Test ID: 82039
ThinPrep Diagnostic Without Physician Interpretation
Secondary ID 
A test code used for billing and in test definitions created prior to November 2011
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Useful For Suggests clinical disorders or settings where the test may be helpful
Routine cytology screen for cervical abnormalities as an alternative to conventional Pap smears.
Special Instructions and Forms Describes specimen collection and preparation information, test algorithms, and other information pertinent to test. Also includes pertinent information and consent forms to be used when requesting a particular test
Method Name A short description of the method used to perform the test
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Aliases Lists additional common names for a test, as an aid in searching
TPRPD
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
For optimal interpretation, Pap smears should be collected near the middle of the menstrual cycle. No douching, lubricant use, or sexual intercourse for 24 hours prior to specimen collection.
Submit only 1 of the following specimens:
Specimen Type: Broom Collection Device
Container/Tube: Cervix broom (Supply T056)
Specimen Volume: Adequate specimen
Collection Instructions:
1.Specimen containers must be labeled with a minimum of 2 unique identifiers (patient’s name and clinic number).
2. Collect specimen from cervix.
3. Rinse broom in PreservCyt solution vial by pushing broom into bottom of vial 10 times forcing bristles apart.
4. As final step, swirl broom vigorously to further release material. Discard device.
5. Tighten cap on vial.
6. Record patient's name and identification number on vial.
Specimen Type: Endocervical Brush/Spatula Collection Device
Container/Tube: Plastic spatula and cytobrush (Supply T434)
Specimen Volume: Adequate specimen
Collection Instructions:
1. Specimen containers must be labeled with a minimum of 2 unique identifiers (patient’s name and clinic number).
2. Collect specimen from ectocervix and endocervix.
3. Rinse spatula in PreservCyt solution by swirling spatula vigorously into vial 10 times. Discard spatula.
4. Next, obtain specimen from endocervix using endocervical brush.
5. Rinse brush in PreservCyt vial by rotating brush 10 times while pushing against side of vial.
6. Swirl brush vigorously as final step to further release material. Discard brush.
7. Tighten cap on vial.
8. Record patient's name and identification number on vial.
Additional 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
3. This test is available only to Mayo Rochester and the Mayo Health System Clinics. All other Mayo Medical Laboratories clients need prior laboratory approval.
Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected
| Hemolysis | NA |
| Lipemia | NA |
| Icterus | NA |
| Other | NA |
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
| Specimen Type | Temperature | Time |
|---|---|---|
| Cervical | Ambient (preferred) | |
| Refrigerated | ||
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-base technique that replaces the direct smear method of the conventional Pap screen. This method is one of several new 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.
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 (TBS) is utilized.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
The ThinPrep PAP Test (TPPT) is a screen, not a diagnostic method. Abnormalities should be confirmed with clinical and tissue biopsy correlation.
Only up to 80% to 90% of cervical abnormalities can be identified by conventional Pap smear methods. Reports suggest that the TPPT will detect a higher proportion of abnormalities, but the detection rate will most likely not be greater than 90% to 95%. Therefore, a negative TPPT result does not preclude the presence of a cervical abnormality.
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 indeterminant 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 Provides recommendations for further in-depth reading of a clinical nature
1. Austin RM, Ramzey I: Increased detection of epithelial cell abnormalities by liquid-based gynecologic cytology preparations. A review of accumulated data. Acta Cytol 1998;42:178-184
2. Guidos BJ, Selvaggi SM: Use of the ThinPrep PAP test in clinical practice. Diagn Cytopathol 1999;20:70-73
3. Kurman RJ, Solomon D: The Bethesda system for reporting cervical/vaginal cytologic diagnoses: definitions, criteria, and explanatory notes for terminology and specimen adequacy. New York, NY, Springer-Verlag, 1994
4. Gay JD, Donaldson LD, Goellner JR: False-negative results in cervical cytologic studies. Acta Cytol 1985;29:1043-1046
Method Description Describes how the test is performed and provides a method-specific reference
The specimen is collected by the clinician by the usual methodology (spatula and brush, or broom) and is transferred to pre-packaged preservative-containing vials (PreserveCyt), rather than smearing directly onto glass slides. The entire vial is sent to the laboratory for processing on the ThinPrep 2000 processor. The automated processing includes mixing with a rotary device, suction filtration of a portion of the specimen (end point defined by a pressure sensor that detects material on the filter), and blot transfer to a glass slide. The slide is then removed from the processor and stained and coverslipped by usual methods.(ThinPrep Processor Overview. In ThinPrep Pap test training manual. Boxborough, Massachusetts: Cytyc, Inc. 1999, p 3)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Friday; Varies
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
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 The location of the laboratory that performs the test
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's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
88142
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
| Result ID | Reporting Name | LOINC Code |
|---|---|---|
| 19041 | Accession Number | N/A |
| 19042 | Final Diagnosis | 22637-3 |
| 19043 | Cytotechnologist | In Process |
| 19044 | Revision Description | In Process |
| 19045 | Signing Pathologist | 19139-5 |
| 19188 | Specimen Description: | 33511-7 |
| 19046 | *Previous Report Follows* | N/A |
| 19047 | Addendum | 35265-8 |
| 19191 | Addendum Comment: | 22638-1 |
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