	N/A
196305	IGP, cobasHPV, rfx16/18	019018	.	11546-9
196305	IGP, cobasHPV, rfx16/18	191157	Pathologist provided ICD9:	52797-8
196305	IGP, cobasHPV, rfx16/18	191175	Pathologist provided ICD10:	52797-8
196305	IGP, cobasHPV, rfx16/18	190120	.	N/A
196305	IGP, cobasHPV, rfx16/18	190109	Note:	8251-1
196305	IGP, cobasHPV, rfx16/18	000000	Test Methodology:	47527-7
196305	IGP, cobasHPV, rfx16/18	507390	HPV, cobas high-risk	59420-0
196305	IGP, cobasHPV, rfx16/18	190140	HPV Genotype Reflex	N/A
196305	IGP, cobasHPV, rfx16/18	019054	PDF	11502-2
196305	IGP, cobasHPV, rfx16/18	191167	Photomicrograph	N/A
196305	IGP, cobasHPV, rfx16/18	019030	.	N/A
196305	IGP, cobasHPV, rfx16/18	019031	Patient Counseling Report	N/A
Order Code	196305
Order Code Name	IGP, cobasHPV, rfx16/18
Order Loinc
Result Code	191121
Result Code Name	Test ordered:
UofM
Result LOINC	N/A
Order Code	196305
Order Code Name	IGP, cobasHPV, rfx16/18
Order Loinc
Result Code	191108
Result Code Name	DIAGNOSIS:
UofM
Result LOINC	47528-5
Order Code	196305
Order Code Name	IGP, cobasHPV, rfx16/18
Order Loinc
Result Code	191166
Result Code Name	Interpretation
UofM
Result LOINC	19764-0
Order Code	196305
Order Code Name	IGP, cobasHPV, rfx16/18
Order Loinc
Result Code	191170
Result Code Name	Category:
UofM
Result LOINC	N/A
Order Code	196305
Order Code Name	IGP, cobasHPV, rfx16/18
Order Loinc
Result Code	191173
Result Code Name	Recommendation:
UofM
Result LOINC	N/A
Order Code	196305
Order Code Name	IGP, cobasHPV, rfx16/18
Order Loinc
Result Code	191169
Result Code Name	Infection:
UofM
Result LOINC	N/A
Order Code	196305
Order Code Name	IGP, cobasHPV, rfx16/18
Order Loinc
Result Code	191172
Result Code Name	Adequacy:
UofM
Result LOINC	N/A
Order Code	196305
Order Code Name	IGP, cobasHPV, rfx16/18
Order Loinc
Result Code	191111
Result Code Name	Recommendation:
UofM
Result LOINC	19773-1
Order Code	196305
Order Code Name	IGP, cobasHPV, rfx16/18
Order Loinc
Result Code	191109
Result Code Name	Specimen adequacy:
UofM
Result LOINC	19764-0
Order Code	196305
Order Code Name	IGP, cobasHPV, rfx16/18
Order Loinc
Result Code	191154
Result Code Name	Source:
UofM
Result LOINC	19763-2
Order Code	196305
Order Code Name	IGP, cobasHPV, rfx16/18
Order Loinc
Result Code	191160
Result Code Name	Clinician provided ICD9:
UofM
Result LOINC	52797-8
Order Code	196305
Order Code Name	IGP, cobasHPV, rfx16/18
Order Loinc
Result Code	191174
Result Code Name	Clinician provided ICD10:
UofM
Result LOINC	52797-8
Order Code	196305
Order Code Name	IGP, cobasHPV, rfx16/18
Order Loinc
Result Code	191107
Result Code Name	Clinical history:
UofM
Result LOINC	22636-5
Order Code	196305
Order Code Name	IGP, cobasHPV, rfx16/18
Order Loinc
Result Code	191124
Result Code Name	Amended report:
UofM
Result LOINC	N/A
Order Code	196305
Order Code Name	IGP, cobasHPV, rfx16/18
Order Loinc
Result Code	191110
Result Code Name	Additional comment:
UofM
Result LOINC	22638-1
Order Code	196305
Order Code Name	IGP, cobasHPV, rfx16/18
Order Loinc
Result Code	191125
Result Code Name	Addendum:
UofM
Result LOINC	22639-9
Order Code	196305
Order Code Name	IGP, cobasHPV, rfx16/18
Order Loinc
Result Code	191123
Result Code Name	Maturation index:
UofM
Result LOINC	N/A
Order Code	196305
Order Code Name	IGP, cobasHPV, rfx16/18
Order Loinc
Result Code	191112
Result Code Name	Performed by:
UofM
Result LOINC	19767-3
Order Code	196305
Order Code Name	IGP, cobasHPV, rfx16/18
Order Loinc
Result Code	191128
Result Code Name	QC reviewed by:
UofM
Result LOINC	N/A
Order Code	196305
Order Code Name	IGP, cobasHPV, rfx16/18
Order Loinc
Result Code	191145
Result Code Name	Diagnosis provided by:
UofM
Result LOINC	N/A
Order Code	196305
Order Code Name	IGP, cobasHPV, rfx16/18
Order Loinc
Result Code	191113
Result Code Name	Electronically signed by:
UofM
Result LOINC	19769-9
Order Code	196305
Order Code Name	IGP, cobasHPV, rfx16/18
Order Loinc
Result Code	191139
Result Code Name	Special procedure:
UofM
Result LOINC	N/A
Order Code	196305
Order Code Name	IGP, cobasHPV, rfx16/18
Order Loinc
Result Code	191129
Result Code Name	Cytology history:
UofM
Result LOINC	N/A
Order Code	196305
Order Code Name	IGP, cobasHPV, rfx16/18
Order Loinc
Result Code	191179
Result Code Name	Previous history:
UofM
Result LOINC	N/A
Order Code	196305
Order Code Name	IGP, cobasHPV, rfx16/18
Order Loinc
Result Code	191144
Result Code Name	QA comment:
UofM
Result LOINC	N/A
Order Code	196305
Order Code Name	IGP, cobasHPV, rfx16/18
Order Loinc
Result Code	019018
Result Code Name	.
UofM
Result LOINC	11546-9
Order Code	196305
Order Code Name	IGP, cobasHPV, rfx16/18
Order Loinc
Result Code	191157
Result Code Name	Pathologist provided ICD9:
UofM
Result LOINC	52797-8
Order Code	196305
Order Code Name	IGP, cobasHPV, rfx16/18
Order Loinc
Result Code	191175
Result Code Name	Pathologist provided ICD10:
UofM
Result LOINC	52797-8
Order Code	196305
Order Code Name	IGP, cobasHPV, rfx16/18
Order Loinc
Result Code	190120
Result Code Name	.
UofM
Result LOINC	N/A
Order Code	196305
Order Code Name	IGP, cobasHPV, rfx16/18
Order Loinc
Result Code	190109
Result Code Name	Note:
UofM
Result LOINC	8251-1
Order Code	196305
Order Code Name	IGP, cobasHPV, rfx16/18
Order Loinc
Result Code	000000
Result Code Name	Test Methodology:
UofM
Result LOINC	47527-7
Order Code	196305
Order Code Name	IGP, cobasHPV, rfx16/18
Order Loinc
Result Code	507390
Result Code Name	HPV, cobas high-risk
UofM
Result LOINC	59420-0
Order Code	196305
Order Code Name	IGP, cobasHPV, rfx16/18
Order Loinc
Result Code	190140
Result Code Name	HPV Genotype Reflex
UofM
Result LOINC	N/A
Order Code	196305
Order Code Name	IGP, cobasHPV, rfx16/18
Order Loinc
Result Code	019054
Result Code Name	PDF
UofM
Result LOINC	11502-2
Order Code	196305
Order Code Name	IGP, cobasHPV, rfx16/18
Order Loinc
Result Code	191167
Result Code Name	Photomicrograph
UofM
Result LOINC	N/A
Order Code	196305
Order Code Name	IGP, cobasHPV, rfx16/18
Order Loinc
Result Code	019030
Result Code Name	.
UofM
Result LOINC	N/A
Order Code	196305
Order Code Name	IGP, cobasHPV, rfx16/18
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 HPV Genotype Reflex
	Order Code	Order Name	Result Code	Result Name	Result LOINC
Reflex 1	507395	HPV, cobas Genotypes 16/18	507387	HPV 16	77399-4
Reflex 1
Order Code	507395
Order Name	HPV, cobas Genotypes 16/18
Result Code	507387
Result Name	HPV 16
UofM
Result LOINC	77399-4

Reflex Table for HPV Genotype Reflex
	Order Code	Order Name	Result Code	Result Name	Result LOINC
Reflex 1	507395	HPV, cobas Genotypes 16/18	507388	HPV 18	77400-0
Reflex 1
Order Code	507395
Order Name	HPV, cobas Genotypes 16/18
Result Code	507388
Result Name	HPV 18
UofM
Result LOINC	77400-0

Reflex Table for HPV Genotype Reflex
	Order Code	Order Name	Result Code	Result Name	Result LOINC
Reflex 1	507395	HPV, cobas Genotypes 16/18	507455	HPV cobas Genotype16&18 Track	N/A
Reflex 1
Order Code	507395
Order Name	HPV, cobas Genotypes 16/18
Result Code	507455
Result Name	HPV cobas Genotype16&18 Track
UofM
Result LOINC	N/A

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