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Test Code STPCO ThinPrep with Human Papillomavirus (HPV) Co-Test-Screen


Advisory Information


1. Mayo Medical Laboratories' clients need prior laboratory approval to order cytology testing.

2. Due to the transient nature of the HPV virus in younger patients, this test is not recommended for patients under 30 years of age; STHPV / ThinPrep Screen 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:

 

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 1/4 or 1/2 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 of cervical carcinoma or intraepithelial lesions and the presence or absence of high-risk human papillomavirus (HR-HPV) when screening women over the age of 30 for possible cervical neoplasia

 

Human papillomavirus (HPV) testing detection of high-risk 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 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
TPSPC Physician Interp Screen No No

Testing Algorithm

When this test is ordered, a ThinPrep Pap cytology screen and human papillomavirus high-risk DNA detection with genotyping by PCR test will be performed. 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-Screen

Specimen Type

Varies

Specimen Minimum Volume

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).

Specimen Stability Information

Specimen Type Temperature Time
Varies Ambient (preferred) 42 days
  Refrigerated  42 days

Reject Due To

Hemolysis

NA

Lipemia

NA

Icterus

NA

Other

NA

Reference Values

ThinPrep PAP Test:

Satisfactory for evaluation. Negative for intraepithelial lesion or malignancy.

 

HPV Test:

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

Analytic Time

5 days

Performing Laboratory

Mayo Medical 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

G0123

88142

88141-TPSPC (if appropriate)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
STPCO ThinPrep w/HPV Co-Test-Screen In Process

 

Result ID Test Result Name Result LOINC Value
71326 Interpretation In Process
71327 Participated in the Interpretation No LOINC Needed
71328 Report electronically signed by In Process
71329 Addendum In Process
71330 Gross Description In Process
CY007 Pap Test Source 19763-2
CY008 Clinical History In Process
CY009 Menstrual Status (LMP, PM, Pregnant) In Process
CY010 Hormone Therapy/Contraceptives In Process
71578 Disclaimer 62364-5
71824 Case Number In Process