Test ID: 89118
ThinPrep Screen with HPV for Women 30 Years and Older
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
Detection of cervical carcinoma or intraepithelial lesions and the presence or absence of high-risk HPV when screening women over the age of 30 for possible cervical neoplasia
Reflex Tests Lists test(s) that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial test(s)
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| 82100 | Phys Interp of ThinPrep, PAP | No | No |
Additional Tests Lists test(s) that are always performed, at an additional charge, with the initial test(s)
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| 19167 | High Risk HPV DNA Detection | Yes, (order #83344) | Yes |
Testing Algorithm Delineates situation(s) when tests are added to the initial order. This includes reflex and additional tests.
When this test is ordered, a ThinPrep screen and high risk HPV DNA test will be performed. If ThinPrep Pap results are abnormal, a pathologist will review the case at an additional charge.
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
ThinPrep with Hybrid Capture/Nucleic Acid Hybridization/Signal Amplification
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
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 or sexual intercourse for 24 hours prior to specimen collection.
Submit only 1 of the following specimens:
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.
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.
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 majority (>99%) of cervical epithelial neoplasms are the result of human papillomavirus (HPV) infection. "High-risk'' HPV types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68) can result in both low-grade squamous intraepithelial lesions (LSIL) and high-grade squamous intraepithelial lesions (HSIL), as well as invasive carcinomas.(1,2) Patients with both a negative cytology and negative HPV have been shown to be at extremely low risk for cervical neoplasia.(1,2)
For women 30 years old and older who have received a negative Pap test and concurrent negative HPV result, the American Cancer Society (ACS) and American College of Obstetricians and Gynecologists (ACOG) recommendations for cervical screening state that physicians may lengthen the screening interval to 3 years when using the combined test. Patients deemed to be high-risk by the clinician should still be screened more frequently.
The presence of high risk HPV types in cervical specimens identifies a subgroup of patients with a greater likelihood of having a high grade squamous intraepithelial lesion. Current guidelines for follow up of a cytology-negative/HPV-positive patient recommend repeat HPV testing in 12 months.(2)
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.
ThinPrep PAP Test Screen:
Satisfactory for evaluation. Negative for intraepithelial lesion or malignancy.
High Risk HPV DNA Detection:
Negative for types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68
Interpretation Provides information to assist in interpretation of the test results
Cytology:
Standard reporting, as defined by the Bethesda System (TBS) is utilized.
HPV:
A positive HPV test result indicates the presence of 1 or more of the high-risk HPV types (16, 18, 31, 33, 35, 39, 45, 51, 52, 58, 59, or 68).
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
A negative HPV test or Pap smear result does not preclude the presence of carcinoma or intraepithelial lesion; false-negative rates of the Pap test range from 15% to 30%; the false-negative rate of the HPV test (Digene, Hybrid Capture II) is 1.1% to 7.5%.(1,4)
This test is not recommended for patients less than 30 years of age due to the transient nature of the HPV virus in younger patients; test 83342 ThinPrep Screen with Human Papillomavirus (HPV) Reflex is available for women under the age of 30 with pap tests diagnosed as ASCUS.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Lorincz AT, Richart RM: Human papillomavirus DNA testing as an adjunct to cytology in cervical screening programs. Arch Pathol Lab Med 2003 August;127(8):959-968
2. Wright TC, Jr, Schiffman M: Adding a test for human papillomavirus DNA to cervical-cancer screening. N Engl J Med 2003 February 6;348(6):489-490
3. Soloman D, Davey D, Kurman R, et al: The 2001 Bethesda System: terminology for reporting results of cervical cytology. JAMA 2002 April;287(16):2114-2119
4. Sherman ME, Lorincz A, Scott DR, et al: Baseline cytology, human papillomavirus testing, and risk for cervical neoplasia: a 10-year cohort analysis. J Nat Cancer Inst 2003 January;95(1):46-52
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.(ThinPrep 2000 System Operator's Manual, Cytyc, Marlboro, MA and ThinPrep 3000 Processor Operator's Manual, Cytyc, Marlboro, MA)
The Digene hc2 High-Risk HPV DNA Test using Hybrid Capture 2 (hc2) technology (Qiagen Inc.) is an In Vitro nucleic acid hybridization assay with signal amplification using microplate chemiluminescence for the qualitative detection of thirteen high-risk types of human papillomavirus (HPV) DNA in cervical specimens. The HPV types detected by the assay are the high-risk HPV types 16/18/31/33/35/39/45/51/52/56/58/59/68. The hc2 High-Risk HPV DNA Test cannot determine the specific HPV type present. Specimens containing the target DNA hybridize with a specific HPV RNA probe cocktail. The resultant RNA:DNA hybrid is captured onto the surface of a microplate well coated with antibodies specific for RNA:DNA hybrids. Immobilized hybrids are then reacted with antihybrid antibodies conjugated to alkaline phosphatase and detected with a chemiluminescent substrate. As the substrate is cleaved by the bound alkaline phosphatase, light is emitted, which is measured as relative light units (RLUs) on a luminometer. The intensity of the light is proportional to the amount of target DNA in the specimen.(Package insert: Digene Hybrid Capture 2 High-Risk HPV DNA Test, Qiagen Inc., Gaithersburg, MD 2007)
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.
ThinPrep Screen with HPV for Women 30 Years and Older
G0123 (Government payers)/ThinPrep Manual Screen
88142 (All other payers)/ThinPrep Manual Screen
Human Papillomavirus (HPV) Detection-High Risk Types
87621
Physician Interpretation of ThinPrep, PAP
G0124 (Government payers)/ (if appropriate)
88141 (All other payers)/ (if appropriate)
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 |
|---|---|---|
| 19795 | Accession Number | N/A |
| 19796 | Final Diagnosis | 22637-3 |
| 19797 | Cytotechnologist | In Process |
| 19798 | Revision Description | In Process |
| 19799 | Signing Pathologist | 19139-5 |
| 19800 | Specimen Description: | 33511-7 |
| 19801 | *Previous Report Follows* | N/A |
| 19802 | Addendum | 35265-8 |
| 19803 | Addendum Comment: | 22638-1 |
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