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.
Forms
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-DiagnosticSpecimen Type
VariesSpecimen 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 daysPerforming Laboratory
Mayo Clinic Laboratories in RochesterTest 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 |