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Test Code TPRPS ThinPrep Screen, Varies


Ordering Guidance


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

2. If the patient has been previously diagnosed with an abnormal Pap result or is at high risk, consider ordering the diagnostic test TPRPD / ThinPrep Diagnostic, Varies.

3. Specimen submitted as endocervical curettage or endocervical brushing need to be ordered as CYTNG / Cytology Non-Gynecologic, Varies.



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, and name of ordering physician and pager number.

2. Submit any pertinent history or clinical information.



Specimen Required


Patient Preparation: For optimal interpretation, Pap smears should be collected near the middle of the menstrual cycle. Avoid 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: Thin Prep Media with Broom Kit (T056)

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 to warm water 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: Thin Prep Media with Spatula and Brush Kit (T434)

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 to warm water 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 one 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.


Useful For

Screening for cervical carcinoma or intraepithelial lesions

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
TPSPC Physician Interp Screen No No

Testing Algorithm

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

Reporting Name

ThinPrep Screen

Specimen Type

Varies

Specimen 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

Clinical Information

The ThinPrep Pap test is an alternative preparation method for the cervical Pap screening test. The method utilizes a liquid-based technique that replaces the direct smear method of the conventional Pap screen. This method is one of several technologies developed to improve visualization of cellular material by reducing smearing trauma, air-drying artifact, and obscuring blood and inflammation. In addition, variability in smearing technique is eliminated as the majority of processing and preparation is performed in the laboratory under controlled conditions.

 

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 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.

Reference Values

Satisfactory for evaluation. Negative for intraepithelial lesion or malignancy.

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

Interpretation

Standard reporting, as defined by the Bethesda System is utilized.(1)

Cautions

The Pap test is a screening test for cervical cancer with inherent false-negative results. A negative human papillomavirus (HPV) test or Pap smear result does not preclude the presence of carcinoma or intraepithelial lesion. The false-negative rates of the Pap test range from 15% to 30%.

Method Description

The ThinPrep Pap specimen is processed on a T2000 or T3000 processor, producing a slide that is stained with a Papanicolaou stain. The stained slides are examined microscopically.(Instruction manuals: ThinPrep 2000 System, Cytyc, Marlboro, MA; ThinPrep 3000 Processor, Cytyc, Marlboro, MA)

Day(s) Performed

Monday through Friday

Report Available

5 to 8 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test 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

G0123 (Government Payers)

88142  

88141-TPSPC (if appropriate)

 

LOINC Code Information

Test ID Test Order Name Order LOINC Value
TPRPS ThinPrep Screen 47527-7

 

Result ID Test Result Name Result LOINC Value
71286 Interpretation 69965-2
71287 Participated in the Interpretation No LOINC Needed
71288 Report electronically signed by 19139-5
71289 Addendum 35265-8
71290 Gross Description 22634-0
CY027 Pap Test Source 22633-2
CY028 Clinical History 22636-5
CY029 Menstrual Status (LMP, PM, Pregnant) 8678-5
CY030 Hormone Therapy/Contraceptives 8659-5
71574 Disclaimer 62364-5
71820 Case Number 80398-1