Test Id : TPRPD
ThinPrep Diagnostic, Varies
Useful For
Suggests clinical disorders or settings where the test may be helpful
Detecting cervical carcinoma or intraepithelial lesions when screening women for possible cervical neoplasia
Reflex Tests
Lists tests that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial tests.
| Test Id | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| TPDPC | Physician Interp Diagnostic | No | No |
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
If ThinPrep Pap results are abnormal, a pathologist will review the case at an additional charge.
Method Name
A short description of the method used to perform the test
ThinPrep Pap Cytology Screening by Light Microscopy
NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.
Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test
Aliases
Lists additional common names for a test, as an aid in searching
Cervical Papanicolaou Smear, Diag
Liquid-Based Preparation (Pap Smear)
TPRPD
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
If ThinPrep Pap results are abnormal, a pathologist will review the case at an additional charge.
Specimen Type
Describes the specimen type validated for testing
Varies
Ordering Guidance
1. Mayo Clinic Laboratories' clients need prior laboratory approval to order cytology testing.
2. If the patient has not been previously diagnosed with an abnormal Pap result or is at high risk, consider ordering the screening test TPRPS / ThinPrep Screen, Varies.
3. Specimens 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, name of ordering physician and pager number.
2. Submit any pertinent history or clinical information.
ORDER QUESTIONS AND ANSWERS
| Question ID | Description | Answers |
|---|---|---|
| CY022 | Pap Smear Source |
Cervical/Endocervical Vaginal |
| CY023 | Clinical History | |
| CY024 | Menstrual Status(LMP, PM, Pregnant) | |
| CY025 | Hormone Therapy/Contraceptives |
None/Not known Oral Contraceptives Depoprovera IUD Hormone Replacement Therapy |
Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing
Patient Preparation: For optimal interpretation, Pap smears should be collected near the middle of the menstrual cycle. Avoid douching, lubricant use, or 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 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: 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 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 on 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.
Special Instructions
Library of PDFs including pertinent information and forms related to the test
Forms
Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.
See Specimen Required
Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected
| SurePath vial | Reject |
Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Varies | Ambient (preferred) | 42 days | THIN PREP |
| Refrigerated | 42 days | THIN PREP |
Useful For
Suggests clinical disorders or settings where the test may be helpful
Detecting cervical carcinoma or intraepithelial lesions when screening women for possible cervical neoplasia
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
If ThinPrep Pap results are abnormal, a pathologist will review the case at an additional charge.
Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
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
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
Satisfactory for evaluation. Negative for intraepithelial lesion or malignancy.
Note: Abnormal results will be reviewed by a pathologist at an additional charge.
Interpretation
Provides information to assist in interpretation of the test results
Standard reporting, as defined by the Bethesda System is utilized.(1)
Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
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%.
Supportive Data
Studies have shown overall increased adequacy (as measured by decreased "unsatisfactory" and "satisfactory but limited by" rates) as compared to the conventional smear method. Some studies showing increased detection rates for epithelial cell abnormalities (low-grade squamous intraepithelial lesions and high-grade squamous intraepithelial lesions) as well as decreased indeterminate rates (atypical squamous cells of undetermined significance and atypical glandular cells of undetermined significance) have been reported in both split specimen (ThinPrep and conventional smears) and direct-to-vial comparison studies.
Clinical Reference
Recommendations for in-depth reading of a clinical nature
1. Nayar R, Wilbur DC, eds The Bethesda System for Reporting Cervical Cytology: Definitions, Criteria, and Explanatory Notes. 3rd ed. Springer; 2015
2. Austin RM, Ramzey I: Increased detection of epithelial cell abnormalities by liquid-based gynecologic cytology preparations. A review of accumulated data. Acta Cytol. 1998 Feb;42(1):178-184
3. Guidos BJ, Selvaggi SM: Use of the ThinPrep Pap test in clinical practice. Diagn Cytopathol. 1999 Feb;20(2):70-73
4. Kurman RJ, Solomon D: The Bethesda System for Reporting Cervical/Vaginal Cytologic Diagnoses: Definitions, Criteria, and Explanatory Notes for Terminology and Specimen Adequacy. Springer-Verlag; 1994
5. Gay JD, Donaldson LD, Goellner JR: False-negative results in cervical cytologic studies. Acta Cytol. 1985 Nov-Dec;29(6):1043-1046
6. Saslow D, Solomon D, Lawson HW, et al: American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer. J Low Genit Tract Dis. 2012 Jul;16(3):175-204
Method Description
Describes how the test is performed and provides a method-specific reference
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)
PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information
Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.
Monday through Friday
Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.
Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location
Indicates the location of the laboratory that performs the test
Fees :
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.
- Authorized users can sign in to Test Prices for detailed fee information.
- Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
- Prospective clients should contact their account representative. For assistance, contact Customer Service.
Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.
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
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
CPT codes are provided by the performing laboratory.
CPT codes are provided by the performing laboratory.
88142
88141 (if appropriate)
LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.
| Test Id | Test Order Name | Order LOINC Value |
|---|---|---|
| TPRPD | ThinPrep Diagnostic | 47527-7 |
| Result Id | Test Result Name |
Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
|
|---|---|---|
| 71311 | Interpretation | 69965-2 |
| 71312 | Participated in the Interpretation | No LOINC Needed |
| 71313 | Report electronically signed by | 19139-5 |
| 71314 | Addendum | 35265-8 |
| 71315 | Gross Description | 22634-0 |
| CY022 | Pap Test Source | 22633-2 |
| CY023 | Clinical History | 22636-5 |
| CY024 | Menstrual Status (LMP, PM, Pregnant) | 8678-5 |
| CY025 | Hormone Therapy/Contraceptives | 8659-5 |
| 71575 | Disclaimer | 62364-5 |
| 71821 | Case Number | 80398-1 |