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
Secondary ID
70338Useful 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
Specimen 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 |
Reject Due To
SurePath vial | Reject |
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.
Method Description
A ThinPrep Pap specimen is collected, processed on a T2000 or T5000 processor, and stained with a Pap stain. Cases are examined microscopically and those with appropriate cytologic diagnoses are referred for human papillomavirus (HPV) testing if the patient is 21 or older.(Instruction manuals: ThinPrep 2000 System Operator's Manual. Hologic; MAN-02585-001 Rev. 006, 02/2017; ThinPrep 5000 Processor Operator's Manual. Hologic; MAN-02203-001 Rev. 002, 2016)
The cobas HPV test targets and detects nucleic acid from the L1 region of the HPV genome using real-time polymerase chain reaction (PCR) technology. The cobas HPV test is used for the in vitro qualitative detection of 14 high-risk HPV types commonly associated with cervical cancer. The assay is able to specifically assess for the presence or absence of HPV genotypes 16 and 18, while concurrently detecting the remaining 12 high-risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68). The cobas HPV test is used in conjunction with the cobas 4800 System. The cobas 4800 System comprises the cobas x 480 instrument and cobas z 480 analyzer that fully automates the cobas HPV from sample extraction through amplification, detection, and data reduction.(Procedure manual and package insert: cobas HPV test. Roche Diagnostics; version 05641268001-01EN, 10/2018)
Day(s) Performed
Monday through Friday
Report Available
5 to 8 daysSpecimen Retention Time
14 days after report issuedPerforming Laboratory
Mayo Clinic Laboratories in RochesterCPT 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 |