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Test ID DTPCO ThinPrep with Human Papillomavirus (HPV) Co-Test-Diagnostic, Varies


Advisory Information


1. Mayo Clinic Laboratories' clients need prior laboratory approval to order Cytology testing.

2. Due to the transient nature of the human papillomavirus (HPV) in younger patients, this test is not recommended for patients younger than 30 years of age; DTHPV / ThinPrep Diagnostic with Human Papillomavirus (HPV) Reflex is available for women under the age of 30 with abnormal pap results.



Necessary Information


1. 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.

2. Submit any pertinent history or clinical information.



Specimen Required


Patient Preparation: For optimal interpretation, Papanicolaou smears should be collected near the middle of the menstrual cycle. No douching, lubricant use, and sexual intercourse for 24 hours prior to specimen collection.

 

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: 4 mL).

 

Submit only 1 of the following specimens:

 

Specimen Type: Cervical

Supplies: ThinPrep Media with Broom Kit (T056)

Collection Container/Tube: ThinPrep

Specimen Volume: 16 mL

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).

 

Specimen Type: Ectocervix and endocervix

Supplies: ThinPrep Media with Spatula and Brush Kit (T434)

Collection Container/Tube: ThinPrep

Specimen Volume: 16 mL

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 spatulas 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 one-quarter or one-half turn in 1 direction. Do not overrotate.

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).


Forms

Gyn-Cytology Patient Information sheet (T601) in Special Instructions

Useful For

Detection and diagnosis of cervical carcinoma or intraepithelial lesions and the presence or absence of high-risk human papillomavirus (HR-HPV) in women over age 30 at risk for cervical neoplasia

 

Detection of high-risk HPV genotypes associated with the development of cervical cancer

 

Aids in triaging women with abnormal Pap smear results

 

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

 

Aids in triaging women with positive HR-HPV 16 and 18, but negative Pap smear results

Additional Tests

Test ID Reporting Name Available Separately Always Performed
HPV HPV with Genotyping, PCR, ThinPrep Yes Yes

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
TPDPC Physician Interp Diagnostic No No

Testing Algorithm

When this test is ordered, a ThinPrep Pap cytology diagnostic and human papillomavirus high-risk DNA detection with genotyping by PCR test will be performed at an additional charge.

 

If ThinPrep Pap results are abnormal, a pathologist will review the case at an additional charge.

Special Instructions

Method Name

ThinPrep Pap Cytology Screening by Light Microscopy with Human Papillomavirus High-Risk DNA Detection with Genotyping by Real-Time Polymerase Chain Reaction

Reporting Name

ThinPrep w/HPV Co-Test-Diagnostic

Specimen Type

Varies

Specimen Minimum Volume

See Specimen Required

Specimen Stability Information

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

Reference Values

ThinPrep PAPANICOLAOU

Satisfactory for evaluation. Negative for intraepithelial lesion or malignancy.

 

HUMAN PAPILLOMAVIRUS (HPV)

Negative for HPV genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68

Day(s) and Time(s) Performed

Monday through Friday; Varies

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test has been cleared or approved by the U.S. 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

88142

88141-TPDPC (if appropriate)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
DTPCO ThinPrep w/HPV Co-Test-Diagnostic In Process

 

Result ID Test Result Name Result LOINC Value
71331 Interpretation 59465-5
71332 Participated in the Interpretation No LOINC Needed
71333 Report electronically signed by 19139-5
71334 Addendum 35265-8
71335 Gross Description 22634-0
CY002 Pap Test Source 19763-2
CY003 Clinical History 22636-5
CY004 Menstrual Status (LMP, PM, Pregnant) 8678-5
CY005 Hormone Therapy/Contraceptives 8659-5
71579 Disclaimer 62364-5
71825 Case Number 80398-1

NY State Approved

Yes