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Test ID HPVP Human Papillomavirus (HPV) DNA Detection with Genotyping, High Risk Types by PCR with Papanicolaou Smear Reflex, ThinPrep, Varies

Useful For

Screening for infection with high-risk (HR) human papillomavirus associated with the development of cervical cancer

 

Individual genotyping of HPV-16 and/or HPV-18, if present

 

This test is not recommended for evaluation of suspected sexual abuse.

 

This test is not intended for women who have undergone hysterectomy.

 

This test is not intended for use with samples other than those collected by a clinician using an endocervical brush or spatula and placed in the ThinPrep Pap test PreservCyt solution.

 

This test is not intended for use in determining the need for treatment (ie, excisional or ablative treatment of the cervix) in the absence of high-grade cervical dysplasia. Patients who are HPV16/18 positive should be monitored carefully for the development of high-grade cervical dysplasia according to current practice guidelines.

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
TPRCY HPV Cytology Reflex No No
TPSPC Physician Interp Screen No No

Testing Algorithm

When this test is ordered, human papillomavirus (HPV) with genotyping by polymerase chain reaction (PCR) will be performed. If the patient is ≥25 years old and HPV with genotyping by PCR is positive for other high-risk types and negative for types 16 and 18, then HPV cytology reflex test will be performed at an additional charge.

Method Name

HPCG: Real-Time Polymerase Chain Reaction (PCR)

TPRCY: Light Microscopy

Reporting Name

HPVG PCR w/ Pap Reflex, ThinPrep

Specimen Type

Varies


Necessary Information


An acceptable cytology request form must accompany specimen containers and include the following: Patient's name, medical record number, date of birth, sex, source (exact location and procedure used), date specimen was taken, name of ordering physician and pager number. Submit any pertinent history, clinical information, or date of last menstrual period.



Specimen Required


Original ThinPrep/PreservCyt collection vial is required for testing.

 

Only 1 aliquot may be removed from PreservCyt sample vial prior to performing the ThinPrep Pap Test, regardless of the volume of the aliquot (maximum aliquot volume=3 mL).

 

For optimal interpretation, Pap smears should be collected near the middle of the menstrual cycle. Avoid douching, lubricant use, and sexual intercourse for 24 hours prior to specimen collection.

 

Specimen source is required.

 

Submit only 1 of the following specimens:

 

Broom Collection Device:

Specimen Type: Cervical (endocervical or ectocervical)

Supplies: Thin Prep Media with Broom Kit (T056)

Container/Tube: ThinPrep/PreservCyt vial

Specimen Volume: 20 mL of solution in ThinPrep/PreservCyt vial

Collection Instructions:

1. Obtain adequate sampling from cervix using a broom-like collection device. If desired, use lukewarm water to warm and lubricate the speculum. Insert the central bristles of the broom into the endocervical canal deep enough to allow the shorter bristles to fully contact the ectocervix. Push gently and rotate the broom in a clockwise direction 5 times.

2. Rinse the broom as quickly as possible into the PreservCyt solution vial by pushing broom into bottom of vial 10 times, forcing the bristles apart.

3. As a final step, swirl broom vigorously to further release material. Discard the collection device.

4. Tighten cap on vial so that the torque line on the cap passes the torque line on the vial.

5. Specimen vial must be labeled with a minimum of 2 unique identifiers (patient's name and medical record number or date of birth).

6. Bag ThinPrep specimens individually as they have a tendency to leak during transport.

7. Place labels on the vial and on the bag.

 

Endocervical Brush/Spatula Collection Device:

Specimen Type: Ectocervix and endocervix

Supplies: Thin Prep Media with Spatula and Brush Kit (T434)

Container/Tube: ThinPrep/PreservCyt vial

Specimen Volume: 20 mL of solution in ThinPrep/PreservCyt vial

Collection Instructions:

1. Obtain an adequate sampling from the ectocervix using a plastic spatula. If desired, use lukewarm water to warm and lubricate the speculum. Select contoured end of plastic spatula and rotate it 360 degrees around the entire exocervix while maintaining tight contact with exocervical surface.

2. Rinse spatula as quickly as possible into the PreservCyt solution vial by swirling spatula vigorously in vial 10 times. Discard the spatula.

3. Next, obtain an adequate specimen from endocervix using an endocervical brush device. Insert the brush into the cervix until only the bottommost fibers are exposed. Slowly rotate 1/4 or 1/2 turn in one direction. Do not over-rotate.

4. Rinse the brush as quickly as possible in the PreservCyt solution by rotating the device in the solution 10 times while pushing against the PreservCyt vial wall.

5. Swirl brush vigorously as final step to further release material. Discard the brush.

6. Tighten the cap so that the torque line on the cap passes the torque line on the vial.

7. Specimen vial must be labeled with a minimum of 2 unique identifiers (patient's name and medical record number or date of birth).

8. Bag ThinPrep specimens individually as they have a tendency to leak during transport.

9. Place labels on the vial.


Specimen Minimum Volume

17 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Varies Ambient (preferred) 42 days
  Refrigerated  42 days

Reference Values

Human papillomavirus (HPV) with Genotyping polymerase chain reaction (PCR): Negative for HPV genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68

 

ThinPrep Pap Test: Satisfactory for evaluation. Negative for intraepithelial lesion or malignancy.

Day(s) Performed

Monday through Friday

Report Available

3 to 14 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information

87624

G0476 (if appropriate)

88142 (if appropriate)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
HPVP HPVG PCR w/ Pap Reflex, ThinPrep 71432-9

 

Result ID Test Result Name Result LOINC Value
SRCPV Specimen Source 31208-2
36402 HPV High Risk type 16, PCR 77399-4
36403 HPV High Risk type 18, PCR 77400-0
36404 HPV other High Risk types, PCR 71431-1
37310 Interpretation 59464-8

NY State Approved

Yes