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


Ordering Guidance


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; order DTHPV / ThinPrep Diagnostic with Human Papillomavirus (HPV) Reflex, Varies for women, under the age of 30, with abnormal Pap smear 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).

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

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

 

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 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 and on the bag.


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

 

Detecting 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

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
TPDPC Physician Interp Diagnostic No No
VHPV HPV Vaginal Detect / Genotyping PCR Yes No
HPV HPV with Genotyping, PCR, ThinPrep Yes No

Testing Algorithm

When this test is ordered, a ThinPrep Pap cytology diagnostic and human papillomavirus high-risk DNA detection with genotyping by polymerase chain reaction 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/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

Interpretation

Cytology:

Standard reporting, as defined by the Bethesda System is utilized.

 

Human papillomavirus (HPV):

A positive result indicates the presence of HPV DNA due to 1 or more of the following genotypes: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68.

 

A negative result indicates the absence of HPV DNA of the targeted genotypes.

 

For patients with atypical squamous cells of undetermined significance (ASC-US) Pap smear result and who are positive for high-risk HPV (HR-HPV), consider referral for colposcopy, if clinically indicated.

 

For women aged 30 years and older with a negative Pap smear result, but who are positive for HPV-16 or HPV-18, consider referral for colposcopy, if clinically indicated.

 

For women aged 30 years and older with a negative Pap smear, positive HR-HPV test result, but who are negative for HPV-16 and HPV-18, consider repeat testing by both cytology and a HR-HPV test in 12 months.

Clinical Reference

1. Lorincz AT, Richart RM: Human papillomavirus DNA testing as an adjunct to cytology in cervical screening programs. Arch Pathol Lab Med. 2003 Aug;127(8):959-968

2. Wright TC Jr, Schiffman M: Adding a test for human papillomavirus DNA to cervical-cancer screening. N Engl J Med. 2003 Feb 6;348(6):489-490

3. Solomon D, Davey D, Kurman R, et al: The 2001 Bethesda System: terminology for reporting results of cervical cytology. JAMA. 2002 Apr 24;287(16):2114-2119

4. Saslow D, Solomon D, Lawson HW, et al: American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer. J Low Genit Tract Dis. 2012 Jul;16(3):175-204

5. Walboomers JM, Jacobs MV, Manos MM, et al: Human papillomavirus is a necessary cause of invasive cervical cancer worldwide. J Pathol. 1999 Sep;189(1):12-19

6. de Sanjose S, Quint WG, Alemany L, et al: Human papillomavirus genotype attribution in invasive cervical cancer: a retrospective cross-sectional worldwide study. Lancet Oncol. 2010 Nov;11(11):1048-1056

7. Wright TC Jr, Stoler MH, Sharma A, Zhang G, Behrens C, Wright TL: Evaluation of HPV-16 and HPV-18 genotyping for the triage of women with high-risk HPV positive, cytology-negative results. Am J Clin Pathol. 2011 Oct;136(4):578-586

8. Massad LS, Einstein MH, Huh WK, et al: 2012 updated consensus guidelines for the management of abnormal cervical cancer screening tests and cancer precursors. J Low Genit Tract Dis. 2013 Apr;17(5 Suppl 1):S1-S27

9. Sherman ME, Lorincz AT, Scott DR, et al: Baseline cytology, human papillomavirus testing, and risk for cervical neoplasia: a 10-year cohort analysis. J Nat Cancer Inst. 2003 Jan 1;95(1):46-52

Day(s) Performed

Monday through Friday

Report Available

5 to 8 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

88142

88141-TPDPC (if appropriate)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
DTPCO ThinPrep w/HPV Co-Test-Diagnostic 101822-5

 

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