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Test Code STHPV ThinPrep Screen with Human Papillomavirus (HPV) Reflex


Advisory Information


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



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

Management and triage of patients, age 21 or greater, with abnormal Pap results

 

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 and HPV-18, if present

 

Aids in triaging women with positive HR-HPV but negative Pap smear results

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
HPV HPV with Genotyping, PCR, ThinPrep Yes No
TPSPC Physician Interp Screen No No

Testing Algorithm

When this test is ordered, a ThinPrep Pap screen will be performed. If the results include the criteria below, a high-risk human papillomavirus test will be performed:

-Atypical cells of undetermined significance (ASCUS), and the patient is 21 years or older

-Atypical squamous cells, cannot exclude high-grade squamous intraepithelial lesion (ASC-H) and the patient is 21 years or older

-Low-grade squamous intraepithelial lesion (LSIL), and the patient is 50 years or older (RST)

-LSIL, and the patient is 25 years or older (ARZ)

-Inadequate endocervical/transformation zone component, negative for intraepithelial lesion or malignancy, and the patient is 30 years or older (RST)

 

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 HPV High-Risk DNA Detection with Genotyping by Real-Time Polymerase Chain Reaction

Reporting Name

ThinPrep Screen HPV Reflex

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.

Note: Abnormal results will be reviewed by a pathologist at an additional charge.

 

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
STHPV ThinPrep Screen HPV Reflex In Process

 

Result ID Test Result Name Result LOINC Value
71316 Interpretation In Process
71317 Participated in the Interpretation No LOINC Needed
71318 Report electronically signed by In Process
71319 Addendum In Process
71320 Gross Description In Process
CY017 Pap Test Source 19763-2
CY018 Clinical History In Process
CY019 Menstrual Status (LMP, PM, Pregnant) In Process
CY020 Hormone Therapy/Contraceptives In Process
71576 Disclaimer 62364-5
71822 Case Number In Process