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HelpTest Code SOFT: Z0517 ThinPrep PAP Screen Reflex HPV>=21YR
Additional Codes
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Performing Laboratory
Mayo Clinic Laboratories in Rochester
Specimen Requirements
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:
Supplies: Thin Prep Media with Broom Kit (T056)
Specimen Type: Cervical
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).
Supplies: Thin Prep Media with Spatula and Brush Kit (T434)
Specimen Type: Ectocervix and endocervix
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).
Specimen Transport Temperature
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Specimen |
Temperature |
Time |
Special Container |
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Varies |
Ambient (preferred) |
42 days |
THIN PREP |
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Refrigerated |
42 days |
THIN PREP |
Reference Values
ThinPrep PAPANICOLAOU
Satisfactory for evaluation. Negative for intraepithelial lesion or malignancy.
Note: Abnormal results will be reviewed by a pathologist at an additional charge.
HUMAN PAPILLOMAVIRUS (HPV)
Negative for HPV genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68
Day(s) Test Set Up
Monday through Friday
Test Classification and CPT Coding
G0123
88142
88141- TPSPC (if appropriate)
Methodology
ThinPrep Pap Cytology Screening by Light Microscopy with HPV High-Risk DNA Detection with Genotyping by Real-Time Polymerase Chain Reaction
Method Description
A ThinPrep Pap specimen is collected, processed on a T2000 or T3000 processor, and stained with a Pap stain. Cases are examined microscopically and those with appropriate cytologic diagnoses are referred to the Virology Laboratory for human papillomavirus (HPV) testing if the patient is 21 or older.(Instruction manuals: ThinPrep 2000 System, Cytyc, Marlboro, MA; ThinPrep 3000 Processor, Cytyc, Marlboro, MA)
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.(Instruction manual and package insert: Cobas HPV test, Roche Diagnostics, Indianapolis, IN, version 05641268001-01EN)
Clinical Information
Squamous cell carcinoma of the cervix is believed to develop in progressive stages from normal through precancerous (dysplastic) stages, to carcinoma in situ, and eventually invasive carcinoma. This sequence is felt to develop over a matter of years in most patients.
Follow-up of the cervical Pap abnormality atypical squamous cells of undetermined significance (ASCUS) is costly and frustrating to patients and clinicians because a large percentage of these patients have normal colposcopic and biopsy findings. Yet, a significant percentage (10%-15%) will have an underlying high-grade squamous intraepithelial lesion (HSIL).
The majority (>99%) of cervical epithelial neoplasms are the result of human papillomavirus (HPV) infection. High-risk HPV (HR-HPV) types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68) can result in both low-grade squamous intraepithelial lesions and HSIL, as well as invasive carcinomas. Patients with HSIL have a greater risk for progression to carcinoma.
In the setting of an abnormal Pap result, the presence of HR-HPV types in cervical specimens identifies a subgroup of patients with a greater likelihood of having a HSIL.
If the patient has been previously diagnosed with an abnormal Pap result or is at high risk, considering ordering the diagnostic test: DTHPV / ThinPrep Diagnostic with Human Papillomavirus (HPV) Reflex, Varies rather than this screen.
Persistent infection with HPV is the principal cause of cervical cancer and its precursor cervical intraepithelial neoplasia (CIN).(1-3) The presence of HPV has been implicated in greater than 99% of cervical cancers worldwide. HPV is a small, nonenveloped, double-stranded DNA virus, with a genome of approximately 8,000 nucleotides. There are more than 118 different types of HPV and approximately 40 different HPVs that can infect the human anogenital mucosa. However, data suggest that 14 of these types (HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) are considered high-risk for the development of cervical cancer and its precursor lesions. Furthermore, HPV types 16 and 18 have been regarded as the genotypes most closely associated with progression to cervical cancer. HPV-16 is the most carcinogenic, and is associated with approximately 60% of all cervical cancers, while HPV-18 accounts for approximately 10% to 15% of cervical cancers.(4-6)
Although persistent infection with HR-HPV is necessary for the development of cervical cancer and its precursor lesions, only a very small percentage of infections progress to these disease states. Sexually transmitted infection with HPV is extremely common, with estimates of up to 75% of all women being exposed to HPV at some point. However, almost all infected women will mount an effective immune response and clear the infection within 2 years without any long-term health consequences. An infection with any HPV type can produce CIN although this also usually resolves once the HPV infection has been cleared.
In developed countries with cervical cancer screening programs, the Pap smear has been used since the mid-1950s as the primary tool to detect early precursors to cervical cancer. Although it has decreased the death rates due to cervical cancer dramatically in those countries, the Pap smear and subsequent liquid-based cytology methods require subjective interpretation by highly trained cytopathologists and misinterpretation can occur. Cytological abnormalities are primarily due to infection with HPV; however, various inflammatory conditions or sampling variations can result in false-positive cytology results. Triage of an abnormal cytology result may involve repeat testing, colposcopy and biopsy. A histologically confirmed high-grade lesion must be surgically removed or ablated in order to prevent the development of invasive cervical cancer.
Nucleic acid (DNA) testing by PCR has become a standard, noninvasive method for determining the presence of a cervical HPV infection. Proper implementation of nucleic acid testing for HPV may 1) increase the sensitivity of cervical cancer screening programs by detecting high-risk lesions earlier in women 30 years and older with normal cytology and 2) reduce the need for unnecessary colposcopy and treatment in patients 21 and older with cytology results showing atypical squamous cells of undetermined significance (ASC-US).
Recently, data suggest that individual genotyping for HPV types 16 and 18 can assist in determining appropriate follow-up testing and triaging women at risk for progression to cervical cancer. Studies have shown that the absolute risk of CIN-2 or worse in HPV-16 or HPV-18 positive women is 11.4% (95% confidence interval [CI] 8.4%-14.8%) compared with 6.1% (95% CI, 4.9%-7.2%) of women positive for other HR-HPV genotypes and 0.8% (95% CI, 0.3%-1.5%) in HR-HPV negative women.(7) Based in part on these data, the American Society for Colposcopy and Cervical Pathology (ASCCP) now recommends that HPV 16/18 genotyping be performed on women who are positive for HR-HPV but negative by routine cytology. Women who are found to be positive for HPV-16 or -18 may be referred to colposcopy, while women who are negative for genotypes 16 and 18 may have repeat cytology and HR-HPV testing in 12 months.(4)
Useful For
Management and triage of patients, age 21 or greater, with abnormal Pap results
Screening for detection of high-risk (HR) human papillomavirus (HPV) genotypes associated with the development of cervical cancer
Aids in triaging women with abnormal Pap smear results
Individual genotyping of HPV-16 and HPV-18, if present
Aids in triaging women with positive HR-HPV but negative Pap smear results